title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Study design | This study was a non-randomised controlled pilot trial conducted between September 2021 and December 2022. This study was approved by the University of Southern Queensland (USQ) Human Research Ethics Committee (ethics application number: H21REA052) and registered with Australia and New Zealand Clinical trial registry (ACTRN12622000063718). | PMC9944478 | ||
Participants | LUPUS, RHEUMATISM | Participants were recruited through advertisement within a tertiary hospital rheumatology department and the Lupus New South Wales (NSW) association. Following initial screening, those who met the inclusion criteria and signed consent were included in the study. Inclusion criteria were age ≥ 18 years, diagnosis of SLE according to the European League Against Rheumatism (EULAR) | PMC9944478 | |
Interventions | RPE | Participants in the exercise group underwent an 8 week, 2 days per week, 45 min, individually supervised telehealth exercise program. All sessions were conducted in real-time on Zoom (Zoom Video Communications, Inc, CA, USA) by an AEP (i.e. SF delivered one session per week, and a trained research assistant delivered one session per week). Exercise was performed at moderate intensity, with a rating of perceived exertion (RPE) between 3 and 4 out of 10, in accordance with the American College of Sports Medicine (ACSM) intensity guidelines, | PMC9944478 | |
Outcomes | Baseline and post-intervention testing were conducted by a blinded investigator (SW), also an AEP. Self-reported questionnaires were sent to the participants to complete, and exercise tests were conducted in real-time on Zoom. Data were stored electronically on a university password-secured OneDrive folder. | PMC9944478 | ||
Pain and fatigue | fatigue, pain | An 11-point scale (e.g. 0 = no pain to 10 = maximum pain) was used to measure participants’ self-reported resting pain and fatigue. Lower scores indicate less pain and fatigue (lower scores are better). This scale has been visually adapted from the 10-point Borg RPE scale, with good reliability (0.898) and correlation to the visual analogue scale (rs = 0.754, | PMC9944478 | |
Fatigue | fatigue, Fatigue | CHRONIC ILLNESS | The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) was used to measure self-reported fatigue. Functional Assessment of Chronic Illness Therapy Fatigue Scale is reliable (α > 0.95) and has been validated in SLE (ρ 0.81). | PMC9944478 |
Quality of life | The RAND 36-Item Health Survey (version 1.0) | PMC9944478 | ||
Lower body endurance | A 30-second sit-to-stand (30sSTS) test was used to measure lower body muscular endurance because of its reliability in telehealth (ICC 0.989), | PMC9944478 | ||
Lower body strength | STS | A five-time STS (5TSTS) was used to measure lower body muscular strength because of its reliability in telehealth (ICC 0.990), | PMC9944478 | |
Upper body endurance | A 30-second arm curl test (30sAC) was used to measure upper body muscular endurance because of its reliability in telehealth (ICC 0.992), | PMC9944478 | ||
Aerobic capacity | The 2 minute step test (2MST) was used to measure aerobic capacity because of its reliability in telehealth (ICC 0.999), | PMC9944478 | ||
Participant feedback | stroke | STROKE | Participants who completed the exercise program provided quantitative feedback about the telehealth-supervised exercise program via a face-validated questionnaire used by Galloway and colleagues in stroke,Post-intervention interview framework. | PMC9944478 |
Attendance | Attendance to the exercise intervention was calculated by taking the number of attended sessions as a percentage of the total number of scheduled sessions. | PMC9944478 | ||
Statistical analysis | The sample size was calculated using SF36 fatigue/energy domain results from Tench (2003) | PMC9944478 | ||
Results | PMC9944478 | |||
Participant characteristics | chronic illness, fatigue, pain | CHRONIC ILLNESS | Fifteen adults with SLE expressed interest in the study and were all eligible (control group Demographic characteristics and baseline data for the two groups.RHR: resting heart rate; Rpain: resting pain; Rfatigue: resting fatigue; FACIT-F: functional assessment of chronic illness therapy (fatigue measurement system); 5TSTS: five-time sit to stand test; 30sSTS: 30 s sit to stand test; 30sAC: 30 s bicep/arm curl test; 2MST: 2 min step test. | PMC9944478 |
Quantitative results | PMC9944478 | |||
Fatigue (FACIT-F) | There was no statistically significant difference between the exercise and control group ( | PMC9944478 | ||
Lower body strength (5TSTS) | There was no statistically significant difference between the exercise and control group for lower body strength ( | PMC9944478 | ||
Lower body endurance (30sSTS) | There was no statistically significant difference between the exercise and control group for lower body endurance ( | PMC9944478 | ||
Upper body endurance (30sAC) | There was no statistically significant difference between the exercise and control group for upper body endurance ( | PMC9944478 | ||
Aerobic capacity (2MST) | There was no statistically significant difference between the exercise and control group for aerobic capacity ( | PMC9944478 | ||
Participant feedback | Participants either strongly agreed or agreed that Zoom was easy to learn and use after the first few sessions. Participants strongly disagreed that they needed someone at home to help them use the system, strongly agreed they were able to use the system by themselves, and rated the audio and video quality as acceptable either all the time or most of the time. Feasibility of telehealth-supervised exercise was high; participants either strongly agreed or agreed they would use it again, were satisfied with the experience, felt safe, and would recommend telehealth to others with SLE. Over half of the participants strongly disagreed or disagreed that they would have preferred to do the exercise sessions on their own without telehealth supervision, and there were mixed responses about whether they would have preferred to go to a central venue instead. Participants strongly agreed or agreed that the exercise program had enough variety, was challenging enough to improve their strength, and that they had sufficient space to perform the exercises at home. The preferred dose parameters were 2 sessions/week (Quantitative feedback following the telehealth-supervised exercise program (Additional information: Note that only the responses that were selected by participants are included in this table for brevity. | PMC9944478 | ||
Attendance | UTI | Attendance to the exercise program was high (110/112, 98%), with two sessions missed: one due to general malaise, and the other due to a suspected UTI. | PMC9944478 | |
Qualitative results | PMC9944478 | |||
Discussion | stroke, fatigue | STROKE, DISEASE, RECRUITMENT | Our main qualitative and quantitative findings suggest that an individually telehealth-supervised exercise program was suitable to and well-accepted by adults with SLE. However, due to a limited number of participants and the possibility that they were more likely to be motivated to exercise and/or have more stable disease, results could exaggerate the true efficacy of the exercise program itself. Recruiting SLE participants was difficult because COVID-19 was of particular concern in Australia during the time of the study, and people with SLE may have been apprehensive about engaging in an exercise trial during this time. It is unclear why there was a lack of male recruitment; however, this is likely because more women have SLE.To our knowledge, this is the first study to explore telehealth-supervised exercise in SLE using a live video platform. A similar study using a live video to supervise people who have suffered a stroke found high levels of satisfaction with the delivery mode and a high likelihood of participants partaking in supervised telehealth sessions again,An important theme that emerged in our study was the ease and efficiency of exercising at home, with most participants valuing the convenience of not commuting to a centre-based venue. Galloway et al.Limitations of this study include low sample size, limiting the statistical credibility of quantitative and qualitative findings; limited number of validated assessments via telehealth, including the SLE disease activity index (SLEDAI) to measure the change in disease activity; non-randomised methodology; inherent lack of blinding; and short duration of exercise, limiting the potential for physiological adaptions.In this small, exploratory mixed-methods pilot study, we identified that individually supervised telehealth exercise was acceptable, feasible, and satisfying for adults with SLE during a pandemic lockdown. The intervention demonstrated a trend to improvement in perceived QOL, fatigue, and strength outcomes. Although we used data from a previous study to estimate the sample required, our study is underpowered. The effect sizes obtained are modest, and the results, although encouraging, need to be corroborated in a larger, confirmatory investigation, ideally undertaken without the confounding influence of a pandemic and lockdown so that there may be controlled comparison with face-to-face supervised exercise. We recommend that future telehealth-supervised studies include more SLE participants, longer exercise intervention duration, and adopt a randomised and longitudinal study design to measure long-term outcomes. | PMC9944478 |
ORCID iD | Stephanie Frade | PMC9944478 | ||
References | PMC9944478 | |||
Objectives | rheumatoid arthritis, RA-ILD | RHEUMATOID ARTHRITIS, INTERSTITIAL LUNG DISEASE, PULMONARY FIBROSIS | Some patients with rheumatoid arthritis develop interstitial lung disease (RA-ILD) that develops into progressive pulmonary fibrosis. We assessed the efficacy and safety of nintedanib versus placebo in patients with progressive RA-ILD in the INBUILD trial. | PMC10412475 |
Methods | reticular abnormality, fibrosing ILD, pulmonary fibrosis | PULMONARY FIBROSIS, TRACTION BRONCHIECTASIS | The INBUILD trial enrolled patients with fibrosing ILD (reticular abnormality with traction bronchiectasis, with or without honeycombing) on high-resolution computed tomography of >10% extent. Patients had shown progression of pulmonary fibrosis within the prior 24 months, despite management in clinical practice. Subjects were randomised to receive nintedanib or placebo. | PMC10412475 |
Results | In the subgroup of 89 patients with RA-ILD, the rate of decline in FVC over 52 weeks was −82.6 mL/year in the nintedanib group versus −199.3 mL/year in the placebo group (difference 116.7 mL/year [95% CI 7.4, 226.1]; nominal | PMC10412475 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s10067-023-06623-7. | PMC10412475 | ||
Keywords | PMC10412475 | |||
Introduction | rheumatoid arthritis, RA, ILD | RHEUMATOID ARTHRITIS, INTERSTITIAL LUNG DISEASE | Interstitial lung disease (ILD) may occur as a manifestation of rheumatoid arthritis (RA) [Disease-modifying anti-rheumatic drugs (DMARDs) and glucocorticoids are the standard of care for RA [ | PMC10412475 |
Methods | PMC10412475 | |||
Trial design | USUAL INTERSTITIAL PNEUMONIA | The INBUILD trial (NCT02999178) was a randomised, double-blind, placebo-controlled trial conducted in 15 countries [Patients were randomised to receive nintedanib 150 mg twice daily (bid) or placebo, stratified by fibrotic pattern on HRCT (usual interstitial pneumonia [UIP]-like fibrotic pattern or other fibrotic patterns [described in | PMC10412475 | |
Outcomes | We assessed the rate of decline in FVC (mL/year) over 52 weeks in all patients with RA-ILD, in subgroups of patients with RA-ILD based on high sensitivity C-reactive protein (hs-CRP) at baseline (<1 vs ≥1 mg/L; <3 vs ≥3 mg/L) and in patients with RA-ILD taking DMARDs and/or glucocorticoids at baseline. DMARDs were identified based on the WHO Drug Dictionary (version 19.MAR) standardised drug grouping with the addition of baricitinib and the exclusion of denosumab. Glucocorticoids were identified based on the WHO Drug Dictionary standardised drug grouping.We report the proportions of patients with RA-ILD with absolute and relative declines from baseline in FVC % predicted >10% at week 52. We also analysed the times to first acute exacerbation (defined in [ | PMC10412475 | ||
Analyses | REGRESSION | Analyses were based on data from patients who received ≥1 dose of trial drug. The rate of decline in FVC (mL/year) over 52 weeks was analysed in patients with RA-ILD using a random coefficient regression model (with random slopes and intercepts) including baseline FVC (mL), HRCT pattern (UIP-like fibrotic pattern or other fibrotic patterns) and treatment, and treatment-by-time and baseline-by-time interactions. Subgroup analyses used the same model but with interaction terms for baseline-by-time, treatment-by-subgroup, and treatment-by-subgroup-by-time interaction. In subgroups by CRP at baseline, the interaction | PMC10412475 | |
Results | PMC10412475 | |||
Patients | RA, RA-ILD | Of 663 patients in the INBUILD trial, 89 (13.4%) had RA-ILD. The RA diagnosis was confirmed by a rheumatologist in 83 of the 84 patients for whom these data were available. The baseline characteristics of the patients with RA-ILD have been described [ | PMC10412475 | |
Exposure to medications | Median exposure to trial drug over the whole trial was 17.4 months in both groups. Based on medications taken at baseline, during treatment with trial drug, or following discontinuation of trial drug, the immunomodulatory therapies that were restricted at baseline were taken by higher proportions of patients in the placebo group than in the nintedanib group (Online Resource | PMC10412475 | ||
Acute exacerbations, hospitalisations, progression of ILD, and death | EVENT | Time to event endpoints over the whole trial are shown in Table | PMC10412475 | |
Safety and tolerability | diarrhoea | ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT | The most common adverse event reported in these patients with RA-ILD was diarrhoea, which was reported in 61.9% of patients in the nintedanib group and 27.7% of patients in the placebo group (Table Adverse events in patients with RA-ILD in the INBUILD trialBased on adverse events reported between first trial drug intake and 28 days after last trial drug intake. Median exposure to trial drug was 17.4 months in both groups. Adverse events were coded based on preferred terms in MedDRA version 22.0. | PMC10412475 |
Discussion | fibrosing RA-ILD, RA, IPF, inflammation | ADVERSE EVENTS, DISEASE PROGRESSION, ADVERSE EVENT, INFLAMMATION | These data from the INBUILD trial show that nintedanib reduced the rate of decline in FVC over 52 weeks in patients with progressive fibrosing RA-ILD by 59% compared with placebo, similar to the relative treatment effect observed in the overall trial population [Decline in FVC in patients with ILDs is reflective of disease progression and is associated with mortality [CRP is a marker of inflammation [Acute exacerbations associated with high morbidity and mortality are a feature of the natural history of IPF [The adverse event profile of nintedanib in patients with RA-ILD in the INBUILD trial was consistent with observations in the overall trial population [DMARDs are an important part of the management of patients with RA, according to international management guidelines [Strengths of our analyses include the randomised placebo-controlled trial design, with standardised reporting of outcomes and adverse events. Limitations include that the INBUILD trial was not designed or powered to study individual ILDs and the number of patients with RA-ILD was small, limiting the potential for subgroup analyses including those based on concomitant medication use. There are no adequately validated patient-reported outcomes for assessing changes in symptoms or quality of life due to worsening of RA-ILD. Data on RA disease activity were not collected. | PMC10412475 |
Conclusions | fibrosing RA-ILD | ADVERSE EVENTS | In the INBUILD trial, nintedanib slowed the rate of decline in FVC in patients with progressive fibrosing RA-ILD, with adverse events that were largely manageable. The efficacy and safety of nintedanib in these patients were consistent with the overall trial population. | PMC10412475 |
Acknowledgements | We thank the patients who participated in the INBUILD trial. | PMC10412475 | ||
Author contribution | HM, LM, and MK contributed to the study conception and design. MK contributed to data collection. HM conducted the data analysis. All authors were involved in interpretation of the data and the writing and critical review of the manuscript. All authors and read and approved the final manuscript. | PMC10412475 | ||
Funding | The INBUILD trial was supported by Boehringer Ingelheim International GmbH (BI). The authors did not receive payment for development of this manuscript. Writing assistance was provided by Elizabeth Ng and Wendy Morris of FleishmanHillard, London, UK, which was contracted and funded by BI. | PMC10412475 | ||
Data availability | To ensure independent interpretation of clinical study results and enable authors to fulfill their role and obligations under the ICMJE criteria, Boehringer Ingelheim grants all external authors access to relevant clinical study data. In adherence with the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete and other criteria are met. Researchers should use | PMC10412475 | ||
Compliance with ethical standards | PMC10412475 | |||
Ethics approval | The INBUILD trial was conducted in accordance with the protocol, the principles of the Declaration of Helsinki, and the Harmonised Tripartite Guideline for Good Clinical Practice from the International Conference on Harmonisation and was approved by local authorities. | PMC10412475 | ||
Consent to participate | Written informed consent was obtained from all patients before study entry. | PMC10412475 | ||
Consent for publication | All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. | PMC10412475 | ||
Competing Interests | Arthritis, Musculoskeletal | ARTHRITIS, SKIN DISEASES | Eric L Matteson reports royalties from UpToDate; consulting fees from Alvotech and Boehringer Ingelheim (BI); fees for speaking from BI and Practice Point Communications; has participated on Data Safety Monitoring Boards or Advisory Boards for Horizon Therapeutics and the National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); has served on a Committee/Task Force for the American College of Rheumatology. Martin Aringer reports consulting fees for advisory boards and fees for lectures from BI and Roche. Gerd R Burmester reports consulting fees from and has served on speakers’ bureaus for AbbVie, Bristol Myers Squibb, BI, Gilead, Lilly, Merck Sharpe and Dohme, Pfizer, Sanofi, Roche. Heiko Mueller and Lizette Moros are employees of BI. Martin Kolb reports research funding from BI, Pieris and Roche; consulting fees from AbbVie, Algernon, Bellerophon, BI, Cipla, CSL Behring, Horizon, LabCorp, Roche, ShouTi, United Therapeutics; fees for speaking from BI, Novartis, Roche; payment for expert testimony from Roche; has participated on Data Safety Monitoring Boards or Advisory Boards for LabCorp and United Therapeutics; and receives an allowance as Chief Editor of the | PMC10412475 |
References | PMC10412475 | |||
Background | OSA, preeclampsia | HIGH-RISK PREGNANCY, OBSTRUCTIVE SLEEP APNEA, PREECLAMPSIA | Obstructive sleep apnea (OSA) during pregnancy is a risk factor for preeclampsia possibly through a link to placental physiology. This study evaluates the efficacy of continuous positive airway pressure (CPAP) on the modulation of blood pressure and the reduction in preeclampsia in women with high-risk pregnancy and OSA. | PMC10294320 |
Methods | obesity, gestational diabetes, OSA, respiratory disturbance, preeclampsia, diabetes | OBESITY, GESTATIONAL DIABETES, HYPERTENSION, PREECLAMPSIA, DIABETES | A multicenter open-label, randomized controlled trial comparing CPAP treatment versus usual antenatal care was conducted in three academic hospitals in Bangkok, Thailand. Participants included singleton pregnant women aged older than 18 years with any high-risk condition (i.e., chronic hypertension, obesity, history of preeclampsia or gestational diabetes in the previous pregnancy, or diabetes), and OSA (respiratory disturbance index 5–29.99 events/hour by polysomnography), who presented either in the first trimester (gestational age, GA 0–16 weeks) or subsequently developed OSA during the 2nd trimester (GA 24–28 weeks). The primary endpoint was blood pressure during antenatal care. Secondary endpoints included the incidence of preeclampsia. An intention-to-treat analysis was performed with additional per-protocol and counterfactual analyses for handling of nonadherence. | PMC10294320 |
Results | Of 340 participants, 96.5% were recruited during the first trimester. Thirty participants were later excluded leaving 153 and 157 participants in the CPAP and usual-care groups for the modified-intention-to-treat analysis. CPAP adherence rate was 32.7% with average use of 2.5 h/night. Overall, CPAP treatment significantly lowered diastolic blood pressure (DBP) by − 2.2 mmHg [95% CI (− 3.9, − 0.4), | PMC10294320 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12931-023-02445-y. | PMC10294320 | ||
Keywords | PMC10294320 | |||
Background | oxygen desaturation, OSA, Preeclampsia, arousals, reduction of blood pressure | COLLAPSE, PREECLAMPSIA, ENDOTHELIAL DYSFUNCTION | Preeclampsia is a leading cause of maternal and fetal morbidity and mortality [OSA is characterized by repetitive upper airway collapse during sleep leading to apneas/hypopneas, causing oxygen desaturation, arousals, sympathetic activation, and endothelial dysfunction [Although, continuous positive airway pressure (CPAP) is a standard treatment for OSA in general population [CPAP treatment, with the elimination of airflow limitation in preeclamptic women, resulted in significant reduction of blood pressure (BP) [ | PMC10294320 |
Methods | PMC10294320 | |||
Study design and oversight | We conducted a multicenter, open-label, parallel-group RCT at three academic hospitals in Bangkok, Thailand. Methodologic details of the design and analysis plan have been registered via ClinicalTrial.gov (NCT03356106) and are provided in the full protocol in the supplement (the Additional file | PMC10294320 | ||
Patients and procedures | obesity, hypopneas, chronic infection, cardiac or kidney disease, oxygen desaturation, OSA, hypertension, preeclampsia | OBESITY, CHRONIC INFECTION, THYROID DISEASE, HIV INFECTION, TUBERCULOSIS, NEUROMUSCULAR DISEASE, GESTATIONAL HYPERTENSION, SLEEP; APNEA, HYPERTENSION, PREECLAMPSIA | Pregnant women attending antenatal care at all collaborating hospitals were recruited for OSA screening if they met all of the following inclusion criteria: (1) singleton high-risk pregnant woman aged > 18 years without significant medical conditions (separate from those used as inclusion criteria), including immunocompromised status, chronic infection (HIV infection, or tuberculosis), chronic lung, cardiac or kidney disease, thyroid disease, or neuromuscular disease; (2) gestational age (GA) < 16 weeks for 1st-trimester, or GA 24–28 weeks for 2nd trimester; and (3) Thai nationality, proficient in Thai language. High-risk pregnancy was defined as any of the following: (a) chronic hypertension defined by preexisting-hypertension or hypertension diagnosed before 20 weeks’ gestation; (b) history of preeclampsia or gestational hypertension in the previous pregnancy; (c) obesity defined by pre-pregnancy body mass index (BMI) ≥ 27.5 kg/mSleep stages and respiratory scorings were performed according to the American Academy of Sleep Medicine (AASM) 2012 guidelines [RDI was defined as a number of apneas, hypopneas, and RERA per hour of sleep; apnea–hypopnea index (AHI) was calculated as a number of apneas and hypopneas per hour of sleep [Exclusion criteria included: (1) severe OSA (RDI ≥ 30 events/hour) or significant oxygen desaturation < 80% during sleep; or (2) known OSA currently on CPAP treatment. For ethical reasons, CPAP treatment was offered to severe cases due to potential harms to the mother and fetus and the possible benefit of treatment. | PMC10294320 |
Randomization and interventions | Randomization was stratified by trimesters with varying block sizes of 4–8. After each participant agreed to participate and signed informed consent, clinical data were entered into a centralized computer system for automatic randomization sequence generation and subsequent immediate allocation. Participants receiving CPAP initiated treatment nightly until delivery. An auto-adjusted CPAP (auto-CPAP: Phillips-Respironics REMstarAutoM®/Dreamstation®) with heated-humidification delivered via nasal mask was used throughout pregnancy with pressure range between 4 and 15 cmH | PMC10294320 | ||
Study measurements | HYPERTENSION IN PREGNANCY, SECONDARY, PREGNANCY COMPLICATIONS | Data were collected during GA 18–20, 24–28, 32–34 weeks during regular scheduled antenatal care and delivery using case record forms that captured demographic data, sleep questionnaires, primary and secondary endpoints, and CPAP adherence. BP measurements by sphygmomanometer were obtained twice on both arms in resting-sitting positions at least 15 min apart; these were then averaged for the analyses. Treating obstetricians were not involved in the conduct of the research. Pregnancy complications were diagnosed by treating obstetricians according to the Report of the American College of Obstetricians and Gynecologists’ Task Force on hypertension in pregnancy [ | PMC10294320 | |
Study endpoints | GDM | HYPERTENSIVE DISORDER, GESTATIONAL HYPERTENSION, GDM, PREECLAMPSIA | The primary outcomes were systolic (SBP) and diastolic BP (DBP) measured during the scheduled antenatal care visit (between 10 am–12 pm) during each specific gestational time-point. For participants randomized during the 2nd-trimester, only outcome data after randomization was included for analyses. Secondary outcomes included the incidence of hypertensive disorders in pregnancy consisting of preeclampsia, and gestational hypertension [GDM was not included in the endpoint analyses as initially planned because it was one of the inclusion criteria, and most cases were detected early before randomization as routine practice in participating sites given the high GDM prevalence in Asians [ | PMC10294320 |
Statistical analysis | OSA | Sample size was calculated based on a 1:1 ratio of CPAP- and usual-care groups, assuming the BP lowering-effect of CPAP in the general population with OSA was 2.5 mmHg (from meta-analysis data) [Data were described using mean and SD or median and interquartile range (IQR) as appropriate for continuous variables, and percentage for categorical variables. Baseline characteristics were compared between treatment groups using t-test and χ | PMC10294320 | |
Results | PMC10294320 | |||
Adherence to intervention | Overall, the intervention group had mean average-CPAP use of 2.5 (SD 2.5) and median of 1.7 (IQR 0.2, 4.5) hours/night; only 50 (32.7%) participants were adherent to treatment (defined as average-CPAP use ≥ 4 h/night). The minimum, maximum, and 90th percentile pressures of auto-CPAP were 4.9 (1.3), 8.2 (1.8), and 6.3 (1.3) cmH | PMC10294320 | ||
Post-hoc analyses | PMC10294320 | |||
Subgroup analysis for mild OSA/upper airway resistance syndrome (UARS) and OSA | OSA [ | Although all participants had RDI ≥ 5 events/hour, those with AHI < 5 were classified as mild OSA/UARS and those with AHI ≥ 5 events/hour were classified as OSA [ | PMC10294320 | |
Subgroup analysis excluding participants randomized during 2nd trimester | OSA | HYPERTENSIVE DISORDER | Analyses excluding participants with new-onset OSA randomized during the 2nd-trimester also demonstrated significant results for CPAP treatment on reductions of BP and incidence of hypertensive disorders in pregnancy (Additional file | PMC10294320 |
Discussion | hypoxia, apnea/hypopnea, heterogeneous disorder, OSA, mild/moderate OSA, preeclampsia | PREECLAMPSIA, HIGH-RISK PREGNANCIES, HYPOXIA, PREECLAMPSIA, HYPERTENSIVE DISORDER, HIGH-RISK PREGNANCY | We conducted an RCT of high-risk pregnant women with mild/moderate OSA (RDI IQR 5–29.8 and AHI IQR 4–13) to assess the efficacy of CPAP in reducing BP and gestational hypertensive disorders. Our findings indicate that CPAP significantly reduced BP, with larger effects on DBP and MAP than SBP. Results were robust for all approaches including modified-intention-to-treat, per-protocol, and counterfactual approaches. In addition, CPAP treatment also significantly reduced preeclampsia and hypertensive disorders in pregnancy by 9% and 11%, respectively.Although modified-intention-to-treat analysis is claimed as the least biased because it preserves random allocations, it may underestimate the causal-treatment effect because of dilution of noncompliers [DBP significantly affects uteroplacental hemodynamics and is more strongly associated with the risk of preeclampsia than SBP [Moreover, the true clinical effect may be larger with higher adherence to CPAP during pregnancy. Of note, this BP-lowering effect of CPAP was seen in both subgroups of participants, i.e. those who did and did not take anti-hypertensive medications. Fewer anti-hypertensive medications were required among those taking anti-hypertensive medications in the CPAP group (Table BP changes in our participants demonstrated the well-described pattern of mid-pregnancy fall, regardless of intervention groups [Preeclampsia is a heterogeneous disorder involving multiple placental mechanisms ranging from poor implantation to placental stress and hypoxia caused by “abnormal placentation” as in early-onset preeclampsia or “maternal stress factors” as in late-onset preeclampsia [Our findings replicated Guilleminault’s studies which similarly showed that the BP-lowering effect of CPAP was markedly apparent after 6 months of gestation, with more anti-hypertensive medication requirement in controls, and more favorable pregnancy outcomes in the CPAP-group [Recent data indicated that airflow limitation or RERA could cause an increase in BP similar to apnea/hypopnea in pregnant population [One strength of our trial was that full-night polysomnography was performed on all participants to detect both early-pregnancy and new-onset OSA. Due to different exposure time, early-pregnancy OSA (or probably chronic longstanding OSA) and new-onset OSA may be clinically different [The high OSA detection rate in our study may not reflect the true OSA prevalence of this population because only 385 (35.1%) of the total 1098 high-risk pregnant women agreed to participate for polysomnography. There might be a selection bias in that those who had more symptoms might have been more motivated to participate. Furthermore, the highly sensitive diagnosis with polysomnography and RDI criteria was used in a high-risk pregnancy population. Based on the home-sleep-apnea test (AHI ≥ 5 criteria), previous studies found OSA prevalence in high-risk pregnancy during 1st and 3rd trimesters of approximately 28–60.3% and 24–50%, respectively [The main limitation of our trial was CPAP nonadherence, which occurred in a large percentage of participants, comparable to other RCTs [Our results may not be generalizable to pregnant women without pre-defined high-risk factors or those with severe OSA. Despite successful treatment case reports, the magnitude of CPAP treatment effect on severe cases is unknown [In conclusion, evidence from a multicenter RCT of high-risk pregnancies with mild/moderate OSA indicates that early CPAP treatment significantly lowers DBP, MAP, and reduces the incidence of preeclampsia and hypertensive disorders in pregnancy. This raises the need for early diagnosis and treatment of OSA in high-risk pregnancies. | PMC10294320 |
Acknowledgements | Nongluck | We would like to express our deepest gratitude towards Professor Christian Guilleminault for the initiatives of the project. We thank Associate Professor Naiphinich Kotchabahakdi for the advice on the grant; the research assistant team including Poompoung Chirakool, Punnee Phongchiewboon, Wimolwan Suksaran, Yaovarit Leepemas, Porntip Arayanun; the Ramathibodi Sleep Center team includining Nongluck Thappratoom, Nipaporn Kosomsai, Phatcharee Kanjana, Thanuchporn Traiyuth, Duangkamol Klomkool, Siriwan Lomwong; and the research team from the Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. | PMC10294320 | |
Author contributions | WS, JP, Werapath | VT initiated the study, led the work on the study design and had the responsibility for running the study, collecting the data, and was involved in analyzing and interpreting the data. VT also drafted and edited the manuscript. AI is the manuscript’s guarantor. AI was involved in the study conceptualization, initiation, study design, analyzing and interpreting the data. AI also drafted and edited the manuscript. SL had the responsibility for running the study, collecting data, and editing the manuscript. SR and SS had the responsibility for data management and analyzing the data. PK, NI-S, SL, SJ, and WS (Werapath Somchit) was involved in running the study. WS (Worakot Suwansathit) and JP had the responsibility for performing the sleep study and providing CPAP care. PP was involved in planning of the study. CG was involved in the study conceptualization, initiation, and study design. AP was involved in the study design, and editing the manuscript. JA was involved in editing the manuscript. AT was involved in the study conceptualization, initiation, study design, analyzing and interpreting the data. AT also drafted and edited the manuscript. All authors read and approved the final manuscript. | PMC10294320 | |
Funding | This work received main funding from The National Research Council of Thailand and supplementary funding from The Development Potentials of Thai People Project, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. | PMC10294320 | ||
Availability of data and materials | Available from the corresponding author on reasonable request. | PMC10294320 | ||
Declarations | PMC10294320 | |||
Ethics approval and consent to participate | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committees and with the 1964 Helsinki declaration and its later amendments (subjects read and signed a dedicated consent form). Ethics committee approval numbers of the Institutional Board are: ID 11-58-12 for the Committee on Human Rights Related to Research Involving Human Subjects, Faculty of Medicine Ramathibodi Hospital, Mahidol University; 60117 for the Ethics Committee on Researches involving Human, Rajavithi Hospital; and Q031h/60 for the Institutional Review Board, Royal Thai Army Medical Department (for Phramongkutklao Hospital). | PMC10294320 | ||
Consent for publication | Not applicable. | PMC10294320 | ||
Competing interests | The authors declare no competing interests. | PMC10294320 | ||
References | PMC10294320 | |||
Abstract | Preliminary results of this study were presented to the 14th Virtual Congress of the European-African Hepato-Pancreato-Biliary Association, September 2021. | PMC10077024 | ||
Background | postoperative pancreatic fistula | The potential of haemostatic patches to reduce the rate of postoperative pancreatic fistula remains unclear. The aim of this trial was to evaluate the impact of a polyethylene glycol-coated haemostatic patch on the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy. | PMC10077024 | |
Methods | postoperative pancreatic fistula | SECONDARY, COMPLICATION | In this randomized, single-centre, clinical trial, patients undergoing pancreatoduodenectomy were randomized 1 : 1 to receive pancreatojejunostomy reinforced with two polyethylene glycol-coated haemostatic patches (patch group) or without any reinforcement (control group). The primary outcome was clinically relevant postoperative pancreatic fistula, defined as grade B/C according to International Study Group of Pancreatic Surgery criteria, within 90 days. Key secondary outcomes were length of hospital stay, total rate of postoperative pancreatic fistula, and overall complication rate. | PMC10077024 |
Results | postoperative pancreatic fistula | MAY | From 15 May 2018 to 22 June 2020, 72 patients were randomized, and 64 were included in the analyses (31 in the patch group and 33 in the control group). The risk of clinically relevant postoperative pancreatic fistula was reduced by 90 per cent (OR 0.10, 95 per cent c.i. 0.01 to 0.89, | PMC10077024 |
Conclusions | postoperative pancreatic fistula | A polyethylene glycol-coated haemostatic patch reduced the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy. | PMC10077024 | |
Registration number | fistula, postoperative pancreatic fistula | NCT03419676 (Hemopatch™ significantly reduced the incidence of clinically relevant postoperative pancreatic fistula in patients who underwent a pancreatoduodenectomy. The effectiveness of the patch was related to the fistula risk score. | PMC10077024 | |
Introduction | Postoperative pancreatic fistula, PD, POPF | PATHOLOGY, SEQUELAE | Postoperative pancreatic fistula (POPF) is a common condition with incidences ranging from 13 to 41 per cent, and remains the most important and challenging determinant of postoperative morbidity and mortality after pancreatoduodenectomy (PD)Identifying patients at risk of having POPF, as well as predicting its development, may be crucial for preventing the incidence of severe sequelae. Different factors have been considered to influence the development of POPF, including soft pancreas, small main pancreatic duct diameter, high-risk pathology, and excessive blood lossDespite improvements in perioperative management and surgical techniques, aiming to decrease the incidence of POPF formation through the use of somatostatin analogues, pancreatic stents, minimally invasive surgery, reinforcement of the anastomosis with glue, autologous tissues, non-autologous absorbable or non-absorbable materials, no differences in POPF rates have been reported over the last decadeAmong the different approaches for preventing the onset of POPF, the use of sealants has emerged as a promising strategyThe purpose of this study was to evaluate the impact of a PEG-coated haemostatic patch on the incidence rate of CR-POPF after PD according to the International Study Group of Pancreatic Surgery (ISGPS) criteria | PMC10077024 |
Methods | PMC10077024 | |||
Study design | This study was conducted in accordance with the Declaration of Helsinki (as revised in 2013), performed according to CONSORT guidelines | PMC10077024 | ||
Participants | PD | TUMOURS, DISEASES, CHRONIC PANCREATITIS, ACUTE NECROTIZING PANCREATITIS | This study assessed for eligibility consecutive patients selected for undergoing PD with benign or malignant periampullary tumours or benign diseases (that is chronic pancreatitis) with a pancreatojejunostomy (PJ) reconstruction, male and female patients, between 18 and 80 years of age, with an ASA Physical Status Classification SystemPatients were excluded if they had any contraindication for performing PD, had acute necrotizing pancreatitis, had immune suppression, were unwilling to comply with the investigators and protocol indications, were incapable of providing written consent, had an ASA grade of greater than or equal to IV, had received neoadjuvant treatment, and required vascular resection during surgery. Data were collected and managed using Research Electronic Data Capture (REDCap, Vanderbilt University, Nashville, TN, USA). The patient cases were discussed in a multidisciplinary committee and surgery procedure was decided. Subsequently, once the patient was informed by any of the three surgeons responsible for performing the surgeries and had signed the informed consent, they were recruited for the trial. | PMC10077024 |
Surgical procedure | PD, pancreatic head and uncinate process | A standard open PD, using a reconstruction in two loops and a PJ, was performed by three surgeons with more than 10 years of experience in pancreatic surgery. Operative technique, patch placement, and drainage were standardized between the three surgeons. PD was performed without pylorus preservation. The pancreatic head and uncinate process were resected beyond the portal vein, and the resection was extended into the retroperitoneal, peripancreatic, pericaval, and interaortocaval lymphatic–fatty tissue with regional lymphadenectomy. For reconstruction, one jejunal limb was moved upwards behind the transverse colon and a PJ was constructed as the first anastomosis, followed by a Roux-en-Y hepatojejunostomy anastomosis. Another jejunal limb was used to perform the gastrojejunostomy in an antecolic position. Finally, a jejunojejunal anastomosis was performed. The PJ was performed in one layer using a continuous barbed suture (V-Loc™ 3/0; Medtronic, Dublin, Ireland) in the posterior and anterior sides of the anastomosis or using a two-layer, duct-to-mucosa, end-to-side technique, with interrupted sutures using monofilament sutures, according to the individual surgeon’s preference. A 5- or 8-Fr internal stent was always placed in the PJ, depending on the diameter of the main pancreatic duct.Different risk factors associated with the onset of POPF | PMC10077024 | |
Intraoperative and postoperative management | According to the Enhanced Recovery After Surgery guideline recommendations for PD | PMC10077024 | ||
Intervention | bleeding | BLEEDING | In the patch group, two PEG-coated, collagen-based, haemostatic patches (Hemopatch™ Sealing Hemostat, Baxter Aktiengesellschaft, Vienna, Austria) with a size of 9 × 4.5 cm per patch were used in each patient. The objective was to place one patch underside and another one anterior, once the anastomosis was completed, according to the manufacturer’s instructions. Patches were usually placed in the absence of bleeding, although traces of blood from the surgical field may be enough to initiate activation of the patch PEG coating. In the case of an insufficient amount of blood, a few drops of sodium bicarbonate were applied over the dry tissue surface before application of the patch, increasing the covalent bonds between the tissue and the active surface of the patch and thus improving adherence. The PJ was left bare in the control group. | PMC10077024 |
Use of drains and postoperative pancreatic fistula assessment | In both groups, a silastic Penrose | PMC10077024 | ||
Outcome measures | The primary outcome was the incidence rate of CR-POPF within 90 days defined according to the ISGPS criteria | PMC10077024 | ||
Sample size | PD | An observational study was carried out for patients undergoing PD in our institution and indicated a baseline 31 per cent CR-POPF rate. According to power calculations, 62 patients (31 per group) were required to show a decrease in CR-POPF rate from 31 to 5 per cent with 80 per cent power and two-tailed 5 per cent significance level, with assumed 10 per cent lost to follow-up. | PMC10077024 | |
Randomization | PD | BLIND | Patients were randomized on a 1 : 1 basis during surgery by the minimization method (preferred treatment probability 0.9), after resection but before anastomosis, to either PEG-coated patch application (patch group) or no patch (control group). Randomization was done by blocks of 10 patients, using a secure, internet-based, randomization service (RandomizerPatients were assigned to one of the following study groups: patch group, patients undergoing PD with PJ reinforced with two PEG-coated collagen-based haemostatic patches; and control group, patients undergoing PD with PJ without any sealant reinforcement. Although operating-room staff and doctors responsible for the follow-up were not blind to the intervention, data analysis was performed in a masked fashion. | PMC10077024 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.