Search Results for: La nevralgia post-erpetica

Objective
To explore the association between perioperative SARS-CoV-2 infection and the postoperative complications during the breakout of the Omicron epidemic wave.

Design
Observational retrospective cohort study. Multivariable logistic regression was performed to explore the association between the duration from surgery to COVID-19 diagnosis and the likelihood of postoperative complications.

Setting
A general hospital in China.

Participants
7927 patients aged 18 years and older who underwent surgical treatment between 1 December 2022 and 28 February 2023.

Primary outcome measures
The outcome was a composite of postoperative adverse events that occurred within the initial 30 postoperative days.

Results
Of all patients, 420 (11.76%) experienced postoperative complications. Compared with No COVID-19, preoperative COVID-19 within 1 week (pre-1w) exhibited a high risk of postoperative complications (adjusted OR (aOR), 2.67; 95% CI 1.50 to 4.78), followed by patients with pre-2w (aOR, 2.14; 95% CI 1.20 to 3.80). For patients with postoperative COVID-19 within 1 week (post-1w), the aOR was 2.48 (95% CI 1.48 to 4.13), followed by patients with post-2w (aOR 1.95; 95% CI 1.10 to 3.45), and those with post-3w (aOR 2.25; 95% CI 1.27 to 3.98). The risks of postoperative complications decreased roughly with the increase of the time interval between the surgery date and SARS-CoV-2 infection. Stratification analyses suggested that perioperative COVID-19 increased the risk of postoperative complications in older patients, smokers, those with comorbidities or experiencing moderate or severe COVID-19 symptoms.

Conclusions
Our findings reveal a significant time-dependent relationship between perioperative COVID-19 and postoperative complications, highlighting the importance of tailored preoperative risk evaluations, enhanced postoperative surveillance, and the implementation of effective postoperative COVID-19 prevention measures.

Trial registration number
ChiCTR2300072473.

Introduction
Patients who have undergone lung cancer surgery often experience reduced exercise tolerance, impaired lung function and increased negative emotions such as anxiety and depression. Baduanjin, a traditional Chinese mind-body exercise, has shown benefits in improving exercise tolerance and lung function in populations with chronic diseases. However, evidence on the effectiveness of Baduanjin for post-lung cancer surgery patients remains limited. This study aims to systematically assess the impact of Baduanjin on exercise tolerance, lung function and emotional well-being in these patients.

Methods and analysis
We will conduct a comprehensive search of PubMed, the Cochrane Library, China National Knowledge Infrastructure, Chinese Biomedical Literatures database, Wangfang database and China Science and Technology Journal Database (VIP) to identify randomised controlled trials (RCTs) assessing Baduanjin in postoperative lung cancer patients. The primary outcome measure will be the 6-minute walk test distance. We will assess the risk of bias in included RCTs using the bias risk assessment form from the Cochrane Collaboration Handbook. This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols 2015 guidelines.

Ethics and dissemination
Ethical approval is not required as no primary data are collected. The results will be presented at scientific conferences or submitted to a peer-reviewed scientific journal.

PROSPERO registration number
CRD42024570196.

Objectives
To explore urologists’ perceptions of barriers to, and facilitators of, adherence to international antimicrobial prophylaxis (AP) guidelines for endourological procedures in Jordan and to identify strategies to optimise guideline-concordant AP prescribing.

Design
The present study is a qualitative study undertaken through semi-structured interviews and inductive thematic analysis. Study results are reported per Consolidated Criteria for Reporting Qualitative Research.

Setting
Secondary and tertiary care across multiple public, private and academic hospitals in Jordan.

Participants
Nineteen practising urologists (all male; median age 32 years, IQR 8; nine residents, 10 specialists) who routinely prescribe AP for endourological procedures. Participants were recruited via convenience snowball sampling and interviewed until thematic saturation was reached.

Interventions
Not applicable.

Primary and secondary outcome measures
The main outcomes were themes describing perceived barriers to guideline adherence and potential facilitators to support appropriate AP use.

Results
Participants identified several barriers: (1) patient level, strong expectations for antibiotics post-procedure and concerns about procedure-site hygiene; (2) clinician level, fear of postoperative infections and litigation, lack of familiarity with updated guidance and doubts about applying international guidelines locally; (3) system level, hierarchical prescribing dynamics, referral communication gaps, high workloads and time pressures, and concerns over sterilisation practices. Facilitators included targeted professional training and regular guideline updates for urologists, development of local AP guidelines informed by local resistance data, enhanced patient education campaigns and active involvement of clinical pharmacists in preoperative antibiotic review and auditing.

Conclusions
Urologists in Jordan face multifaceted barriers to AP guideline adherence. Future stewardship programmes can use insights from this study to develop locally tailored guidelines, targeted clinician training and pharmacist-led audits. Pilot testing with metrics such as prescribing rates, guideline concordance, antibiotic consumption and postoperative infection incidence will be essential to validate their impact before wider implementation.

Introduction
The COVID-19 pandemic has had a significant impact on medical education, with many institutions shifting to online learning to ensure the safety of students and staff. However, there appears to be a decline in in-person attendance at medical schools across the UK and worldwide following the relaxation of social distancing rules and the reinstatement of in-person teaching. Importantly, this trend was also observed before the pandemic. While reflected within the literature, there is currently no systematic review describing these changes. We aim to find out how medical students’ attendance is changing as documented within the literature and its impact on their educational outcomes.

Methods
This systematic review followed the guidelines of the Centre of Research and Dissemination, Moose and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We searched the major databases of Medline via Ovid, Embase via Ovid, Scopus, Web of Science, British Education Index via EBSCOhost and ERIC via EBSCOhost in September 2023. Two reviewers independently screened each paper and extracted the data, with a third reviewer for dispute resolution. All studies reporting on medical students from various universities, both graduate and undergraduate, and describing changes in attendance and/or students’ educational outcomes were included. Risk of bias in individual studies was assessed using the Agency for Healthcare Research and Quality tool. A narrative synthesis of the findings from all included studies was done.

Results
12 papers were included in the analysis. Primary aim: Of the eight papers that measured attendance data over more than one academic year, only one paper demonstrated a statistically significant decrease while one paper demonstrated a statistically significant increase in attendance over the observational period. Other papers either did not perform statistical tests or did not demonstrate statistical significance. Secondary aims: Most papers showed a general positive correlation between attendance and educational outcomes. No studies explicitly explored reasons for changes in attendance seen. Only one paper outlined a possible strategy to address changes in attendance, a mandatory attendance policy, which has mixed outcomes.

Discussion
Despite widespread anecdotally reported attendance decline post-COVID-19, overall, there was no consistent change in attendance noted. However, there was a large heterogeneity in the studies included. Further research is required to elucidate trends in attendance and its impact on medical education.

Objective
Adolescents and young adults (AYA) with HIV are a population at high risk of experiencing mental issues and sleep disorder. We aim to summarise the global prevalence and risks of depression, anxiety, post-traumatic stress disorder (PTSD) and sleep disorder among AYA with HIV.

Design
Systematic review and meta-analysis.

Data sources
PubMed, Web of Science, Embase and PsycINFO were searched from inception to 3 August 2024.

Eligibility criteria
Observational studies reporting the prevalence of depression, anxiety, PTSD or sleep disorder among AYA with HIV and published in English were included. Reviews, case reports, conference papers, notes, editorials and non-observational research were excluded.

Data extraction and synthesis
Titles, abstracts and full texts were reviewed and screened, and data were independently extracted. A modified Newcastle-Ottawa Quality Assessment Scale (NOS) was used to evaluate study quality. Heterogeneity was assessed by I2 statistics, and subgroup analysis was performed to identify the source of heterogeneity. The pooled prevalence and the risks of depression, anxiety, PTSD and sleep disorder by comparison with HIV-uninfected peers were measured with random-effects and fixed-effects models. Publication bias was examined using Egger’s correlation tests and funnel plot. The Grading of Recommendations Assessment, Development and Evaluation was used to assess the certainty of evidence.

Results
56 articles were included in the final analysis. According to the modified NOS, 13 (23.2%) studies were considered good, 38 (67.9%) were satisfactory and 5 (8.9%) were unsatisfactory. 51 studies including 21 735 AYA with HIV contributed data for the pooled prevalence of depression (28%, 95% CI 24% to 32%, I2=98.68%; low certainty evidence); 21 studies including 8021 cases contributed data for the pooled prevalence of anxiety (22%, 95% CI 17% to 27%, I2=98.35%; low certainty evidence); 9 studies including 3691 cases contributed data for the pooled prevalence of PTSD (12%, 95% CI 8% to 17%, I2=95.60%; low certainty evidence); and 4 studies including 1909 cases contributed data for the pooled prevalence of sleep disorder (51%, 95% CI 31% to 70%, I2=98.37%; low certainty evidence). Compared with AYA without HIV, those with HIV had a higher risk of depression (OR=2.67, 95% CI 1.63 to 5.90, I2=84.0%), anxiety (OR=1.89, 95% CI 1.32 to 2.69, I2=50.3%), PTSD (OR=1.58, 95% CI 1.23 to 2.04, I2=40.1%) and sleep disorder (OR=2.11, 95% CI 1.51 to 2.95, I2=0.0%). A subgroup analysis found that studies conducted in Asia had a lower prevalence of depression (21.7% vs 29.6%, p

Introduction
Depressive disorders in adolescents are highly prevalent and debilitating and are a risk factor for self-harm and death by suicide. In the context of recovery from the COVID-19 pandemic, strained healthcare resources are compounded by an increased demand for treatment services for adolescents with depression. The objective of this study protocol is to delineate the proposed economic evaluation of an integrated care pathway for depression in adolescents within the Care for Adolescents who Received Information ‘Bout Outcomes, 2nd iteration (CARIBOU-2) non-randomised, cluster-controlled trial.

Methods and analysis
Two economic evaluations of the CARIBOU-2 trial (n=300) will be conducted—a cost-effectiveness analysis and a cost-utility analysis. In the cost-effectiveness analysis, we will examine the primary clinical outcome of the trial, change in the Mood and Feelings Questionnaire total score. In the cost-utility analysis, the clinical outcome will be quality-adjusted life-years, a generic measure of health burden. Data on the resources and respective costs required to deliver the intervention will be collected by the research team. Data on resource use post-intervention will be obtained from a mix of administrative data holdings and self-report; relevant unit costs will be obtained from existing data sources. The outcome of both economic evaluations will be the incremental cost-effectiveness ratio. Relevant sensitivity analyses will be undertaken, and cost-effectiveness acceptability curves will be produced to characterise any sources of uncertainty in the analysis. Equity considerations will also be examined, where relevant.

Ethics and dissemination
Ethical approval for the larger CARIBOU-2 trial, including the economic evaluation, has been obtained by the Centre for Addiction and Mental Health as well as site-level ethics boards (019/2021; Centre for Addiction and Mental Health). All participants will provide informed consent for their data to be analysed and reported. The results of the main trial and the economic evaluation will be submitted for publication in a peer-reviewed journal and shared with relevant policy makers across Canada.

Trial registration number
NCT05142683.

Objectives
We aimed to establish a diagnostic system using retrospective data to predict difficult wean from mechanical ventilation.

Design
A multicentre retrospective study

Setting
Five tertiary hospitals from China.

Participants
Critically ill patients received mechanical ventilation between January 2018 and December 2022.

Primary and secondary outcome measures
The primary endpoint was success weaning from mechanical ventilation ( >48 hours), reintubation or death, whichever occurred first.

Results
Among 1365 initially screened patients, 703 patients (median age: 69 years; 63.02% male) were included. From 42 factors, 22 (p≤0.10) were identified for multivariate analysis. Subsequently, the lung injury score, brain natriuretic peptide level at 24 hours, 24 hour fluid balance, use of dexmedetomidine, spontaneous breathing trial (continuous positive airway pressure vs other) and endotracheal tube reinsertion were included in the predictive model. The area under the curve value was 0.8888 (95% CI: 0.8382, 0.9394). The sensitivity, specificity, positive predictive value, negative predictive value, accuracy, likelihood ratio (LR)+ and LR– were 0.7559, 0.875, 0.9746, 0.3608, 0.7721, 6.0743 and 0.279, respectively. We established a nomogram model based on the optimal model.

Conclusions
A model with six factors was established to predict difficult wean from mechanical ventilation in critically ill patients. However, the model should be verified in future well-designed studies before being extended to other populations.

Trial registration
ChiCTR1900021432. Registered on February 21, 2019; Post-results.

Introduction
Vast empirical evidence highlights the importance of early identification, diagnosis and support for autistic children. Caregivers of autistic children often experience high levels of psychological distress; hence there is a need for parallel child and caregiver support. Autism New Zealand’s Let’s Play programme is a caregiver-mediated, community-based programme based on the principles of developmental and relational interventions (henceforth, developmental). Developmental interventions are evidence-based supports designed to enhance children’s learning within the context of developmentally appropriate, naturalistic settings (eg, everyday routines, play). We aim to evaluate the effects of the Let’s Play programme on autistic children’s engagement and caregiver stress.

Methods and analysis
This study will be a single-blind (rater) randomised controlled trial with two parallel arms: immediate programme access (intervention) versus a waitlist control. Participants will be 64 caregivers of children aged 0–5 years with diagnosed or suspected autism, allowing for 20% attrition, based on power calculations. The Let’s Play programme will be delivered over 9 weeks using a combination of small group workshops and in-home coaching. Primary outcome variables include child engagement and caregiver stress. Caregivers will complete measures at three time points (baseline, immediately post-programme and at the 6-month follow-up), and effectiveness will be analysed using generalised estimating equation models and intention-to-treat and per protocol analyses.

Ethics and dissemination
This trial was approved by Aotearoa New Zealand Ministry of Health’s Health and Disability Ethics Committee (2022 FULL 13041). Findings will be communicated nationally and internationally via conferences, journal publications and stakeholder groups (eg, service providers for autistic children). Results will be shared regardless of magnitude or direction of effect.

Trial registration number
ACTRN12622001139763.

Objectives
In Indonesia, antibiotics are often purchased without a prescription at community pharmacies, contrary to current regulations. This practice may increase the risk of out-of-specification (OOS) medicines being dispensed, potentially contributing to treatment failure and antibiotic resistance. To address this concern, we assessed the quality of antibiotics purchased without a prescription at private drug retail outlets (PDROs) in Indonesia.

Design and setting
We conducted a cross-sectional study in Tabalong and Bekasi, Indonesia, using standardised patients (SPs) who purchased antibiotics without a prescription for three clinical scenarios: upper respiratory tract infection (URTI), tuberculosis (TB) and child diarrhoea. The pharmacies and drug stores were randomly selected from each subdistrict based on the probability proportional method. We measured the active pharmaceutical ingredient (API) content of the antibiotic samples using high-performance liquid chromatography (HPLC).

Samples and analysis
The quality of 183 antibiotics including amoxicillin tablets (148/183, 80.9%, 95% CI 74.7% to 86.1%), amoxicillin dry syrup (12/183, 6.6%, 95% CI 3.6% to 10.8%), ampicillin tablets (5/183, 2.7%, 95% CI 1.1% to 5.9%) and ciprofloxacin tablets (18/183, 9.8%, 95% CI 6.2% to 14.8%) obtained from 117/166 (70.5%, 95% CI 62.8 to 77.2) PDROs were tested. Descriptive statistics were used to describe the characteristics of the purchased antibiotics, and the API content of each antibiotic was compared against the United States Pharmacopeia 43-National Formulary 38 (USP 43-NF 38) standards in absolute values and percentages.

Results
Almost all samples produced in Indonesia (182/183, 99.5%, 95% CI 97.5% to 99.9%) were unbranded (123/183, 67.2%, 95% CI 60.2% to 73.7%) or branded generic (60/183, 32.8%, 95% CI 26.3% to 39.8%) and packaged in strips (165/183, 90.2%, 95% CI 85.2% to 93.8%). Around 12/183 (6.6%, 95% CI 3.6% to 10.8%) antibiotics were found to be OOS; these were mostly amoxicillin 125 mg dry syrup (6/12, 50%, 95% CI 24.3% to 75.7%) and ciprofloxacin 500 mg tablet (5/18, 27.8%, 95% CI 11.5% to 50.6%). Around 33% (4/12, 95% CI 12.5% to 61.2%) of amoxicillin 125 mg dry syrup samples had an API content above the label claim, the highest being 187%, whereas 16.7% (2/12, 95% CI 3.6% to 43.6%) were below the label claim, the lowest being 64%. About 27.8% (5/18, 95% CI 11.5% to 50.6%) of ciprofloxacin samples tested had an API content above the label claim; the highest was 120%.

Conclusion
While the proportion of OOS antibiotics identified was relatively small, at a population level, it represents a significant proportion of sub-optimally treated infections.

Objectives
To observe the association between passive leg raising (PLR) and the cross-sectional area (CSA) of the right internal jugular vein (IJV) in obese patients undergoing elective surgery.

Design
Prospective observational study with randomised position sequence.

Setting
Single-centre, tertiary care hospital in Shanghai, China.

Participants
Forty obese patients (body mass index (BMI) >30 kg/m²) scheduled for elective surgery were enrolled. Inclusion criteria were American Society of Anesthesiologists Physical Status Classification (ASA) physical status II–III and age ≥18 years. Exclusion criteria included history of neck surgery, severe cardiovascular disease, end-stage renal disease, severe infection or sepsis and significant coagulopathy.

Observations
Patients underwent ultrasound measurements of the right IJV in two positions: supine (S0) and passive leg raise at 40° (PLR40). Each position was maintained for at least 1 min prior to measurement.

Primary outcome
The primary outcome was to observe whether the CSA of the right IJV differed between the S0 position and passive leg elevation. In post hoc analyses, we examined factors affecting the relative CSA change (CSA), including neck circumference, BMI, age, sex, ASA physical status and heart rate as predictors.

Results
The CSA of the right IJV was significantly larger in the PLR40 position (2.05 cm²) compared to the S0 position (1.67 cm², p=0.003). Linear regression analysis showed a slight positive correlation between neck circumference and the percentage change in CSA (correlation coefficient: 0.066, p

Objectives
The primary aim of this study is to investigate the factors contributing to the development of kinesiophobia in patients following coronary artery stent implantation, integrating perspectives from both patients and healthcare professionals. The main hypothesis is that understanding and methods for effectively overcoming the fear of exercise and improving the effectiveness of cardiac rehabilitation require further exploration from both patient and professional viewpoints.

Design
This qualitative study used a semi-structured interview approach to gather data from participants.

Setting
The study was conducted at a hospital in Gansu province, China, focusing on the level of care provided to cardiac rehabilitation patients.

Participants
A total of 11 cardiac rehabilitation patients identified as having kinesiophobia (Tampa Scale for kinesiophobia Heart, TSK-SV Heart >37) through screening and nine healthcare professionals participated in the study. The selection criteria included patients undergoing cardiac rehabilitation and professionals involved in their care.

Results
The study identified a core theme, ‘Navigating Fear and Uncertainty’, encompassing five themes that elucidate how various factors contribute to the prevalent phenomenon of kinesiophobia among patients. These were further delineated into 11 subthemes: (1) physiological factors (fatigue, negative illness experiences), (2) psychological factors (hypervigilance, psychogenic anxiety and depression), (3) capacity factors (reduced physical abilities, lack of rehabilitation knowledge and skills), (4) motivational factors (low exercise self-efficacy, rehabilitation cognitive errors) and (5) support systems (primary caregivers, healthcare professionals and medical support). The results provide a qualitative understanding rather than quantitative measures, hence no CIs or statistical significance levels are provided.

Conclusions
The kinesiophobia observed in patients following coronary artery stent implantation stems from the combined influence of multiple factors, warranting early assessment and intervention by healthcare professionals. The study suggests that healthcare institutions should address the practical concerns faced by cardiac rehabilitation patients and enhance familial, medical and societal support systems to increase patient engagement and compliance with exercise rehabilitation. Further research is needed to develop and validate interventions based on these findings.

Clostridioides difficile epidemiology is rapidly evolving, and understanding the factors that contribute to one’s risk of C. difficile infection (CDI) is urgently needed. Based on our observations in a dietary intervention study, we hypothesized that fiber modulates susceptibility to C. difficile post-antibiotic exposure and investigated this using human specimens and murine models.

Introduction
Cholecystitis is a highly prevalent disease that imposes a substantial burden on the healthcare system. Despite strong underlying evidence, guideline adherence in the treatment of cholecystitis remains low. Moreover, important gaps in knowledge persist that must be addressed to optimise existing guidelines. The primary aim is to assess the nationwide variation in cholecystitis treatment and identify opportunities to improve guideline adherence. Secondary aims include determining the best cystic duct closure method; the best model to predict concomitant choledocholithiasis; the optimal treatment for cholecystitis lasting 7 days or more at diagnosis and the optimal strategy for gallbladder drainage and post-drainage care.

Methods and analysis
The Dutch CHESS is a multicentre observational cohort study, including 67 out of 69 Dutch hospitals. From 1 April to 30 September 2024, all patients diagnosed with cholecystitis (Tokyo Guidelines definition) will be prospectively identified. Data on patient characteristics, treatment and outcome (with 6-month follow-up) will be collected to address the primary and secondary aims. For the primary aim, guideline adherence is defined as the percentage of patients who undergo early cholecystectomy for cholecystitis lasting 0–7 days. Current adherence, nationally and for each individual hospital, along with predictors of adherence, will be determined. The adherence of each hospital will be set against the national average and best practices. To further support improvement, the impact of guideline adherence on total hospital stay and morbidity will be determined. Three months after performance feedback to the participating hospitals, the impact on local practice will be assessed through questionnaires. Subgroup analyses and statistical methods for addressing both the primary and secondary aims are predefined in this protocol.

Ethics and dissemination
The Medical research Ethics Committees United reviewed the protocol and decided that the Dutch Medical Research Involving Human Subjects Act is not applicable (reference Number: W23.225). Approval was obtained from the institutional review board and board of directors at each participating hospital. Results will be disseminated through peer-reviewed publications and conference presentations.

Study registration number
ClinicalTrials.gov, NCT06349863; Pre-results.

Objective
This study aims to observe the correlation between infarction pattern and intracranial arterial stenosis (ICAS) on magnetic resonance and functional outcome in acute ischaemic stroke (AIS) patients after reperfusion therapy.

Design
This is a post hoc analysis of the Third China National Stroke Registry (CNSR-III) study.

Setting
The data was derived from the CNSR-III study, which was a nationwide clinical registry of ischaemic stroke or transient ischaemic attack based in China.

Participants
Patients with anterior circulation AIS who underwent reperfusion therapy were included for analysis. The patients were divided into single acute infarction and multiple acute infarctions (MAIs) based on the diffusion-weighted imaging findings. Additionally, patients were categorised according to the degree of ICAS assessed by magnetic resonance angiography as either ≥50% or

Introduction
A traumatic childbirth can have severe negative effects on the mental health of the mother and can negatively impact the child and partner. Eye movement desensitisation and reprocessing (EMDR) is a psychological intervention used to treat symptoms of trauma. The National Institute for Health and Care Excellence guidelines for antenatal and postnatal mental health recommend that trauma-focused cognitive behavioural therapy or EMDR should be offered to women who suffer from post-traumatic stress disorder resulting from a traumatic birth. However, the use of EMDR for birth trauma has not been clearly outlined in the literature.

Objectives
The aim of this scoping review is to explore the extent of the currently available research and to identify knowledge gaps in the use of EMDR for treating birth trauma.

Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines will be followed to provide a comprehensive scoping review of the use of EMDR for birth trauma. Several databases will be searched, such as PsychInfo, Pubmed, the Cochrane Library, Embase, Scopus and CINAHL, from the date the database was developed, until approximately August 2026. The grey literature sources will also be searched, and searches will be limited to include studies written in the English language. Two researchers will independently screen and extract data from both quantitative and qualitative studies, which meet the inclusion criteria. Data will be analysed in a descriptive and thematic manner. Data extraction may include study characteristics, data collection procedures, outcomes and results. Findings will be presented in tabular and narrative formats.

Ethics and dissemination
Ethical Approval is not necessary for this review, as only secondary data will be used. It is expected that the review will be disseminated at psychological conferences and in relevant journal articles.

Trial registration number
This scoping review protocol has been registered on Open Science Framework. The registration DOI is: https://doi.org/10.17605/OSF.IO/UJZ52.

Objectives
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease. Chest high-resolution CT (HRCT) is instrumental in IPF management, and the Quantitative Lung Fibrosis (QLF) score is a computer-assisted metric for quantifying lung disease using HRCT. This study aimed to assess the change in QLF score associated with a minimum clinically important difference (MCID) of IPF symptoms and physiological lung function, and also determine the MCID of QLF change associated with all-cause mortality to serve as an imaging biomarker to confirm disease progression and response to therapy.

Design and study setting
We conducted post hoc analyses of prospective data from two IPF phase II studies of pamrevlumab, a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity.

Participants
Overall, 152 patients with follow-up visits after week 24.

Methods
We used the anchor-based Jaeschke’s method to estimate the MCID of the QLF score that corresponded with the already established MCID of St. George’s Respiratory Questionnaire (SGRQ) and percent-predicted forced vital capacity (ppFVC). We also conducted a Cox regression analysis to establish a sensitive and robust MCID of the QLF score in predicting all-cause mortality.

Results
QLF changes of 4.4% and 3.6% corresponded to the established MCID of a 5-point increase in SGRQ and a 3.4% reduction in ppFVC, respectively. QLF changes of 1% (HR=4.98, p=0.05), 2% (HR=4.04, p=0.041), 20 mL (HR=6.37, p=0.024) and 22 mL (HR=6.38, p=0.024) predicted mortality.

Conclusion
A conservative metric of 2% can be used as the MCID of QLF for predicting all-cause mortality. This may be considered in IPF trials in which the degree of structural fibrosis assessed via HRCT is an endpoint. The MCID of SGRQ and FVC corresponds with a greater amount of QLF and may reflect that a greater amount of change in fibrosis is required before there is functional change.

Trial registration number
NCT01262001, NCT01890265.