Baseline characteristics and comorbidities in the CAnadian REgistry for Pulmonary Fibrosis

Abstract Background The CAnadian REgistry for Pulmonary Fibrosis (CARE-PF) is a multi-center, prospective registry designed to study the natural history of fibrotic interstitial lung disease (ILD) in adults. The aim of this cross-sectional sub-study was to describe the baseline characteristics, risk factors, and comorbidities of patients enrolled in CARE-PF to date. Methods Patients completed study questionnaires and clinical measurements at enrollment and each follow-up visit. Environmental exposures were assessed by patient self-report and comorbidities by the Charlson Comorbidity Index (CCI). Baseline characteristics, exposures, and comorbidities were described for the overall study population and for incident cases, and were compared across ILD subtypes. Results The full cohort included 1285 patients with ILD (961 incident cases (74.8%)). Diagnoses included connective tissue disease-associated ILD (33.3%), idiopathic pulmonary fibrosis (IPF) (24.7%), unclassifiable ILD (22.3%), chronic hypersensitivity pneumonitis (HP) (7.5%), sarcoidosis (3.2%), non-IPF idiopathic interstitial pneumonias (3.0%, including idiopathic nonspecific interstitial pneumonia (NSIP) in 0.9%), and other ILDs (6.0%). Patient-reported exposures were most frequent amongst chronic HP, but common across all ILD subtypes. The CCI was ≤2 in 81% of patients, with a narrow distribution and range of values. Conclusions CTD-ILD, IPF, and unclassifiable ILD made up 80% of ILD diagnoses at ILD referral centers in Canada, while idiopathic NSIP was rare when adhering to recommended diagnostic criteria. CCI had a very narrow distribution across our cohort suggesting it may be a poor discriminator in assessing the impact of comorbidities on patients with ILD.

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The Canadian Registry for Pulmonary Fibrosis: Design and Rationale of a National Pulmonary Fibrosis Registry

Canadian Respiratory Journal ◽

10.1155/2016/3562923 ◽

2016 ◽

Vol 2016 ◽

pp. 1-7 ◽

Cited By ~ 11

Author(s):

Christopher J. Ryerson ◽

Benjamin Tan ◽

Charlene D. Fell ◽

Hélène Manganas ◽

Shane Shapera ◽

...

Keyword(s):

Natural History ◽

Pulmonary Fibrosis ◽

Health Services ◽

Self Report ◽

Administrative Databases ◽

Health Services Use ◽

Acute Exacerbations ◽

History Of ◽

The Impact ◽

Services Use

Background. The relative rarity and diversity of fibrotic interstitial lung disease (ILD) have made it challenging to study these diseases in single-centre cohorts. Here we describe formation of a multicentre Canadian registry that is needed to describe the outcomes of fibrotic ILD and to enable detailed healthcare utilization analyses that will be the cornerstone for future healthcare planning.Methods. The Canadian Registry for Pulmonary Fibrosis (CARE-PF) is a prospective cohort anticipated to consist of at least 2,800 patients with fibrotic ILD. CARE-PF will be used to (1) describe the natural history of fibrotic ILD, specifically determining the incidence and outcomes of acute exacerbations of ILD subtypes and (2) determine the impact of ILD and acute exacerbations of ILD on health services use and healthcare costs in the Canadian population. Consecutive patients with fibrotic ILD will be recruited from five Canadian ILD centres over a period of five years. Patients will be followed up as clinically indicated and will complete standardized questionnaires at each clinic visit. Prespecified outcomes and health services use will be measured based on self-report and linkage to provincial health administrative databases.Conclusion. CARE-PF will be among the largest prospective multicentre ILD registries in the world, providing detailed data on the natural history of fibrotic ILD and the healthcare resources used by these patients. As the largest and most comprehensive cohort of Canadian ILD patients, CARE-PF establishes a network for future clinical research and early phase clinical trials and provides a platform for translational and basic science research.

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Patients With a History of Oronasal Fistula Repair Exhibit Lower Oral Health Measured With Patient-Centric Outcomes Measures

The Cleft Palate-Craniofacial Journal ◽

10.1177/1055665620981331 ◽

2020 ◽

pp. 105566562098133

Author(s):

Alyssa Fritz ◽

Diana S. Jodeh ◽

Fatima Qamar ◽

James J. Cray ◽

S. Alex Rottgers

Keyword(s):

Quality Of Life ◽

Oral Health ◽

Cleft Palate ◽

Fistula Repair ◽

Old Patients ◽

Oronasal Fistula ◽

Patient Reported ◽

History Of ◽

The Impact

Introduction: Oronasal fistulae following palatoplasty may affect patients’ quality of life by impacting their ability to eat, speak, and maintain oral hygiene. We aimed to quantify the impact of previous oronasal fistula repair on patients’ quality of life using patient-reported outcome psychometric tools. Methods: A cross-sectional study of 8- to 9-year-old patients with cleft palate and/or lip was completed. Patients who had a cleft team clinic between September 2018 and August 2019 were recruited. Participants were divided into 2 groups (no fistula, prior fistula repair). Differences in the individual CLEFT-Q and Child Oral Health Impact Profile-Short Form 19 (COHIP-SF 19) Oral Health scores between the 2 groups were evaluated using a multivariate analysis controlling for Veau classification and syndromic diagnosis. Results: Sixty patients with a history of cleft palate were included. Forty-two (70%) patients had an associated cleft lip. Thirty-two (53.3%) patients had no history of fistula and 28 (46.7%) patients had undergone a fistula repair. CLEFT-Q Dental, Jaw, and Speech Function were all higher in patients without a history of a fistula repair; however, none of these differences were statistically significant. The COHIP-SF 19 Oral Health score demonstrated a significantly lower score in the fistula group, indicating poorer oral health ( P = .05). Conclusions: One would expect that successful repair of a fistula would result in improved function and patient satisfaction, but the consistent trend toward lower CLEFT-Q scores and significantly increased COHIP-SF 19 Oral Health scores in our study group suggests that residual effects linger and that the morbidity of a fistula may not be completely treated with a secondary correction.

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Assessing the Impact of Multi-Morbidity and Related Constructs on Patient Reported Safety in Primary Care: Generalized Structural Equation Modelling of Observational Data

Journal of Clinical Medicine ◽

10.3390/jcm10081782 ◽

2021 ◽

Vol 10 (8) ◽

pp. 1782

Author(s):

Ignacio Ricci-Cabello ◽

Aina María Yañez-Juan ◽

Maria A. Fiol-deRoque ◽

Alfonso Leiva ◽

Joan Llobera Canaves ◽

...

Keyword(s):

Primary Care ◽

Patient Safety ◽

Structural Equation ◽

Structural Equation Models ◽

Cross Sectional ◽

Morbidity Burden ◽

Patient Reported ◽

Patient Complexity ◽

Complex Relationships ◽

The Impact

We aimed to examine the complex relationships between patient safety processes and outcomes and multimorbidity using a comprehensive set of constructs: multimorbidity, polypharmacy, discordant comorbidity (diseases not sharing either pathogenesis nor management), morbidity burden and patient complexity. We used cross-sectional data from 4782 patients in 69 primary care centres in Spain. We constructed generalized structural equation models to examine the associations between multimorbidity constructs and patient-reported patient safety (PREOS-PC questionnaire). These associations were modelled through direct and indirect (mediated by increased interactions with healthcare) pathways. For women, a consistent association between higher levels of the multimorbidity constructs and lower levels of patient safety was observed via either pathway. The findings for men replicated these observations for polypharmacy, morbidity burden and patient complexity via indirect pathways. However, direct pathways showed unexpected associations between higher levels of multimorbidity and better safety. The consistent association between multimorbidity constructs and worse patient safety among women makes it advisable to target this group for the development of interventions, with particular attention to the role of comorbidity discordance. Further research, particularly qualitative research, is needed for clarifying the complex associations among men.

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PROMIS Scales for Assessment of Persistent Post-COVID Symptoms: A Cross Sectional Study

Journal of Primary Care & Community Health ◽

10.1177/21501327211030413 ◽

2021 ◽

Vol 12 ◽

pp. 215013272110304

Author(s):

Ravindra Ganesh ◽

Aditya K. Ghosh ◽

Mark A. Nyman ◽

Ivana T. Croghan ◽

Stephanie L. Grach ◽

...

Keyword(s):

Health Status ◽

Social Roles ◽

Disease Process ◽

Cross Sectional Study ◽

Large Sample Size ◽

Sectional Study ◽

Cross Sectional ◽

Data Set ◽

Patient Reported ◽

The Impact

Objective Persistent post-COVID symptoms are estimated to occur in up to 10% of patients who have had COVID-19. These lingering symptoms may persist for weeks to months after resolution of the acute illness. This study aimed to add insight into our understanding of certain post-acute conditions and clinical findings. The primary purpose was to determine the persistent post COVID impairments prevalence and characteristics by collecting post COVID illness data utilizing Patient-Reported Outcomes Measurement Information System (PROMIS®). The resulting measures were used to assess surveyed patients physical, mental, and social health status. Methods A cross-sectional study and 6-months Mayo Clinic COVID recovered registry data were used to evaluate continuing symptoms severity among the 817 positive tested patients surveyed between March and September 2020. The resulting PROMIS® data set was used to analyze patients post 30 days health status. The e-mailed questionnaires focused on fatigue, sleep, ability to participate in social roles, physical function, and pain. Results The large sample size (n = 817) represented post hospitalized and other managed outpatients. Persistent post COVID impairments prevalence and characteristics were determined to be demographically young (44 years), white (87%), and female (61%). Dysfunction as measured by the PROMIS® scales in patients recovered from acute COVID-19 was reported as significant in the following domains: ability to participate in social roles (43.2%), pain (17.8%), and fatigue (16.2%). Conclusion Patient response on the PROMIS® scales was similar to that seen in multiple other studies which used patient reported symptoms. As a result of this experience, we recommend utilizing standardized scales such as the PROMIS® to obtain comparable data across the patients’ clinical course and define the disease trajectory. This would further allow for effective comparison of data across studies to better define the disease process, risk factors, and assess the impact of future treatments.

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S19 The impact of clotting abnormalities on the natural history of idiopathic pulmonary fibrosis: an extended follow up of a population based cohort

Thorax ◽

10.1136/thoraxjnl-2016-209333.25 ◽

2016 ◽

Vol 71 (Suppl 3) ◽

pp. A13.1-A13

Author(s):

V Navaratnam ◽

AW Fogarty ◽

T McKeever ◽

N Thompson ◽

G Jenkins ◽

...

Keyword(s):

Natural History ◽

Idiopathic Pulmonary Fibrosis ◽

Pulmonary Fibrosis ◽

Population Based ◽

History Of ◽

The Impact

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JUUL E-Cigarette Quit Attempts and Cessation Perceptions in College Student JUUL E-Cigarette Users

American Journal of Health Promotion ◽

10.1177/0890117120982408 ◽

2020 ◽

pp. 089011712098240

Author(s):

Kim Pulvers ◽

John B. Correa ◽

Paul Krebs ◽

Omar El Shahawy ◽

Crystal Marez ◽

...

Keyword(s):

College Student ◽

Undergraduate Students ◽

Online Survey ◽

Self Report ◽

Cross Sectional ◽

Quit Attempt ◽

Lower Confidence ◽

Perceived Difficulty ◽

Quit Attempts ◽

History Of

Purpose: This study describes the frequency of JUUL e-cigarette (referred to as JUUL) quit attempts and identifies characteristics associated with confidence in quitting and perceived difficulty quitting JUUL. Design: Cross-sectional study from a self-administered online survey. Setting: Two public southern California universities. Participants: A total of 1,001 undergraduate students completed the survey from February to May 2019. Measures: Self-report measures about JUUL included use, history of quit attempts, time to first use, perceived difficulty with cessation/reduction, and confidence in quitting. Analysis: Binary logistic regressions were used to identify demographic and tobacco-related behavioral correlates of JUUL cessation-related perceptions and behaviors. Results: Nearly half of ever-JUUL users (47.8%) reported a JUUL quit attempt. Adjusting for demographic factors and other tobacco product use, shorter time to first JUUL use after waking was associated with lower confidence in quitting JUUL (aOR = 0.02, 0.00-0.13) and greater perceived difficulty in quitting JUUL (aOR = 8.08, 2.15-30.35). Previous JUUL quit attempt history was also associated with greater odds of perceived difficulty quitting JUUL (aOR = 5.97, 1.74-20.53). Conclusions: History of JUUL quit attempts among college students was common. Those who had previously tried quitting were more likely to perceive difficulty with cessation. Time to first JUUL use, a marker of dependence, was linked with greater perceived cessation difficulty and lower confidence in quitting. These findings suggest that there is a need for cessation and relapse prevention support for college student JUUL users.

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Epidemiological Characteristics of Sport-Related Concussion in Athletes of Brazilian Jiu-Jitsu and Muay Thai

Neurology ◽

10.1212/01.wnl.0000801952.77967.51 ◽

2021 ◽

Vol 98 (1 Supplement 1) ◽

pp. S23.1-S23

Author(s):

Carlos Pinheiro ◽

Francisca Taciane Nascimento Sousa

Keyword(s):

Close Contact ◽

Cross Sectional Study ◽

Self Report ◽

Combat Sports ◽

Cross Sectional ◽

Brazilian Sample ◽

Individual Interviews ◽

History Of ◽

The Moment ◽

Epidemiological Characteristics

ObjectiveTo evaluate the self-reported history of concussion in athletes of both Brazilian Jiu-Jitsu (BJJ) and Muay Thai.BackgroundCombat sports are widely practiced around the world. They include modalities that involves punches or kicks directed at the opponent's head (Striking sports) or that consists of grabbing an opponent and taking him to the ground (Grappling sports). Due to the objectives and close contact in combat sports, the risk of concussion is significant.Design/MethodsThis was a cross-sectional study involving a Brazilian sample of BJJ athletes (n-18) and Muay Thai athletes (n-22). The sample was consisted of both professional and amateur athletes (Women constituted 20% of sample). Through individual interviews with a researcher the following data were collected: self-report of concussion and the moment of the injury (whether in practice or in the fight). The Post-Concussion Symptoms Scale (PCSS) was also applied. In the present study, a concussion was considered as a direct impact on the head followed by symptoms. This study was approved by a local Ethics Committee.ResultsAmong BJJ athletes, 61% reported a history of concussion, while among Muay Thai athletes the percentage was more higher (86%). The main mechanisms of head impact were the throw/takedown and elbow-hits to the head in BJJ and punches and knee-hits to the head in Muay Thai. There was no difference in the symptom score between BJJ and Muay Thai concussed athletes (average of 11 vs 10.7, respectively). The most common symptoms were dizziness, headache and nausea in BJJ athletes, and headache, nausea, drowsiness and brain fogginess in Muay Thai ones.ConclusionsThe results presented herein suggest that concussions in Muay Thai and BJJ occur through different mechanisms. The clinical profile of post-concussion symptoms appears to be different between BJJ and Muay Thai athletes.

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Patient reported outcomes in patients with desmoid type fibromatosis.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.11574 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 11574-11574

Author(s):

VIKAS GARG ◽

Sameer Rastogi ◽

Adarsh Barwad ◽

Rambha Panday ◽

Sandeep Kumar Bhoriwal ◽

...

Keyword(s):

Patient Reported Outcomes ◽

Symptom Burden ◽

Benign Neoplasm ◽

Anxiety And Depression ◽

Appendicular Skeleton ◽

Healthy Controls ◽

Symptom Scale ◽

Cross Sectional ◽

Patient Reported ◽

The Impact

11574 Background: Desmoid type fibromatosis (DTF) is a rare benign neoplasm with infiltrative growth and high local recurrences. Due to long disease course, unpredictable growth pattern, and low mortality, using only survival outcomes may be inappropriate. In this study we assessed the impact of DTF on health related quality of life (HRQoL). Methods: This was a cross-sectional study done in patients with DTF. The study participants were asked to fill the EORTC QLQ-C30, GAD-7 and PHQ- 9 q uestionnaires to assess HRQoL, anxiety and depression . Outcomes were also compared with healthy controls. Results: 204 subjects (102 DTF patients and 102 healthy controls) were recruited. Study parameters have been summarized in Table. Appendicular skeleton (limbs + girdle) was most commonly involved in 59 % patients and abdominal wall or mesentery was involved in 22.5 %. Patients have received median of 2 lines of therapy. 54 % patients were currently on sorafenib and 41 % were under active surveillance. Mean global health status in DTF patient 65.58 ± 22.64, was significantly lower than healthy controls. Similarly, DTF patients scored low on all functional scales except cognitive functioning. Symptom scale showed significantly higher symptom burden of fatigue, pain, insomnia and financial difficulties. Anxiety & depression was observed in 39.22 % and 50 % of DTF patients respectively. DTF patients had higher rates of mild, moderate and severe anxiety and depression compared to healthy controls. No difference was observed based on site of disease. Conclusions: DTF patients have significant symptom burden, poor functioning, and heightened anxiety and depression. Patient reported outcomes should be routinely used to assess treatment efficacy in DTF patients.[Table: see text]

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Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT™ Toolbox initiative

F1000Research ◽

10.12688/f1000research.16810.1 ◽

2018 ◽

Vol 7 ◽

pp. 1878 ◽

Cited By ~ 2

Author(s):

Christelle Chrea ◽

Catherine Acquadro ◽

Esther F. Afolalu ◽

Erica Spies ◽

Thomas Salzberger ◽

...

Keyword(s):

Public Health ◽

Wide Spectrum ◽

Medical Product ◽

Consumer Perception ◽

Self Report ◽

Measurement Instruments ◽

Patient Reported ◽

Fit For Purpose ◽

And Behavior ◽

The Impact

Background. Determining the public health impact of tobacco harm reduction strategies requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNPs) with different exposure and risk profiles. In this context, rigorous methods to develop and validate psychometrically sound self-report instruments to measure consumers’ responses to TNPs are needed. Methods. Consistent with best practice guidelines, including the U.S. Food and Drug Administration’s “Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims,” scientifically designed, fit-for-purpose, reliable, and valid instruments are now being applied to tobacco regulatory research. Results. This brief report presents the ABOUT™ Toolbox (Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) initiative. This communication: (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT™ Toolbox, (2) presents a summary of the high-priority tobacco-related domains that are currently covered in the ABOUT™ Toolbox (i.e., risk perception, dependence, product experience, health and functioning, and use history), and (3) details how the measurement instruments are made accessible to the scientific community. Conclusions. By making the ABOUT™ Toolbox available to the tobacco research and public health community, we envision a rapidly expanding knowledge base, with the goals of (1) supporting consumer perception and behavior research to allow comparisons across a wide spectrum of TNPs, (2) enabling public health and regulatory communities to make better-informed decisions for future regulation of TNPs, and (3) enhancing surveillance activities associated with the impact of TNPs on population health.

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Clinical outcomes in patients (pts) with a history of central nervous system (CNS) metastases receiving talazoparib (TALA) or physician’s choice of chemotherapy (PCT) in the phase 3 EMBRACA trial.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.1090 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 1090-1090

Author(s):

Jennifer Keating Litton ◽

Johannes Ettl ◽

Sara A. Hurvitz ◽

Miguel Martin ◽

Henri Roche ◽

...

Keyword(s):

Stable Disease ◽

Subgroup Analysis ◽

Odds Ratio ◽

Objective Response ◽

Locally Advanced ◽

Cns Metastases ◽

Intracranial Disease ◽

Patient Reported ◽

History Of ◽

Baseline Characteristics

1090 Background: In the EMBRACA trial (NCT01945775) of pts with germline BRCA1/2-mutated HER2-negative locally advanced/metastatic breast cancer (ABC), the poly(ADP-ribose) polymerase (PARP) inhibitor TALA significantly improved progression-free survival (PFS) vs PCT (8.6 vs 5.6 mo; HR [95% CI] 0.54 [0.41-0.71]; P < 0.0001). Patient-reported outcomes favored TALA, and most common adverse events included anemia, fatigue, and nausea. Previous subgroup analyses found that pts with a history of CNS metastases had improved PFS for TALA vs PCT (HR [95% CI] 0.32 [0.15-0.68]; P = 0.0016) and improved objective response rate (ORR) 63.2% vs 15.8%, respectively (odds ratio [95% CI] 8.95 [1.86-52.26]; P = 0.0013). This retrospective subgroup analysis further explored the clinical characteristics and outcomes in pts with a history of CNS metastases in EMBRACA. Methods: Pts were randomized 2:1 to TALA or PCT. Pts with adequately treated and stable CNS metastases not requiring corticosteroids were included. This analysis assessed intracranial ORR and best overall response (BOR) based on investigator assessment per RECIST 1.1 in pts with intracranial disease at baseline (data cutoff 15-Sep-17), and overall survival (OS; data cutoff 30-Sep-19). Results: In the intent-to-treat (ITT) population, 63 pts (43/287 [15.0%] TALA and 20/144 [13.9%] PCT) had a history of CNS metastases, of which 33 (11.5%) pts (TALA) and 15 (10.4%) pts (PCT) had intracranial disease at baseline. Additional baseline characteristics are shown in the table. Intracranial ORR in pts with intracranial disease at baseline and unconfirmed complete or partial response was 18.2% (TALA) vs 20.0% (PCT) (odds ratio [95% CI] 0.78 [0.13-5.80]; P = 0.765). In pts with intracranial disease at baseline, an intracranial BOR of stable disease was 69.7% for TALA vs 33.3% for PCT. Median OS in pts with a history of CNS metastases was 12.9 mo (95% CI 9.4-15.6) for TALA and 13.4 mo (95% CI 8.8-17.6) for PCT (HR [95% CI] 0.67 [0.37-1.2]; P = 0.1936 [stratified log-rank test]). In the safety population ([n = 43, TALA]; [n = 19, PCT]), median treatment duration (range) with TALA was 5.0 (0.1-36.0) mo compared with 2.1 (0.4-6.9) mo for PCT. Conclusions: In this subgroup analysis, baseline characteristics between pts with a history of CNS metastases treated with TALA or PCT were comparable. More pts with intracranial disease at baseline treated with TALA vs PCT experienced stable disease. Intracranial ORR in pts with intracranial disease was 18.2% for TALA vs 20.0% for PCT. Treatment options for pts with a history of CNS metastases are limited and further investigation in larger data sets is warranted. Clinical trial information: NCT01945775 .[Table: see text]

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