Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies.

INTRODUCTION: In the European Union (EU), the indication for the antifibrotic pirfenidone prior to April 2023 did not include patients with advanced idiopathic pulmonary fibrosis (IPF). This analysis compared the efficacy and safety of pirfenidone in advanced IPF versus non-advanced IPF. METHODS: Data were included from the following studies of pirfenidone: ASCEND (NCT01366209); CAPACITY (004 [NCT00287716] and 006 [NCT00287729]); RECAP (NCT00662038; advanced IPF defined as percent predicted forced vital capacity [%FVC] < 50% and/or percent predicted carbon monoxide diffusing capacity [%DLco] < 35% at baseline); PASSPORT (NCT02699879; advanced IPF defined as baseline %FVC < 50%); and SP-IPF (NCT02951429; patients with advanced IPF [defined as %DLco ≤ 40% at screening] at risk of group 3 pulmonary hypertension). RESULTS: In the pooled ASCEND/CAPACITY studies, the annual mean rate of FVC decline from baseline to Week 52 was significantly lower for pirfenidone versus placebo in advanced (p = 0.0035) and non-advanced IPF (p = 0.0001). Rate of all-cause mortality over 52 weeks was numerically lower for pirfenidone versus placebo in advanced and non-advanced IPF. In RECAP, the mean annual rate of FVC decline from baseline to Week 180 of pirfenidone treatment was similar in patients with advanced (- 141.5 mL) and non-advanced IPF (- 153.5 mL). In SP-IPF, the mean annual rate of FVC decline and rate of all-cause mortality from baseline to Week 52 in patients treated with placebo + pirfenidone were - 93.0 mL and 20.2%, respectively. No new safety signals were identified, and the safety profile of pirfenidone in patients with advanced IPF was generally consistent with that of non-advanced IPF. CONCLUSIONS: These results highlight the benefit of pirfenidone treatment in patients with advanced and non-advanced IPF. As such, the indication for pirfenidone in the EU has now been updated to include the treatment of adult patients with advanced IPF. TRIAL REGISTRATIONS: ASCEND (NCT01366209), CAPACITY 004 (NCT00287716), CAPACITY 006 (NCT00287729), RECAP (NCT00662038), PASSPORT (NCT02699879), and SP-IPF (NCT02951429).

Evolution of practice patterns in plastic surgery using Current Procedural Terminology mapping: a 9-year analysis of cases submitted by primary and recertification candidates to the American Board of Plastic Surgery.

BACKGROUND: Understanding plastic surgery practice patterns allows the specialty to detect subtle shifts in the market and develop proactive strategies to maintain market share. METHODS: Current Procedural Terminology codes from American Board of Plastic Surgery recertification and primary certification candidates from 2003 to 2011 were examined. Statistical analyses identified significant changes (p < 0.05) in the percentage of surgeons performing each type of procedure and trends in average case volume per surgeon. RESULTS: The overall number of procedures decreased from 2003 to 2011. There was a statistically significant (p < 0.05) decrease in the percentage of recertification and primary certification candidates performing facial cosmetic and facial malignancy procedures. Both groups also experienced statistically significant decrease in facial plastic surgery case volume. The percentage of surgeons performing breast reconstruction remained stable for the recertification group and increased significantly for primary certification surgeons. Breast reconstruction volume increased significantly for both groups. Craniofacial surgery remained stable in the percentage of surgeons performing the cases and case volume. Hand surgery experienced a significant loss of recertification surgeons performing hand surgery; however, hand surgery case volume remained stable for both groups. CONCLUSION: From 2003 to 2011, plastic surgery lost market share in facial cosmetic, facial malignancy, and hand surgery and maintained market share in breast and craniofacial surgery. CPT mapping enables us to analyze these trends to better train plastic surgeons to adapt to changing pressures both from economic recovery and from competing specialties seeking to benefit from redistribution of case loads.

Infant obesity and severe obesity growth patterns in the first two years of life.

Distinguishing an obesity growth pattern that originates during infancy is clinically important. Infancy based obesity prevention interventions may be needed while precursors of later health are forming. Infant obesity and severe obesity growth patterns in the first 2-years are described and distinguished from a normal weight growth pattern. A retrospective chart review was conducted. Body mass index (BMI) growth patterns from birth to 2-years are described for children categorized at 5-years as normal weight (n = 61), overweight (n = 47), obese (n = 41) and severely obese (n = 72) cohorts using WHO reference standards. BMI values were calculated at birth, 1-week; 2-, 4-, 6-, 9-, 12-, 15-, 18-months; and 2- and 5-years. Graphs of the longitudinal Analysis of Variance of Means of BMI values identified the earliest significant divergence of a cohort's average BMI pattern from other cohorts' patterns. ANOVA and Pearson Product Moment correlations were also performed. Statistically significant differences in BMI values and differences in growth patterns between cohorts were evident as early as 2-6 months post-birth. Children who were obese or severely obese at 5-years demonstrated a BMI pattern that differed within the first 2-years of life from that of children who were normal weight at 5-years. The earliest significant correlation between early BMI values and 5-year BMI value was at 4-months post-birth. The study fills an important gap by demonstrating early onset of an infant obesity growth pattern in full-term children who were healthy throughout their first 5 years of life.

Utilising infant growth to predict obesity status at 5 years.

AIM: This study determines if an early life growth pattern in healthy infants can predict obesity at age 5. METHODS: Randomly selected from all healthy children born from 1997 to 2001 in a Midwestern US Health Maintenance Organization; growth patterns from birth to 5 years were described for children who were categorised by obesity classification at 5 years into normal weight (n = 61), overweight (n = 47), obese (n = 41) and morbidly obese (n = 72) cohorts using World Health Organization body mass index (BMI) criteria. A retrospective longitudinal analysis based on weighted least squares was performed on BMI by age (1 week; 2, 4, 6, 9, 12, 15 and 18 months; and 2, 3, 4 and 5 years). Graphs of the longitudinal repeated measures analysis of variance of means allowed identification of the earliest significant divergence of a cohort's average BMI pattern from other cohorts' patterns. RESULTS: Distinctions in growth patterns and BMIs were evident before 1-year post-birth. Children who were obese or morbidly obese at 5 years demonstrated a BMI pattern that differed from children who were normal weight at 5 years. CONCLUSIONS: Identifying obesity development in early life may assist with prevention of later obesity. The results merit future study. An early life BMI growth pattern is clinically important because it permits discrimination of those who do and do not fit a normal weight pattern, guiding individualised interventions in the first year of life while precursors of later health are still forming.

A 9-year comparison of practice profiles of candidates for primary and recertification examinations of the American Board of Plastic Surgery relative to economic indicators.

BACKGROUND: This study compared the practice profiles of plastic surgeons applying for recertification/maintenance of certification with those applying for primary certification by the American Board of Plastic Surgery between 2003 and 2011. METHODS: American Board of Plastic Surgery case logs from both recertification and primary certification candidates from 2003 to 2011 were examined. Deidentified data included operative year, Current Procedural Terminology codes, and the candidate's designation of the case relative to (1) cosmetic or reconstructive and (2) the Maintenance of Certification in Plastic Surgery module (i.e., comprehensive, cosmetic, craniomaxillofacial, and hand). Department of Commerce unemployment data from 2003 to 2011 served as an economic indicator for the period studied. RESULTS: A negative trend in the median number of cases per candidate was observed for both groups for cosmetic, reconstructive, and total number of cases, corresponding to a rise in unemployment. With every 1 percent increase in the unemployment rate, recertification candidates demonstrated a greater loss of cosmetic cases relative to primary candidates and an accelerated decline in reconstructive cases starting in 2007. Distribution of the four Maintenance of Certification modules demonstrated a negative trend for cosmetic and comprehensive cases in both groups. Hand and craniofacial consistently constituted approximately 20 percent of cases for primary and 14 percent of cases for recertification candidates. There was a shift away from hand cases toward craniofacial cases in both groups. CONCLUSIONS: Both primary and recertification candidates reported a decline in overall caseload from 2003 to 2011. Negative economic trends have a greater impact on the practice profile of recertification candidates.

A pilot study: does obesity begin in the first year of life?

AIM: To determine if growth patterns in healthy infants can identify associations with obesity at age 5 years. METHOD: Body mass index growth patterns from birth to 1 year were described for cohorts of children who were classified at 5 years as normal weight (n = 61), overweight (n = 47), obese (n = 41), and morbidly obese (n = 72). A longitudinal analysis of body mass index means based on the age postbirth was conducted and graphed. RESULTS: Distinctions in growth patterns were evident before 1 year postbirth. Children who were normal weight at 5 years demonstrated a growth pattern in the first year that differed from children who were overweight, obese, or morbidly obese at 5 years. CONCLUSIONS: Obesity growth patterns were seen in infancy and are clinically important because identification of infants who do not fit a normal weight pattern can occur and thus guide individualized interventions in the first year postbirth while precursors of later health are still forming.

Bidirectional NK/DC interactions promote CD4 expression on NK cells, DC maturation, and HIV infection.

Interactions between natural killer (NK) and dendritic cells (DCs) are integral to immune response development, potentially leading to bidirectional NK/DC activation. We demonstrate that autologous NK/DC interactions induce CD4 expression on NK cells, influencing degranulation. Cell contact is required, with high NK:DC ratios and mature DCs most effectively inducing CD4 expression. CD4(+) NK cells, in turn, mediate DC maturation via contact-dependent and independent pathways, more effectively maturing DCs than CD4(-) NK cells. Bidirectional NK/DC interactions also impact HIV infection, as NK-matured DCs effectively deliver infectious HIV to T cells, via trans-infection. DC-induced CD4 expression also renders NK cells susceptible to HIV infection. Focusing on NK/DC interactions, DCs can transfer infectious virus and enhance HIV infection of CD4(+) NK cells, strongly suggesting that these interactions influence HIV pathogenesis. Findings provide new insight regarding NK/DC interactions, defining a mechanism by which cellular interactions in the absence of pathogens promote DC-mediated amplification of HIV infection.

Fall Risk Assessment in Geriatric-Psychiatric Inpatients to Lower Events (FRAGILE).

The objectives of this retrospective case-control study were to identify risk factors of falls in geriatric-psychiatric inpatients and develop a screening tool to accurately predict falls. The study sample consisted of 225 geriatric-psychiatric inpatients at a Midwestern referral facility. The sample included 136 inpatients who fell and a random stratified sample of 89 inpatients who did not fall. Data collected included age, gender, activities of daily living, and nursing parameters such as bathing assistance, bed height, use of bed rails, one-on-one observation, fall warning system, Conley Scale fall risk assessment, medical diagnosis, and medications. History of falls, impaired judgment, impaired gait, dizziness, delusions, delirium, chronic use of sedative or antipsychotic agents, and anticholinergic urinary bladder medications significantly increased fall risk. Alzheimer's disease, acute use of sedative or anti-psychotic agents, and depression reduced fall risk. A falls risk tool, Fall Risk Assessment in Geriatric-psychiatric Inpatients to Lower Events (FRAGILE), was developed for assessment and risk stratification with new diagnoses or medications.

A naturalistic evaluation of psychosocial interventions for cancer patients in a community setting.

We used a naturalistic methodology to examine associations between change in cancer patients' emotional functioning and their use of interventions in a community organization. One-hundred ninety-two patients completed measures at baseline and 6 months later. During this time, they utilized the organization's various interventions as they wished. Attendance at educational events was associated with decreased well-being. Use of art therapy groups was not associated with decreases in negative emotion but was consistently associated with increases in positive emotion. Improved functioning on some measures was associated with use of psychoeducational groups, expressive/supportive groups, movement classes, healing arts, and a buddy-matching service.

Coping-related variables associated with individual differences in adjustment to cancer.

This study examined relationships between emotional adjustment and a number of coping styles and strategies in people with cancer. Two-hundred eighty-three adults completed measures of positive and negative emotions, subjective ratings of cancer-related symptoms and functional impairment, coping strategies, hope, benefit finding, emotional approach/avoidance, and cancer-related social support. Among the coping strategies, self-blame and behavioral disengagement were consistently associated with poor adjustment, while acceptance and humor were consistently associated with good adjustment. Among the broader measures of coping style, there were associations between poor adjustment and emotional processing, and between good adjustment and hope, benefit finding, and cancer-related social support.