Glucagon-like peptide-1 receptor agonists compared with basal insulins for the treatment of type 2 diabetes mellitus: a systematic review and meta-analysis.

AIMS: Since 2005, several glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been approved to treat people with type 2 diabetes. These agents are considered for use at the same point in the treatment paradigm as basal insulins. A comprehensive comparison of these drug classes, therefore, can help inform treatment decisions. This systematic review and meta-analysis assessed the clinical efficacy and safety of GLP-1 RAs compared with basal insulins. MATERIALS AND METHODS: MEDLINE, EMBASE, CENTRAL and PubMed databases were searched. Randomized clinical trials (RCTs) of ≥16 weeks' duration comparing GLP-1 RAs vs basal insulins in adults with type 2 diabetes inadequately controlled with oral antihyperglycemic drugs were included. Data on the change from baseline to 26 weeks (±10 weeks) of treatment in hemoglobin A1c (HbA1c) and weight, as well as the proportion of patients experiencing hypoglycaemia, were extracted. Fixed-effect pairwise meta-analyses were conducted where data were available from ≥2 studies. RESULTS: Fifteen RCTs were identified and 11 were meta-analysed. The once-weekly GLP-1 RAs, exenatide long acting release (LAR) and dulaglutide, led to greater, statistically significant mean HbA1c reductions vs basal insulins (exenatide: -0.31% [95% confidence interval -0.42, -0.19], dulaglutide: -0.39% [-0.49, -0.29]) whilst once-daily liraglutide and twice-daily exenatide did not (liraglutide: 0.06% [-0.06, 0.18], exenatide: 0.01% [-0.11, 0.13]). Mean weight reduction was seen with all GLP-1 RAs while mean weight gain was seen with basal insulins. Interpretation of the analysis of hypoglycaemia was limited by inconsistent definitions and reporting. Because of the limited number of available studies sensitivity analyses to explore heterogeneity could not be conducted. CONCLUSIONS: Although weight reduction is seen with all GLP-1 RA's, only the once-weekly agents, exenatide LAR and dulaglutide, demonstrate significant HbA1c reductions when compared to basal insulins.

The development of scales to measure childhood cancer survivors' readiness for transition to long-term follow-up care as adults.

PURPOSE: To develop and validate scales to measure constructs that survivors of childhood cancer report as barriers and/or facilitators to the process of transitioning from paediatric to adult-oriented long-term follow-up (LTFU) care. METHODS: Qualitative interviews provided a dataset that were used to develop items for three new scales that measure cancer worry, self-management skills and expectations about adult care. These scales were field-tested in a sample of 250 survivors aged 15-26 years recruited from three Canadian hospitals between July 2011 and January 2012. Rasch Measurement Theory (RMT) analysis was used to identify the items that represent the best indicators of each scale using tests of validity (i.e. thresholds for item response options, item fit statistics, item locations, differential item function) and reliability (Person Separation Index). Traditional psychometric tests of measurement performance were also conducted. RESULTS: RMT led to the refinement of a 6-item Cancer Worry scale (focused on worry about cancer-related issues such as late effects), a 15-item Self-Management Skills scale (focused on skills an adolescent needs to acquire to manage their own health care), and a 12-item Expectations scale (about the nature of adult LTFU care). Our study provides preliminary evidence about the reliability and validity of these new scales (e.g. Person Separation Index ≥ 0.81; Cronbach's α ≥ 0.81; test-retest reliability ≥ 0.85). CONCLUSION: There is limited knowledge about the transition experience of childhood cancer survivors. These scales can be used to investigate barriers survivors face in the process of transition from paediatric to adult care.

Feasibility of a randomized controlled trial to evaluate the impact of decision boxes on shared decision-making processes.

BACKGROUND: Decision boxes (DBoxes) are two-page evidence summaries to prepare clinicians for shared decision making (SDM). We sought to assess the feasibility of a clustered Randomized Controlled Trial (RCT) to evaluate their impact. METHODS: A convenience sample of clinicians (nurses, physicians and residents) from six primary healthcare clinics who received eight DBoxes and rated their interest in the topic and satisfaction. After consultations, their patients rated their involvement in decision-making processes (SDM-Q-9 instrument). We measured clinic and clinician recruitment rates, questionnaire completion rates, patient eligibility rates, and estimated the RCT needed sample size. RESULTS: Among the 20 family medicine clinics invited to participate in this study, four agreed to participate, giving an overall recruitment rate of 20%. Of 148 clinicians invited to the study, 93 participated (63%). Clinicians rated an interest in the topics ranging 6.4-8.2 out of 10 (with 10 highest) and a satisfaction with DBoxes of 4 or 5 out of 5 (with 5 highest) for 81% DBoxes. For the future RCT, we estimated that a sample size of 320 patients would allow detecting a 9% mean difference in the SDM-Q-9 ratings between our two arms (0.02 ICC; 0.05 significance level; 80% power). CONCLUSIONS: Clinicians' recruitment and questionnaire completion rates support the feasibility of the planned RCT. The level of interest of participants for the DBox topics, and their level of satisfaction with the Dboxes demonstrate the acceptability of the intervention. Processes to recruit clinics and patients should be optimized.

Real-World Treatment Patterns and Survival Among Patients with Stage I-III, Non-Squamous, Non-Small Cell Lung Cancer Receiving Surgery as Primary Treatment.

INTRODUCTION: Approximately half of patients with non-small cell lung cancer (NSCLC) present with early-stage disease at diagnosis. Real-world outcomes data are limited for this population but are of interest given recent and impending results from trials evaluating epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) and immunotherapies in neoadjuvant, adjuvant, and perioperative settings. METHODS: A retrospective, longitudinal, population-level study was conducted in patients diagnosed with resected stage I-III non-squamous NSCLC in Ontario, Canada, between April 2010 and March 2019. Study outcomes included patient characteristics and median overall survival (mOS), with stratification by disease stage and treatment exposure. Patients receiving EGFR-TKIs (assumed EGFR mutation-positive by proxy) were a key population of interest. RESULTS: Among 8255 cases, 4881 had stage I, 2124 had stage II, and 1250 had stage III NSCLC at diagnosis. The mean patient age was 68 years; 53.5% were female. In the overall cohort, 19.6% received adjuvant chemotherapy. Receipt of adjuvant chemotherapy was associated with significantly longer mOS than not receiving such therapy: stage II (7.6 [95% confidence interval: 6.5-8.5] vs. 4.4 [4.0-4.9] years) or stage III (4.4 [3.6-5.1] vs. 2.7 [2.3-3.3] years), both p < 0.0001. Patients receiving treatment (EGFR-TKIs and chemotherapy) were assumed to have experienced disease recurrence/relapse; mOS was longer among those receiving an EGFR-TKI than among those receiving chemotherapy (2.3 [1.8-3.0] vs. 1.1 [1.0-1.3] years). CONCLUSION: In Ontario, between 2010 and 2019, uptake of adjuvant therapy was low among patients with resected NSCLC, despite such therapy being associated with improved survival. Patients assumed to have recurred/relapsed had markedly reduced mOS, regardless of subsequent therapy, compared with those who did not relapse/recur. Novel peri-adjuvant treatment options are needed to enhance outcomes after lung resection.

Real-world treatment patterns and survival outcomes for treated biliary tract cancer patients using administrative databases in Ontario.

Background: There are limited data available on treatment patterns and outcomes of biliary tract cancers (BTCs) in Canada. The aim of this study was to understand treatment patterns, survival outcomes and healthcare resource use of BTC patients in Ontario, Canada. Methods: We conducted a retrospective population-level study using administrative data of patients diagnosed with advanced or metastatic BTC between January 1, 2010 and December 31, 2019. Results: A total of 2,142 BTC patients were identified; 702 (32.8%) with intrahepatic cholangiocarcinoma, 688 (32.1%) with extrahepatic cholangiocarcinoma, 363 (16.9%) with gallbladder cancer, 174 (8.1%) with ampulla of Vater cancer, and 215 (10.0%) with other types of BTC. In total, 1,314 patients (61.3%) were recurrent cases, and 828 (38.7%) were diagnosed with de novo advanced disease. A total of 1,727 patients (80.6%) received first-line systemic treatment of cisplatin plus gemcitabine (75.2%), FOLFOX [5-fluorouracil (5-FU), folinic acid (FA), and oxaliplatin] or FOLFIRI (5-FU, FA, and irinotecan) (11.5%), carboplatin plus gemcitabine (7.6%), or gemcitabine plus taxane (5.7%). Five hundred and twelve patients (29.6%) went on to receive a second-line treatment. Mean and median overall survival from diagnosis was 20.6 and 11.0 months, respectively. Mean and median overall survival from diagnosis was much higher among patients who received a systemic treatment at 23.8 and 14.1 months, respectively compared to 7.0 and 3.3 months, respectively for untreated patients (P<0.0001). Conclusions: Platinum and gemcitabine combinations are the most common first-line treatments. However, only a small proportion of patients go on to receive subsequent treatments. Survival in treated patients is higher than that in untreated patients. Our findings highlight the unmet need for effective systemic therapies for BTC.

Real-world predictors of survival in patients with extensive-stage small-cell lung cancer in Manitoba, Canada: a retrospective cohort study.

Background: Extensive-stage small-cell lung cancer (ES-SCLC) is an incurable cancer with poor prognosis in which characteristics predictive of long-term survival are debated. The utility of agents such as immune checkpoint inhibitors highlights the importance of identifying key characteristics and treatment strategies that contribute to long-term survival and could help guide therapeutic decisions. Objective: This real-world analysis examines the characteristics, treatment patterns, and clinical outcomes of patients receiving chemotherapy without immunotherapy for ES-SCLC in Manitoba, Canada. Methods: A retrospective cohort study assessed patient characteristics, treatment, and survival duration (short: <6 months; medium: 6-24 months; long: >24 months) using the Manitoba Cancer Registry and CancerCare Manitoba records. Eligible patients were aged >18 years with cytologically confirmed ES-SCLC diagnosed between January 1, 2004, and December 31, 2018, and received cytotoxic chemotherapy (CT). The one-, two-, and five-year probabilities of overall survival (OS) were assessed relative to patient, disease, and treatment characteristics using Kaplan-Meier methods and Cox proportional hazards models. Results: This analysis included 537 patients. Cisplatin was used in 56.1% of patients, 45.6% received thoracic radiotherapy (RT), and few received prophylactic cranial irradiation (PCI). In the overall cohort, one-, two- and five-year OS rates were 26%, 8%, and 3%, respectively. For patients with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, OS rates at one, two, and five years were 43%, 17%, and 10%, respectively, vs. 27%, 8%, and 2% for those with ECOG PS 1-2, and 16%, 3%, and 3% for those with ECOG PS 3-4. In long-term survivors, ECOG PS scores were lower and abnormal laboratory test results were less frequent. Overall, 74.4% of long-term survivors received thoracic RT and 53.5% received PCI. Known poor prognostic factors - including brain/liver metastases, high lactate dehydrogenase (LDH), abnormal sodium, and low hemoglobin levels - were less common but still seen in long-term survivors. Conclusion: Although rare, patients with ES-SCLC may experience long-term survival with CT ± thoracic RT ± PCI. Factors predicting long-term survival include traditional prognostic factors such as ECOG PS, LDH level, and receipt of thoracic RT or PCI. These findings support current treatment algorithms for ES-SCLC and provide baseline survival estimates to assess the real-world impact of adding immune checkpoint inhibitors in the future.

Real-world predictors of survival in patients with limited-stage small-cell lung cancer in Manitoba, Canada.

Background: Although therapy for limited-stage small-cell lung cancer (LS-SCLC) is administered with curative intent, most patients relapse and eventually die of recurrent disease. Chemotherapy (CT) with concurrent radiotherapy (RT) remains the standard of care for LS-SCLC; however, this could evolve in the near future. Therefore, understanding the current prognostic factors associated with survival is essential. Objective: This real-world analysis examines factors associated with long-term survival in patients with LS-SCLC treated with CT in Manitoba, Canada. Methods: A retrospective cohort study was conducted using Manitoba Cancer Registry and CancerCare Manitoba records. Eligible patients were aged >18 years and had cytologically confirmed LS-SCLC diagnosed between January 1, 2004, and December 31, 2018, for which they received CT ± RT. Baseline patient, disease, and treatment characteristics and survival duration, characterized as short (<6 months), medium (6-24 months), and long term (>24 months), were extracted. Overall survival (OS) was estimated at one, two, and five years and assessed using Kaplan-Meier methods and Cox proportional hazards models. Results: Over the 15-year study period, 304 patients met the eligibility criteria. Long-term survivors comprised 39.1% of the cohort; at diagnosis, this subgroup was younger, more likely to have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, and have normal lactate dehydrogenase, sodium, and hemoglobin levels. OS estimates for the entire cohort at one, two, and five years were 66%, 38%, and 18%, respectively. In the ECOG PS 0 subgroup, OS estimates at one, two, and five years were 85%, 52%, and 24%, respectively; OS estimates were 60%, 35%, and 17%, respectively, for ECOG PS 1-2 and were 47%, 23%, and 10%, respectively, for ECOG PS 3-4. OS was significantly higher among patients with normal serum sodium and hemoglobin levels than those with abnormal levels. Univariable hazard regression models found that ECOG PS, age at diagnosis, receipt of prophylactic cranial irradiation (PCI), and thoracic RT were associated with survival. On multivariable hazard regression, ECOG PS and receipt of PCI were associated with survival. Conclusion: Survival for greater than two years in patients with LS-SCLC treated with CT ± RT was associated with ECOG PS and receipt of PCI.

Demands and rewards associated with working in pediatric oncology: a qualitative study of Canadian health care providers.

OBJECTIVE: Despite recent advances in the outcome of children with cancer, the demands on medical professionals caring for these patients can be intense. Our qualitative study explored the work-related demands and rewards experienced by Canadian pediatric oncology staff. STUDY DESIGN: Interviews were conducted with 33 staff members (10 oncologists, 3 subspecialty residents, 9 nurses, 5 social workers, and 6 child life specialists) from 4 hospitals. Participants were asked to describe work-related rewards and demands. Interviews were recorded and transcribed verbatim. Interview transcripts were analyzed to identify all sources of demands and rewards. RESULTS: Pediatric oncology staff described work-related rewards and demands related to the following areas: (1) working with children; (2) working with families; (3) working within a multidisciplinary health care team; (4) working in a pediatric oncology unit; and (5) working within a hospital or academic health center. Overall, health care providers described their job as fulfilling and meaningful. For most health care providers, many work-related issues were described as both rewarding and demanding. CONCLUSIONS: Our study identifies important demands and rewards associated with working in pediatric oncology. Future research could explore the relationship between work-related stress and job satisfaction and how these factors either cause or prevent burnout syndrome.

EGFR mutation prevalence, real-world treatment patterns, and outcomes among patients with resected, early-stage, non-small cell lung cancer in Canada.

OBJECTIVES: The ADAURA trial demonstrated the benefit of adjuvant osimertinib among patients with resected, early-stage, epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). To understand the potential population impact, it is critical to deduce the prevalence, management, and outcomes of this patient population in the real-world setting before use of adjuvant osimertinib. MATERIALS AND METHODS: Using PALEOS (Pan-cAnadian Lung cancEr Observational Study) data (2012-2019), a retrospective, multi-center, observational cohort study was conducted among patients with early-stage (IB-IIIA) resected NSCLC who had not received neoadjuvant therapy. Study outcomes included EGFRm prevalence, treatment patterns, recurrence outcomes, and overall and disease-free survival (OS/DFS). RESULTS: Among patients undergoing reflexive EGFRm testing by a pathologist at time of diagnosis irrespective of disease stage (N = 535), 23 % were EGFRm-positive; 15.9 % had common mutations and 5.6 % had uncommon mutations. Within the EGFRm-positive cohort (N = 156), mean age at diagnosis was 68 years, 65 % of patients were female, and 35 % were of Asian descent. At diagnosis, 48 %, 31 %, and 21 % had stage IB, II, or IIIA disease, respectively; 46 % received adjuvant therapy after resection. Half of patients experienced disease recurrence, typically involving distant sites; central nervous system metastasis varied from 12 % to 15.0 % across disease stages. EGFR tyrosine kinase inhibitors were the most commonly received therapy after first metastatic recurrence. Median OS (DFS) was not reached, 71.2 (22.8) months, and 50.1 (18.0) months among stage IB, II, and IIIA patients. Patients with uncommon EGFRm had a lower probability of survival than those with common EGFRm (2 years: 87 % vs 91 %-94 %; 4 years: 56 % vs 73 %-82 %). CONCLUSION: Approximately-one-quarter of patients with resected, early-stage NSCLC were EGFRm-positive in this study. These patients had high recurrence rates and suboptimal long-term survival after treatment with current therapies. New adjuvant treatments are warranted.

Real-world treatment patterns, clinical outcomes, and health care resource utilization in advanced unresectable hepatocellular carcinoma.

BACKGROUND: The incidence of advanced unresectable hepatocellular carcinoma (HCC) is increasing in developed countries and the prognosis of advanced HCC remains poor. Real-world evidence of treatment patterns and outcomes can highlight the unmet clinical need. METHODS: We conducted a retrospective population-based cohort study of patients with advanced unresectable HCC diagnosed in Alberta, Canada (2008-2018) using electronic medical records and administrative claims data. A chart review was conducted on patients treated with systemic therapy to capture additional information related to treatment. RESULTS: A total of 1,297 advanced HCC patients were included of whom 555 (42.8%) were recurrent cases and the remainder were unresectable at diagnosis. Median age at diagnosis was 64 (range 21-94) years and 82.1% were men. Only 274 patients (21.1%) received first-line systemic therapy and, of those, 32 patients (11.7%) initiated second-line therapy. Nearly all of the patients received sorafenib (>96.4%) in first-line, and these patients had considerably higher median survival (12.23 months; 95% CI 10.72-14.10) compared with patients not treated with systemic therapy (2.66 months; 95% CI 2.33-3.12; log-rank p <0.001). Among patients treated with systemic therapy, overall survival was higher for recurrent cases, patients with Child-Pugh A functional status, and patients with HCV or multiple known HCC risk factors (p <0.05). CONCLUSIONS: In a Canadian real-world setting, patients who received systemic therapy had greater survival than those who did not, but outcomes were universally poor. These results underscore the need for effective front-line therapeutic options.

Real-World Treatment Patterns, Clinical Outcomes, and Health Care Resource Utilization in Extensive-Stage Small Cell Lung Cancer in Canada.

The prognosis for extensive-stage small cell lung cancer (ES-SCLC) is poor. Real-world evidence can highlight the unmet clinical need within this population. We conducted a population-based cohort study of ES-SCLC patients diagnosed in a large Canadian province (2010-2018) using electronic medical records and administrative claims data. In all, 1941 ES-SCLC patients were included, of which 476 (25%) were recurrent cases. Median age at diagnosis was 70 years (range: 39-94) and 50.2% were men. Of the 1941 ES-SCLC patients, 29.5% received chemotherapy and radiotherapy, 17.0% chemotherapy alone, 8.7% radiotherapy alone, and 44.8% received best supportive care. Chemotherapy was initiated by 46.5%, 8.5%, and 1.4% of first-, second-, and third-line patients, with lower uptake for recurrent cases. Median survival from first-, second-, and third-line chemotherapy was 7.82 months (95% CI: 7.50-8.22), 5.72 months (95% CI: 4.90-6.87), and 3.83 months (95% CI: 2.99-4.60). Among patients who received first-line therapy, the 2-year and 5-year survival was 7.3% (95% CI: 5.7-9.2) and 2.9% (95% CI: 1.8-4.5). In conclusion, initiation of first-line treatment in ES-SCLC was low with significant attrition in subsequent lines. These results underscore the need for effective front-line treatments and highlight the potential for novel therapies to improve patient outcomes.

Identification of Patient Characteristics Influencing Setting of Care Decisions for Patients With Acute Bacterial Skin and Skin Structure Infections: Results of a Discrete Choice Experiment.

PURPOSE: Rates of acute bacterial skin and skin structure infections (ABSSSI) have sharply increased since 2000. Treatment may be administered in the inpatient or outpatient setting; clinical decision-making regarding hospitalization is inconsistent, often leading to hospitalization of some patients with ABSSSI who qualify for outpatient parenteral antimicrobial therapy, which leads to increased overall care costs. New antibiotics such as oritavancin are hypothesized to be a cost-effective option improving accessibility to ambulatory treatment of ABSSSI. The goal of this study was to understand the patient attributes that affect clinical decision-making regarding the setting of care for ABSSSI treatment. METHODS: An observational, cross-sectional study was conducted that surveyed clinicians of various specialties from the United States and the United Kingdom. The survey collected quantitative responses and used a series of choice-based experimental designs to evaluate patient attributes influencing clinical treatment decisions. FINDINGS: Infection severity, severe comorbidities, and age ≥ 75 years were observed to have the greatest impact on treatment location decisions (odds ratio [OR], 0.000-0.004 [95% CI, 0.000-0.011], vs mild ABSSSI; OR, 0.246-0.484 [95% CI, 0.154-0.788], vs no active comorbidities; OR, 0.136-0.523 [95% CI, 0.070-0.888], vs ≤ 18 years, respectively). The majority of respondents indicated they would consider oritavancin to avoid postdischarge outpatient parenteral antimicrobial therapy or oral therapy, regardless of the pathogen (63.5%-83.5%). IMPLICATIONS: Key factors influencing ABSSSI treatment setting were severity of infection, severity of comorbidities, and age. Clinicians surveyed identified patient profiles in which single-dose oritavancin might enable wholly outpatient or shortened inpatient management. Additional studies to elucidate the ABSSSI care pathways that include oritavancin and other novel antibiotics are needed.

Examining factors associated with self-management skills in teenage survivors of cancer.

BACKGROUND: Monitoring long-term health of teenage cancer survivors is dependent on successful transition from pediatric to adult long-term follow-up (LTFU) care. This study identified factors associated with self-management skills (SMSs), an important correlate of successful transition. METHODS: Data were collected from a cross-sectional survey conducted at three Canadian hospitals between July 2011 and January 2012. The sample included 184 childhood cancer survivors aged between 15 and 19 years. Independent factors included demographic- and illness-related factors. The outcome of interest was SMSs, measured using the SMSs scale, with higher scores indicating more SMSs. RESULTS: More SMSs were associated positively with older age (ß = 1.2, 95 % confidence interval (CI) = 0.1 to 2.4), being female (ß = 4.6, 95 % CI = 1.9 to 7.4), and having a non-married parent (ß = 5.2, 95 % CI = 0.04 to 10.4). There was a negative association between SMSs and having had a central nervous system tumor (CNS) compared to having leukemia (ß = -7.9, 95 % CI = -13.5 to -2.2). CONCLUSIONS: Younger, male, and CNS tumor survivors lack SMSs. Future research is needed to explore the extent and nature of associations between SMSs and parents' marital status. IMPLICATIONS FOR CANCER SURVIVORS: Younger, male, and CNS tumor survivors should be targeted for interventions in order to ensure that adequate SMSs are attained before completion of transition.

Factors associated with childhood cancer survivors' knowledge about their diagnosis, treatment, and risk for late effects.

BACKGROUND: While most children with cancer survive their initial disease, cancer therapy places them at risk for late effects (LE). Knowledge of their diagnosis, treatment, and LE risk may motivate survivors to attend long-term follow-up care. The aims of this study were to examine knowledge of cancer history and future risks, and to identify factors associated with such knowledge, in a cohort of childhood cancer survivors. METHODS: Survivors (i.e., patients finished cancer treatment, regardless of time since completion) aged 15 to 26 years from three Canadian cancer centers were invited to complete a questionnaire that assessed knowledge of cancer history and potential LE of treatments, including five specific LE known to have considerable long-term health impact. Clinical data were extracted from hospital records and used to validate participants' answers. RESULTS: Of 250 participants, 16 (6%) were unable to name their cancer, 79 (32%) had partial or no knowledge of their therapy, and 83 (33%) were unaware of at least some of their risks for LE. Decreasing age (OR for increase in age = 1.2 (1.1-1.4)), having had a renal tumor compared to leukemia (OR = 0.3 (0.1-0.9)), and lacking knowledge about treatment (OR = 0.4 (0.2-0.9)) were associated with lack of knowledge of LE. Of the five, the most and least familiar LE was LE associated with impaired pulmonary function and risk of second malignancy, respectively. CONCLUSION: This study highlights knowledge deficits in survivors, specifically regarding their risk for LE. IMPLICATIONS FOR CANCER SURVIVORS: Findings can be utilized to target survivors at risk for knowledge deficits.

The Logistics and Coordination of Respiratory Syncytial Virus Immunoprophylaxis Use Among US Pediatric Specialists.

This study was conducted to survey US pediatric specialists about administration of respiratory syncytial virus (RSV) immunoprophylaxis, communication patterns among physicians and parents, and barriers to access. Separate surveys were sent to neonatologists, pediatricians, pediatric pulmonologists, and pediatric cardiologists. Most physicians (≥93.5%) routinely recommended immunoprophylaxis to high-risk children. Most respondents (≥71.8%) reported that >50.0% of eligible infants and young children received each monthly dose throughout the RSV season, with the first dose most commonly administered before discharge from the birth hospitalization. To ensure receipt of subsequent doses, specialists frequently scheduled a follow-up visit at the end of the current appointment. All specialists reported insurance denials as the biggest obstacle to the administration of immunoprophylaxis to high-risk children. These findings may be used to improve adherence to immunoprophylaxis by enhancing education and physician-parent communications about severe RSV disease prevention, and by reducing known barriers to use of this preventive therapy.

Perceived Risk of Severe Respiratory Syncytial Virus Disease and Immunoprophylaxis Use Among US Pediatric Specialists.

This study was conducted to assess the perception of US pediatric specialists of respiratory syncytial virus (RSV) disease risk and determine their clinical practices regarding immunoprophylaxis for high-risk children. Separate surveys were sent to neonatologists, pediatricians, pediatric pulmonologists, and pediatric cardiologists. Data were collected using structured questions requiring quantitative responses. Most neonatologists and pediatricians (>82.7%) reported a high clinical need for RSV immunoprophylaxis in preterm infants <32 weeks' gestational age. Pediatric pulmonologists and pediatric cardiologists suggested that health conditions indicative of chronic lung disease of prematurity and hemodynamically significant congenital heart disease, respectively, confer eligibility for RSV immunoprophylaxis. Agreement with the changes in the 2014 American Academy of Pediatrics guidance for RSV immunoprophylaxis was mixed among respondents from the 4 specialties. Survey findings may provide a basis to improve education about risk for severe RSV disease and evaluate changes in physician use of RSV immunoprophylaxis based on the 2014 guidance.

Exploring Cancer Worry in Adolescent and Young Adult Survivors of Childhood Cancers.

PURPOSE: Adolescent and young adult (AYA) survivors of cancers in childhood experience cancer worry, defined as concerns about cancer-related issues such as relapse and late effects of treatment. Cancer worry is an important determinant of successful transition to long-term follow-up care. The primary aim of this study was to identify patient-, cancer-, and treatment-related factors associated with cancer worry in AYA survivors. A secondary aim was to explore and understand inappropriate cancer worry (e.g., worry of developing a late effect when not at risk) in this population. METHODS: Two hundred and fifty AYA survivors, aged 15­26 years, completed a 6-item Cancer Worry Scale. Selection of factors potentially associated with cancer worry was guided by literature and expert opinion for inclusion in univariable and multivariable regression analyses. RESULTS: Female survivors reported significantly more cancer worry than males did (b=-9.4; 95% CI -14.4 to -4.5; p < 0.001). Survivors treated with the most intensive therapies reported more cancer worry compared with those who received the least intensive therapies (b=-18.5; 95% CI -31.2 to -5.9; p = 0.004). Thirty-one percent of participants had inappropriate worry regarding infertility and/or secondary malignancy. CONCLUSIONS: In AYA survivors, female sex and higher treatment intensity were associated with increased cancer worry. Inappropriate worry was prevalent among survivors and may contribute to unnecessary distress. These findings can help identify survivors who are more likely to worry and support the development of appropriate services to reduce the effect of cancer worry on survivor well-being.

Quality of life of children treated for cleft lip and/or palate: a systematic review.

OBJECTIVE: Cleft lip and/or palate (CLP) is the most common congenital craniofacial anomaly. As a first step toward developing a quality of life (QOL) questionnaire for CLP patients, our team conducted a systematic literature review to identify studies that measured child- or proxy-reported outcomes of CLP. DESIGN: PUBMED, CINAHL, EMBASE and PsycINFO were searched from their inception to July 2010 to identify studies that measured health-related concepts in CLP patients. Abstract and title screening was performed by two screeners. Full texts of all potentially relevant papers were obtained and examined by two reviewers. We identified publications that measured health concepts and categorized them to form a preliminary conceptual framework of CLP QOL issues. RESULTS: A total of 4594 publications were identified. Twenty-six studies met our inclusion criteria. Research involved CLP patients living in nine countries with sample sizes ranging from 23 to 661. Health concepts were measured using 29 different questionnaires. No patient-reported outcome (PRO) instrument measuring QOL concerns of CLP patients currently exists. CLP-specific health concepts measured to date were categorized into a preliminary conceptual QOL framework with the following categories: physical, psychological and social health. CONCLUSIONS: Our review has helped to identify areas of health that have been well researched using either a patient or proxy patient-reported outcome instrument (e.g., self-concept; behavior) and areas where more research is required.