Delays Starting Postoperative Radiotherapy Among Head and Neck Cancer Patients: A Systematic Review and Meta-analysis.

OBJECTIVE: Initiating postoperative radiotherapy (PORT) within 6 weeks (42 days) of surgery is the first and only Commission on Cancer (CoC) approved quality metric for head and neck squamous cell carcinoma (HNSCC). No study has systematically reviewed nor synthesized the literature to establish national benchmarks for delays in starting PORT. DATA SOURCES: Following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, we performed a systematic review of PubMed, Scopus, and CINAHL. REVIEW METHODS: Studies that described time-to-PORT or PORT delays in patients with HNSCC treated in the United States after 2003 were included. Meta-analysis of proportions and continuous measures was performed on nonoverlapping datasets to examine the pooled frequency of PORT delays and time-to-PORT. RESULTS: Thirty-six studies were included in the systematic review and 14 in the meta-analysis. Most studies utilized single-institution (n = 17; 47.2%) or cancer registry (n = 16; 44.4%) data. Twenty-five studies (69.4%) defined PORT delay as >6 weeks after surgery (the definition utilized by the CoC and National Comprehensive Cancer Network Guidelines), whereas 4 (11.1%) defined PORT delay as a time interval other than >6 weeks, and 7 (19.4%) characterized time-to-PORT without defining delay. Meta-analysis revealed that 48.6% (95% confidence interval [CI], 41.4-55.9) of patients started PORT > 6 weeks after surgery. Median and mean time-to-PORT were 45.8 (95% CI, 42.4-51.4 days) and 47.4 days (95% CI, 43.4-51.4 days), respectively. CONCLUSION: Delays in initiating guideline-adherent PORT occur in approximately half of patients with HNSCC. These meta-analytic data can be used to set national benchmarks and assess progress in reducing delays.

The placebo effect in randomized-controlled trials of medical treatments for chronic rhinosinusitis: A systematic review and meta-analysis.

BACKGROUND: The placebo effect observed in clinical trials evaluating medical treatments for chronic rhinosinusitis (CRS) is not well understood. This systematic review and meta-analysis sought to characterize the placebo effect present within CRS outcomes. METHODS: A systematic review of PubMed, Scopus, and Cumulated Index in Nursing and Allied Health Nursing (CINAHL) was performed. Randomized controlled trials (RCTs) evaluating medical treatments for CRS versus placebo were included. We assessed patient-reported (sino-nasal outcome test 22 [SNOT-22], nasal obstruction, sense of smell, nasal obstruction visual analogue score [VAS], sense of smell VAS, anterior rhinorrhea, and postnasal drip) and objective (Lund-Mackay Computed tomography (CT) score, peak nasal inspiratory flow [PNIF], nasal polyp scores, 40-item Smell Identification Test, serum IgE, and blood eosinophil levels) outcomes. RESULTS: Twenty-one RCTs were included, comprising 1437 patients (mean age 49.2 years). Biologics were the most common treatment investigated (n = 9). Eleven studies administered background steroids along with placebo. Following placebo administration, multiple patient-reported outcomes significantly decreased, including SNOT-22 (mean difference -9.49, 95% confidence interval [CI] [-11.26, -7.73]), nasal obstruction (-0.33 [-0.54, -0.13]), sense of smell (-0.22 [-0.33, -0.11]), nasal obstruction VAS (-2.47 [-2.87, -2.06]), and loss of smell VAS (-2.31 [-4.14, -0.47]) scores. For objective measures, significant changes occurred in Lund-Mackay CT score (-0.82, [-1.48, -0.16]) and PNIF (4.70, [4.76, 24.64]) with placebo. Placebo arms had the greatest impact when no background medications were used. CONCLUSIONS: Placebo treatments have a statistically and potentially clinically significant effect on patient-reported and some objective CRS outcomes. Further investigation is required to fully understand placebo effect, which could improve assessment of RCTs and impact patient care.

ACG Clinical Guideline: Diagnosis and Management of Biliary Strictures.

A biliary stricture is an abnormal narrowing in the ductal drainage system of the liver that can result in clinically and physiologically relevant obstruction to the flow of bile. The most common and ominous etiology is malignancy, underscoring the importance of a high index of suspicion in the evaluation of this condition. The goals of care in patients with a biliary stricture are confirming or excluding malignancy (diagnosis) and reestablishing flow of bile to the duodenum (drainage); the approach to diagnosis and drainage varies according to anatomic location (extrahepatic vs perihilar). For extrahepatic strictures, endoscopic ultrasound-guided tissue acquisition is highly accurate and has become the diagnostic mainstay. In contrast, the diagnosis of perihilar strictures remains a challenge. Similarly, the drainage of extrahepatic strictures tends to be more straightforward and safer and less controversial than that of perihilar strictures. Recent evidence has provided some clarity in multiple important areas pertaining to biliary strictures, whereas several remaining controversies require additional research. The goal of this guideline is to provide practicing clinicians with the most evidence-based guidance on the approach to patients with extrahepatic and perihilar strictures, focusing on diagnosis and drainage.

The efficacy of psychosocial interventions for cancer caregiver burden: A systematic review and meta-analysis of randomized controlled trials.

Caregivers of adults with cancer often provide prolonged demanding assistance (e.g., physical, emotional) to their loved ones, resulting in caregiver burden. This meta-analytic review examined the efficacy of psychosocial interventions in reducing caregiver burden in caregivers of adults with cancer. Randomized controlled trials (RCTs) were identified from six electronic databases and clinical trial registries. Random-effects meta-analyses were conducted for subgroups of interventions and control conditions. Overall, 90 records describing 50 RCTs showed that psychosocial interventions reduced caregiver burden compared to passive controls (e.g. wait-list) at post-intervention (g = 0.26, 95%CI [0.12, 0.40]), but not at the first follow-up (g = 0.10, 95%CI [-0.05, 0.24]). Subgroup analyses showed that compared to passive controls, therapeutic counseling and skills training interventions significantly reduced caregiver burden at post-intervention, whereas psycho-education/support interventions did not significantly reduce burden. Very few RCTs examined intervention efficacy compared to active controls (e.g., psycho-education/support). The evidence grade ranged from very low to moderate due to inconsistency and imprecision of the results. Therapeutic counseling and skills training interventions appear efficacious in improving caregiver burden at post-intervention, although these improvements attenuate over time. Rigorous trials examining intervention effects on long-term outcomes are needed to better understand the effective mechanisms to sustain reduction in caregiver burden.

Trends and Outcomes of Fungal Temporal Bone Osteomyelitis: A Scoping Review.

INTRODUCTION: Temporal bone osteomyelitis is an invasive infection most often caused by bacteria and associated with high mortality. Fungal etiologies are rare and little is known of the predictors of disease severity and outcomes in fungal temporal bone osteomyelitis. MATERIALS AND METHODS: A scoping review was performed to determine what is known from the literature on how clinical, diagnostic, and treatment characteristics relate to patient outcomes in fungal temporal bone osteomyelitis. Using PRISMA guidelines, three databases were searched to identify all published cases of fungal temporal bone osteomyelitis. Data were extracted from each study, including clinical, diagnostic, and treatment characteristics, and outcomes. RESULTS: Sixty-eight studies comprising 74 individual cases of fungal temporal bone osteomyelitis were included. All studies were case reports. There were high rates of diabetes, facial nerve palsy, infectious complications, and need for surgical intervention, as well as a significant delay in the evaluation and diagnosis of fungal temporal bone osteomyelitis. Disease recovery was greater in patients presenting with otorrhea, comorbid diabetes, and in those without facial nerve palsy. DISCUSSION: Many of the defining characteristics of fungal temporal bone osteomyelitis remain unknown, and future reports should focus on determining factors that improve timely diagnosis and treatment of fungal TBO in addition to identifying prognostic indicators for outcomes and survival.

Evaluating the management timeline of tracheoesophageal fistulas secondary to button batteries: A systematic review.

INTRODUCTION: During the SARS-CoV-2 pandemic, the incidence of pediatric button battery (BB) ingestions has risen. Children have spent more time at home from school, while many parents try to balance working from home and childcare. Additionally, the amount of electronics powered by BB has increased. Tracheoesophageal fistula (TEF) secondary to a retained aerodigestive BB is a devastating development. Management is challenging, and the clinical timeline of watchful waiting versus surgical intervention for TEF is poorly defined in the literature. METHODS: In accordance with PRISMA guidelines, databases searched include PubMed, Scopus, and CINAHL from database date of inception through August 13, 2021. All study designs were included, and no language, publication date, or other restrictions were applied. Case series and reports of TEFs secondary to BBs were included. Clinical risk factors and outcomes were compared between the spontaneous closure and surgical repair groups. RESULTS: A total of 79 studies with 105 total patients were included. Mortality was 11.4%. There were 23 (21.9%) TEFs that spontaneously closed and 71 (67.6%) that underwent surgical repair. Median time to spontaneous closure compared to surgical repair was significantly different (8.0 weeks [IQR 4.0-18.4] vs. 2.0 weeks [IQR 0.1-3.3], p<0.001). Smaller TEFs were more likely to spontaneously close versus being surgically repaired (9.3 mm ± 3.5 vs. 14.9 mm ± 8.3, p=0.022). Duration of symptoms before BB discovery, BB size, time between BB removal and TEF discovery, and location of the TEF were not statistically different between the spontaneous closure and surgical repair groups. CONCLUSION: A TEF secondary to BB ingestion is a potentially deadly complication. Timing of reported TEF spontaneous closure varies significantly. While smaller TEFs may be amenable to healing without surgical repair, no other significant factors were identified that may be associated with spontaneous closure. If clinical status permits, these data suggest a period of observation of at least 8 weeks prior to surgical intervention may be practical for many BB-induced TEFs.

Adhesion barriers in cardiac surgery: A systematic review of efficacy.

BACKGROUND: Postoperative pericardial adhesions have been associated with increased morbidity, mortality, and surgical difficulty. Barriers exist to limit adhesion formation, yet little is known about their use in cardiac surgery. The study presented here provides the first major systematic review of adhesion barriers in cardiac surgery. METHODS: Scopus and PubMed were assessed on November 20, 2020. Inclusion criteria were clinical studies on human subjects, and exclusion criteria were studies not published in English and case reports. Risk of bias was evaluated with the Cochrane Risk of Bias Tool. Barrier efficacy data was assessed with Excel and GraphPad Prism 5. RESULTS: Twenty-five studies were identified with a total of 13 barriers and 2928 patients. Polytetrafluoroethylene (PTFE) was the most frequently evaluated barrier (13 studies, 67% of patients) with adhesion formation rate of 37.31% and standardized tenacity score of 26.50. Several barriers had improved efficacy. In particular, Cova CARD had a standardized tenacity score of 15.00. CONCLUSIONS: Overall, the data varied considerably in terms of study design and reporting bias. The amount of data was also limited for the non-PTFE studies. PTFE has historically been effective in preventing adhesions. More recent barriers may be superior, yet the current data is nonconfirmatory. No ideal adhesion barrier currently exists, and future barriers must focus on the requirements unique to operating in and around the heart.

Pharmacological Prevention of Noise-induced Hearing Loss: A Systematic Review.

OBJECTIVE: This study aims to explore and determine the effectiveness of current pharmacologic agents for the prevention of noise-induced hearing loss (NIHL) via a systematic review. DATABASES REVIEWED: The PubMed, Scopus, ClinicalTrials.gov, and Cochrane Library databases were searched from inception through February 6, 2020. METHODS: Full-text, English-language articles detailing prospective randomized and nonrandomized clinical trials with pharmacological interventions administered to prevent NIHL were included in accordance with PRISMA guidelines. The detailed search terms are included in the Appendix, http://links.lww.com/MAO/B67. RESULTS: Eleven articles were included in this review with 701 patients receiving a pharmacologic prevention for various noise exposures. Various regimens included administration of alpha-lipoic acid, ambient oxygen, beta-carotene, carbogen, ebselen, Mg-aspartate, N-acetylcysteine, and vitamins C, E, and B12. A number of studies demonstrated statistically significant amelioration of NIHL with pharmacologic intervention. Two studies demonstrated significantly better hearing outcomes for pharmacological prophylaxis with carbogen or ebselen as compared with placebo for the 4 kHz frequency, where the noise-notch is most likely to be encountered. Given the considerable heterogeneity in agents and methodologies, however, it was not possible to conduct a meta-analysis. CONCLUSIONS: While several heterogenous articles demonstrated promising results for Mg-aspartate, carbogen, vitamin B12, and alpha-lipoic acid, the clinical significance of these pharmaceuticals remains unclear. Initial data from this study alongside future clinical trials might potentially contribute to the generation of clinical practice guidelines to prevent NIHL. LEVEL OF EVIDENCE: 2.

Introducing a health information literacy competencies map: connecting the Association of American Medical Colleges Core Entrustable Professional Activities and Accreditation Council for Graduate Medical Education Common Program Requirements to the Association of College & Research Libraries Framework.

BACKGROUND: Librarians teach evidence-based medicine (EBM) and information-seeking principles in undergraduate, graduate, and post-graduate medical education. These curricula are informed by medical education standards, medical education competencies, information literacy frameworks, and background literature on EBM and teaching. As this multidimensional body of knowledge evolves, librarians must adapt their teaching and involvement with medical education. Identifying explicit connections between the information literacy discipline and the field of medical education requires ongoing attention to multiple guideposts but offers the potential to leverage information literacy skills in the larger health sciences education sphere. METHODS: A subgroup of the Association of Academic Health Sciences Libraries Competency-Based Medical Education Task Force cross-referenced medical education documents (Core Entrustable Professional Activities and 2017-2018 Liaison Committee on Medical Education Functions and Structures of a Medical School) with the Association of College & Research Libraries Framework for Information Literacy for Higher Education using nominal group technique. RESULTS: In addition to serving as a vocabulary, the map can also be used to identify gaps between and opportunities for enhancing the scholarly expectations of undergraduate and graduate medical education standards and the building blocks of information literacy education.

Evaluation of literature searching and article selection skills of an evidence-based practice team.

BACKGROUND: An evidence-based practice (EBP) team at an academic medical center supports the development of evidence-based hospital policies and protocols via "Evidence Briefs." An early career librarian was added to the EBP team to meet increased requests for Evidence Briefs, which provided an opportunity to initiate a quality improvement (QI) analysis, improve work flow, and cross-train staff on literature searching and article selection skills. CASE PRESENTATION: This QI project evaluated literature searching and article selection skills of an early career librarian (less than 2 years' experience), a mid-career librarian (more than 10 years' experience), and a critical appraisal expert. This project examined 10 Evidence Brief requests completed within a 6-month period. Analysis of each individual's performance of literature searching and article selection was completed for each Evidence Brief. Across all Evidence Brief requests, the mid-career librarian performed the most comprehensive literature searches and captured the highest number of articles that ultimately ended up being included in Evidence Briefs (75%). The critical appraisal expert performed best on the article selection portion of the project and identified the highest number of relevant articles that were included in Evidence Briefs (74%). CONCLUSIONS: This project provided a formalized method of assessing the literature searching and article selection skills of each member of the EBP team. This project illustrated the skill level of each individual and led to improvements in the Evidence Brief request work flow.

Earlier re-initiation of enteral feeding after necrotizing enterocolitis decreases recurrence or stricture: a systematic review and meta-analysis.

OBJECTIVE: To assess the effects of earlier vs. later re-initiation of enteral feeds after necrotizing enterocolitis (NEC). STUDY DESIGN: We reviewed the literature to assess timing of enteral feeding after NEC using fixed effects models. RESULTS: Three studies met inclusion criteria; no randomized trials. After removal of Bell's Stage I infants, the earlier refeeding group (<5-7 or median 4 days) included 79 infants and later refeeding group (≥5-7 or median 10 days) included 119 infants. Pooled analysis revealed earlier re-initiation reduced the incidence in the composite outcome of recurrent NEC and/or post-NEC stricture (OR = 0.27; 95% Cl = 0.10-0.75; p = 0.012). Individually, NEC recurrence (pooled OR = 0.34; 95% Cl = 0.09-1.29; p = 0.112) or stricture (OR = 0.34; 95% Cl = 0.09-1.26; p = 1.06) did not differ between groups. CONCLUSIONS: There was no increase in negative outcomes with earlier refeeding after NEC. Earlier initiation of enteral feeds resulted in a significantly lower risk for the combined outcome of recurrent NEC and/or post-NEC stricture.

A Systematic Review of Patient-Reported Outcome Measures Assessing Body Image Disturbance in Patients with Head and Neck Cancer.

OBJECTIVE: To synthesize published literature describing the severity of body image disturbance (BID) in patients with head and neck cancer (HNC) over time, its psychosocial and functional associations, and treatment strategies as assessed by patient-reported outcome measures (PROMs). DATA SOURCE: PubMed/MEDLINE, Scopus, PsycINFO, Web of Science, and Google Scholar. REVIEW METHODS: A systematic review of the English-language literature was performed to identify studies of BID in patients with HNC using psychometrically validated PROMs to assess (1) severity of BID over time, (2) psychosocial and functional associations, and (3) management strategies. RESULTS: A total of 17 studies met inclusion criteria. BID was assessed via 10 different PROMs, none of which were HNC-specific measures of BID. Two of 2 longitudinal studies (100%) reported that BID improved from pretreatment to posttreatment, and 2 of 3 longitudinal studies (67%) showed that the severity of BID decreased over time as survivors got further out from treatment. Seven of 17 studies (41%) described negative functional and psychosocial associations with BID, although study methodology limited conclusions about cause and effect. None of the studies assessing interventions to manage BID (0/2, 0%) demonstrated an improvement in BID relative to control. CONCLUSION: BID in patients with HNC has negative functional and psychosocial associations and lacks evidence-based treatment. Research is limited by the lack of an HNC-specific BID PROM. Further research should address knowledge gaps related to the lack of an HNC-specific BID PROM, longitudinal course of BID in patients with HNC, confusion with regards to risk factors and outcomes, and lack of prevention and treatment strategies.