Construct validity and responsiveness of a health-related symptom index for persons either treated or monitored for anal high-grade squamous intraepithelial lesions (HSIL): AMC-A01/-A03.

PURPOSE: To determine whether treatment of anal high-grade squamous intraepithelial lesions (HSIL), vs active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV, the US National Cancer Institute funded the Phase III ANal Cancer/HSIL Outcomes Research (ANCHOR) clinical trial. As no established patient-reported outcomes (PRO) tool exists for persons with anal HSIL, we sought to estimate the construct validity and responsiveness of the ANCHOR Health-Related Symptom Index (A-HRSI). METHODS: The construct validity phase enrolled ANCHOR participants who were within two weeks of randomization to complete A-HRSI and legacy PRO questionnaires at a single time point. The responsiveness phase enrolled a separate cohort of ANCHOR participants who were not yet randomized to complete A-HRSI at three time points: prior to randomization (T1), 14-70 (T2), and 71-112 (T3) days following randomization. RESULTS: Confirmatory factor analysis techniques established a three-factor model (i.e., physical symptoms, impact on physical functioning, impact on psychological functioning), with moderate evidence of convergent validity and strong evidence of discriminant validity in the construct validity phase (n = 303). We observed a significant moderate effect for changes in A-HRSI impact on physical functioning (standardized response mean = 0.52) and psychological symptoms (standardized response mean = 0.60) from T2 (n = 86) to T3 (n = 92), providing evidence of responsiveness. CONCLUSION: A-HRSI is a brief PRO index that captures health-related symptoms and impacts related to anal HSIL. This instrument may have broad applicability in other contexts assessing individuals with anal HSIL, which may ultimately help improve clinical care and assist providers and patients with medical decision-making.

Professional commitment, resilience and intent to leave the profession among nurses during the COVID-19 pandemic - a descriptive study.

AIM: The three-component model of commitment, resilience and selected nurse characteristics were tested as predictors of nurses' intent to leave the profession. BACKGROUND: In the wake of the COVID-19 pandemic, news reports suggest that a mass exodus of nursing professionals is occurring. METHOD: This nonexperimental, descriptive, correlational, predictive study used a cross-sectional approach to collect survey data from a convenience sample of 189 registered nurses (RNs) who were providing direct patient care in adult inpatient units with a high likelihood of admitting patients diagnosed with COVID-19 and met other eligibility requirements. RESULTS: Most (73.5%) plan to remain in the nursing profession and feel highly resilient. Only affective commitment demonstrated a significant relationship to the intention to leave the nursing profession. CONCLUSIONS: The study was conducted after the pandemic had been in effect for a prolonged time, and it is likely the nurses with the intent to leave the profession had already left. The findings provide a glimpse of a sample of nurses drawn from a population likely much different from only a few months prior. IMPLICATIONS FOR NURSING MANAGEMENT: Strategies to retain nurses should include efforts to strengthen professional commitment and build resilience.

Feasibility and acceptability of using an IVRS to assess decision making about sun protection.

OBJECTIVE: We developed an interactive voice response system (IVRS), an automated telephone survey technology, to assess real-time decision making about sun protection. We examined the feasibility and acceptability of IVRS in this electronic health (eHealth) context. METHODS: Melanoma patients who underwent surgery referred their first-degree relatives (FDRs) for participation. Eligible FDRs were contacted twice daily (12:30 pm; 5:00 pm) over 14 consecutive days via IVRS to complete a survey about their sun protection behaviors and decisions about those behaviors. RESULTS: Of the 81 eligible FDRs, 69 (85%) consented to the study, and 53 (77%) completed the study. We assessed adherence with the IVRS via the number and pattern of missing survey items across all answered IVRS calls. About 80% of scheduled IVRS calls were answered (1316/1652). Most surveys (93%) of the IVRS-answered calls were completed. To examine acceptability, we analyzed the program satisfaction survey data collected at the end of the study. Most participants viewed the IVRS to be highly acceptable and easy to use. CONCLUSIONS: These findings illustrate that use of real-time IVRS data collection regarding sun protection decision making is feasible and acceptable to higher-risk research participants and could thus be used with time and location-sensitive eHealth support to enhance sun protection decision making.

Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial.

Importance: Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care. Objective: To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking. Design, Setting, and Participants: This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018. Interventions: Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline). Main Outcome and Measures: The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates. Results: Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2). Conclusions and Relevance: Among smokers recently diagnosed with cancer in 2 National Cancer Institute-designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research. Trial Registration: ClinicalTrials.gov Identifier: NCT01871506.

Deliberative and intuitive risk perceptions as predictors of colorectal cancer screening over time.

Cancer risk perceptions may involve intuitions-including both affect as well as gut-level thoughts about risk-and deliberative risk magnitudes. Yet, little research has examined the potentially diverse relations between risk perceptions and behavior across time. A highly diverse primary care sample (N = 544, aged ≥50) was utilized to compare how deliberative and intuitive perceptions of risk relate to chart-confirmed colorectal cancer screening at cross-sectional and prospective time points. At baseline, deliberative and intuitive risk perceptions were negatively associated with chart-confirmed colorectal cancer screening adherence in bivariable but not multivariable analyses. Among those who were non-adherent with colorectal cancer screening at baseline, deliberative and intuitive risk perceptions were positively associated with prospective uptake of chart-confirmed colorectal cancer screening adherence at 12-months in bivariable analyses; only deliberative risk perceptions remained significant in the multivariable model. This study indicates that diverse risk perceptions are differentially important for screening at different time points.

Challenges and Solutions to Patient Safety During a Pandemic.

When exploring the realm of Patient Safety in the context of a COVID-19 global pandemic, the traditional methods of assessment may not be sufficient. This was a crisis that could not be isolated to intensive care units or the hospital environment. In addition to patient safety, one must consider the safety of health care providers and others. Understanding human behavior when faced with a novel disease such as COVID-19 may help prepare for the future when society may once again face a public health crisis together.

Factors associated with inconsistent sun protection in first-degree relatives of melanoma survivors.

First-degree relatives (FDRs) of melanoma survivors are at heightened risk for developing melanoma, but use sun protection inconsistently. To develop appropriate interventions, in this article we identify factors related to sun protection inconsistency in melanoma FDRs using ethnographic decision tree modeling. We conducted in-home interviews with 25 melanoma FDRs balanced across gender and sunbathing attitudes and identified factors related to daily decision making about use of sunscreen, shade seeking, hats, and clothing. Results indicated primary facilitators for sun protection involved water settings and sunny weather. Physical activities such as exercise served to promote as well as inhibit sun protection. If participants anticipated shade cover, they tended to forgo other sun protection. The use of hats and clothing was often dictated by nonsun-protection goals. Understanding factors related to inconsistent sun protection with detail and nuance is an important prerequisite to interventions aimed to improve sun-protection maintenance in this population.

Diagnosing, managing and preventing urinary tract infections in older people with dementia in hospital.

Urinary tract infections (UTIs) are common in older people and are frequently more complicated to diagnose than in younger adults. There are often challenges associated with distinguishing symptomatic UTIs from asymptomatic bacteriuria, particularly in people with cognitive impairment. Older people with dementia are at increased risk of developing a UTI because dementia can lead to voiding issues, impede personal hygiene and increase the need for urinary catheterisation. Furthermore, while a UTI is usually diagnosed based on an individual's physical signs and symptoms, people with dementia may only exhibit signs of sudden altered mental status such as increased confusion, agitation or withdrawal, making diagnosis challenging. This article discusses the main considerations regarding UTIs in people with dementia in hospital and outlines prevention strategies that nurses can implement in their practice.

Linguistic validation of the Spanish version of the Anal Cancer High-Grade squamous intraepithelial lesions outcomes Research Health-Related Symptom Index (A-HRSI): AMC-A04.

OBJECTIVES: The Anal Cancer High-grade squamous intraepithelial lesions (HSIL) Outcomes Research (ANCHOR) Health-Related Symptom Index (A-HRSI) is a 25-item measure that assesses physical symptoms and impacts, and psychological symptoms. To promote generalizability and equity in the capture of these concepts in Spanish-speaking participants, we linguistically validated a Spanish version of A-HRSI. METHODS: Following independent forward translation and reconciliation of A-HRSI from English to Spanish, two rounds of cognitive interviews were completed with ANCHOR participants who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish. Interviews were coded to highlight any items and concepts that were reported as being difficult for any reason by ≥ 3 participants, with such items revised during a research team panel discussion and tested in a second round of interviews if applicable. RESULTS: Seventeen participants representing 8 nationalities were enrolled (Round 1 n=10, Round 2 n=7); 7 participants reported not completing high school (41.2%). No difficulties were reported with respect to the theoretical concepts measured by A-HRSI. We made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). CONCLUSION: The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL. Language is a tremendous barrier to enrolling patients to clinical trials. The anal cancer high-grade squamous intraepithelial lesions (HSIL) outcomes research [ANCHOR] trial is a randomized clinical trial that recently established that the treatment of anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV (PLWH). The ANCHOR Health-Related Symptom Index (A-HRSI) is a 25-item patient-reported outcomes measure that was developed to assess physical symptoms, physical impacts, and psychological symptoms related to anal HSIL. As approximately 10% of ANCHOR participants preferred the delivery of their healthcare in Spanish, the purpose of the present study was to linguistically validate a Spanish version of A-HRSI. Based on feedback from interviews with 17 participants from the ANCHOR trial who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish, we made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL as part of clinical trials or routine care.

Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings.

BACKGROUND: There is widespread agreement that the integration of cessation services in lung cancer screening (LCS) is essential for achieving the full benefits of LCS with low-dose computed tomography (LDCT). There is a formidable knowledge gap about how to best design feasible, effective, and scalable cessation services in LCS facilities. A collective of NCI-funded clinical trials addressing this gap is the Smoking Cessation at Lung Examination (SCALE) Collaboration. METHODS: The Cessation and Screening to Save Lives (CASTL) trial seeks to advance knowledge about the reach, effectiveness, and implementation of tobacco treatment in lung cancer screening. We describe the rationale, design, evaluation plan, and interventions tested in this multiphase optimization strategy trial (MOST). A total of 1152 screening-eligible current smokers are being recruited from 18 LCS sites (n = 64/site) in both academic and community settings across the USA. Participants receive enhanced standard care (cessation advice and referral to the national Quitline) and are randomized to receive additional tobacco treatment components (motivational counseling, nicotine replacement patches/lozenges, message framing). The primary outcome is biochemically validated, abstinence at 6 months follow-up. Secondary outcomes are self-reported smoking abstinence, quit attempts, and smoking reduction at 3 and 6 months. Guided by the Implementation Outcomes Framework (IOF), our evaluation includes measurement of implementation processes (reach, fidelity, acceptability, appropriateness, sustainability, and cost). CONCLUSION: We will identify effective treatment components for delivery by LCS sites. The findings will guide the assembly of an optimized smoking cessation package that achieves superior cessation outcomes. Future trials can examine the strategies for wider implementation of tobacco treatment in LDCT-LCS sites. TRIAL REGISTRATION: ClinicalTrials.gov NCT03315910.

Calretinin immunostaining as an adjunct in the diagnosis of Hirschsprung disease.

Historically, the diagnosis of Hirschsprung disease was made by evaluating multiple hematoxylin and eosin-stained slides and performing acetylcholinesterase histochemical staining. Recently, calretinin immunohistochemical staining has been reported and found to be superior to acetylcholinesterase staining in the confirmation of aganglionosis. We retrieved tissue blocks from 23 patients with proven Hirschsprung disease from the archives of the Medical College of Georgia. In addition, we selected 23 control patients with ganglion cells. All cases were stained with calretinin, and the presence or absence of both intrinsic nerve fibers (INFs) and ganglion cells was scored by 4 pathologists with fairly strong agreement (κ = 0.858). All cases of proven Hirschsprung disease were negative for INFs. Eighty-three percent of non-Hirschsprung patients were positive for INFs. Based on statistical analysis, the association between disease status and pathologist rating was statistically significant (P < .0001). We also found calretinin immunostaining to be a useful adjunctive modality in the diagnosis of Hirschsprung disease.

Supporting Frontline Staff During the COVID-19 Pandemic.

ABSTRACT: The coronavirus disease 2019 (COVID-19) pandemic that emerged in early 2020 put unprecedented physical, mental, and emotional strain on the staff of health care organizations, who have been caring for a critically ill patient population for more than a year and a half. Amid the ongoing pandemic, health care workers have struggled to keep up with new information about the disease, while also coping with the anxiety associated with caring for affected patients. It has also been a continual challenge for nurse leaders to provide adequate support for staff members and keep them informed about frequently changing practices and protocols. In this article, nursing leaders at an academic medical center in Boston reflect on the initial COVID-19 patient surge, which occurred from March to June 2020, and identify key actions taken to provide clinical and emotional support to frontline staff who cared for these patients. Lessons learned in this period provide insight into the management of redeployed staff, use of emotional support and debriefing, and relationship between access to information and staff morale. The knowledge gained through these initial experiences has been a vital resource as health care workers continue to face challenges associated with the ongoing pandemic.

Utilization of peripherin and S-100 immunohistochemistry in the diagnosis of Hirschsprung disease.

Evaluation of rectal biopsies for ganglion cells is performed for patients suspected of having Hirschsprung disease. At times, identification of ganglion cells can be difficult, especially in newborns. To assist in diagnosis, frozen tissue can be collected for acetylcholinesterase histochemical staining. At our institution, we developed a protocol using peripherin and S-100 immunostaining as an adjunct to hematoxylin and eosin (H&E) for the identification of ganglion cells. Further, at the time of frozen section, we performed Diff Quik staining to highlight ganglion cells. One hundred and thirty eight rectal biopsies submitted for evaluation of Hirschsprung disease were compiled from the archives of the Medical College of Georgia from 2002 to 2009. Initial evaluation consisted of eight levels of H&E-stained slides and two unstained slides each for immunostaining with peripherin and S-100. If on initial evaluation, ganglion cells were not identified, additional H&E and peripherin immunostains were performed. Peripherin immunostaining was unequivocally identified in the cytoplasm of ganglion cells of patients at all ages. Of the 136 patients with diagnostic biopsies, 80% had ganglion cells. Of these, 93% of cases were diagnosed on the original eight levels. Twenty-seven cases were devoid of ganglion cells, and of these, 81% showed submucosal neural hypertrophy on S-100 staining. Twenty-six patients had confirmed aganglionic segments at the time of colonic resection. One patient had colostomy only. A total of 54 frozen sections were performed on 25 patients over this same period of time. Diff Quick staining was found to be very useful. In this study, our protocol proved to be very sensitive, specific, and efficient for the diagnosis of Hirschsprung disease.

Patient and Care Delivery Characteristics Associated With Harm From Neuromuscular Blockade.

OBJECTIVES: To identify the prevalence of and evaluate factors associated with down-titration of sedation in patients receiving neuromuscular blockade. DESIGN: Retrospective cohort study. SETTING: Tertiary care teaching hospital in Boston, MA. PATIENTS: All patients over 18 years old admitted to the medical, surgical, or cardiac ICUs from 2013 to 2016, and who received cisatracurium for at least 24 hours. INTERVENTIONS: We examined patients for whom sedation was decreased despite accompanying ongoing neuromuscular blockade administration. MEASUREMENTS AND MAIN RESULTS: Of the 300 patients who met inclusion criteria (39% female, mean age of 57 yr old), 168 (56%) had sedation down-titrated while receiving neuromuscular blockade with a mean decrease in sedation dose of 18.7%. Factors associated with down-titration of sedation were bispectral index usage (90/168 [53.6%] vs 50/168 [29.8%] patients; p < 0.01; odds ratio, 1.82; 1.12-2.94), and bolus dose of neuromuscular blockade prior to continuous infusion (138/168 [82.1%] vs 79/168 [47.0%] patients; p < 0.0001). CONCLUSIONS: Down-titration of sedation among mechanically ventilated patients receiving neuromuscular blockade was common and was correlated with bispectral index monitor usage. Clinicians should be aware of the limitations of quantitative electroencephalography monitoring devices and recognize their potential to cause inappropriate down-titration of sedation. Substantial opportunity exists to improve the quality of care of patients receiving neuromuscular blockade through development of guidelines and standardized care pathways.

Real-time sun protection decisions in first-degree relatives of melanoma patients.

OBJECTIVE: Melanoma is the most serious skin cancer, and consistent use of sun protection is recommended to reduce risk. Yet sun protection use is generally inconsistent. Understanding the decisional factors driving sun protection choices could aid in intervention development to promote sun protection maintenance. METHOD: In 59 first-degree relatives of melanoma patients, an interactive voice response system (IVRS) on participants' cell phones was used to assess twice daily (morning, afternoon) real-time sun protection usage (sunscreen, shade, hats, protective clothing) and decision factors (weather, type of activity, convenience, social support) over a 14-day summer interval where morning and afternoon outdoor exposures were anticipated. Generalized estimating equations and hierarchical linear models were used to examine the effect of demographics and decisional factors on sun protection choices over time. RESULTS: Sun protection use was inconsistent (e.g., 61% used sunscreen inconsistently). Most strategies were used independently, with the exception of moderate overlap of sunscreen and hat usage. Decision factors were highly relevant for sun protection. For instance, sunscreen use was related to the perception of having adequate time to apply it, whereas shade and hat usage were each related to convenience. Few findings emerged by gender, age, time of day, or year. Significant within-subject variation remained, however. CONCLUSIONS: The findings support continued examination of decision factors in understanding sun protection consistency in real time. Interventions where cues to action and environmental supports work together in varied settings can be developed to improve sun protection maintenance in populations at risk for this common disease. (PsycINFO Database Record

Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial.

BACKGROUND: Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence-based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. METHODS/DESIGN: A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. DISCUSSION: This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients.

Randomized trial of a presurgical scheduled reduced smoking intervention for patients newly diagnosed with cancer.

OBJECTIVE: Cancer patients who smoke are advised to quit smoking to reduce treatment complications and future cancer risk. This study's main objective was to evaluate the efficacy of a novel, presurgical cessation intervention in newly diagnosed cancer patients scheduled for surgical hospitalization. METHOD: We conducted a parallel-arm, randomized controlled trial comparing the efficacy of our hospital-based, tobacco cessation "best practices" treatment model (BP; cessation counseling and nicotine replacement therapy) with BP enhanced by a behavioral tapering regimen (scheduled reduced smoking; BP + SRS) administered by a handheld computer before hospitalization for surgery. Cessation outcomes were short (hospital admission and 3 months) and longer-term (6 months) biochemically verified smoking abstinence. We hypothesized that BP + SRS would be superior to BP alone. One hundred eighty-five smokers were enrolled. RESULTS: Overall, 7-day-point prevalence, confirmed abstinence rates at 6 months for BP alone (32%) and BP + SRS (32%) were high; however, no main effect of treatment was observed. Patients who were older and diagnosed with lung cancer were more likely to quit smoking. CONCLUSION: Compared to best practices for treating tobacco dependence, a presurgical, scheduled reduced smoking intervention did not improve abstinence rates among newly diagnosed cancer patients.reserved).