Search

Objectives We estimated prevalence of complementary and alternative medicine (CAM) use by reason for use (treatment, wellness, or both) among non-institutionalized adults with cancer in the United States. We also examined health-related quality of life (HRQOL) outcomes among adults with cancer who used CAM. Methods We used data from the 2012 National Health Interview Survey (NHIS), which represents non-institutionalized adults with cancer (n = 2967 unweighted). Using a cross-sectional design with survey sampling techniques, we estimated past year prevalence of CAM use. We ran multivariable logistic regression analyses to investigate the odds of perceived benefits of CAM. Results In the past 12 months, 35.1% of adults with cancer reported using some form of CAM. Among CAM users, 56.0% used CAM for both treatment and wellness, and 32.4% used CAM for wellness only. Only 11.6% used CAM for treatment only. Regardless of reason for use, the most commonly used CAM types in the past year were herbal therapies (56.8%), chiropractic (27.1%), and massage (24.9%). Among CAM users, those using CAM for wellness only and for a combination of treatment and wellness reported significantly higher odds of "a better sense of controlling health" and "improved overall health and feeling better" compared with treatment only users. Similar patterns were found in other HRQOL outcomes, but they were not statistically different. Conclusions CAM is widely used among adults with cancer for wellness only or a combination of treatment and wellness. Given improved HRQOL outcomes, CAM may be a promising approach for enhancing health promotion and well-being among adults with cancer.

12122 Background: Patients with cancer are increasingly using cannabis to alleviate symptoms of pain, nausea, insomnia, and appetite loss. Despite the increased popularity of cannabis, little is known about the patterns of use in the cancer population, efficacy in treating symptoms outside of small clinical studies, and out-of-pocket expenses. We assessed self-reported efficacy and patterns of cannabis use from patients with cancer registered with the Minnesota Cannabis Program (MCP). Methods: We conducted an anonymous survey from December 2021-January 2022 of 797 individuals with cancer-associated pain, nausea/vomiting and/or anorexia currently enrolled in the MCP who had purchased a cannabis related product in the preceding three months. The mailed survey included questions about cancer history, cannabis use, and changes in symptoms. We conducted a descriptive analysis to describe patterns of use. Results: 225 individuals responded to the survey after a single mailing for a 28% response rate. 70% reported using cannabis at least once prior to cancer diagnosis. Respondents had diverse cancer diagnoses (breast (24%), lung (14%), colorectal (10%), prostate (9%)) and were more often female (52%), married, (71%), white (95%), and retired (40%) with a median age of 62.0. Most respondents (46%) had stage IV disease with the remaining 34% stage 1-3 (20% unknown). Household income varied across respondents with 10% reporting annual income 1. Respondents reported that oral products were preferred to vaporizers (81% vs 45%) and 75% reported at least daily use. 27% reported monthly average out of pocket expenses for cannabis of $100-200; with 31% spending ≥$200/mo. The Table outlines perceived change in symptoms amongst users. Conclusions: Patients with cancer in the MCP with recent cannabis purchases predominantly use high THC:CBD products delivered via oral or vaporizer route on daily basis. While out of pocket costs for these products can be significant, many respondents report significant improvements in cancer related symptoms.[Table: see text]

Aims Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery. Methods We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, and trial registries up to 26 March 2020. We included randomized controlled trials (RCTs), comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: pain, function, serious adverse events (SAEs), blood loss, implant stability, duration of surgery, and length of hospital stay. Results We included 41 RCTs with 2,819 participants. SAEs were significantly more common in the tourniquet group (53/901 vs 26/898, tourniquet vs no tourniquet respectively) (risk ratio 1.73 (95% confidence interval (CI) 1.10 to 2.73). The mean pain score on the first postoperative day was 1.25 points higher (95% CI 0.32 to 2.19) in the tourniquet group. Overall blood loss did not differ between groups (mean difference 8.61 ml; 95% CI -83.76 to 100.97). The mean length of hospital stay was 0.34 days longer in the group that had surgery with a tourniquet (95% CI 0.03 to 0.64) and the mean duration of surgery was 3.7 minutes shorter (95% CI -5.53 to -1.87). Conclusion TKA with a tourniquet is associated with an increased risk of SAEs, pain, and a marginally longer hospital stay. The only finding in favour of tourniquet use was a shorter time in theatre. The results make it difficult to justify the routine use of a tourniquet in TKA surgery. Cite this article: Bone Joint J 2021;103-B(5):830–839.

Background Bladder cancer outcomes have not changed significantly in 30 years; the BladderPath trial (Image Directed Redesign of Bladder Cancer Treatment Pathway, ISRCTN35296862) proposes to evaluate a modified pathway for diagnosis and treatment ensuring appropriate pathways are undertaken earlier to improve outcomes. We are piloting a novel data collection technique based on routine National Health Service (NHS) data, with no traditional patient-Health Care Professional contact after recruitment, where trial data are traditionally collected on case report forms. Data will be collected from routine administrative sources and validated via data queries to sites. We report here the feasibility and pre-trial methodological development and validation of the schema proposed for BladderPath. Methods Locally treated patient cohorts were utilised for routine data validation (hospital interactions data (HID) and administrative radiotherapy department data (RTD)). Single site events of interest were algorithmically extracted from the 2008–2018 HID and validated against reference datasets to determine detection sensitivity. Survival analysis was performed using RTD and HID data. Hazard ratios and survival statistics were calculated estimating treatment effects and further validating and assessing the scope of routine data. Results Overall, 829/1042 (sensitivity 0.80) events of interest were identified in the HID, with varying levels of sensitivity; identifying, 202/206 (sensitivity 0.98; PPV 0.96) surgical events but only 391/568 (sensitivity 0.69; PPV 0.95) radiotherapy regimens. An overall temporal quality improvement trend was present: detecting 41/117 events (35%) in 2011 to 104/109 (95%) in 2017 (all event types). Using the RTD, 5-year survival rates were 43% (95% CI 25–59%) in the chemoradiotherapy group and 30% (95% CI 23–36%) in the radiotherapy group; using the HID, the 5-year radical cystectomy survival rate was 57% (95% CI 50–63%). Conclusions Routine data are a feasible method for trial data collection. As long as events of interest are pre-validated, very high sensitivities for trial conduct can be achieved and further improved with targeted data queries. Outcomes can also be produced comparable to clinical trial and national dataset results. Given the real-time, obligatory nature of the HID, which forms the Hospital Episode Statistics (HES) data, alongside other datasets, we believe routine data extraction and validation is a robust way of rapidly collecting datasets for trials.

Because the coronavirus disease 2019 (COVID-19) has completely transformed the accepted norms and approaches to cancer care delivery in the United States, we sought to understand the sources of medical information that oncology physicians seek and trust. We recruited 486 oncology physicians to an anonymous cross-sectional online survey through social media from March 27, 2020, to April 10, 2020, with 79.2% reporting their sources of medical information during the COVID-19 pandemic. We found a diverse array of reported sources for COVID-19 information that most commonly included professional societies (90.7%), hospital or institutional communications (88.6%), and the Centers for Disease Control and Prevention (69.9%); however, trust in these sources of information varied widely, with professional societies being the most trusted source. These results highlight the important role that professional societies, hospitals, and the Centers for Disease Control and Prevention play in ensuring dissemination of consistent, high-quality practice recommendations for oncology physicians.

Background Despite improvements in overall survival for pediatric cancers, treatment disparities remain for racial/ethnic minorities compared to non-Hispanic Whites; however, the impact of race on treatment outcomes for pediatric brain and central nervous system (CNS) tumors in the United States is not well known. Methods We included 8713 children aged 0-19 years with newly diagnosed primary brain and CNS tumors between 2000 and 2015 from the Census Tract-level SES and Rurality Database developed by Surveillance, Epidemiology, and End Results (SEER) Program. We used chi-square tests to assess differences in sociodemographic, cancer, and treatment characteristics by race/ethnicity and Kaplan-Meier curves and Cox proportional hazards models to examine differences in 10-year survival, adjusting for these characteristics. Results Among 8713 patients, 56.75% were non-Hispanic White, 9.59% non-Hispanic Black, 25.46% Hispanic, and 8.19% from "other" racial/ethnic groups. Median unadjusted survival for all pediatric brain tumors was 53 months, but varied significantly by race/ethnicity with a median survival of 62 months for non-Hispanic Whites, 41 months for non-Hispanic Blacks, and 40 months for Hispanic and other. Multivariable analyses demonstrated minority racial groups still had significantly higher hazard of death than non-Hispanic Whites; Hispanic (adjusted hazard ratio [aHR] 1.25 [1.18-1.31]); non-Hispanic Black (aHR 1.12 [1.04-1.21]); other (aHR 1.22 [1.12-1.32]). Results were consistent when stratified by tumor histology. Conclusion We identified disparities in survival among racial/ethnic minorities with pediatric brain and CNS tumors, with Hispanic patients having the highest risk of mortality. Eliminating these disparities requires commitment toward promoting heath equity and personalized cancer treatment.

Introduction Cancer care is significantly impacted by the Coronavirus Disease 2019 (COVID-19) pandemic. Our objective was to evaluate the early effects of the pandemic on the emotional well-being of oncology providers across the United States and explore factors associated with anxiety and depression symptoms. Materials and methods A cross-sectional survey was administered to United States cancer-care physicians recruited over a two-week period (3/27/2020–4/10/2020) using snowball-convenience sampling through social media. Symptoms of anxiety and depression were measured using the Patient Health Questionnaire (PHQ-4). Results Of 486 participants, 374 (77.0%) completed the PHQ-4: median age was 43 years; 63.2% female; all oncologic specialties were represented. The rates of anxiety and depression symptoms were 62.0% and 23.5%, respectively. Demographic factors associated with anxiety included female sex, younger age, and less time in clinical practice. Perception of inadequate personal protective equipment (68.6% vs. 57.4%, p = 0.03) and practicing in a state with more COVID-19 cases (65.8% vs. 51.1%, p = 0.01) were associated with anxiety symptoms. Factors significantly associated with both anxiety and depression included the degree to which COVID-19 has interfered with the ability to provide treatment to cancer patients and concern that patients will not receive the level of care needed for non-COVID-19 illness (all p-values Conclusion The perceived degree of interference with clinical practice along with personal concerns about COVID-19 were significantly associated with both anxiety and depression among oncology physicians in the United States during the COVID-19 pandemic. Our findings highlight factors associated with and sources of psychological distress to be addressed to protect the well-being of oncology physicians.

Background Complicated intra-abdominal infections (cIAIs) are associated with significant morbidity and mortality. The aim of this study was to describe the clinical characteristics of patients with cIAI in a multicentre study and to develop clinical prediction models (CPMs) to help identify patients at risk of mortality or relapse. Methods A multicentre observational study was conducted from August 2016 to February 2017 in the UK. Adult patients diagnosed with cIAI were included. Multivariable logistic regression was performed to develop CPMs for mortality and cIAI relapse. The c-statistic was used to test model discrimination. Model calibration was tested using calibration slopes and calibration in the large (CITL). The CPMs were then presented as point scoring systems and validated further. Results Overall, 417 patients from 31 surgical centres were included in the analysis. At 90 days after diagnosis, 17.3 per cent had a cIAI relapse and the mortality rate was 11.3 per cent. Predictors in the mortality model were age, cIAI aetiology, presence of a perforated viscus and source control procedure. Predictors of cIAI relapse included the presence of collections, outcome of initial management, and duration of antibiotic treatment. The c-statistic adjusted for model optimism was 0.79 (95 per cent c.i. 0.75 to 0.87) and 0.74 (0.73 to 0.85) for mortality and cIAI relapse CPMs. Adjusted calibration slopes were 0.88 (95 per cent c.i. 0.76 to 0.90) for the mortality model and 0.91 (0.88 to 0.94) for the relapse model; CITL was −0.19 (95 per cent c.i. −0.39 to −0.12) and − 0.01 (− 0.17 to −0.03) respectively. Conclusion Relapse of infection and death after complicated intra-abdominal infections are common. Clinical prediction models were developed to identify patients at increased risk of relapse or death after treatment, these now require external validation.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the clinical effectiveness and potential harms of surgical intervention for adults with a failed primary knee replacement.

Compulsory community treatment for people with severe mental illness remains controversial due to conflicting research evidence. Recently, there have been challenges to the conventional view that trial‐based evidence should take precedence. This paper adds to these challenges in three ways. First, it emphasizes the need for critiques of trials to engage with conceptual and not just technical issues. Second, it develops a critique of trials centred on both how we can have knowledge and what it is we can have knowledge of. Third, it uses this critique to develop a research strategy that capitalizes on the information in large‐scale datasets.\ud \ud

Background Fatigue in axSpA is described as a complex, multidimensional symptom that involve disease-specific, cognitive/behavioural and personal factors. However, current assessment guidance in axSpA recommends using a single-item visual analogue scale on fatigue severity. This type of provides a limited assessment and may fail to adequately capture the multiplicity of fatigue experience. Despite the high prevalence and significant impact of fatigue, there is currently no axSpA-specific patient-derived multi-item questionnaire for fatigue. In our previous qualitative research, we identified energy as a related but distinct component of fatigue experience in axSpA. In response, and in collaboration with our patient and public involvement (PPI) group, we have co-produced a 30-item patient-reported outcome measure (PROM) specific to axSpA-fatigue and energy: the Warwick Axial Spondyloarthritis faTigue and Energy measure (WASTEd). The aim of this study was to evaluate the quality of the WASTEd and make statistically informed item refinement decisions following completion by a UK-wide patient cohort. Methods A UK-based postal survey of 580 axSpA patients provided necessary data supporting both classic (Classic Test Theory; CTT) and modern (Rasch Measurement Theory; RMT) psychometric evaluation. CTT analysis included evaluating structural validity using exploratory factor analysis (EFA), internal consistency using Cronbach’s alpha and assessing item-total correlations. RMT analysis included evaluating evidence of local dependency between items, item fit and category characteristic curves. Results The survey response rate was 64.13% (n = 372). EFA identified four factors: energy, fatigue, symptoms and control. Five items were removed due to narrow cross-loadings. Final item-total correlations ranged from 0.61 to 0.83. Cronbach’s alpha was estimated to be 0.97. Rasch analysis highlighted one item as under discriminating. Numerous items showed evidence of respondents opting for a middle-option answer following visual inspection of the category characteristic curves. Findings were discussed with the study PRP group and co-refinement (item removal, modification or introduction) decisions were made during the meeting. A further seven items were removed to produce a final 18-item short-form version of the WASTEd. Conclusion The WASTEd has good evidence of data quality, structural validity and content validity. Psychometric evidence supports qualitative findings that energy is a distinct but related component in fatigue experience. Following a final stage of testing, the WASTEd will be ready for incorporation into both research and clinical practice settings, providing an essential patient-derived assessment of fatigue and energy with which to inform shared decision-making. Disclosures N.A. Pearson None. H. Parsons None. E. Tutton None. J. Martindale Honoraria; JM has received speaker fees and/or honoraia from Abbvie Ltd, Novartis, Pfizer and UCB. Grants/research support; JM has received a research grant from Pfizer. G. Strickland None. J. Thompson None. J. Packham None. K.L. Haywood None.

Background The last decade has witnessed significant growth in the active involvement of patients as research partners (PRPs) in health and social care research to facilitate a stronger patient-focus in research endeavours and outputs. Whilst general guidance is available - e.g. INVOLVE - there is limited guidance pertaining to how one should collaborate with patients as partners in the development of patient-reported outcome measures (PROMs). Here, we describe our active collaboration with patients as research partners in the co-production of a new PROM: the Warwick Axial Spondyloarthritis measure of faTigue and Energy (WASTEd). Methods An established PRP group contributed to the development of the initial funding application, whom received training and support from the PRP group facilitator (JM). The key stages for PRP collaboration throughout the PROM development process were jointly agreed and included: developing qualitative research topic guides and supporting data analysis; supporting development and refinement of the measurement framework to underpin the new PROM, and; supporting question (item) generation and refinement following both qualitative and quantitative explorations. All key decisions were made following face-to-face meetings between the lead research and the PRP group. Results Six face-to-face meetings were held over 2.5 years (average meeting duration 2 hours; range 1.5 to 3 hours) with between three and eight PRP members attended each meeting. Additional e-mail correspondence and summary reports were shared between meetings. The group contributed across all project stages including: developing ethics applications which included assessing the acceptability of the study to patients; generating interview topic guides and verbal probes for key issues identified by the PRP group; interpreting qualitative data with the lead researcher; co-designing and editing the draft PROM and refining the long form version of the PROM using both qualitative and statistical data. PRP collaboration was particularly integral to the appropriate use of relevant language and, most substantively, in providing a clearer understanding of the distinction between fatigue and energy. Conclusion The active collaboration with PRPs has supported the co-production of a relevant and acceptable PROM, driven by the needs and perspectives of patients. Additionally, the PRP groups were able to ensure all refinement decisions made to the PROM did not undermine the content validity of the measure. Finally, their involvement has sought to act as a check, support and challenge on inferences drawn by the researchers, enriching the process and study outcomes. Disclosures N.A. Pearson None. G. Strickland None. J. Thompson None. J. Martindale Honoraria; JM has received speaker fees and/or honoraria from Abbvie Ltd, Novartis, Pfizer and UCB. Grants/research support; JM has received a research grant from Pfizer. E. Tutton None. H. Parsons None. J. Packham None. K. Haywood None.

ObjectivesTo test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia.DesignMixed-methods, with qualitative process evaluation on a two-arm randomised controlled feasibility trial.SettingPrimary care.ParticipantsTwenty-five adult patients with chronic pain and insomnia.InterventionHybrid CBT or self-help control intervention.Primary and secondary outcome measuresPrimary outcomes measures were the Insomnia Severity Index and interference scale of the Brief Pain Inventory (BPI). Secondary outcomes measures were the present pain intensity rating from the BPI, Multidimensional Fatigue Inventory, Hospital Anxiety and Depression Scale and EQ-5D-5L.ResultsFourteen participants were randomised to receive Hybrid CBT, 11 to receive the self-help control treatment. Of the 14 in the Hybrid CBT group, 9 (64%) completed all four treatment sessions (4 discontinued due to poor health; 1 due to time constraints). Adherence to the self-help control treatment was not monitored. The total number of participants completing the 12-week and 24-week follow-ups were 12 (6 in each group; Hybrid CBT: 43%; self-help: 55%) and 10 (5 in each group; Hybrid CBT: 36%; self-help: 45%). Based on the data available, candidate outcome measures appeared to be sensitive to changes associated with interventions. Thematic analysis of pre-postintervention interview data revealed satisfaction with treatment content among those who completed the Hybrid CBT, whereas those in the self-help control treatment wanted more contact hours and therapist guidance. Other practical suggestions for improvement included shortening the duration of each treatment session, reducing the amount of assessment paperwork, and minimising the burden of sleep and pain monitoring.ConclusionImportant lessons were learnt with regard to the infrastructure required to achieve better patient adherence and retention. Based on the qualitative feedback provided by a subset of treatment completers, future trials should also consider lowering the intensity of treatment and streamlining the data collection procedure.Trial registration numberISRCTN17294365.

Rationale, aims, and objectives\ud Decisions about whether to refer or admit a patient to an intensive care unit (ICU) are clinically, organizationally, and ethically challenging. Many explicit and implicit factors influence these decisions, and there is substantial variability in how they are made, leading to concerns about access to appropriate treatment for critically ill patients. There is currently no guidance to support doctors making these decisions. We developed an intervention with the aim of supporting doctors to make more transparent, consistent, patient‐centred, and ethically justified decisions. This paper reports on the implementation of the intervention at three NHS hospitals in England and evaluates its feasibility in terms of usage, acceptability, and perceived impact on decision making.\ud \ud Methods\ud A mixed method study including quantitative assessment of usage and qualitative interviews.\ud \ud Results\ud There was moderate uptake of the framework (28.2% of referrals to ICU across all sites during the 3‐month study period). Organizational structure and culture affected implementation. Concerns about increased workload in the context of limited resources were obstacles to its use. Doctors who used it reported a positive impact on decision making, with better articulation and communication of reasons for decisions, and greater attention to patient wishes. The intervention made explicit the uncertainty inherent in these decisions, and this was sometimes challenging. The patient and family information leaflets were not used.\ud \ud Conclusions\ud While it is feasible to implement an intervention to improve decision making around referral and admission to ICU, embedding the intervention into existing organizational culture and practice would likely increase adoption. The doctor‐facing elements of the intervention were generally acceptable and were perceived as making ICU decision making more transparent and patient‐centred. While there remained difficulties in articulating the clinical reasoning behind some decisions, the intervention offers an important step towards establishing a more clinically and ethically sound approach to ICU admission.

Background Adolescents and young adults (AYAs) with public or no insurance experience later stage at diagnosis and worse overall survival compared with those with private insurance. However, prior studies have not distinguished the survival impact of continuous Medicaid coverage prior to diagnosis compared with gaining Medicaid coverage at diagnosis. Methods We linked a cohort of AYAs aged 15-39 who were diagnosed with 13 common cancers from 2005 to 2014 in the California Cancer Registry with California Medicaid enrollment files to ascertain Medicaid enrollment, with other insurance determined from registry data. We used Cox proportional hazards regression to evaluate the impact of insurance on survival, adjusting for clinical and demographic characteristics. Results Among 62 218 AYAs, over 65% had private/military insurance, 10% received Medicaid at diagnosis, 13.2% had continuous Medicaid, 4.1% had discontinuous Medicaid, 1.7% had other public insurance, 3% were uninsured, and 2.6% had unknown insurance. Compared with those with private/military insurance, individuals with Medicaid insurance had significantly worse survival regardless of when coverage began (received Medicaid at diagnosis: hazard ratio [95% confidence interval]: 1.51 [1.42-1.61]; continuously Medicaid insured: 1.42 [1.33-1.52]; discontinuous Medicaid: 1.64 [1.49, 1.80]). Analyses of those with Medicaid insurance only demonstrated slightly worse cancer-specific survival among those with discontinuous Medicaid or enrollment at diagnosis compared with those with continuous enrollment, but results were not significant stratified by cancer site. Conclusions and relevance AYAs with Medicaid insurance experience worse cancer-specific survival compared with those with private/military insurance, yet continuous enrollment demonstrates slight survival improvements, providing potential opportunities for future policy intervention.

IntroductionThe immunosuppressive nature of some cancers and many cancer-directed treatments may increase the risk of infection with and severe sequelae from Coronavirus Disease 2019 (COVID-19). The objective of this study was to compare concerns about COVID-19 among individuals undergoing cancer treatment to those with a history of cancer not currently receiving therapy and to those without a cancer history.MethodsWe conducted a cross-sectional anonymous online survey study of adults currently residing in the United States. Participants were recruited over a one-week period (April 3-11, 2020) using promoted advertisements on Facebook and Twitter. Groups were compared using chi-squared tests, Fisher’s exact tests, and t-tests.Results543 respondents from 47 states provided information on their cancer history and were included in analyses. Participants receiving active treatment reported greater concern about coronavirus infection (pConclusionsPatients undergoing active treatment for cancer were most concerned about the short-term effects of the COVID-19 pandemic on the logistics as well as potential efficacy of ongoing cancer treatment, longer term effects, and overarching societal concerns that the population at large is not as concerned about the public health implications of the coronavirus.

Survival among adolescents and young adults (AYAs) ages 15 to 39 with cancer has not improved to the same extent as that of pediatric and older adult cancer patients, which is thought to relate, in part, to the lower participation of AYAs in clinical trials. Because significant efforts have been made to improve clinical trial enrollment for AYAs, we (1) present contemporary clinical trial enrollment rates by cancer type, sociodemographic characteristics, and treatment setting and (2) discuss provider-, patient-, and system-level barriers to clinical trial participation. Contemporary studies examining clinical trial enrollment among AYAs have continued to find low overall participation relative to pediatric populations, with most studies observing no significant improvements in enrollment over time. In addition to age and cancer type, enrollment varies by treatment setting, health insurance, and race/ethnicity. Access to available clinical trials may be increased by appropriate referral of AYAs to pediatric and adult specialty cancer centers with studies relevant to the AYA population because most AYAs are treated in the community setting. Even with similar access to trials, however, AYAs may be less likely to participate, and therefore, future efforts should focus on better understanding and addressing barriers to enrollment as well as improving education and outreach regarding clinical trials.

BACKGROUND: The Medicare Modernization Act (MMA) reduced reimbursement for many antineoplastics delivered in outpatient settings, altering practice patterns for some cancers. To further evaluate the MMA’s effect, we focus on colon cancer, where longstanding fluorouracil-based regimens were augmented in 2004 with 3 newly-approved drugs (oxaliplatin, bevacizumab, and/or cetuximab). Staggered implementation of MMA reimbursement changes (physician offices implemented reimbursement changes in 2005 vs hospital outpatient departments(OPD) in 2006) provide a natural experiment to examine policy effects. METHODS: Using the 2000–2009 SEER-Medicare data, we examined antineoplastic use among 59,642 stage II–IV colon cancer patients. Using multivariate logistic regression models, we conducted difference-in-differences analyses to examine an interaction between time (pre-post MMA) and setting (physician offices versus OPDs) on antineoplastic receipt, adjusting for patient and cancer characteristics. A significant interaction indicates different practice patterns in physician offices versus OPD during the staggered implementation. RESULTS: After the reimbursement change in 2007–09 relative to 2000–03, use of fluorouracil-based therapy decreased slightly (Marginal Probability(MP): −0.07 stage II; −0.05 stage III; −0.05 stage IV; p< 0.01), while use of new drugs increased substantially (MP: 0.48 stage II; 0.69 stage III, 0.79 stage IV; p< 0.01). The interaction between MMA implementation and physician office setting was significant when examining use of new agents for Stage IV disease only. CONCLUSIONS: Our results indicate that providers responded to reimbursement changes after the MMA by increasing use of newly approved agents, but the magnitude of the response was small and limited to individuals diagnosed with Stage IV disease.

BackgroundThere is widespread concern across the clinical and research communities that clinical trials, powered for patient-reported outcomes, testing new surgical procedures are often expensive and time-consuming, particularly when the new intervention is shown to be no better than the standard. Conventional (non-adaptive) randomised controlled trials (RCTs) are perceived as being particularly inefficient in this setting. Therefore, we have developed an adaptive group sequential design that allows early endpoints to inform decision making and show, through simulations and a worked example, that these designs are feasible and often preferable to conventional non-adaptive designs. The methodology is motivated by an ongoing clinical trial investigating a saline-filled balloon, inserted above the main joint of the shoulder at the end of arthroscopic debridement, for treatment of tears of rotor cuff tendons. This research question and setting is typical of many studies undertaken to assess new surgical procedures.MethodsTest statistics are presented based on the setting of two early outcomes, and methods for estimation of sequential stopping boundaries are described. A framework for the implementation of simulations to evaluate design characteristics is also described.ResultsSimulations show that designs with one, two and three early looks are feasible and, with appropriately chosen futility stopping boundaries, have appealing design characteristics. A number of possible design options are described that have good power and a high probability of stopping for futility if there is no evidence of a treatment effect at early looks. A worked example, with code in R, provides a practical demonstration of how the design might work in a real study.ConclusionsIn summary, we show that adaptive designs are feasible and could work in practice. We describe the operating characteristics of the designs and provide guidelines for appropriate values for the stopping boundaries for the START:REACTS (Sub-acromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery) study.Trial registrationISRCTN Registry, ISRCTN17825590. Registered on 5 March 2018.

Many health services researchers are interested in assessing long term, individual physician treatment patterns, particularly for cancer care. In 2007, Medicare changed the physician identifier used on billed services from the Unique Physician Identification Number (UPIN) to the National Provider Identifier (NPI), precluding the ability to use Medicare claims data to evaluate individual physician treatment patterns across this transition period.Using the 2007-2008 carrier (physician) claims from the linked Surveillance, Epidemiology and End Results (SEER) cancer registry-Medicare data and Medicare's NPI and UPIN Directories, we created a crosswalk that paired physician NPIs included in SEER-Medicare data with UPINs. We evaluated the ability to identify an NPI-UPIN match by physician sex and specialty.We identified 470,313 unique NPIs in the 2007-2008 SEER-Medicare carrier claims and found a UPIN match for 90.1% of these NPIs (n=423,842) based on 3 approaches: (1) NPI and UPIN coreported on the SEER-Medicare claims; (2) UPINs reported on the NPI Directory; or (3) a name match between the NPI and UPIN Directories. A total of 46.6% (n=219,315) of NPIs matched to the same UPIN across all 3 approaches, 34.1% (n=160,277) agreed across 2 approaches, and 9.4% (n=44,250) had a match identified by 1 approach only. NPIs were paired to UPINs less frequently for women and primary care physicians compared with other specialists.National Cancer Institute has created a crosswalk resource available to researchers that links NPIs and UPINs based on the SEER-Medicare data. In addition, the documented process could be used to create other NPI-UPIN crosswalks using data beyond SEER-Medicare.

322 Background: Natural language processing (NLP) algorithms can be leveraged to better understand prevailing themes in healthcare conversations. Sentiment analysis, an NLP technique to analyze and interpret sentiments from text, has been validated on Twitter in tracking natural disasters and disease outbreaks. To establish its role in healthcare discourse, we sought to explore the feasibility and accuracy of sentiment analysis on Twitter posts (‘’tweets’’) related to prior authorizations (PAs), a common occurrence in oncology built to curb payer-concerns about costs of cancer care, but which can obstruct timely and appropriate care and increase administrative burden and clinician frustration. Methods: We identified tweets related to PAs between 03/09/2021-04/29/2021 using pre-specified keywords [e.g., #priorauth etc.] and used Twarc, a command-line tool and Python library for archiving Twitter JavaScript Object Notation data. We performed sentiment analysis using two NLP models: (1) TextBlob (trained on movie reviews); and (2) VADER (trained on social media). These models provide results as polarity, a score between 0-1, and a sentiment as ‘’positive’’ (>0), ‘’neutral’’ (exactly 0), or ‘’negative’’ (

55 Background: To date, drugs used for CACS have limited efficacy and may have unwanted side effects. Despite this, clinicians commonly prescribe certain drugs for CACS, adding financial burden to patients through out-of-pocket costs near or at the end of life. We sought to describe the range of costs of the multiple drugs commonly used to manage CACS. Methods: We reviewed oncology, nutrition, and supportive care guidelines (ASCO, ESMO, ESPEN, MASCC) and compiled a list of drugs recommended for CACS. We also included drugs commonly used off-label in clinical practice as identified by study authors. Using GoodRx.com, we extracted available formulations (e.g., tablet [tab] vs capsule [cap] vs oral disintegrating tablet [ODT] vs solution [sol]), and brand name vs generic products for each drug. We identified the average retail price, and the lowest price with coupons, for each formulation using the most commonly used dosage for a 2-week period (typical fill). The average retail price is the cash price for consumers without prescription drug coverage. The lowest price represents a discounted, ‘’best case’’ scenario of out-of-pocket costs for patients without prescription drug coverage. We collected data using the zip code 10065 in May 2021 to describe the range of costs of these drug formulations. Results: We included 7 drugs available in 20 formulations (Table). For a 2-week fill, the least expensive options included generic olanzapine 5 mg tab (once daily) and generic mirtazapine 15 mg tab (once daily), costing $4.50 per fill. Brand-name solutions were costly, ranging from $605.50 (megestrol acetate, Megace ES) to $1,156.30 (dronabinol, Syndros). Costs between formulations of the same drug/dosage varied widely: for olanzapine 5 mg, the lowest price varied from $4.50 [generic, tab] to $238.40 [Zyprexa zydis, brand-name, ODT]. Conclusions: We found that the costs of drugs used for CACS are highly variable, ranging from < $5 to > $1000 per fill. Overall there is limited data supporting use of drugs for managing CACS. Thus, our findings can help guide patient-clinician discussions about the risk/benefit ratio of a prescription for managing CACS, while highlighting the importance of seeking less expensive formulations when possible.[Table: see text]

100 Background: The coronavirus (COVID-19) pandemic transformed norms and approaches to delivering cancer care in the US throughout 2020. While initial reports in regional and single institution studies suggest postponement or modification of cancer treatments, limited evidence exists on the long-term national impact of COVID-19 on cancer treatment throughout the year. Methods: Using de-identified OptumLabs Data Warehouse data, which includes data from the Optum Cancer Guidance Program’s electronic prior authorization (ePA) platform, we compared monthly rates (per 100,000 person-months) of requests for authorization for insurance coverage of systemic cancer therapy in January-December 2020 (COVID) versus January-December 2019 (non-COVID). Results: We identified a total of 94,726 prior-authorization requests for chemotherapy in 2020 compared to 106,272 requests in 2019, indicating a 10.8% overall decline during the pandemic. Prior-authorization request rates were 6.3% higher in March 2020 as many stay-at-home orders were implemented across states (Table). Prior authorization requests then significantly declined in April and May 2020 (3.3% and 14.4% lower rates in 2020 vs. 2019) during the stay-at-home orders before briefly increasing again in June. As COVID-19 infections and deaths increased throughout the fall, requests for prior-authorization significantly declined in each month from August through December 2020. Conclusions: The COVID-19 pandemic led to significant overall declines in requests for prior authorizations for chemotherapy in 2020 versus 2019. While requests rebounded somewhat in early spring and summer of 2020, rates were markedly lower, relative to those in 2019, during COVID-19’s second wave. Overall, these results suggest continued modifications or delays in cancer treatment that may result in worse outcomes for individuals with cancer in 2020 and should be evaluated in future studies. [Table: see text]

OBJECTIVE: This study aimed to provide a better understanding of the medical decision-making preferences and experiences of young adult survivors of pediatric, adolescent, and young adult cancers. METHODS: We conducted key informant interviews and a cross-sectional mailed survey with young adult survivors (currently aged 18–39 years) of pediatric, adolescent and young adult cancers in South Texas. RESULTS: Of the responding survivors, almost all wanted to be actively involved in medical decision-making, but preferences regarding family and doctor involvement varied. In open-ended responses, the most commonly reported concerns related to medical decision-making were feelings of uncertainty and fear of receiving bad news. Survivors reported that they desired more information in order to feel better about medical decision-making. CONCLUSIONS: Due to the variety of preferences regarding decision-making and who to include in the process, physicians should be prepared to ask and accommodate patients regarding their decision-making preferences.

Aims The aim of this study was to compare the effectiveness of a femoral nerve block and a periarticular infiltration in the management of early post-operative pain after total knee arthroplasty (TKA). Patients and Methods A pragmatic, single centre, two arm parallel group, patient blinded, randomised controlled trial was undertaken. All patients due for TKA were eligible. Exclusion criteria included contraindications to the medications involved in the study and patients with a neurological abnormality of the lower limb. Patients received either a femoral nerve block with 75 mg of 0.25% levobupivacaine hydrochloride around the nerve, or periarticular infiltration with 150 mg of 0.25% levobupivacaine hydrochloride, 10 mg morphine sulphate, 30 mg ketorolac trometamol and 0.25 mg of adrenaline all diluted with 0.9% saline to make a volume of 150 ml. Results A total of 264 patients were recruited and data from 230 (88%) were available for the primary analysis. Intention-to-treat analysis of the primary outcome measure of a visual analogue score for pain on the first post-operative day, prior to physiotherapy, was similar in both groups. The mean difference was -0.7 (95% confidence interval (CI) -5.9 to 4.5; p = 0.834). The periarticular group used less morphine in the first post-operative day compared with the femoral nerve block group (74%, 95% CI 55 to 99). The femoral nerve block group reported 39 adverse events, of which 27 were serious, in 31 patients and the periarticular group reported 51 adverse events, of which 38 were serious, in 42 patients up to six weeks post-operatively. None of the adverse events were directly attributed to either of the interventions under investigation. Conclusion Periarticular infiltration is a viable and safe alternative to femoral nerve block for the early post-operative relief of pain following TKA. Cite this article: Bone Joint J 2017;99-B:904–11.

PurposeTo investigate associations of sociodemographic factors-race/ethnicity, neighborhood socioeconomic status (SES), and health insurance-with survival for adolescents and young adults (AYAs) with invasive cancer.MethodsData on 80,855 AYAs with invasive cancer diagnosed in California 2001-2011 were obtained from the California Cancer Registry. We used multivariable Cox proportional hazards regression to estimate overall survival.ResultsAssociations of public or no insurance with greater risk of death were observed for 11 of 12 AYA cancers examined. Compared to Whites, Blacks experienced greater risk of death, regardless of age or insurance, while greater risk of death among Hispanics and Asians was more apparent for younger AYAs and for those with private/military insurance. More pronounced neighborhood SES disparities in survival were observed among AYAs with private/military insurance, especially among younger AYAs.ConclusionsLacking or having public insurance was consistently associated with shorter survival, while disparities according to race/ethnicity and neighborhood SES were greater among AYAs with private/military insurance. While health insurance coverage associates with survival, remaining racial/ethnic and socioeconomic disparities among AYAs with cancer suggest additionalsocial factors also need consideration in intervention and policy development.

Background: The adoption of sorafenib into oncology practice as a first-line systemic treatment for advanced hepatocellular carcinoma (HCC) is not well understood. We examined sorafenib use since Food and Drug Administration (FDA) approval in 2007 and associated survival for individuals diagnosed with advanced HCC, conducting a population-based evaluation of treatment patterns and outcomes for this newly approved drug in the US over time. Methods: We identified individuals diagnosed with Barcelona Clinic Liver Cancer Stage C from the 2007 and 2012 National Cancer Institute Patterns of Care study. We examined trends in use as well as patient and clinical factors associated with receiving sorafenib using multivariate logistic regression analysis. We then evaluated the association between sorafenib use and overall hazard of death using multivariate Cox proportional hazards regression. Results: Among 550 individuals diagnosed with advanced HCC, we found no significant increase in the proportion of patients treated with sorafenib from 2007 to 2012 (26.3 vs. 30.4%). After adjusting for patient and clinical characteristics, non-Hispanic Blacks (compared to non-Hispanic Whites) and those with a lower Child-Pugh score remained more likely to receive sorafenib. Individuals receiving systemic chemotherapy only, radiation therapy only, or no treatment at all experienced a higher risk of death than those treated with sorafenib, while those receiving a transplant experienced a lower risk of death. Conclusions: Sorafenib has not been widely adopted into oncology practice since FDA approval for advanced HCC. Few factors apart from Child-Pugh score and race/ethnicity predict sorafenib use in clinical practice, although sorafenib treatment is associated with a lower risk of death.

BackgroundIntensive care treatment can be life-saving, but it is invasive and distressing for patients receiving it and it is not always successful. Deciding whether or not a patient will benefit from intensive care is a difficult clinical and ethical challenge.ObjectivesTo explore the decision-making process for referral and admission to the intensive care unit and to develop and test an intervention to improve it.MethodsA mixed-methods study comprising (1) two systematic reviews investigating the factors associated with decisions to admit patients to the intensive care unit and the experiences of clinicians, patients and families; (2) observation of decisions and interviews with intensive care unit doctors, referring doctors, and patients and families in six NHS trusts in the Midlands, UK; (3) a choice experiment survey distributed to UK intensive care unit consultants and critical care outreach nurses, eliciting their preferences for factors used in decision-making for intensive care unit admission; (4) development of a decision-support intervention informed by the previous work streams, including an ethical framework for decision-making and supporting referral and decision-support forms and patient and family information leaflets. Implementation feasibility was tested in three NHS trusts; (5) development and testing of a tool to evaluate the ethical quality of decision-making related to intensive care unit admission, based on the assessment of patient records. The tool was tested for inter-rater and intersite reliability in 120 patient records.ResultsInfluences on decision-making identified in the systematic review and ethnographic study included age, presence of chronic illness, functional status, presence of a do not attempt cardiopulmonary resuscitation order, referring specialty, referrer seniority and intensive care unit bed availability. Intensive care unit doctors used a gestalt assessment of the patient when making decisions. The choice experiment showed that age was the most important factor in consultants’ and critical care outreach nurses’ preferences for admission. The ethnographic study illuminated the complexity of the decision-making process, and the importance of interprofessional relationships and good communication between teams and with patients and families. Doctors found it difficult to articulate and balance the benefits and burdens of intensive care unit treatment for a patient. There was low uptake of the decision-support intervention, although doctors who used it noted that it improved articulation of reasons for decisions and communication with patients.LimitationsLimitations existed in each of the component studies; for example, we had difficulty recruiting patients and families in our qualitative work. However, the project benefited from a mixed-method approach that mitigated the potential limitations of the component studies.ConclusionsDecision-making surrounding referral and admission to the intensive care unit is complex. This study has provided evidence and resources to help clinicians and organisations aiming to improve the decision-making for and, ultimately, the care of critically ill patients.Future workFurther research is needed into decision-making practices, particularly in how best to engage with patients and families during the decision process. The development and evaluation of training for clinicians involved in these decisions should be a priority for future work.Study registrationThe systematic reviews of this study are registered as PROSPERO CRD42016039054, CRD42015019711 and CRD42015019714.FundingThe National Institute for Health Research Health Services and Delivery Research programme. The University of Aberdeen and the Chief Scientist Office of the Scottish Government Health and Social Care Directorates fund the Health Economics Research Unit.

Background and Objectives Though subjective age is a well-recognized risk factor for several chronic diseases, the biological basis for these associations remains poorly understood. Research Design and Methods We used new comprehensive biomarker data from the 2016 wave of the nationally representative Health and Retirement Study (HRS) to evaluate the association between biomarker levels and self-reported subjective age in a subset of 3,740 HRS participants who provided a blood sample. We measured biomarkers in seven biological domains associated with aging: inflammation, glycemia, lipids, liver function, endocrine function, renal function, and cardiac function. The primary outcome was the age discrepancy score (subjective age − chronological age) categorized as those who felt younger, older, or the same as their chronological age (reference group). Analyses adjusted for comprehensive psychosocial factors (chronic stress index, depression score), demographic factors (race, sex, body mass index, marital status, physical activity), and prevalence of chronic health conditions (comorbidity index). Results The prevalence of clinically relevant reduced levels of albumin concentrations was lower in those who felt younger (8.8% vs. 16.0%; p = .006) and higher in those who felt older (20.4% vs. 16.0%; p = .03) when compared with the reference category. The prevalence of clinically significant elevation in liver enzymes such as alanine aminotransferase was also significantly lower among those who felt younger (7.1% vs. 8.6%; p = .04) when compared with the reference category. Prevalence of clinically elevated levels in cystatin C was also lower among those who felt younger when compared with the reference category (50.0% vs. 59.1%; p = .04). There was no association between lipids, glucose, or C-reactive protein (inflammatory marker) and subjective age categories. Discussion and Implications These results suggest that people who feel younger may have favorable biomarker profiles and as a result may have lower prevalence of age-related diseases when compared with those who feel older or those who feel the same as their chronological age.

Background The National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database was first created almost 30 years ago. Over time, additional data have been added to the SEER-Medicare database, allowing for expanded insights into the delivery of health care across the cancer continuum from screening to end of life. Methods This article includes an overview of the current SEER-Medicare database, presenting potential users with an introduction to how the data can facilitate innovative epidemiologic and health services research studies. With a focus on the population 65 years and older, this article presents descriptive data on beneficiary demographics, cancer characteristics, service settings, Medicare coverage (eg, Parts A, B, C, and D), and use (number of services or bills) from 2011 to 2015. Results From 2011 to 2015, 857 056 cancer patients and 601 470 population-based noncancer controls were added to the database. The database includes detailed tumor characteristics and clinical assessments for cancer cases, and demographics and health-care use (eg, hospitals, outpatient facilities, individual providers, hospice, home health-care providers, and pharmacies) for both cases and controls. Although characteristics varied overall between cases and controls, sufficient cancer-specific matched controls are available. Roughly 60% of cases were enrolled in fee for service at cancer diagnosis. The annual average number of claims per case was 60.7 and 92.3 during the year before and after cancer diagnosis, respectively, and 127.5 during the year before death. Conclusions The large sample size and diverse array of data on cancer patients and noncancer controls in the SEER-Medicare database make it a unique resource for conducting cancer health services research.

Author(s): Parsons, Helen M; Penn, Dolly C; Li, Qian; Cress, Rosemary D; Pollock, Brad H; Malogolowkin, Marcio H; Wun, Ted; Keegan, Theresa HM | Abstract: BackgroundStagnant outcomes for adolescents and young adults (AYAs) 15-39 years of age with cancer are partly attributed to poor enrollment onto clinical trials. Initiatives have focused on increasing accrual, but changes at the population-level are unknown. We examined patterns of clinical trial participation over time in AYA patients with cancer.ProcedureWe utilized medical record data from AYAs in two population-based National Cancer Institute Patterns of Care Studies identified through the Surveillance, Epidemiology and End Results Program. Among 3135 AYAs diagnosed with non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, acute lymphoblastic leukemia (ALL), and sarcoma, we used multivariate logistic regression to evaluate patient and provider characteristics associated with clinical trial enrollment. Interaction terms evaluated variation in clinical trial enrollment across patient and provider characteristics by year of diagnosis.ResultsFrom 2006 to 2012-2013, clinical trial participation increased from 14.8% to 17.9% (Pnln0.01). Adjusting for patient and provider characteristics, we found lower clinical trial enrollment among those who were older at diagnosis, diagnosed with NHL vs ALL, treated by adult hematologist/oncologists only (vs pediatric hematologist/oncologists), and of non-Hispanic Black race/ethnicity (vs non-Hispanic White) (Pnln0.05 for all). Interaction analyses indicate improved clinical trial enrollment from 2006 to 2012-2013 among young adults 25-29 years of age and the uninsured.ConclusionsAlthough disparities in enrollment onto clinical trials remain for AYAs with cancer, our study identified increasing overall clinical trial participation over time.nFurther, we identify promising trends in enrollment uptake among AYAs 25-29 years of age and the uninsured.

IntroductionEach year in the UK over 120 000 people fracture their ankle. It is not known what the best rehabilitation strategy is for these people. Traditionally standard care has involved immobilisation in a plaster cast but an alternative is a functional brace, which can be removed to allow early movement. This paper details the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with an ankle fracture.Methods and analysisWe will recruit adults with a fractured ankle, for which the treating clinician would consider plaster cast to be a reasonable management option. Randomisation will be on a 1:1 basis, stratified by centre, operative or non-operative management and age. Participants will be allocated to either plaster cast or a functional brace, both treatments are widely used. To have 90% power to detect a difference of 10 points on the primary outcome (Olerud and Molander Ankle Score) at the primary outcome time point (16 weeks), we need to randomise a minimum of 478 people. Quality of life and resource use will be collected at 6, 10, 16, 24 weeks and 12, 18, 24 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The economic evaluation will adhere to the recommendations of the National Institute for Health and Care Excellence reference case.Ethics, registration and disseminationNational Research Ethic Committee approved this study on 4 July 2017 (17/WM/0239). The first site opened to recruitment 9 October 2017. The results of this trial will be submitted to a peer-reviewed journal and will inform clinical practice.Trial registration numberISRCTN15537280; Pre-results.

1582 Background: During the COVID-19 pandemic, most cancer care in the United States transitioned to telehealth (phone or video visits) to reduce infection risks for patients and providers. Telehealth may simplify care logistics (e.g. reduce travel and waiting times), but it may also unintentionally exacerbate existing disparities in healthcare utilization by race/ethnicity, age, or rural/urban status. As telehealth will likely continue long-term, we examined telehealth use at a comprehensive cancer center during the COVID-19 pandemic across patient populations with established disparities in cancer treatment and outcomes. Methods: We retrospectively reviewed telehealth visits from March until December 2020 among individuals diagnosed with cancer at the University of Minnesota Masonic Cancer Center (MCC). We used Chi-squared tests and GEE logistic regression to compare video vs. phone visits by age, urban/rural status, and race/ethnicity (American Indian / American Native [AIAN], Asian, Non-Hispanic Black/African American [NH Black/AA], Hispanic, Multiple, Native Hawaiian / Pacific Islander [NHPI], NH White). Results: Over the study period, 42,171 telehealth visits were performed with 11,097 patients at the MCC. Patients had a mean age of 62.7±13.9 years; 59.2% were female; 88.7% lived in urban areas; 90.0% of patients were NH White, 4.4% NH Black/AA, 3.0% Asian, 1.5% Hispanic, 0.8% AIAN, 0.3% of multiple races, and 0.1% NHPI. The most common cancer sites were breast (24.1%), hematological (21.0%), gynecologic (10.0%), and lung (8.4%). NH White individuals were more likely (53.9%) to use video than AIAN (39.7%), Black/AA (37.8%), or NHPI individuals (34.9%). Video use was less common among rural (45.3%) than urban (53.7%; p

Research service cores at academic health centers are important in driving translational advancements. Specifically, biostatistics and research design units provide services and training in data analytics, biostatistics, and study design. However, the increasing demand and complexity of assigning appropriate personnel to time-sensitive projects strains existing resources, potentially decreasing productivity and increasing costs. Improving processes for project initiation, assigning appropriate personnel, and tracking time-sensitive projects can eliminate bottlenecks and utilize resources more efficiently. In this case study, we describe our application of lean six sigma principles to our biostatistics unit to establish a systematic continual process improvement cycle for intake, allocation, and tracking of research design and data analysis projects. The define, measure, analyze, improve, and control methodology was used to guide the process improvement. Our goal was to assess and improve the efficiency and effectiveness of operations by objectively measuring outcomes, automating processes, and reducing bottlenecks. As a result, we developed a web-based dashboard application to capture, track, categorize, streamline, and automate project flow. Our workflow system resulted in improved transparency, efficiency, and workload allocation. Using the dashboard application, we reduced the average study intake time from 18 to 6 days, a 66.7% reduction over 12 months (January to December 2015).

Author(s): Wettergren, Lena; Kent, Erin E; Mitchell, Sandra A; Zebrack, Brad; Lynch, Charles F; Rubenstein, Mara B; Keegan, Theresa HM; Wu, Xiao-Cheng; Parsons, Helen M; Smith, Ashley Wilder; AYA HOPE Study Collaborative Group | Abstract: ObjectiveThis cohort study examined the impact of cancer on sexual function and intimate relationships in adolescents and young adults (AYAs). We also explored factors predicting an increased likelihood that cancer had negatively affected these outcomes.MethodsParticipants (n = 465, ages 15-39) in the Adolescent and Young Adult Health Outcomes and Patient Experience (AYA HOPE) study completed two surveys approximately 1 and 2nyears post-cancer diagnosis. We used multivariable logistic regression to determine factors negatively affected by perceptions of sexual function at 2nyears post-diagnosis.ResultsForty-nine percent of AYAs reported negative effects on sexual function at 1nyear post-cancer diagnosis and 70% of those persisted in their negative perceptions 2nyears after diagnosis. Those reporting a negative impact at 2nyears were more likely to be 25nyears or older (OR, 2.53; 95% CI, 1.44-4.42), currently not raising children (OR, 1.81; 95% CI, 1.06-3.08), experiencing fatigue (OR, 0.99; 95% CI, 0.975-0.998) and more likely to report that their diagnosis has had a negative effect on physical appearance (OR, 3.08; 95% CI, 1.97-4.81). Clinical factors and mental health were not significant predictors of negative effects on sexual function.ConclusionsMany AYAs diagnosed with cancer experience a persistent negative impact on sexual life up to 2nyears following diagnosis. The findings underscore the need to develop routine protocols to assess sexual function in AYAs with cancer and to provide comprehensive management in the clinical setting. Copyright © 2016 John Wiley a Sons, Ltd.

Author(s): Parsons, Helen M; Schmidt, Susanne; Tenner, Laura L; Bang, Heejung; Keegan, Theresa HM | Abstract: BackgroundThe Patient Protection and Affordable Care Act (ACA) included provisions to extend dependent health care coverage up to the age of 26 years in 2010. The authors examined the early impact of the ACA (before the implementation of insurance exchanges in 2014) on insurance rates in young adults with cancer, a historically underinsured group.MethodsUsing National Cancer Institute Surveillance, Epidemiology, and End Results data for 18 cancer registries, the authors examined insurance rates before (pre) (January 2007-September 2010) versus after (post) (October 2010-December 2012) dependent insurance provisions among young adults aged 18 to 29 years when diagnosed with cancer during 2007 through 2012. Using multivariate generalized mixed effect models, the authors conducted difference-in-differences analysis to examine changes in overall and Medicaid insurance after the ACA among young adults who were eligible (those aged 18-25 years) and ineligible (those aged 26-29 years) for policy changes.ResultsAmong 39,632 young adult cancer survivors, the authors found an increase in overall insurance rates in those aged 18 to 25 years after the dependent provisions (83.5% for pre-ACA vs 85.4% for post-ACA; Pl.01), but not among individuals aged 26 to 29 years (83.4% for pre-ACA vs 82.9% for post-ACA; P = .38). After adjusting for patient sociodemographics and cancer characteristics, the authors found that those aged 18 to 25 years had a 3.1% increase in being insured compared with individuals aged 26 to 29 years (Pl.01); however, there were no significant changes noted in Medicaid enrollment (P = .17).ConclusionsThe findings of the current study identify an increase in insurance rates for young adults aged 18 to 25 years compared with those aged 26 to 29 years (1.9% vs -0.5%) that was not due to increases in Medicaid enrollment, thereby demonstrating a positive impact of the ACA dependent care provisions on insurance rates in this population. Cancer 2016;122:1766-73. © 2016 American Cancer Society.

Purpose:\ud There is substantial evidence to suggest that Black and minority ethnic (BME) patients are disproportionately detained under the Mental Health Act (MHA). We examined ethnic differences in patients assessed for detention and explored the effect of ethnicity after controlling for confounders.\ud Methods:\ud A prospective study of all MHA assessments conducted in 1 year (April 2009–March 2010) within Birmingham and Solihull Mental Health Foundation Trust, UK. Proportion of assessments and detentions within denominator population of service users and regional populations were calculated. Multiple regression analysis was conducted to determine which variables were associated with the outcome of MHA assessment and the role of ethnicity.\ud Results:\ud Of the 1115 assessments, 709 led to detentions (63.58 %). BME ethnic groups were statistically more likely to be assessed and detained under the MHA as compared to Whites, both in the service user and the ethnic population estimates in Birmingham, UK. MHA detention was predicted by having a serious mental illness, the presence of risk, older age and living alone. Ethnicity was not associated with detention under the MHA with age, diagnosis, risk and level of social support accounted for.\ud Conclusion:\ud The BME ‘disproportionality’ in detention rates seems to be due to higher rates of mental illness, greater risk and poorer levels of social support rather than ethnicity per se.

BACKGROUND A cancer diagnosis during adolescence or young adulthood may negatively influence social well-being. The existing literature concerning the social well-being of adolescents and young adults (AYAs) with cancer was reviewed to identify gaps in current research and highlight priority areas for future research.

Background: Existing comorbidity indices were not developed for adolescent and young adults (AYA) 15 to 39 years of age. The aim of this study was to assess impact of comorbidities on health care service needs and health status among AYA cancer survivors using the newly developed AYA HOPE comorbidity index in comparison with the existing indices. Methods: Data on comorbid conditions were obtained from medical records and service needs and health status were from a survey of AYA cancer survivors. Prevalence of comorbidities was based on the AYA HOPE index. Charlson and NCI indices were compared. Multivariable logistic regression was used. Results: Of the 485 patients, 14.6% had ≥2 comorbidities based on the AYA HOPE Index. Prevalence of mental illness and obesity/overweight, which were not included in existing indices, were 8.2% and 5.8%, respectively. Prevalence of cardiovascular, endocrine, gastrointestinal, and neurologic conditions were higher with the AYA HOPE Index than the other two indices. Forty percent of AYA patients reported service needs, particularly for mental health services (25.2%) and support groups (17.7%). Having ≥2 comorbidities on the AYA index was associated with higher mental health service needs [OR, 2.05; 95% confidence interval (CI), 1.10–3.82] adjusting for demographic and clinical factors. Comorbidities were associated with fair/poor self-reported health status. Conclusion: The AYA HOPE Index is a more comprehensive comorbidity index for AYA cancer patients than existing indices, and the number of comorbidities is associated with service needs and health status. Impact: The AYA HOPE index could identify patients' additional service needs early in therapy. Cancer Epidemiol Biomarkers Prev; 24(12); 1844–9. ©2015 AACR.

IntroductionFirst-time traumatic anterior shoulder dislocation (TASD) is predominantly managed non-operatively. People sustaining TASD have ongoing pain, disability and future risk of redislocation. There are no published randomised controlled trials (RCTs) comparing different non-operative rehabilitation strategies to ascertain the optimum clinically effective approach after TASD.Methods and analysisIn this multicentre adaptive RCT, with internal pilot, adults with a radiologically confirmed first time TASD treated non-surgically will be screened at a minimum of 30 sites. People with neurovascular complications, bilateral dislocations or are unable to attend physiotherapy will be excluded.Randomisation will be on a 1:1 treatment allocation, stratified by age, hand dominance and site. Participants will receive a single session of advice; or a single session of advice plus offer of further physiotherapy (maximum 4 months). The primary analysis will be the difference in Oxford Shoulder Instability Score at 6 months. A sample size of a minimum of 478 participants will allow us to show a four point difference with 90% power.An embedded qualitative study will explore the participants’ experiences of the trial interventions.Ethics, registration and disseminationFunded by NIHR HTA (16/167/56), 1 June 2018; National Research Ethic Committee approved (18/WA/0236), 26 July 2018. First site opened 5 November 2018 and final results will be updated on trial registries and submitted to a peer-reviewed journal and will inform rehabilitation strategies after a TASD. Study Within A Trial (SWAT) funded by MRC (MR/R013748/1), 1 May 2019; registered on the MRC-HTMR All-Ireland Hub (reference number SWAT 121).Trial registration numberISRCTN63184243. (Trial stage: Pre-results)

This survey study uses data from the 2018 Behavioral Risk Factor Surveillance System survey to evaluate e-cigarette use in young adults who have a history of cancer relative to young adults without cancer.

IntroductionShoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.Methods and analysisSubacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.Ethics and disseminationNRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.Trial registration numberISRCTN17825590

IntroductionSupervised community treatment (SCT) for people with serious mental disorders has become accepted practice in many countries around the world. In England, SCT was adopted in 2008 in the form of community treatment orders (CTOs). CTOs have been used more than expected, with significant variations between people and places. There is conflicting evidence about the effectiveness of SCT; studies based on randomised controlled trials (RCTs) have suggested few positive impacts, while those employing observational designs have been more favourable. Robust population-based studies are needed, because of the ethical challenges of undertaking further RCTs and because variation across previous studies may reflect the effects of sociospatial context on SCT outcomes. We aim to examine spatial and temporal variation in the use, effectiveness and cost of CTOs in England through the analysis of routine administrative data.Methods and analysisFour years of data from the Mental Health Services Dataset (MHSDS) will be analysed using multilevel models. Models based on all patients eligible for CTOs will be used to explore variation in their use. A subset of CTO-eligible patients comprising a treatment group (CTO patients) and a matched control group (non-CTO patients) will be used to examine variation in the association between CTO use and study outcomes. Primary outcome will be total time in hospital. Secondary outcomes will include time to first readmission and mortality. Outputs from these models will be used to populate predictive models of healthcare resource use.Ethics and disseminationEthical approval has been granted by the National Health Service Data Access and Advisory Group and Warwick University. To ensure patient confidentiality and to meet data governance requirements, analyses will be carried out in a secure microdata laboratory using de-identified data. Study findings will be disseminated through academic channels and shared with mental health policy-makers and other stakeholders.

BACKGROUND: The prevalence of axial spondyloarthritis (axSpA) is estimated between 0.15 and 1.2%, with many of those patients experiencing severe fatigue. Current axSpA assessment guidance recommends use of a single-item visual analogue scale for fatigue severity. However, concerns have been raised about the ability of such a limited assessment to identify patients with major fatigue, to detect important change in fatigue or to reflect the multi-dimensional nature of fatigue. The proposed systematic review will identify and evaluate the quality and acceptability of single- and multi-item patient-reported outcome measures (PROMs) used to assess fatigue in axSpA, seeking to make recommendations for the ‘best’ measures for research and/or clinical practice.\ud \ud METHODS/DESIGN: The review will seek to include published studies which report evidence of the development and/or measurement and/or practical properties of clearly defined and reproducible measures of fatigue following completion by patients with axSpA. Five major databases will be searched from 1980 to August 2017: MEDLINE (OVID), EMBASE (OVID), PsycINFO (OVID), World of Science and CINAHL. Study methodological quality will be assessed against the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. The measurement and/or practical properties of reviewed measures will be assessed against current international standards. A short list of the ‘best’-quality PROMs will be produced. The review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.\ud \ud DISCUSSION: This study will provide the first robust and transparent evaluation of patient-reported measures of fatigue used in the axSpA population, synthesising evidence of quality, relevance and acceptability. The review will benefit patients, clinicians, health professionals and researchers wishing to enhance axSpA-fatigue assessment in routine practice, service evaluation and research. The findings will impact future research which seeks to better understand the nature of axSpA fatigue and evaluate the relative benefit of fatigue-management strategies.\ud \ud SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016042271 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13643-018-0777-7) contains supplementary material, which is available to authorized users.

SummaryConventional approaches to evidence that prioritise randomised controlled trials appear increasingly inadequate for the evaluation of complex mental health interventions. By focusing on causal mechanisms and understanding the complex interactions between interventions, patients and contexts, realist approaches offer a productive alternative. Although the approaches might be combined, substantial barriers remain.Declaration of interestAll authors had financial support from the National Institute for Health Research Health Services and Delivery Research Programme while completing this work. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the National Health Service, the National Institute for Health Research, the Medical Research Council, Central Commissioning Facility, National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, the Health Services and Delivery Research Programme or the Department of Health. S.P.S. is part funded by Collaboration for Leadership in Applied Health Research and Care West Midlands. K.B. is editor of the British Journal of Psychiatry.