The Sarcoma Assessment Measure (SAM): Preliminary Psychometric Validation of a Novel Patient-Reported Outcome Measure.

The Sarcoma Assessment Measure (SAM) was developed as a sarcoma-specific patient-reported outcome measure to be used in clinical practice. We have reported in detail how SAM has been developed in collaboration with patients and healthcare professionals. The aim of this paper is to report the preliminary validation of SAM. The 22-item SAM was administered alongside a validated quality of life questionnaire and measure of activities of daily living. Linear modelling was used to build a measure, which had predictive validity in comparison to more established outcome measures. Of the 762 patients who participated in the study, 44.1% identified as male, and participant age ranged from 13 to 82 years. Clinically, participants presented with a range of soft tissue (82.2%) and bone (21.8%) sarcomas. Our preliminary analysis indicates that SAM accounts for 35% of the global quality of life scale and 18% of the Toronto Extremity Salvage Scale (TESS); so psychometrically, it overlaps with quality of life and activities of daily living, but also measures distinct concerns. This demonstrates that this measure picks up issues that are important to patients with sarcoma that are not reflected in other measures. We have established the preliminary validity of SAM and believe it has utility as a patient-reported outcome measure both as a research tool and for assessing the impact of symptoms and dysfunction related to sarcoma as part of clinical care. Further validation using a larger and more clinically diverse sample is now needed.

Efficacy Studies of Home-Based Occupational Therapy Services Following Stroke: A Scoping Review.

The aim of this scoping review was to review and assess recent studies on the efficacy of home-based occupational therapy interventions for adults post-stroke. The number of efficacy studies is limited. The few studies available suggest that occupational therapy delivered in home settings may improve outcomes for stroke patients. There is also limited use of occupation-based assessments, interventions, and outcome measures in studies addressing home-based occupational therapy. Methodologies should be improved to include contexts, caregiver training, and self-efficacy. Further high-quality studies are needed on the efficacy home-based occupational therapy services.

Disparities in program enrollment and employment outcomes for veterans with psychiatric and co-occurring substance use disorders referred or enrolled for VHA vocational rehabilitation.

Introduction: The purpose of the study was to investigate factors that influence vocational rehabilitation program enrollment and employment at discharge of veterans with psychiatric and co-occurring alcohol and other substance use disorders enrolled at a veteran health administration (VHA) medical center. Methods: A sample of 2,550 veteran patients referred for VHA vocational rehabilitation between 2016 and 2021 were examined for the current study. The current study was classified as quality improvement/assurance, thus resulting in exempt research by the U.S. Department of Veteran Affairs Institutional Review Board. Results: Veterans with active alcohol use disorders (AUDs) and co-occurring depression, anxiety, post-traumatic stress disorder, or bipolar disorders were less likely to be enrolled for vocational rehabilitation program services compared to those without these co-occurring diagnoses. Veterans with AUD (active & in-remission status combined into one category) and a diagnosis of anxiety were less likely to be employed at discharge compared to veterans with AUDs and no anxiety diagnosis (anxiety diagnosis - 3.5% vs. no anxiety diagnosis - 5.8%). Discussion: VHA vocational rehabilitation can be an effective intervention to assist veterans in reintegrating back into the community. Yet, there appears to be some disparities in the program enrollment and employment at discharge, depending on the nature of the psychiatric diagnosis. Investigating the factors contributing (mediating or moderating) to these discrepancies are needed. Although it appears access is not the issue in being referred for vocational rehabilitation services, other factors are likely contributing to program entry.

Facilitators, Barriers and Views on the Role of Public Health Institutes in Promoting and Using Health Impact Assessment-An International Virtual Scoping Survey and Expert Interviews.

Public health institutes have an important role in promoting and protecting the health and well-being of populations. A key focus of such institutes are the wider determinants of health, embracing the need to advocate for 'Health in All Policies' (HiAP). A valuable tool to support this is the health impact assessment. This study aims to support public health institutes to advocate more successfully for the use of health impact assessments and HiAP in order to promote and protect health, well-being and equity. During July 2021, a quantitative online survey was undertaken across international networks with 17 valid responses received. Semi-structured interviews were also administered with nine expert representatives and analysed thematically. In total, 64.7% (n = 11) of survey respondents were aware of health impact assessments and 47.1% (n = 8) currently conducted health impact assessments. It was noted that there are differing approaches to HIAs, with a need for a clear set of standards. Barriers to use included lack of knowledge, training and resources. Overall, 64.7% (n = 11) of survey respondents would like to do more to develop knowledge and capacity around health impact assessments. The results from this study can serve as a platform to help build knowledge, networks and expertise, to help support a 'Health in All Policies' approach and address inequalities which exist in all societies.

Exploring the social value of Public Health Institutes: An international scoping survey and expert interviews.

Introduction: Making the case for investing in preventative public health by illustrating not only the health impact but the social, economic and environmental value of Public Health Institutes is imperative. This is captured by the concept of Social Value, which when measured, demonstrates the combined intersectoral value of public health. There is currently insufficient research and evidence to show the social value of Public Health Institutes and their work across the life course, population groups and settings, in order to make the case for more investment. Methods: During July 2021, a quantitative online self-administered questionnaire was conducted across international networks. Semi-structured interviews were also carried out with nine representatives to gain a deeper understanding. A thematic analysis was undertaken on the data collected. Results: In total, 82.3% (n = 14) were aware of the terminology of social value and 58.8% (n = 10) were aware of the economic method of Social Return on Investment. However, only two Institutes reported capturing social and community impacts within their economic analysis and only 41.2% (n = 7) currently capture or measure the social value of their actions. Interviews and survey responses indicate a lack of resources, skills and buy-in from political powers. Finally, 76.5% (n = 12) wanted to do more to understand and measure wider outcomes and impact of their actions. It was noted this can be achieved through enhancing political will, developing a community of best practice and tools. Conclusion: This research can inform future work to understand how to measure the holistic social value of Public Health Institutes, in order to strengthen institutional capacity and impact, as well as to achieve a more equitable society, and a more sustainable health system and economy, making the case for investing in public health, as we recover from COVID-19.

Web-Based Psychological Interventions for People Living With and Beyond Cancer: Meta-Review of What Works and What Does Not for Maximizing Recruitment, Engagement, and Efficacy.

BACKGROUND: Despite high levels of psychological distress experienced by many patients with cancer, previous research has identified several barriers to accessing traditional face-to-face psychological support. Web-based psychosocial interventions have emerged as a promising alternative. OBJECTIVE: This meta-review aimed to synthesize evidence on recruitment challenges and enablers, factors that promote engagement and adherence to web-based intervention content, and factors that promote the efficacy of web-based psychosocial interventions for patients with cancer and cancer survivors. METHODS: We conducted a systematic search of previous reviews that investigated the recruitment, engagement, and efficacy of web-based and app-based psychosocial interventions in adult patients with cancer and cancer survivors. We searched PubMed, CINAHL, PsycINFO, and the Cochrane Library database for relevant literature. The search terms focused on a combination of topics pertaining to neoplasms and telemedicine. Two independent authors conducted abstract screening, full text screening, and data extraction for each identified article. RESULTS: A total of 20 articles met eligibility criteria. There was inconsistency in the reporting of uptake and engagement data; however, anxiety about technology and perceived time burden were identified as 2 key barriers. Web-based psychosocial oncology interventions demonstrated efficacy in reducing depression and stress but reported weak to mixed findings for distress, anxiety, quality of life, and well-being. Although no factors consistently moderated intervention efficacy, preliminary evidence indicated that multicomponent interventions and greater communication with a health care professional were preferred by participants and were associated with superior effects. CONCLUSIONS: Several consistently cited barriers to intervention uptake and recruitment have emerged, which we recommend future intervention studies address. Preliminary evidence also supports the superior efficacy of multicomponent interventions and interventions that facilitate communication with a health care professional. However, a greater number of appropriately powered clinical trials, including randomized trials with head-to-head comparisons, are needed to enable more confident conclusions regarding which web-based psychosocial oncology interventions work best and for whom. TRIAL REGISTRATION: PROSPERO CRD42020202633; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=202633.

The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors.

BACKGROUND: Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. OBJECTIVE: This study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control. METHODS: To an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements. RESULTS: The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. CONCLUSIONS: Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31976.

Acceptance and commitment therapy (ACT)-enhanced communication skills: development and evaluation of a novel training programme.

BACKGROUND: Psychological suffering is ubiquitous with cancer and frequently presents as an unmet supportive care need. In clinical practice, distress-related needs are often addressed by nurses and non-psychologist allied healthcare professionals who may have limited training in psychological therapeutic frameworks, particularly more recently developed interventions such as Acceptance and Commitment Therapy (ACT). AIMS: We developed a single-day training programme for professionals working in supportive and palliative cancer care settings to change the nature of clinical communication about psychological distress and suffering towards an ACT-consistent approach. METHOD: We report on experiences of training delivery, and evaluation data about training satisfaction and intention to apply the training to clinical practice, from three training iterations in British and Australian, government-funded and charitable sectors. One hundred and sixteen cancer care professionals participated in the training. Evaluation data were collected from 53 participants (at either 2-week or 3-month follow-ups, or both) using self-report survey, including both quantitative and free-text questions. RESULTS: At 2 week follow-up, 73% of trainees rating our course as having relevance to their work, and at 3 month follow-up, 46% agreed that they were better placed to provide improved clinical services. Qualitative feedback supported the inclusion of experiential learning and theoretical explanations underpinning ACT techniques. Undertaking this training did not significantly increase trainees' stress levels, nor did implementation of this new way of working negatively affect staff well-being. Positive, ACT-consistent, changes in communication behaviours and attitudes were reported, however there was a lack of significant change in psychological flexibility. DISCUSSION: Acceptability and applicability of this training to supportive and palliative healthcare is positive. The lack of change in psychological flexibility suggests a potential need for more experiential content in the training programme. Logistical challenges in one training group suggests the need for more robust train-the-trainer models moving forward.

Evaluating the impact of COVID-19 on supportive care needs, psychological distress and quality of life in UK cancer survivors and their support network.

OBJECTIVES: The COVID-19 pandemic is having considerable impact on cancer care, including restricted access to hospital-based care, treatment and psychosocial support. We investigated the impact on unmet needs and psychosocial well-being. METHODS: One hundred and forty four participants (77% female), including people with cancer and their support networks, were recruited. The most prevalent diagnosis was breast cancer. Forty-one participants recruited pre-pandemic were compared with 103 participants recruited during the COVID-19 pandemic. We measured participants' unmet supportive care needs, psychological distress and quality of life. RESULTS: Half of our patient respondents reported unexpected changes to treatment following pandemic onset, with widespread confusion about their longer-term consequences. Although overall need levels have not increased, specific needs have changed in prominence. People with cancer reported significantly reduced anxiety (p = 0.049) and improved quality of life (p = 0.032) following pandemic onset, but support network participants reported reduced quality of life (p = 0.009), and non-significantly elevated anxiety, stress and depression. CONCLUSION: Psychological well-being of people with cancer has not been detrimentally affected by pandemic onset. Reliance on home-based support to compensate for the lost availability of structured healthcare pathways may, however, explain significant and detrimental effects on the well-being and quality of life of people in their support and informal care networks.

PEGylated polymeric nanocapsules for oral delivery of trypsin targeted to the small intestines.

The lack of trypsin in the intestines may end up with malnutrition; thus, trypsin replacement therapy is required in such cases. The main objective of this study is to formulate and evaluate polymeric nanocapsule (PNC) systems able to deliver trypsin to the small intestines with the minimal release in the stomach with the maximum biological activity. Four nanocapsule formulations were prepared by double emulsion/evaporation method as w/o/w and s/o/w. Particle size, encapsulation efficiencies, drug release in simulated gastric fluids (SGF) and simulated intestinal fluids (SIF), morphology, the biological activity of encapsulated trypsin and shelf-life stability were investigated for all formulations. All formulations had a spherical shape with submicron size, and encapsulation efficiency more than 80%. The biological activity of encapsulated trypsin was significantly affected by the amount of trehalose and whether the formulations were prepared as s/o/w or w/o/w (P < 0.05). Most of the encapsulated protein was released sustainedly at the target site (SIF) over 24 h with minimum amount release in the gastric fluids. Also, more than 90% of physical integrity trypsin encapsulated in all formulations was retained after storage under chilled conditions for six months. However, the enzymatic assay results show that with low trehalose content, the biological activity was low, while increasing the trehalose amount increased the shelf stability to reach around 100% after six months of the study. The results obtained in this research work clearly indicated a promising potential of controlled release polymeric nanocapsules containing trypsin to target the small intestine and protect trypsin from the harsh condition facing the proteins during the process of preparation or the period of storage.

Evaluating process and effectiveness of a low-intensity CBT intervention for women with gynaecological cancer (the EPELIT Trial).

Background: Improving survival from gynaecological cancers is creating an increasing clinical challenge for long-term distress management. Psychologist-led interventions for cancer survivors can be beneficial, but are often costly. The rise of the Psychological Wellbeing Practitioner (PWP) workforce in the UK might offer a cheaper, but equally effective, intervention delivery method that is more sustainable and accessible. We aimed to test the effectiveness of a PWP co-facilitated intervention for reducing depression and anxiety, quality of life and unmet needs. Methods: We planned this trial using a pragmatic, non-randomised controlled design, recruiting a comparator sample from a second clinical site. The intervention was delivered over six-weekly sessions; data were collected from participants at baseline, weekly during the intervention, and at one-week and three-month follow-up. Logistical challenges meant that we only recruited 8 participants to the intervention group, and 26 participants to the control group. Results: We did not find significant, between-group differences for depression, quality of life or unmet needs, though some differences at follow-up were found for anxiety ( p<.001). Analysis of potential intervention mediator processes indicated the potential importance of self-management self-efficacy. Low uptake into the psychological intervention raises questions about (a) patient-driven needs for group-based support, and (b) the sustainability of this intervention programme. Conclusions: This study failed to recruit to target; the under-powered analysis likely explains the lack of significant effects reported, though some trends in the data are of interest. Retention in the intervention group, and low attrition in the control group indicate acceptability of the intervention content and trial design; however a small baseline population rendered this trial infeasible in its current design. Further work is required to answer our research questions, but also, importantly, to address low uptake for psychological interventions in this group of cancer survivors. Trial registration: ClinicalTrials.gov, NCT03553784 (registered 14 June 2018).

An increasing number of people are surviving for longer time periods following treatment for gynaecological cancer and this means we need to change how we care for and support a growing cancer survivor population. Psychological distress and poor quality of life are common in people affected by cancer, and these do not always improve once treatment ends. Providing psychological support can be expensive, which means that not everyone who wants it can access it. Psychological Wellbeing Practitioners (PWPs) have been introduced in UK health care. This workforce might offer an alternative for providing psychological support to a greater number of cancer survivors. We aimed to test how good a PWP co-delivered intervention is at improving depression, anxiety and quality of life in people who had been treated for gynaecological cancer. The intervention was delivered to small groups of patients over six weekly sessions. We compared those who received the intervention with a similar patient group who did not have access to the same psychological support from a different hospital. Participants reported their psychological wellbeing and quality of life at the point of recruitment, weekly for six weeks, and then at follow-up time-points one week and three months later. Because of low interest in the group intervention we did not recruit to target. Only 8 participants took part in the intervention, and we recruited only 26 participants in the control group. This means we can't have full confidence in our results. Nonetheless, the findings indicate that this intervention was helpful for improving participants' anxiety levels. Further trials, which recruit a larger number of cancer survivors, are needed to answer our research questions. However, this trial indicates acceptability and potential benefit. We also need to undertake research to understand why so few cancer survivors wanted to take part in this group-based intervention.

Recent Advances in Health Impact Assessment and Health in All Policies Implementation: Lessons from an International Convening in Barcelona.

Health Impact Assessment (HIA) and Health in All Policies (HiAP) are policy tools used to include health considerations in decision-making processes across sectors such as transportation, education, and criminal justice that can play a role in improving health and equity. This article summarizes proceedings from an international convening of HIA and HiAP experts held in July 2019 in Barcelona, Spain. The presentations and panel discussions included different models, best practices, and lessons learned, including from government, international banks, think tanks, and academia. Participants discussed ideas from around the world for cross-sector collaboration to advance health. The convening covered the following topics: community engagement, building greater understanding of and support for HiAP, and exploring how mandates for HIA and HiAP approaches may advance health and equity.

Rapid Implementation of an Inpatient Telehealth Program during the COVID-19 Pandemic.

BACKGROUND: Relaxation of laws and regulations around privacy and billing during the COVID-19 pandemic provide expanded opportunities to use telehealth to provide patient care at a distance. Many health systems have transitioned to providing outpatient care via telehealth; however, there is an opportunity to utilize telehealth for inpatients to promote physical distancing. OBJECTIVE: This article evaluates the use of a rapidly implemented, secure inpatient telehealth program. METHODS: We assembled a multidisciplinary team to rapidly design, implement, and iteratively improve an inpatient telehealth quality improvement initiative using an existing videoconferencing system at our academic medical center. We assigned each hospital bed space a unique meeting link and updated the meeting password for each new patient. Patients and families were encouraged to use their own mobile devices to join meetings when possible. RESULTS: Within 7 weeks of go-live, we hosted 1,820 inpatient telehealth sessions (13.3 sessions per 100 bedded days). We logged 104,647 minutes of inpatient telehealth time with a median session duration of 22 minutes (range 1-1,961). There were 5,288 participant devices used with a mean of 3 devices per telehealth session (range 2-22). Clinicians found they were able to build rapport and perform a reasonable physical exam. CONCLUSION: We successfully implemented and scaled a secure inpatient telehealth program using an existing videoconferencing system in less than 1 week. Our implementation provided an intuitive naming convention for providers and capitalized on the broad availability of smartphones and tablets. Initial comments from clinicians suggest the system was useful; however, further work is needed to streamline initial setup for patients and families as well as care coordination to support clinician communication and workflows. Numerous use cases identified suggest a role for inpatient telehealth will remain after the COVID-19 crisis underscoring the importance of lasting regulatory reform.

Health Impact and Social Value of Interventions, Services, and Policies: A Methodological Discussion of Health Impact Assessment and Social Return on Investment Methodologies.

Introduction: Assessing the positive and negative impact of policies, services and interventions on health and well-being is of great importance to public health. Health Impact Assessment (HIA) and Social Return on Investment (SROI) are established methodologies which assess potential effects on health and well-being, including social, economic and environmental factors, indicating synergies, and cross-over in their approach. Within this paper, we explore how HIA and SROI could complement each other to capture and account for the impact and social value of an assessed intervention or policy. Methods: A scoping review of academic and gray literature was undertaken to identify case studies published between January 1996 and April 2019 where HIA and SROI methodologies have been used to complement each other previously. Semi-structured interviews were carried out with nine international experts from a range of regulatory and legislative contexts to gain a deeper understanding of past experiences and expertise of both HIA and SROI. A thematic analysis was undertaken on the data collected. Results: The scoping review identified two published reports on scenarios where HIA and SROI have both been used to assess the same intervention. Results from the interviews suggest that both methods have strengths as standalone methodologies. HIAs were noted to be well-structured in their approach, assessing health and well-being in its broadest context. SROI was noted to add value by monetizing social value, as well as capturing the social and environmental impact. Similarities of the two methods was suggested as their strong emphasis on stakeholder engagement and common shared principles. When questioned how the two methods could complement each other in practice, our results indicate the benefits of using HIA as an initial exploration of impact, potentially using SROI subsequently to monetarize social value. Conclusion: HIA and SROI have many synergies in their approaches. This research suggests potential benefits when used in tandem, or combining the methods to assess impact and account for social value. Further research is needed to understand the implications of this in practice, and to understand how the results of the two methods could be used by decision-makers.

Short stay unit for patients in acute mental health crisis: A case-control study of readmission rates.

INTRODUCTION: Past evaluations of psychiatric short stay units have shown positive outcomes for patients, yet very little is known about the factors related to readmissions. METHODS: A Short Stay Pathway (SSP) has been introduced on the Gold Coast, Australia, for patients in acute mental health crisis with admissions of up to 3 days. Rates of readmissions within 28 days were compared for SSP patients (N = 678), and a diagnosis-matched control group of patients from acute mental health beds (N = 1356). Demographic and clinical factors were considered as predictors of subsequent readmissions. RESULTS: Average length of stay for SSP patients was 3.4 days, compared to 7.6 days in the control group. 10.6% of SSP patients and 18.4% of the control group were readmitted within 28 days (P < .001). For both groups, a 7-day follow up significantly reduced readmissions (P < .05). Indigenous patients on SSP had higher odds of readmissions than non-Indigenous patients (P < .05), and a diagnosis of a personality disorder increased readmission in the control group but not the SSP group (P < .001). DISCUSSION: SSP reduced repeated hospitalizations for patients in acute crisis by 42%. An identification of factors related to future admissions can inform future tailoring of this model of care to subgroups of patients.

Ultra-brief non-expert-delivered defusion and acceptance exercises for food cravings: A partial replication study.

Food cravings are a common barrier to losing weight. This article presents a randomised comparison of non-expert group-delivered ultra-brief defusion and acceptance interventions against a distraction control. A total of 63 participants were asked to carry a bag of chocolates for a week while trying to resist the temptation to eat them. A behavioural rebound measure was administered. Each intervention out-performed control in respect of consumption, but not cravings. These techniques may have a place in the clinical management of food cravings. We provide tentative evidence that the mechanism of action is through decreased reactivity to cravings, not through reduced frequency of cravings.

Recruiting cancer survivors into research studies using online methods: a secondary analysis from an international cancer survivorship cohort study.

Recruiting participants into cancer survivorship research remains a significant challenge. Few studies have tested and compared the relative use of non-clinical online recruitment methods, especially in samples of adult cancer survivors. This paper reports on the feasibility of recruiting a representative cohort of cancer survivors using online social media. Two hundred participants with cancer diagnosis within the past 12 months were recruited via social media (Facebook, Twitter and Reddit) into a longitudinal questionnaire study. Different methods of online recruitment proved to be more effective than others over time. Paid Facebook boosting, Reddit posts and Twitter advertisements placed by existing cancer charities proved most helpful in reaching our recruitment target (contributing 27%, 22% and 32%, respectively). Recruiting online achieved a more demographically and clinically representative sample for our study: our subject was younger, less heteronormative, including those with a range of clinical diagnoses, primary and recurrence illness, and patients who had both completed and were still receiving treatment. This was certainly not a quick method of sample recruitment but that could have been optimised by focussing only on the three most effective methods described earlier. While we found that online recruitment is significantly lower in cost than traditional recruitment methods, and can reduce some biases, there still remains the potential for some biases (e.g. excluding much older participants) and ethical/methodological issues (e.g. excluding those without access to Internet). We outline our recruitment strategy, retention rates and a cost breakdown in order to guide other researchers considering such methods for future research in cancer survivorship.

Lysozyme and DNase I loaded poly (D, L lactide-co-caprolactone) nanocapsules as an oral delivery system.

Clinical applications of oral protein therapy for the treatment of various chronic diseases are limited due to the harsh conditions encounter the proteins during their journey in the Gastrointestinal Tract. Although nanotechnology forms a platform for the development of oral protein formulations, obtaining physiochemically stable formulations able to deliver active proteins is still challenging because of harsh preparation conditions. This study proposes the use of poly (D, L-lactic-co-caprolactone)-based polymeric nanocapsules at different monomers' ratios for protein loading and oral delivery. All formulations had a spherical shape and nano-scale size, and lysozyme encapsulation efficiency reached 80% and significantly affected by monomers' ratio. Trehalose and physical state of lysozyme had a significant effect on its biological activity (P < 0.05). Less than 10% of the protein was released in simulated gastric fluid, and 73% was the highest recorded accumulative release percentage in simulated intestinal fluid (SIF) over 24 h. The higher caprolactone content, the higher encapsulation efficiency (EE) and the lower SIF release recorded. Therefore, the formulation factors were optimised and the obtained system was PEGylated wisely to attain EE 80%, 81% SIF release within 24 h, and 98% lysozyme biological activity. The optimum formulation was prepared to deliver DNase, and similar attributes were obtained.

Multi-laboratory validation of a Δ9-tetrahydrocannabinol LC-MS/MS test kit designed for quantifying THC and marijuana metabolites in blood.

Marijuana legalization has increased the demand for testing of Δ9-tetrahydrocannabinol (THC) and THC metabolites. The THC ToxBox® test kit (THC ToxBox®) is commercially available and supports high-throughput LC-MS/MS analytical methods designed to quantify low levels of THC and THC metabolites in blood. The purpose of this study is to determine if this new test kit meets the rigors of laboratory accreditation and produces equivalent results across six states- and locally-funded laboratories. Each laboratory followed internal method validation procedures established for their clinical (CLIA) or international (ISO17025) accreditation program. Test performance indicators included accuracy, precision, measurement of uncertainty, calibration models, reportable range, sensitivity, specificity, carryover, interference, ion suppression/enhancement and analyte stability. Analytes and interferents were resolved within the 6-min analytical runtime, and the 48-well plate pre-manufactured with calibrators, second source quality control material, and internal standards at precise concentrations allowed for simple and consistent sample preparation in less than one hour. Every laboratory successfully validated test kit procedures for forensic use. Differences in sensitivity were generally associated with the use of older equipment. Statistical analysis of results spanning reportable ranges show that laboratories with different instrument platforms produce equivalent results at levels sufficiently low enough to support per se limit testing of THC and THC metabolites (1-5 ng/mL). THC ToxBox® represents a viable option for state- and locally-funded laboratories charged with investigating impaired driving cases involving marijuana use.

Demographic-Specific Rates for Life Events in the Cardiovascular Health Study and Comparisons With Other Studies.

PURPOSE OF THE STUDY: (1a) We use the Cardiovascular Health Study (CHS), a multi-site heterogeneous sample of Medicare enrollees (N = 5,849) to provide rates for specific life events experienced within 6 months; (1b) We present rates for 29 other studies of community-residing older adults (N = 41,308); (2) For the CHS, we provide demographic-specific rates and predicted probabilities for age [young-old (65-75) vs old-old (≥75)], gender, race, marital status, and education. DESIGN/METHODS: The CHS sample is 57.6% women, 84.2% white (15.8% black), and 66.3% married. Mean age is 72.8 years (standard deviation [SD] = 5.6, range = 65-100) and education is 13.7 years (SD = 4.8). Life events were interviewer-assessed. Regressions estimated associations of life event rates with demographic groups (e.g., age), controlling for other demographic variables (e.g., gender, etc.). RESULTS: (1a) CHS rates ranged from 44.7% (death of someone close) to 1.1% (retirement/work changes). (1b) Most life event studies used total scores and only 5 that met our inclusion criteria used time intervals <1 year; longer intervals were associated with higher rates. (2) In the CHS, the life event for illnesses was related to 5 demographic variables (net the other 4 demographic variables), difficulties caregiving to 4, and worse relationships to 3 demographic variables. Race was related to 8 life events, marital status to 7, education to 6, and age to 4 events. IMPLICATIONS: By identifying demographic groups at highest risk for life events, this research focuses on older adults at greatest risk for health problems. These data are necessary for translating research into interventions, practice, and policy.