Health-related quality of life after a diagnosis of bladder cancer: a longitudinal survey over the first year.

OBJECTIVES: To describe the health-related quality of life (HRQoL) of patients in a prospective 12-month observational cohort study of new bladder cancer diagnoses and compare with national cancer and general population surveys. PATIENTS AND METHODS: A prospective UK study in patients with new bladder cancer diagnoses at 13 NHS Trusts. The HRQoL data were collected at 3, 6, 9 and 12 months. Questionnaires used included: the EuroQoL five Dimensions (EQ-5D), European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-30-item core, EORTC QLQ-24-item non-muscle-invasive bladder cancer, and EORTC QLQ-30-item muscle-invasive bladder cancer. Results were compared with the Cancer Quality of Life Survey and Health Survey for England. RESULTS: A total of 349 patients were recruited, 296 (85%) completed the first (baseline) and 233 (67%) the final survey. The patients underwent transurethral resection of bladder tumour (TURBT) ± intravesical therapy (238 patients, 80%), radical cystectomy/radiotherapy (51, 17%) or palliation (seven, 2%). At baseline, patients needing radical treatment reported worse HRQoL including lower social function (74.2 vs 83.8, P = 0.002), increased fatigue (31.5 vs 26.1, P = 0.03) and more future worries (39.2 vs 29.4, P = 0.005) than patients who underwent TURBT. Post-treatment surveys showed no change/improvements for patients who underwent TURBT but deterioration for the radically treated cohort. At final survey, reports were similar to baseline, regardless of treatment. Radically treated patients continued to report poorer HRQoL including issues with body image (23.4 vs 12.5, P = 0.007) and male sexual function (75.8 vs 40.4, P < 0.001) compared to those who underwent TURBT. Radically treated patients reported lower EQ-5D utility scores and more problems with usual activities than the general population. DISCUSSION: Patients undergoing TURBT can be reassured regarding HRQoL following treatment. However, those requiring radical treatment report greater changes in HRQoL with the need for appropriate clinical and supportive care to minimise the impact of treatments.

Electronic patient-reported monitoring of symptoms during follow-up of ovarian cancer patients: a feasibility study.

BACKGROUND: Ovarian cancer patients require monitoring for relapse. Innovative follow-up methods are increasingly being explored. An electronic patient-reported outcome (ePRO) follow-up pathway was developed for women treated for ovarian cancer. This feasibility study explored patient acceptability and compliance. METHODS: A single-arm non-blinded prospective feasibility study was undertaken at two hospitals. Participants were women who had completed treatment for ovarian cancer whose clinician was happy for them to be monitored remotely. Automated 3-monthly reminders were sent to participants to complete an ePRO questionnaire and obtain blood tests. Participants were reviewed over the phone by their clinical nurse specialist instead of attending clinic-based follow-up. The primary outcome was compliance (expected ePRO completions/blood tests) across the 12-month study period. Secondary outcomes were recruitment, attrition, resource use, symptom severity/alerts and patient acceptability. RESULTS: Twenty-four women consented (50% consent rate), and 13 remained on study at 12 months. Seven women relapsed, 3 chose to withdraw, and 1 withdrew for other clinical reasons. ePRO compliance was high and consistent at 75-82%, although the two hospitals differed. Adherence to the clinical protocol was evident for blood tests and contacts with staff (fewer visits, more phonecalls compared to an earlier audit). End-of-study feedback indicated high patient satisfaction. CONCLUSIONS: Remote ePRO follow-up for ovarian cancer is feasible and acceptable to patients who are able and willing to participate. However, the low recruitment rate (ineligible + declined) indicate it is not suitable/acceptable to all patients immediately post-treatment. Further large-scale research and implementation work is required, especially in a post-COVID era. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02847715 (first registered 19/05/2016).

Sexual Activity, Function and Dysfunction After a Diagnosis of Bladder Cancer.

BACKGROUND: Sexual dysfunction is common in those affected by cancer and local and radical treatments for Bladder Cancer (BC) can affect sexual function directly. AIM: To evaluate sexual function following a bladder cancer (BC) diagnosis. METHODS: Self-reported sexual function was collected 10 years after a diagnosis of BC as part of a cross-sectional patient reported outcome measure (PROM) survey exploring life after BC diagnosis and treatment. OUTCOMES: Participants completed a combined EORTC QLQ-BLM30 and QLQ-NMIBC24 questionnaire, including questions on sexual activity, intimacy, erectile/ejaculatory function and vaginal dryness. RESULTS: A total of 1796 participants returned a completed survey out of 3279 eligible participants (55%). Of the participants who returned a completed survey, a total of 1530 (85%) participants answered sexual function questions. The median (IQR) age was 75 (70-81). Participants were predominantly men (78%) and married/in civil partnerships (66%). In total, 31% were sexually active. Vaginal dryness was common (66%) in women. Erectile and ejaculatory dysfunction (80% and 58% respectively) were common in men. Compared to TURBT +/- intravesical treatments, those who had radical treatment were less likely to be sexually active (adjusted OR 0.56, 95% CI: 0.44-0.72, P<0.001) and had worse mean scores for intimacy problems (29.1 [radical treatment] vs 12.1, P<0.001), male sexual problems (72.2 [radical treatment] vs 45.7, P<0.001) and overall sexual function (17.1 [radical treatment] vs 20.3, P=0.01). CLINICAL IMPLICATIONS: These findings highlight the magnitude of sexual dysfunction in the BC patient cohort and can help inform patients during the pre-op counselling process and shared decision making prior to BC treatments. STRENGTHS AND LIMITATIONS: This study provides the largest in-depth analysis of sexual activity and function after BC diagnosis and treatment, to date. Limitations include the lack of data on participants' sexual function prior to BC treatment and the heterogeneity with respect to time passed since last BC treatment. CONCLUSION: Sexual dysfunction in BC patients is common and rates appear higher following radical treatments compared to endoscopic. It is important to elicit these problems in clinics to enable counselling and treatment. Jubber I, Rogers Z, Catto JWF, et al. Sexual Activity, Function and Dysfunction After a Diagnosis of Bladder Cancer. J Sex Med 2022;19:1431-1441.

Key influences on the decision to initiate PrEP among adolescent girls and young women within routine maternal child health and family planning clinics in Western Kenya.

We sought to understand influences on PrEP uptake among Kenyan adolescent girls and young women (AGYW) whose decision on PrEP use was misaligned with their risk for HIV acquisition. In-depth interviews were conducted with 47 Kenyan HIV-negative AGYW aged 15-24 years who were offered PrEP during routine maternal and child health and family planning services. AGYW were sampled from two groups (1) declined PrEP and had ≥1 sexual partner(s) of unknown HIV status and (2) initiated PrEP and reported having one HIV-negative partner. AGYW with HIV-negative partners initiated PrEP due to known or suspected infidelity. AGYW with partners of unknown HIV status recognized PrEP as a helpful HIV prevention tool, yet worried about partner reactions and prioritized avoiding uncomfortable or unsafe situations over PrEP. Among pregnant AGYW, the responsibility of motherhood and providing a future for one's family, through staying healthy and remaining HIV-free, was a strong PrEP use motivator. Among AGYW who desired future motherhood, fears that PrEP could negatively impact fertility or reduce contraceptive effectiveness led to declining PrEP. Peers positively influenced PrEP decision-making, especially personally knowing a PrEP user. Strategies are needed to enhance messaging and delivery approaches that are tailored to AGYW, including peer-led strategies.

A quantitative and multiplexed approach to uncover the fitness landscape of tumor suppression in vivo.

Cancer growth is a multistage, stochastic evolutionary process. While cancer genome sequencing has been instrumental in identifying the genomic alterations that occur in human tumors, the consequences of these alterations on tumor growth remain largely unexplored. Conventional genetically engineered mouse models enable the study of tumor growth in vivo, but they are neither readily scalable nor sufficiently quantitative to unravel the magnitude and mode of action of many tumor-suppressor genes. Here, we present a method that integrates tumor barcoding with ultradeep barcode sequencing (Tuba-seq) to interrogate tumor-suppressor function in mouse models of human cancer. Tuba-seq uncovers genotype-dependent distributions of tumor sizes. By combining Tuba-seq with multiplexed CRISPR-Cas9-mediated genome editing, we quantified the effects of 11 tumor-suppressor pathways that are frequently altered in human lung adenocarcinoma. Tuba-seq enables the broad quantification of the function of tumor-suppressor genes with unprecedented resolution, parallelization, and precision.

Patients' confidence in treatment decisions for early stage non-small cell lung cancer (NSCLC).

BACKGROUND: In early-stage Non-Small Cell Lung Cancer (NSCLC) patients, little is known about how to measure patient participation in Shared-Decision Making (SDM). We examined the psychometric properties and clinical acceptability of the Decision Self-Efficacy scale (DSE) in a cohort of patients undergoing to Stereotactic Ablative Radiotherapy (SABR) or Video-assisted Thoracoscopic Surgery (VATS) to capture patient involvement in treatment decisions. METHODS: In the context of a prospective longitudinal study (Life after Lung Cancer-LiLAC) involving 244 patients with early-stage NSCLC, 158 (64.7%) patients completed the DSE either on paper or electronically online prior to treatment with SABR or VATS pulmonary resection. DSE psychometric properties were examined using: principal components analysis of item properties and internal structure, and internal construct validity; we also performed a sensitivity analysis according to Eastern Cooperative Oncology Group Performance Status (ECOG PS), gender, age and treatment received (VATS or SABR) difference. RESULTS: Exploratory factor analysis using polychoric correlations substantiated that the 11 item DSE is one scale accounting for 81% of the variance. We calculated a value of 0.96 for Cronbach's alpha for the total DSE score. DSE scores did not differ by gender (p = 0.37), between the two treatment groups (p = 0.09) and between younger and older patients (p = 0.4). However, patients with an ECOG PS > 1 have a DSE mean of 73.8 (SD 26) compared to patients with a PS 0-1 who have a DSE mean of 85.8 (SD 20.3 p = 0.002). CONCLUSION: Findings provide preliminary evidence for the reliability and validity of the DSE questionnaire in this population. However, future studies are warranted to identify the most appropriate SDM tool for clinical practice in the lung cancer treatment field.

An in vivo multiplexed small-molecule screening platform.

Phenotype-based small-molecule screening is a powerful method to identify molecules that regulate cellular functions. However, such screens are generally performed in vitro under conditions that do not necessarily model complex physiological conditions or disease states. Here, we use molecular cell barcoding to enable direct in vivo phenotypic screening of small-molecule libraries. The multiplexed nature of this approach allows rapid in vivo analysis of hundreds to thousands of compounds. Using this platform, we screened >700 covalent inhibitors directed toward hydrolases for their effect on pancreatic cancer metastatic seeding. We identified multiple hits and confirmed the relevant target of one compound as the lipase ABHD6. Pharmacological and genetic studies confirmed the role of this enzyme as a regulator of metastatic fitness. Our results highlight the applicability of this multiplexed screening platform for investigating complex processes in vivo.

Which symptoms are linked to a delayed presentation among melanoma patients? A retrospective study.

BACKGROUND: The incidence of melanoma is rising. Early detection is associated with a more favourable outcome. The factors that influence the timing of a patient's presentation for medical assessment are not fully understood. The aims of the study were to measure the nature and duration of melanoma symptoms in a group of patients diagnosed with melanoma within the preceding 18 months and to identify the symptoms and barriers associated with a delay in presentation. METHODS: A questionnaire was distributed to a random sample of 200 of the 963 melanoma patients who had participated in the Cancer Patient Experience Survey 2010 and were known to be alive 1 year later. Data were collected on symptoms, duration of symptoms prior to presentation and the reasons for not attending a doctor sooner. RESULTS: A total of 159 patients responded to the questionnaire; 74 (47%) were men; mean age was 62 (range 24-90) years. Of the 149 patients who reported a symptom, 40 (27%) had a delayed presentation (i.e. >3 months). A mole growing bigger was the most common symptom and reporting this symptom was significantly associated with a delayed presentation (odds ratio (OR) 2.04, 95% confidence interval (95% CI) 1.14-5.08). Patients aged ≥65 years were less likely to report a barrier to presentation and were less likely to delay than those under 40, although this was of borderline statistical significance (OR 0.28, 95% CI 0.08-1.00). CONCLUSIONS: This study highlights that an enlarging mole is a significant symptom influencing the timing of presentation. Increasing public awareness of the signs of melanoma and of the importance of early presentation is desirable. Health professionals should take advantage of the opportunity to educate patients on such symptoms and signs where feasible. Further exploration of the barriers to presentation in younger people should be considered.

Subtherapeutic concentrations of first-line anti-TB drugs in South African children treated according to current guidelines: the PHATISA study.

OBJECTIVES: There is a paucity of evidence regarding the optimal dosing of anti-TB drugs in children. The aim of this study was to identify the pharmacokinetic parameters of first-line anti-TB drugs and the concentrations achieved after implementation of the 2010 WHO-recommended paediatric dosages. METHODS: We conducted a prospective, observational pharmacokinetic study in children 10 years old or younger who were on isoniazid, rifampicin, pyrazinamide and ethambutol therapy in Durban, KwaZulu-Natal, South Africa. Blood was collected at six timepoints over a 24 h period, chosen using optimal sampling theory. The drug concentrations were simultaneously modelled to identify the compartmental pharmacokinetics of each drug in each child, using the ADAPT program. RESULTS: The best six sampling timepoints in children were identified as 0 (pre-dose) and 0.42, 1.76, 3.37, 10.31 and 24 h post-dose. Thirty-one children were recruited and blood was drawn at these timepoints. Rifampicin, ethambutol and pyrazinamide were best described using a one-compartment model, while isoniazid was best described with a two-compartment model. Only 2/31 (6%), 20/31 (65%), 17/31 (55%) and 2/13 (15%) of children attained the WHO 2 h target therapeutic concentrations of rifampicin, isoniazid, pyrazinamide and ethambutol, respectively. Moreover, only 24/31 (77%), 6/31 (19%) and 8/31 (26%) achieved the AUCs associated with an optimal clinical response to rifampicin, pyrazinamide and isoniazid, respectively. No single risk factor was significantly associated with below-normal drug levels. CONCLUSIONS: The drug concentrations of all first-line anti-TB drugs were markedly below the target therapeutic concentrations in most South African children who received the revised WHO-recommended paediatric weight-based dosages.

A decline in p38 MAPK signaling underlies immunosenescence in Caenorhabditis elegans.

The decline in immune function with aging, known as immunosenescence, has been implicated in evolutionarily diverse species, but the underlying molecular mechanisms are not understood. During aging in Caenorhabditis elegans, intestinal tissue deterioration and the increased intestinal proliferation of bacteria are observed, but how innate immunity changes during C. elegans aging has not been defined. Here we show that C. elegans exhibits increased susceptibility to bacterial infection with age, and we establish that aging is associated with a decline in the activity of the conserved PMK-1 p38 mitogen-activated protein kinase pathway, which regulates innate immunity in C. elegans. Our data define the phenomenon of innate immunosenescence in C. elegans in terms of the age-dependent dynamics of the PMK-1 innate immune signaling pathway, and they suggest that a cycle of intestinal tissue aging, immunosenescence, and bacterial proliferation leads to death in aging C. elegans.

Cost-Effectiveness of eRAPID eHealth Intervention for Symptom Management During Chemotherapy.

PURPOSE: A randomized controlled trial of online symptom monitoring during chemotherapy with electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) system found improved symptom control and patient self-efficacy, without increasing hospital admissions and visits. The aim of this study was to evaluate the cost-effectiveness of the eRAPID eHealth intervention compared with usual care for patients receiving systemic treatment for colorectal, breast, or gynecologic cancers in the United Kingdom. METHODS: An embedded economic evaluation was conducted alongside the trial evaluating the effectiveness of eRAPID from health care provider and societal perspectives. Costs and quality-adjusted life-years (QALYs) of patients were compared over 18 weeks of the trial. Incremental cost-effectiveness ratios (ICERs) were estimated and compared with the National Institute for Health and Care Excellence cost-effectiveness threshold. Uncertainty around the ICER was explored using nonparametric bootstrapping and sensitivity analyses. Follow-up data were collected 12-months after random assignment for a subset of the study sample to conduct exploratory analysis of potential longer-term effects. RESULTS: Patients in the eRAPID group had the highest QALY gain and lowest costs over 18 weeks. Although differences were small and not statistically significant, eRAPID had a 55%-58% probability of being more cost-effective than usual care. Patient out-of-pocket costs were lower in the eRAPID group, indicating eRAPID may help patients access support needed within the National Health Service. Exploratory 12-months analysis showed small differences in costs and QALYs, with higher QALY gains in the eRAPID group but also higher costs. Exploratory subgroup analysis by disease status indicated that the eRAPID intervention was cost-effective for patients with early-stage cancers but not for patients with metastatic disease. CONCLUSION: Despite small differences in QALYs and costs, the analyses show potential cost-effectiveness of online symptom monitoring, when added to usual care, particularly during adjuvant systemic treatment for early-stage cancers.

HIV-associated gut microbial alterations are dependent on host and geographic context.

HIV-associated changes in intestinal microbiota are believed to be important drivers of disease progression. However, the majority of studies have focused on populations in high-income countries rather than in developing regions where HIV burden is greatest. To better understand the impact of HIV on fecal microbiota globally, we compare the fecal microbial community of individuals in the U.S., Uganda, and Botswana. We identify significant bacterial taxa alterations with both treated and untreated HIV infection with a high degree of uniqueness in each cohort. HIV-associated taxa alterations are also significantly different between populations that report men who have sex with men (MSM) behavior and non-MSM populations. Additionally, while we find that HIV infection is consistently associated with higher soluble markers of immune activation, most specific bacterial taxa associated with these markers in each region are not shared and none are shared across all three geographic locations in our study. Our findings demonstrate that HIV-associated changes in fecal microbiota are overall distinct among geographical locations and sexual behavior groups, although a small number of taxa shared between pairs of geographic locations warrant further investigation, highlighting the importance of considering host context to fully assess the impact of the gut microbiome on human health and disease.

Lifestyle Factors in Patients with Bladder Cancer: A Contemporary Picture of Tobacco Smoking, Electronic Cigarette Use, Body Mass Index, and Levels of Physical Activity.

BACKGROUND: Little is known about contemporary lifestyle choices in patients with bladder cancer (BC). These choices include carcinogenic risk factors and could affect fitness to receive treatments. OBJECTIVE: To evaluate the contemporary lifestyle choices in BC patients. DESIGN, SETTING, AND PARTICIPANTS: Self-reported surveys from participants diagnosed with BC in the previous 10 yr captured smoking patterns, e-cigarette use, physical activity using the GODIN Leisure-Time Exercise Questionnaire, long-term conditions (LTCs), relationship status, sociodemographics, and body mass index (BMI; height and weight). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Findings were compared with the general population and men with prostate cancer. RESULTS AND LIMITATIONS: Completed surveys were received from 2092 participants. Most respondents were ex-smokers (61% vs 10% current vs 29% never). The use of e-cigarettes was uncommon (9%) and at lower rates than the age-equivalent general population. Passive smoke exposure was frequent (48%). Most participants (68%) were "insufficiently active" using the GODIN criteria and less physically active than the age-equivalent general population. Most respondents (44%) were classified as overweight (BMI 25-29.99) or obese (22%, BMI >30). Lifestyle factors varied with age, sex, socioeconomic deprivation, and LTCs. Younger participants were less likely to smoke (p < 0.001), more likely to have used e-cigarettes (p < 0.001), but more likely to have had passive smoke exposure (p = 0.008). Those from less affluent areas were more likely to smoke (p < 0.001), have used e-cigarettes (p < 0.001), and have had passive smoke exposure (p = 0.02). Females were less likely to be smokers (p < 0.001) but more likely to have been exposed to passive smoke (p < 0.001). CONCLUSIONS: Persons affected by BC often have smoking exposures and high BMI, and are insufficiently active. Rates of e-cigarette use were lower than in the general population. Efforts to improve quality of life in this cohort should include wider advocation of smoking cessation, perhaps including the use of e-cigarettes, and programmes to increase exercise and reduce BMI. PATIENT SUMMARY: We looked at the lifestyle choices, such as smoking, e-cigarette use, physical activity levels, and obesity, of patients following a bladder cancer diagnosis. We conclude that this population would benefit from healthy lifestyle interventions.

Online Symptom Monitoring During Pelvic Radiation Therapy: Randomized Pilot Trial of the eRAPID Intervention.

PURPOSE: Radiation therapy (RT) and chemoRT for pelvic cancers increase survival but are associated with serious treatment-related symptoms. Electronic-patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is a secure online system for patients to self-report symptoms, generating immediate advice for hospital contact or self-management. This pilot study aimed to establish feasibility and acceptability of the system. METHODS AND MATERIALS: In a prospective 2-center randomized parallel-group pilot study, patients undergoing radical pelvic RT for prostate cancer (prostateRT) or chemoRT for lower gastrointestinal and gynecological cancers were randomized to usual care (UC) or eRAPID (weekly online symptom reporting for 12, 18, and 24 weeks). Primary outcomes were recruitment/attrition, study completion, and patient adherence. Secondary outcomes were effect on hospital services and performance of patient outcome measures. Missing data, floor/ceiling effects, and mean change scores were examined for Functional Assessment of Cancer Therapy (FACT-G), European Organisation for Research and Treatment of Cancer, Quality of Life (EORTC QLQ C-30), self-efficacy, and EuroQol (EQ5D). RESULTS: From 228 patients approached, 167 (73.2%) were consented and randomized (83, eRAPID; 84, UC; 87, prostateRT; 80, chemoRT); 150 of 167 completed 24 study weeks. Only 16 patients (9.6%) withdrew (10, eRAPID; 6, UC). In the eRAPID arm, completion rates were higher in patients treated with prostateRT compared with chemoRT (week 1, 93% vs 69%; week 2, 93% vs 68%; week 12, 69% vs 55%). Overall, over 50% of online reports triggered self-management advice for milder adverse events. Unscheduled hospital contact was low, with no difference between eRAPID and UC. Return rates for outcome measures were excellent in prostateRT (97%-91%; 6-24 weeks) but lower in chemoRT (95%-55%; 6-24 weeks). Missing data were low (1%-4.1%), ceiling effects were evident in EQ5D-5L, self-efficacy-scale, and FACT-Physical Wellbeing. At 6 weeks, the chemoRT-eRAPID group showed less deterioration in FACT-G, EORTC QLQ-C30, and EQ5D-Visual Analogue Scale than UC, after baseline adjustment. CONCLUSIONS: eRAPID was successfully added to UC at 2 cancer centers in different patient populations. Acceptability and feasibility were confirmed with excellent adherence by prostate patients, but lower by those undergoing chemoRT for gynecological cancers.

Contraceptive Use Among Women in the United States Aged 18-44 Years with Selected Medical Contraindications to Estrogen.

Objective: Medical contraindications to estrogen limit women's contraceptive options. This study assessed the association between selected medical contraindications to estrogen on contraceptive use and examined whether contraindications serve as a barrier to the prevention of unintended pregnancy. Materials and Methods: We analyzed women aged 18-44 at risk of unintended pregnancy participating in the 2017 Behavioral Risk Factor Surveillance System. Survey questions queried women regarding contraceptive use and contraindications to estrogen use. We assessed the most recently used contraceptive method and compared the odds of women using each category of contraception (no methods, less effective methods, pill/patch/ring, injection, intrauterine device, implant, permanent contraception) between those with and without potential contraindications to estrogen using multinomial logistic regression models. Results: This study included 32,098 women, of whom 16% had one or more potential contraindications to estrogen. There were significant differences in contraceptive choice by potential contraindication status (p < 0.01). Fifteen percent of women with potential contraindications reported using estrogen-containing methods (pill, patch, or ring) compared with 20% of women with no potential contraindication. Women with potential contraindications to estrogen more frequently used permanent contraception (odds ratio [OR] vs. pill/patch/ring: 1.48 95% confidence interval [CI]: 1.17-1.88) or no contraceptive method (OR vs. pill/patch/ring: 1.37 95% CI: 1.07-1.75) after adjustment for race, age, marital status, and income. Conclusions: Potential medical contraindications to estrogen are associated with permanent contraception and the use of no contraception. These results portray a complicated relationship but could suggest a lack of access to other contraceptive options.

Factors influencing patient satisfaction after treatments for early-stage non-small cell lung cancer.

PURPOSE: Patient-reported outcome measures, including satisfaction with treatment decisions, provide important information in addition to clinical outcomes, survival and decision-making in lung cancer surgery. We investigated associations between preoperative clinical and socio-demographic factors and patient-reported satisfaction 6 weeks after radical treatment for early-stage non-small cell lung cancer (NSCLC). METHODS: We conducted a sub-group analysis of the prospective observational longitudinal study of 225 participants in two treatment groups-surgical (VATS) and radiotherapy (SABR). The Patient Satisfaction Questionnaire-18 (PSQ-18) was used to measure patient satisfaction 6 weeks after treatment. Clinical variables, Index of Multiple Deprivation decile and Decision self-efficacy scores were used in regression analysis. Variables with a p level < 0.1 were used as independent predictors in generalised linear logistic regression analyses. RESULTS: As expected, the two groups differed in pre-treatment clinical features. The SABR group experienced more grade 1-2 complications than the VATS group. No differences were found between the groups in any subscale of the PSQ-18 questionnaire. Patients experiencing complications or living in more deprived areas were more satisfied with care. Properative factors independently associated with patient satisfaction were the efficacy in decision-making and age. CONCLUSION: We showed that efficacy in treatment decision-making and age was the sole predictor of patient satisfaction with their care after radical treatment for early-stage NSCLC. Patients from more deprived areas and patients who suffered complications reported greater subsequent satisfaction. Involving patients in their care may improve satisfaction after treatment for early-stage NSCLC.

Benthic infaunal assemblages adjacent to an ocean outfall in Australian marine waters: Impact assessment and identification of indicator taxa.

An impact assessment of oceanic effluent releases from Belmont wastewater treatment works (WWTW) in Newcastle, Australia, was undertaken. Benthic infaunal assemblages in sandy sediments of ~25 m water depth were examined, at sites adjacent to the release point, and at increasing distances up to 2 km in both a NE and SW direction over five consecutive years (2016-2020). Localised impacts were evident for infaunal assemblages, with sites within 20 m of the outfall ("Impact" site types) exhibiting lower taxa richness and Shannon diversity, higher abundances of polychaetes and/or nematodes, higher polychaete ratios, and shifts in assemblage composition in comparison to sites at greater distances during some years. Taxa with increased localised abundances at the outfall were identified as indicators for monitoring impacts, including deposit-feeding polychaetes (Families Polygordiidae, Paraonidae and Dorvilleidae) and Phylum Nematoda. Future infaunal monitoring could include molecular tools and paired sediment analyses.

REDCap mobile data collection: Using implementation science to explore the potential and pitfalls of a digital health tool in routine voluntary medical male circumcision outreach settings in Zimbabwe.

Background: Digital data collection tools improve data quality but are limited by connectivity. ZAZIC, a Zimbabwean consortium focused on scaling up male circumcision (MC) services, provides MC in outreach settings where both data quality and connectivity is poor. ZAZIC implemented REDCap Mobile app for data collection among roving ZAZIC MC nurses. To inform continued scale-up or discontinuation, this paper details if, how, and for whom REDCap improved data quality using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Methods: Data were collected for this retrospective, cross-sectional study for nine months, from July 2019 to March 2020, before COVID-19 paused MC services. Data completeness was compared between paper- and REDCap-based tools and between two ZAZIC partners using two sample, one-tailed t-tests. Results: REDCap reached all roving nurses who reported 26,904 MCs from 1773 submissions. REDCap effectiveness, as measured by data completeness, decreased from 89.2% in paper to 76.6% in REDCap app for Partner 1 (p < 0.001, 95% CI: -0.24, -0.12) but increased modestly from 86.2% to 90.3% in REDCap for Partner 2 (p = 0.05, 95% CI: -.007, 0.12). Adoption of REDCap was 100%; paper-based reporting concluded in October 2019. Implementation varied by partner and user. Maintenance appeared high. Conclusion: Although initial transition from paper to REDCap showed mixed effectiveness, post-hoc analysis from service resumption found increased REDCap data completeness across partners, suggesting locally-led momentum for REDCap-based data collection. Staff training, consistent mentoring, and continued technical support appear critical for continued use of digital health tools for quality data collection in rural Zimbabwe and similar low connectivity settings.

Quality of life after VATS lung resection and SABR for early-stage non-small cell lung cancer: A longitudinal study.

INTRODUCTION: Video-assisted thoracoscopic (VATS) lung resection is the recommended curative treatment for early-stage non-small cell lung cancer (NSCLC). Patients considered at high surgical risk, are treated with stereotactic ablative body radiotherapy (SABR) as a lower morbidity alternative. This study aims to investigate the impact of SABR and VATS resection on patients' quality of life (QoL) over the first year after treatment. METHODS: A prospective longitudinal observational study recruiting early-stage NSCLC patients from a single UK centre. QoL was assessed with EORTC QLQ-C30 and Lung Cancer Module LC13 at baseline, 6 weeks and 3, 6 and 12 months post-treatment. RESULTS: From 01.03.2017 till 01.03.2018, 244/281 patients (87%) consented to participate, 225 (95 SABR and 130 VATS) were included in the analysis. SABR patients had significantly worse baseline QoL scores than VATS patients, even after adjusting for preoperative clinical factors (C-30 Global Health mean: SABR = 53.8, VATS = 71.2; Physical Functioning mean: SABR = 57, VATS = 82.2; Fatigue mean: SABR = 43.5, VATS = 23.7; C30 Dyspnea mean: SABR = 49.5, VATS = 26.2). During the 12 months post SABR treatment patients' QoL scores remained stable. In the VATS group, there was a deterioration 6-weeks after treatment in Role, Physical, Social Functions, Global Health, Fatigue, C30/LC13 Dyspnoea, Pain, Appetite loss, Constipation, LC13 Pain in Chest and Arms. The scores improved by 12 months without reaching the preoperative values. CONCLUSIONS: Although QoL outcomes for SABR and VATS are not comparable due to different medical selection criteria, the QoL impact of the two treatments during the first year showed different trends which will inform patients and clinicians during decision-making discussions.

Electronic Patient Reporting of Adverse Events and Quality of Life: A Prospective Feasibility Study in General Oncology.

PURPOSE: Adverse event (AE) reporting is essential in clinical trials. Clinician interpretation can result in under-reporting; therefore, the value of patient self-reporting has been recognized. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for direct patient AE reporting. A nonrandomized prospective cohort feasibility study aimed to explore the compliance and acceptability of an electronic (Internet or telephone) system for collecting patient self-reported AEs and quality of life (QOL). METHODS: Oncology patients undergoing treatment (chemotherapy, targeted agents, hormone therapy, radiotherapy, and/or surgery) at 2 hospitals were sent automated weekly reminders to complete PRO-CTCAE once a week and QOL (for a maximum of 12 weeks). Patients had to speak/understand English and have access to the Internet or a touch-tone telephone. Primary outcome was compliance (proportion of expected questionnaires), and recruitment rate, attrition, and patient/staff feedback were also explored. RESULTS: Of 520 patients, 249 consented (47.9%)-mean age was 62 years, 51% were male, and 70% were married-and 230 remained on the study at week 12. PRO-CTCAE was completed at 2,301 (74.9%) of 3,074 timepoints and QOL at 749 (79.1%) of 947 timepoints. Individual weekly/once every 4 weeks compliance reduced over time but was more than 60% throughout. Of 230 patients, 106 (46.1%) completed 13 or more PRO-CTCAE, and 136 (59.1%) of 230 patients completed 4 QOL questionnaires. Most were completed on the Internet (82.3%; mean age, 60.8 years), which was quicker, but older patients preferred the telephone option (mean age, 70.0 years). Positive feedback was received from patients and staff. CONCLUSION: Self-reporting of AEs and QOL using an electronic home-based system is feasible and acceptable. Implementation of this approach in cancer clinical trials may improve the precision and accuracy of AE reporting.