Academic literature on the topic 'Care Plus (Coordinated Care) Trial'

BackgroundGPs have limited capacity to routinely provide smoking cessation support. New strategies are needed to reach all smokers within this setting.AimTo evaluate the effect of a pharmacist-coordinated interdisciplinary smoking cessation intervention delivered in Australian general practice.Design and settingSecondary analysis of a cluster randomised controlled trial (RCT) conducted in 41 Australian general practices.MethodIn all, 690 current smokers were included in this study: 373 from intervention clinics (n = 21) and 317 from control clinics (n = 18). A total of 166 current smokers had spirometry-confirmed chronic obstructive pulmonary disease (COPD). In the intervention clinics, trained pharmacists provided smoking cessation support plus Quitline referral. Control clinics provided usual care plus Quitline referral. Those with COPD in the intervention group (n = 84) were referred for home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase), which included further smoking cessation support. Outcomes included carbon monoxide (CO)-validated smoking abstinence, self-reported use of smoking cessation aids, and differences between groups in readiness-to-quit score at 6 months.ResultsIntention-to-treat analysis showed similar CO-validated abstinence rates at 6 months in the intervention (4.0%) and control clinics (3.5%). No differences were observed in readiness-to-quit scores between groups at 6 months. CO-validated abstinence rates were similar in those who completed HMR and at least six sessions of HomeBase to those with COPD in usual care.ConclusionA pharmacist-coordinated interdisciplinary smoking cessation intervention when integrated in a general practice setting had no advantages over usual care. Further research is needed to evaluate the effect of HMR and home-based pulmonary rehabilitation on smoking abstinence in smokers with COPD.

172 Background: CAFÉ is a three-arm randomized controlled trial testing whether financial navigation for people with cancer improves quality of life and financial distress compared to enhanced usual care at two integrated health systems (Kaiser Permanente Washington, KPWA; and Kaiser Permanente Northwest, KPNW). Our current objective was to describe financial concerns reported by a subset of participants enrolled and receiving financial navigation in the trial. Methods: We descriptively summarized the financial concerns in participants randomized to receive financial navigation between August 2021 and May 2022 (Total n = 135; KPWA = 75 and KPNW = 60). Participants received either one or three proactive outreach with financial concerns assessment plus any participant-initiated assessment. Navigators followed up with personalized liaison and warm handoff to resources and coordinated with oncology care team and organizational partners about participant cost concerns. We used the study’s bespoke REDCap database, including participant sociodemographic and clinical characteristics and discrete notes entered by CAFE financial navigators. During financial concerns assessments, CAFE navigators recorded the type of each concern: planning and budgeting; care decision-making; or acute financial needs; resource referrals provided; and time to concern resolution. Results: The sample was 36% male; mean age 61 years; and 62% married or living with a partner. Self-reported race/ethnicity was 9% Black, 15% other, and 76% White; 6% reported Hispanic/Latino ethnicity. 43% reported less than four-year college education. Cancer types were 38% breast; 16% prostate; 6% colorectal; 4% lung; and 36% other types. 5% had Medicaid and 44% Medicare. 58% reported < $75,000 total family income in 2021. 16% were enrolled in the KP medical financial assistance (MFA) program. Navigators documented 179 assessments. Number of concerns/participant ranged from zero to 5 (mean = 1.3 concerns/participant). Participants reported a financial concern at 61% of assessments. The most common concern was planning/budgeting (68%), followed by acute financial needs (28%) and care decision-making (3%). Mean time-to-resolution was 22 days (planning/budgeting); 27 days (acute needs) and 33 days (clinical decision-making). The most common resource referrals included the KP MFA (77 times); coordination with KP member services (73 times) (e.g., for cost estimates), community resource navigators (35 times) and nurse navigators (25), and patient financial services (i.e. billing, 10). Conclusions: Proactive assessment by oncology financial navigators identifies financial concerns related to planning for cancer care expenses and acute financial needs. Concerns related to financial hardship as a factor in clinical decision-making were rare. Resource referrals varied by concern type, with time-to-resolution ranging from 22-33 days. Clinical trial information: NCT05018000.

TPS4174 Background: Pancreatic cancer will claim an estimated 47,050 lives in the USA in 2020, with an expected 5 year survival of 10%. Thus there is an urgent need for novel treatment options in this disease. We hypothesize that effective response against pancreatic cancer requires a coordinated approach that orchestrates both the innate and adaptive immune system. We further hypothesize that by orchestrating the activation of the entire immune system, we could accomplish immunogenic cell death with durable responses in this disease. We describe a novel combination immunotherapy protocol of low-dose chemoradiation, cytokine-induced NK and T cell activation via N-803 (an IL-15 cytokine fusion protein), and off-the-shelf PDL1-targeted high-affinity NK cell (PDL1 t-haNK) infusion. Methods: The ongoing QUILT 88 phase II/III, multi-center, three-cohort, open-label, US study (NCT04390399) to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (ie, first line maintenance, second line, or third line or greater) will be evaluated independently as a separate cohort. Subjects with locally advanced or metastatic pancreatic cancer who have received at least 16 weeks of treatment with gemcitabine plus nab-paclitaxel, and have had either a partial response (PR), CR, or stable disease (SD), will be enrolled into Cohort A to receive first-line maintenance therapy. Subjects who have disease progression on or after receiving first-line treatment with gemcitabine plus nab-paclitaxel or another first-line chemotherapy regimen (eg, FOLFIRINOX), or who have discontinued first-line treatment (eg, due to toxicity or intolerance) will be enrolled into Cohort B to receive second-line therapy randomized to irinotecan-liposome/5FU/LV versus experimental arm. Subjects who have disease progression after receiving at least 2 lines of therapy for pancreatic cancer, will be enrolled into Cohort C to receive third-line or greater treatment. Primary endpoints by cohort are: A) PFS per RECIST V1., B & C) OS. The secondary endpoints include overall response rate, DoR, DCR, OS(cohort A) and QoL by patient-reported outcomes. Clinical trial information: NCT04390399.

IntroductionPatients with multiple sclerosis (MS) have complex needs that range from organising one’s everyday life to measures of disease-specific therapy monitoring to palliative care. Patients with MS are likely to depend on multiple healthcare providers and various authorities, which are often difficult to coordinate. Thus, they will probably benefit from comprehensive cross-sectoral coordination of services provided by care and case management (CCM). Though studies have shown that case management improves quality of life (QoL), functional status and reduces service use, such benefits have not yet been investigated in severely affected patients with MS. In this explorative phase ll clinical trial, we evaluated a CCM with long-term, cross-sectoral and outreaching services and, in addition, considered the unit of care (patients and caregivers).Methods and analysisEighty patients with MS and their caregivers will be randomly assigned to either the control (standard care) or the intervention group (standard care plus CCM (for 12 months)). Regular data assessments will be done at baseline and then at 3-month intervals. As primary outcome, we will evaluate patients’ QoL. Secondary outcomes are patients’ treatment-related risk perception, palliative care needs, anxiety/depression, use of healthcare services, caregivers’ burden and QoL, meeting patients’ and caregivers’ needs, and evaluating the CCM intervention. We will also evaluate CCM through individual interviews and focus groups. The sample size calculation is based on a standardised effect of 0.5, and one baseline and four follow-up assessments (with correlation 0.5). Linear mixed models for repeated measures will be applied to analyse changes in quantitative outcomes over time. Multiple imputation approaches are taken to assess the robustness of the results. The explorative approach (phase ll clinical trial) with embedded qualitative research will allow for the development of a final design for a confirmative phase lll trial.Ethics and disseminationThe trial will be conducted under the Declaration of Helsinki and has been approved by the Ethics Commission of Cologne University’s Faculty of Medicine. Trial results will be published in an open-access scientific journal and presented at conferences.Trial registration numberGerman Register for Clinical Studies (DRKS) (DRKS00022771).

448 Background: Whilst cisplatin combination therapy remains the standard of care for patients with advanced urothelial cancers, many patients are unsuitable for cisplatin and go on to receive carboplatin combination therapy. Although responses are frequent, overall outcomes remain poor, and there is a high unmet need for more effective first line treatment. Vandetanib is a well-tolerated, oral inhibitor of vascular and epidermal growth factor receptor tyrosine kinases, both of which are implicated in the pathogenesis of urothelial cancers. Methods: Patients with metastatic or inoperable urothelial cancer who had no prior chemotherapy and were unsuitable for cisplatin were randomly allocated to receive carboplatin (AUC 4.5, day 1) plus gemcitabine (1000mg/m2, days 1 and 8) plus either vandetanib (100mg od, days 1-21) (GCV) or matching placebo (GCP) in 21-day cycles up to a total of 6 cycles. Treatment allocation was double-blind. There was a planned safety review after the first 40 patients had received at least one cycle. The primary endpoint was progression free survival (PFS). Sample size (n=82) was calculated using a one-sided alpha of 0.2 and power 80% to detect a HR of 0.65 for PFS. We present the final efficacy results. The trial was coordinated by the Wales Cancer Trials Unit at Cardiff University and funded by Cancer Research UK (CRUK/09/024) and AstraZeneca. Results: Of 82 patients, 40 received GCV. 62 (76%) had a bladder primary, and 56 (68%) had poor renal function. The arms were well balanced except for age > 75 (13 (16%) GCV, 23 (28%) GCP). Median PFS was 8.5 months (m) (95% CI 6.0, 9.7) and 8.8 m (5.8, 9.0) for GCV and GCP respectively (adjusted hazard ratio (HR) 0.93 (0.50, 1.71), P=0.89). Overall survival was 10.8 m (8.0, 13.0) and 13.8 m (11.1, 16.6) for GCV and GCP respectively (adjusted HR 1.38 (0.77, 2.46), P=0.24). Response rates were 50% (n=20) and 55% (n=23) for GCV and GCP. All-grade adverse events were similar but there were significantly more grade 3+ events in the GCV arm. Conclusion: Vandetanib did not improve efficacy of chemotherapy but increased toxicity in advanced urothelial cancer not suitable for cisplatin. Clinical trial information: 68146831.

Background: In a trial of early in-bed cycling in critically ill patients, a video demonstrating use of the cycle in addition to verbal description may improve satisfaction with the informed consent process for all persons involved. Methods: A convenience sample of in-person consent encounters for enrolment in TryCYCLE (NCT01885442), a 33-patient pilot study of in-bed cycling with mechanically ventilated patients in an intensive care unit, were recruited. In this study within a trial, using concealed allocation, we randomized consent encounters to a Video or Standard consent approach. Those in the Video group viewed a 2-minute video of a model using in-bed cycling plus the routine verbal description of the study. The Standard group received the routine verbal description only. Patients and/or substitute decision makers (SDMs) were blinded to the study purpose. After each encounter, patients and/or SDMs and the research coordinator submitted written satisfaction and comfort ratings using 7-point scales (higher scores better). We documented consent outcomes and analyzed between group differences with independent group t-tests. Results: We randomized 14 encounters (6 Video, 8 Standard). Ten completed questionnaires (5 in each group) demonstrated no difference in patient and/or SDM satisfaction or comfort between Video or Standard (mean [standard deviation] Satisfaction: 6.8[0.45] vs. 7.0[0] vs. p=0.37; Comfort: 7.0[0] vs. 7.0[0], p>0.99). The research coordinator evaluated all randomized encounters, with no differences between Video or Standard (Satisfaction: 7.0[0] vs. 6.9[0.35], p=0.41; Comfort: 6.7[0.52] vs. 6.9[0.35], p=0.39). All 14 consent encounters enrolled in TryCYCLE. Conclusions: Patient and/or SDM satisfaction and comfort with consent was very high for both the Video and Standard approaches. Further research, including use of videos to portray different study interventions, is needed, including analysis of patient and/or SDM satisfaction, comfort, comprehension, and consent rates. Registration for host trial: ClinicalTrials.gov, NCT01885442, registered on June 25, 2013

Objectives: To explicate the organisational change agenda of the COAG coordinated care trials within the Australian health system and to illuminate the role of science in this process. Methods and Results: This article briefly outlines the COAG coordinated care trial aims and the effect of the trial as a change initiative in rural South Australia. It is proposed that although the formal trial outcomes are still not clear, the trial had significant impact upon health service delivery in some sites. The trial involved standard research methods with control and intervention groups and with key hypotheses being tested to compare the costs and service utilization profile of intervention and control groups. Formal results indicate that costs were not significantly different between intervention and control groups across all sites, but that the trial, nonetheless, had a powerful impact on the attitude and behaviours of service providers in the rural trial on Eyre Peninsula in particular. Some of the key structural changes now in place are outlined. Conclusions: The COAG trial has had many and varied impacts upon those organisations and individual providers involved with it. It is argued here that since successive initiatives had been implemented before final evaluation results were published, other agendas were served by the trial apart from those of standard scientific research and hypothesis testing. That is, the main impact of the coordinated care trial in Eyre Region at least has been change by stealth, and not through scientific research and demonstration. Implications: The COAG trials have set in train a series of structural and procedural changes in the methods of delivery and management of primary health care systems; changes that are embodied in the Enhanced Primary Care packages (EPC) and other initiatives recently introduced by the Commonwealth Government. These changes have occurred and are occurring across the system without formal evidence as to their efficacy, suggesting that other financial motives are driving these new approaches apart from the goal of improving health outcomes for consumers. Also, if science is to be used in this way to drive policy and procedural change ahead of actual outcome evidence, it is important that we examine the more subtle agendas of such research projects in future if the integrity of the scientific method is to be maintained. The occurrence of such phenomena questions the very foundation of scientific endeavour and weakens the application of scientific principles in the arena of social and political science.

Abstract Abstract 415 Background: The ability to cure patients (pts) with advanced Hodgkin's Lymphoma (HL) with combination chemotherapy (CC) (MOPP and variants, ABVD and variants) represented a major milestone in oncology research, and CC became a paradigm for other malignancies. Further, the rationale for combined modality therapy (CMT) (radiation (RT) and CC) in HL evolved based on the high frequency of relapse in initially involved sites. As response rates and survival improved, newer treatments such as the combined modality Stanford V regimen were developed to shorten the duration of chemotherapy, add RT to sites of disease and reduce toxicity while maintaining or improving the cure rate. Indeed, the Stanford V regimen was tested and validated in a Phase II co-operative group trial (E1492) (J Clin Oncol 2000; 18:972). In order to investigate this approach against “standard” therapy, we conducted a randomized Phase III Intergroup trial of ABVD vs. the Stanford V regimen for patients with locally extensive or advanced HL. Objectives: The trial was designed to detect a 33% reduction in the failure free survival (FFS) hazard rate with Stanford V compared with ABVD, which corresponds to a difference in five-year FFS of 64% vs. 74%. Method: Patients with locally extensive (defined as clinical Ann Arbor Stage I-IIA/B and bulky mediastinal disease (BMD) (mass > 1/3 maximum intrathoracic diameter on standing postero-anterior chest x-ray or >/−10 cm on computerized tomography) or advanced (Ann Arbor Stage III or IV) HL were randomized to receive either ABVD × 6–8 cycles (C) (51% had 6 C, 35% had 8 C, 14% had <6 C) + 36 Gy (only in pts with BMD) or Stanford V × 12 weeks (95% had 12 weeks) + 36 Gy (for sites >5cm or for macroscopic splenic disease). The log-rank test was used to compare FFS for all eligible patients stratified on extent of disease (locally extensive vs. advanced), and number of International Prognostic Factor Project (IPFP) risk factors (0–2 vs. 3–7). An extended Cox model was also used to address non-proportional hazard between the two arms. Results: 854 pts enrolled from April, 1999 to June, 2006 and 812 were eligible for analysis. 404 pts were randomized to ABVD and 408 to Stanford V. Median age was 33 yrs in both arms (range 16–83). 53% were men and 47% women; 4% had Stage I, 31% had Stage II, 39% had Stage III and 25% had Stage IV disease by Ann Arbor criteria. 35% of pts on ABVD and 35% on Stanford V had BMD. Three % of pts had nodular lymphocyte predominant HL, 77% of pts had nodular sclerosis HL, 14% had mixed cell HL. Age, stage, pathology and risk factors (0–2 vs. 3–7) were similar in both arms. In total, 65% were IPFP score 0–2 and 33% were 3–6. Response rate. There was no difference in response rates (RR) between the two arms (ABVD=72% CR+ CCR, 7.7% PR, 7.9% SD; Stanford V= 69 % CR +CCR, 7% PR and 10 % SD. 8% were not evaluable for response on ABVD and 9% on Stanford V. Toxicity was similar in both groups. The most frequent Grade 3 + 4 toxicity was neutropenia, and was similar between the 2 groups (76% Grade 3 + 4 in ABVD and 70% Grade 3+ 4 in Stanford V). Grade 5 toxicity was <1% in both groups. There was, however, more Grade 3 lymphopenia in Stanford V (78% vs. 42%, p< 0.0001) and more Grade 3 +4 sensory neuropathy in Stanford V (10%) than in ABVD (3%) (p< 0.0001). A total of 26 second primary cancers developed, 12 after ABVD and 14 after Stanford V (p=NS). FFS and OS. For 812 eligible patients, with a median follow up of 5.25 years, 5-year FFS was 73% for ABVD and 71% for Stanford V (p=0.29 by log rank) (Figure left); 5-year OS was 88% for ABVD and 87% for Stanford V (p=0.87 by log-rank, HR=0.97, 95% CI: 0.65 to 1.44) (Figure right) indicating no significant difference in either FFS or OS between the 2 arms. Conclusion: In the largest Phase III intergroup trial of HL in North America, there was no significant difference in RR, FFS, OS, and 5-year toxicity when ABVD (+ RT for BMD) is compared with Stanford V (+RT for nodal sites >5 cm and macroscopic splenic disease). There was more Grade 3 lymphopenia (p< 0.0001) and more Grade 3 + 4 sensory neuropathy (p< 0.0001) on Stanford V. Thus ABVD (plus RT for BMD) remains the standard of care because Stanford V did not meet the objective of 33% improvement in FFS. For some patients, Stanford V, when given as described with RT, remains an acceptable alternative. Disclosures: Friedberg: Genentech: Honoraria. Blum:Seattle Genetics: Research Funding; Novartis: Research Funding; Celgene: Research Funding. Horning:Genentech: Employment.

The Illawarra Coordinated Care Trial was one of nine Australian trials undertaken to see whether different modelsof coordinated care could improve the health of people with multiple service needs within existing resources. This papersummarises the findings of an extensive local evaluation and discusses the impact of the trial on clients and serviceproviders. It examines the main findings related to the principal trial hypothesis and points to lessons that mightinform the next round of trials.

Despite the many interventions and trials aimed at improving coordination of health care, there is currently no accepted measurement of coordination. My professional interests and an opportunity provided by the Care Plus (Coordinated Care) Trial in the ACT led me to consider client perceptions as a potentially appropriate measure. My research question is “can coordination of health care be usefully measured through client perceptions?” ¶ I addressed this question by developing and testing an instrument to measure perceptions of coordination called the Client Perceptions of Coordination Questionnaire (CPCQ). In the thesis I describe the processes of developing the instrument, testing it through use in several studies and considering how useful such an instrument may be for health services research. In addition to the Coordinated Care Trial, I conducted two validation studies - in a chronic pain population and a general practice sample. ¶ ...

The Balanced Budget Act of 1997 introduced the new payment methodology for Medicare managed care plans. However, many managed care organizations started to withdraw from the Medicare market after the implementation of the Act, adversely affecting the accessibility to managed care plans for Medicare beneficiaries. The objective of the study is to examine the determinants of Medicare plus Choice Coordinated Care Plan withdrawal in the post-BBA era. Data on HMO plans for the years 1999 to 2002 were obtained from various sources for the pooled cross section and time series analyses. Samples were organized as per county, per contract, and per county-contract units. Several factors, including organizational attributes, geographic characteristics, performance measures, plan attributes, the degree of market competition, and time, were used for this study. Binomial logit model, multinomial logit model, and negative binomial regression model were employed for data analysis The results demonstrated that factors such as a higher level of M+C payment rate, higher out-of-pocket premiums, the provision of drug coverage, for-profit MCOs, contracts serving large amounts of counties, and a higher number of competitors in the service areas, would increase the probability of contract withdrawal. On the other hand, a higher number of M+C CCP enrollment, higher inpatient care capacity in counties, and more preventive care for enrollees offered by MCOs would reduce the probability of contract withdrawal. The selection effect of MCOs in choosing the service areas based on the demographic factors was detected. In addition, counties experiencing lower payment growth after the BBA tended to have lower numbers of M+C CCP contracts. Though contracts whose service areas had a smaller variance of payment growth after the BBA were found to be less likely to experience termination, they were more likely to experience partial withdrawal. This study advised policymakers to devise a more flexible reimbursement system, to develop a monitoring system to investigate weak contracts, and to develop policies for helping MCOs alleviate the problem of contract withdrawal while controlling the quantity and quality of care for beneficiaries
acase@tulane.edu

This chapter reports the results of a parallel, double-blinded randomized controlled trial to examine the effect of video-supported nurse-led advance care planning (ACP) as compared with a health education program plus an ACP promotion leaflet on end-of-life decision-making outcomes in older adults with frailty. Outcomes were assessed at 1 month and 6 months after the intervention via telephone. Between December 2018 and January 2020, 449 older adults were screened for eligibility. The trial was terminated early after 105 subjects had been assigned (intervention: 51; control: 54) because of the COVID-19 pandemic and the end of the funding period. No significant between-group difference was found in the retention rate at 1 (41.2% vs. 38.9%) and 6 months (35.3% vs. 44.4%). In the intention-to-treat analysis, the ACP group reported a higher but non-significant advance directive completion rate (5.9% vs. 1.9%) and a significantly higher mean score in quality of communication about end-of-life care at 1 month [estimated difference: 8.73 (1.16–16.30). There was no evidence of a difference in favorable outcomes of subjects receiving the video-supported, nurse-led ACP compared with those receiving active control. Results might have been confounded by high attrition, poor intervention completion, and reduced sample size due to the early termination of the study.

The Decompressive Craniectomy in Diffuse Traumatic Brain Injury or DECRA trial was the first neurosurgical randomized controlled trail that sought to answer whether decompressive craniectomies (DC) improved patient outcomes after severe diffuse traumatic brain injury (TBI). The trial was conducted over a decade in centers across New Zealand, Saudi Arabia, and Australia, and the results were published in 2011; 155 patients were randomized to two cohorts, the medical management cohort and the medical management plus DC cohort. The primary endpoint was the functional outcomes, measured at 6 months post discharge. The results of the trial were somewhat unanticipated. In spite of achieving superior ICP control and intensive care outcomes, the DC cohort had worse long-term outcomes. The DECRA trial raised several questions and criticisms that currently preclude us from drawing broad conclusions about the efficacy of DC in diffuse TBI.

BACKGROUND AND OBJECTIVES Effective treatment of childhood obesity remains elusive. Integration of clinical and community systems may achieve effective and sustainable treatment. However, the feasibility and effectiveness of this integrated model are unknown. METHODS We conducted a randomized clinical trial among children aged 5 to 11 presenting for obesity treatment. We randomized participants to clinical care or clinical care plus community-based programming at a local parks and recreation facility. Primary outcomes were the change in child BMI at 6 months and the intensity of the program in treatment hours. Secondary outcomes included health behaviors, fitness, attrition, and quality of life. RESULTS We enrolled 97 children with obesity, and retention at 6 months was 70%. Participants had a mean age of 9.1 years and a mean baseline BMI z score of 2.28, and 70% were living in poverty. Intervention participants achieved more treatment hours than controls (11.4 vs 4.4, SD: 15.3 and 1.6, respectively). We did not observe differences in child BMI z score or percent of the 95th percentile at 6 months. Intervention participants had significantly greater improvements in physical activity (P = .010) and quality of life (P = .008). CONCLUSIONS An integrated clinic-community model of child obesity treatment is feasible to deliver in a low-income and racially diverse population. As compared with multidisciplinary treatment, the integrated model provides more treatment hours, improves physical activity, and increases quality of life. Parks and recreation departments hold significant promise as a partner agency to deliver child obesity treatment.

Fragility affects the ability to recover from stress conditions as the use of information and communication technologies in health care grows. The objective of this chapter is to identify evidence on interventions using ICT technology to prevent or delay frailty. A systematic review of the literature was used. Search was performed in April 2019 through B-on and EBSCO host, in databases Academic Search Complet, with Full Test in MEDLINE, CINAHL Plus®, and MedicLatina. Boolean equation ((Telemedicine) OR (mobile health) OR (computer reality) OR (virtual reality)) AND (Frail Elderly) AND (randomized controlled trial), from 2013 to 2017. Articles followed PRISMA flowchart. Results show that 2946 articles were selected, and 17 met the criteria. The used ICT were virtual-augmented reality, multidisciplinary home-telehealth and telemonitoring, nurse home visits, Wii Fit, and other interactive video games. The chapter conclude that the implementation of ICT to manage self-care at home requires an interdisciplinary, collaborative, and user-centered approach to improve the viability, acceptability, and usability of innovations.

Fragility affects the ability to recover from stress conditions as the use of information and communication technologies in health care grows. The objective of this chapter is to identify evidence on interventions using ICT technology to prevent or delay frailty. A systematic review of the literature was used. Search was performed in April 2019 through B-on and EBSCO host, in databases Academic Search Complet, with Full Test in MEDLINE, CINAHL Plus®, and MedicLatina. Boolean equation ((Telemedicine) OR (mobile health) OR (computer reality) OR (virtual reality)) AND (Frail Elderly) AND (randomized controlled trial), from 2013 to 2017. Articles followed PRISMA flowchart. Results show that 2946 articles were selected, and 17 met the criteria. The used ICT were virtual-augmented reality, multidisciplinary home-telehealth and telemonitoring, nurse home visits, Wii Fit, and other interactive video games. The chapter conclude that the implementation of ICT to manage self-care at home requires an interdisciplinary, collaborative, and user-centered approach to improve the viability, acceptability, and usability of innovations.

Over the last decade, several large-scale randomized trials have reported results that disagreed substantially with the motivating observational studies on the value of various chronic disease–prevention strategies. One high-profile example of these discrepancies was related to postmenopausal hormone therapy (HT) use and its effects on cardiovascular disease and cancer. The Women’s Health Initiative (WHI), a National Heart, Lung, and Blood Institute–sponsored program, was designed to test three interventions for the prevention of chronic diseases in postmenopausal women, each of which was motivated by a decade or more of analytic epidemiology. Specifically, the trials were testing the potential for HT to prevent coronary heart disease (CHD), a low-fat eating pattern to reduce breast and colorectal cancer incidence, and calcium and vitamin D supplements to prevent hip fractures. Over 68,000 postmenopausal women were randomized to one, two, or all three randomized clinical trial (CT) components between 1993 and 1998 at 40 U.S. clinical centers (Anderson et al., 2003a). The HT component consisted of two parallel trials testing the effects of conjugated equine estrogens alone (E-alone) among women with prior hysterectomy and the effect of combined estrogen plus progestin therapy (E+P), in this case conjugated equine estrogens plus medroxyprogesterone acetate, among women with an intact uterus, on the incidence of CHD and overall health. In 2002, the randomized trial of E+P was stopped early, based on an assessment of risks exceeding benefits for chronic disease prevention, raising concerns among millions of menopausal women and their care providers about their use of these medicines. The trial confirmed the benefit of HT for fracture-risk reduction but the expected benefit for CHD, the primary study end point, was not observed. Rather, the trial results documented increased risks of CHD, stroke, venous thromboembolism (VTE), and breast cancer with combined hormones (Writing Group for the Women’s Health Initiative Investigators, 2002). Approximately 18 months later, the E-alone trial was also stopped, based on the finding of an adverse effect on stroke rates and the likelihood that the study would not confirm the CHD-prevention hypothesis.

Antiphospholipid syndrome (APS) is characterized by thrombotic events and obstetric complications in the presence of persistently positive antiphospholipid antibodies. Obstetric manifestations include, recurrent miscarriages, fetal death at or beyond the 10th week of gestation, and premature birth due to pre-eclampsia/placental insufficiency. Even now, both clinical features and laboratory parameters are controversial. Both can be used to stratify women with APS in terms of risk of adverse pregnancy outcome, and thus adjust treatment. APS pregnancies should be classified into low, medium and high-risk classes based on clinical and laboratory features. Depending on the risk class, the most appropriate therapy must be then selected. Heparin plus LDA is considered the standard of care for patients with a confirmed diagnosis of obstetric APS and generally results in over 70–80% successful pregnancies. The 20–30% pregnancies in which treatment fails are defined as “high-risk” or “refractory” pregnancies. Numerous treatments have been used in addition to standard of care, to treat these patients, but no well-designed trial has yet been conducted. New insights into the etiopathogenetic mechanisms of obstetric APS have led to the testing of new therapeutic approaches, that may soon change the way we manage this condition.

Advanced modes of mechanical ventilation emerged from the need for better control of the ventilator by the patient, the possibility of respiratory mechanics and respiratory drive monitoring in assisted modes and a better patient-ventilator synchrony. Volume-assured pressure support ventilation (VAPSV) has the advantage of the variable of flow pressure support ventilation (PSV) assuring tidal volume in each respiratory cycle. Proportional assist ventilation plus (PAV+) delivers assistance in proportion of inspiratory efforts while monitoring work of breathing, respiratory compliance, resistance and auto-PEEP, improving patient-ventilator asynchrony. Neurally adjusted ventilatory assist ventilation (NAVA) provides diaphragmatic electroactivity information and a better inspiratory and expiratory patient-ventilator synchrony. Adaptative support ventilation (ASV) assures a pre-set minute ventilation adjusting Pressure Support according to respiratory rate. Intellivent-ASV adds SpO2 and PETCO2 monitoring to adjust minute ventilation and PEEP/FIO2 according to lung pathology. Smart-Care ventilation provides an algorithm that decreases PSV according to patients tidal volume, respiratory rate and ETCO2 according to lung pathology and performs a spontaneous breathing trial indicating the redness for extubation. Clinical indications of advanced modes are to improve patient-ventilator synchrony and provide better respiratory monitoring in the assisted modes of mechanical ventilation.

Background: It has been suggested that interventions focusing on individual behaviour change, such as behavioural weight management interventions, may exacerbate health inequalities. These intervention-generated inequalities may occur at different stages, including intervention uptake, adherence and effectiveness. We conducted a systematic review to synthesise evidence on how different measures of inequality moderate the uptake of, adherence to and effectiveness of behavioural weight management interventions in adults. Methods: We updated a previous systematic literature review from the US Preventive Services Taskforce to identify trials of behavioural weight management interventions in adults that could be conducted in or recruited from primary care. Medline, Cochrane database (CENTRAL) and PsycINFO were searched. Only randomised controlled trials and cluster-randomised controlled trials were included. Two investigators independently screened articles for eligibility and conducted risk of bias assessment. We curated publication families for eligible trials. The PROGRESS-Plus acronym (place of residence, race/ethnicity, occupation, gender, religion, education, socioeconomic status, social capital, plus other discriminating factors) was used to consider a comprehensive range of health inequalities. Data on trial uptake, intervention adherence, weight change, and PROGRESS-Plus related-data were extracted. Results: Data extraction in currently underway. A total of 108 studies are included in the review. Data will be synthesised narratively and through the use of Harvest Plots. A Harvest plot for each PROGRESS-Plus criterion will be presented, showing whether each trial found a negative, positive or no health inequality gradient. We will also identify potential sources of unpublished original research data on these factors which can be synthesised through a future individual participant data meta- analysis. Conclusions and implications: The review findings will contribute towards the consideration of intervention-generated inequalities by researchers, policy makers and healthcare and public health practitioners. Authors of trials included in the completed systematic review may be invited to collaborate on a future IPD meta-analysis. PROSPERO registration number: CRD42020173242

Background Lung cancer is the number one cause of cancer death worldwide.(1) It is the fifth most commonly diagnosed cancer in Australia (12,741 cases diagnosed in 2018) and the leading cause of cancer death.(2) The number of years of potential life lost to lung cancer in Australia is estimated to be 58,450, similar to that of colorectal and breast cancer combined.(3) While tobacco control strategies are most effective for disease prevention in the general population, early detection via low dose computed tomography (LDCT) screening in high-risk populations is a viable option for detecting asymptomatic disease in current (13%) and former (24%) Australian smokers.(4) The purpose of this Evidence Check review is to identify and analyse existing and emerging evidence for LDCT lung cancer screening in high-risk individuals to guide future program and policy planning. Evidence Check questions This review aimed to address the following questions: 1. What is the evidence for the effectiveness of lung cancer screening for higher-risk individuals? 2. What is the evidence of potential harms from lung cancer screening for higher-risk individuals? 3. What are the main components of recent major lung cancer screening programs or trials? 4. What is the cost-effectiveness of lung cancer screening programs (include studies of cost–utility)? Summary of methods The authors searched the peer-reviewed literature across three databases (MEDLINE, PsycINFO and Embase) for existing systematic reviews and original studies published between 1 January 2009 and 8 August 2019. Fifteen systematic reviews (of which 8 were contemporary) and 64 original publications met the inclusion criteria set across the four questions. Key findings Question 1: What is the evidence for the effectiveness of lung cancer screening for higher-risk individuals? There is sufficient evidence from systematic reviews and meta-analyses of combined (pooled) data from screening trials (of high-risk individuals) to indicate that LDCT examination is clinically effective in reducing lung cancer mortality. In 2011, the landmark National Lung Cancer Screening Trial (NLST, a large-scale randomised controlled trial [RCT] conducted in the US) reported a 20% (95% CI 6.8% – 26.7%; P=0.004) relative reduction in mortality among long-term heavy smokers over three rounds of annual screening. High-risk eligibility criteria was defined as people aged 55–74 years with a smoking history of ≥30 pack-years (years in which a smoker has consumed 20-plus cigarettes each day) and, for former smokers, ≥30 pack-years and have quit within the past 15 years.(5) All-cause mortality was reduced by 6.7% (95% CI, 1.2% – 13.6%; P=0.02). Initial data from the second landmark RCT, the NEderlands-Leuvens Longkanker Screenings ONderzoek (known as the NELSON trial), have found an even greater reduction of 26% (95% CI, 9% – 41%) in lung cancer mortality, with full trial results yet to be published.(6, 7) Pooled analyses, including several smaller-scale European LDCT screening trials insufficiently powered in their own right, collectively demonstrate a statistically significant reduction in lung cancer mortality (RR 0.82, 95% CI 0.73–0.91).(8) Despite the reduction in all-cause mortality found in the NLST, pooled analyses of seven trials found no statistically significant difference in all-cause mortality (RR 0.95, 95% CI 0.90–1.00).(8) However, cancer-specific mortality is currently the most relevant outcome in cancer screening trials. These seven trials demonstrated a significantly greater proportion of early stage cancers in LDCT groups compared with controls (RR 2.08, 95% CI 1.43–3.03). Thus, when considering results across mortality outcomes and early stage cancers diagnosed, LDCT screening is considered to be clinically effective. Question 2: What is the evidence of potential harms from lung cancer screening for higher-risk individuals? The harms of LDCT lung cancer screening include false positive tests and the consequences of unnecessary invasive follow-up procedures for conditions that are eventually diagnosed as benign. While LDCT screening leads to an increased frequency of invasive procedures, it does not result in greater mortality soon after an invasive procedure (in trial settings when compared with the control arm).(8) Overdiagnosis, exposure to radiation, psychological distress and an impact on quality of life are other known harms. Systematic review evidence indicates the benefits of LDCT screening are likely to outweigh the harms. The potential harms are likely to be reduced as refinements are made to LDCT screening protocols through: i) the application of risk predication models (e.g. the PLCOm2012), which enable a more accurate selection of the high-risk population through the use of specific criteria (beyond age and smoking history); ii) the use of nodule management algorithms (e.g. Lung-RADS, PanCan), which assist in the diagnostic evaluation of screen-detected nodules and cancers (e.g. more precise volumetric assessment of nodules); and, iii) more judicious selection of patients for invasive procedures. Recent evidence suggests a positive LDCT result may transiently increase psychological distress but does not have long-term adverse effects on psychological distress or health-related quality of life (HRQoL). With regards to smoking cessation, there is no evidence to suggest screening participation invokes a false sense of assurance in smokers, nor a reduction in motivation to quit. The NELSON and Danish trials found no difference in smoking cessation rates between LDCT screening and control groups. Higher net cessation rates, compared with general population, suggest those who participate in screening trials may already be motivated to quit. Question 3: What are the main components of recent major lung cancer screening programs or trials? There are no systematic reviews that capture the main components of recent major lung cancer screening trials and programs. We extracted evidence from original studies and clinical guidance documents and organised this into key groups to form a concise set of components for potential implementation of a national lung cancer screening program in Australia: 1. Identifying the high-risk population: recruitment, eligibility, selection and referral 2. Educating the public, people at high risk and healthcare providers; this includes creating awareness of lung cancer, the benefits and harms of LDCT screening, and shared decision-making 3. Components necessary for health services to deliver a screening program: a. Planning phase: e.g. human resources to coordinate the program, electronic data systems that integrate medical records information and link to an established national registry b. Implementation phase: e.g. human and technological resources required to conduct LDCT examinations, interpretation of reports and communication of results to participants c. Monitoring and evaluation phase: e.g. monitoring outcomes across patients, radiological reporting, compliance with established standards and a quality assurance program 4. Data reporting and research, e.g. audit and feedback to multidisciplinary teams, reporting outcomes to enhance international research into LDCT screening 5. Incorporation of smoking cessation interventions, e.g. specific programs designed for LDCT screening or referral to existing community or hospital-based services that deliver cessation interventions. Most original studies are single-institution evaluations that contain descriptive data about the processes required to establish and implement a high-risk population-based screening program. Across all studies there is a consistent message as to the challenges and complexities of establishing LDCT screening programs to attract people at high risk who will receive the greatest benefits from participation. With regards to smoking cessation, evidence from one systematic review indicates the optimal strategy for incorporating smoking cessation interventions into a LDCT screening program is unclear. There is widespread agreement that LDCT screening attendance presents a ‘teachable moment’ for cessation advice, especially among those people who receive a positive scan result. Smoking cessation is an area of significant research investment; for instance, eight US-based clinical trials are now underway that aim to address how best to design and deliver cessation programs within large-scale LDCT screening programs.(9) Question 4: What is the cost-effectiveness of lung cancer screening programs (include studies of cost–utility)? Assessing the value or cost-effectiveness of LDCT screening involves a complex interplay of factors including data on effectiveness and costs, and institutional context. A key input is data about the effectiveness of potential and current screening programs with respect to case detection, and the likely outcomes of treating those cases sooner (in the presence of LDCT screening) as opposed to later (in the absence of LDCT screening). Evidence about the cost-effectiveness of LDCT screening programs has been summarised in two systematic reviews. We identified a further 13 studies—five modelling studies, one discrete choice experiment and seven articles—that used a variety of methods to assess cost-effectiveness. Three modelling studies indicated LDCT screening was cost-effective in the settings of the US and Europe. Two studies—one from Australia and one from New Zealand—reported LDCT screening would not be cost-effective using NLST-like protocols. We anticipate that, following the full publication of the NELSON trial, cost-effectiveness studies will likely be updated with new data that reduce uncertainty about factors that influence modelling outcomes, including the findings of indeterminate nodules. Gaps in the evidence There is a large and accessible body of evidence as to the effectiveness (Q1) and harms (Q2) of LDCT screening for lung cancer. Nevertheless, there are significant gaps in the evidence about the program components that are required to implement an effective LDCT screening program (Q3). Questions about LDCT screening acceptability and feasibility were not explicitly included in the scope. However, as the evidence is based primarily on US programs and UK pilot studies, the relevance to the local setting requires careful consideration. The Queensland Lung Cancer Screening Study provides feasibility data about clinical aspects of LDCT screening but little about program design. The International Lung Screening Trial is still in the recruitment phase and findings are not yet available for inclusion in this Evidence Check. The Australian Population Based Screening Framework was developed to “inform decision-makers on the key issues to be considered when assessing potential screening programs in Australia”.(10) As the Framework is specific to population-based, rather than high-risk, screening programs, there is a lack of clarity about transferability of criteria. However, the Framework criteria do stipulate that a screening program must be acceptable to “important subgroups such as target participants who are from culturally and linguistically diverse backgrounds, Aboriginal and Torres Strait Islander people, people from disadvantaged groups and people with a disability”.(10) An extensive search of the literature highlighted that there is very little information about the acceptability of LDCT screening to these population groups in Australia. Yet they are part of the high-risk population.(10) There are also considerable gaps in the evidence about the cost-effectiveness of LDCT screening in different settings, including Australia. The evidence base in this area is rapidly evolving and is likely to include new data from the NELSON trial and incorporate data about the costs of targeted- and immuno-therapies as these treatments become more widely available in Australia.