Geriatric oncology health services research: Cancer and Aging Research Group infrastructure core

Founded by the late Dr. Arti Hurria, the Cancer and Aging Research Group (CARG) is a collaborative, interdisciplinary team of investigators dedicated to improving the care of older adults with cancer through research, advocacy, and other scholarly initiatives.1 As part of the CARG National Institute on Aging R21/R33 infrastructure grant to harness the available expertise and prioritize the development of high-impact research, the Health Services Research (HSR) Core was developed to foster and advance HSR in geriatric oncology. The mission of the HSR Core is to support clinical investigators to design and conduct highquality HSR focused on older adults with cancer and their caregivers including patterns of care, comparative effectiveness, and care delivery. At the first R21/R33 conference held at City of Hope in October 2018, Dr. Harvey Jay Cohen (Chair, CARG Oversight Board and HSR Core) led the development of this Core. In this perspective paper, we present a review of HSR in geriatric oncology to build a foundation for the Core rationale; proposed Core function, workflow, policies, and procedures; anticipated interactions with other CARG Cores; and proposed plans for sustainabilit

Protocol for diaphragm pacing in patients with respiratory muscle weakness due to motor neurone disease (DiPALS): a randomised controlled trial

Background Motor neurone disease (MND) is a devastating illness which leads to muscle weakness and death, usually within 2-3 years of symptom onset. Respiratory insufficiency is a common cause of morbidity, particularly in later stages of MND and respiratory complications are the leading cause of mortality in MND patients. Non Invasive Ventilation (NIV) is the current standard therapy to manage respiratory insufficiency. Some MND patients however do not tolerate NIV due to a number of issues including mask interface problems and claustrophobia. In those that do tolerate NIV, eventually respiratory muscle weakness will progress to a point at which intermittent/overnight NIV is ineffective. The NeuRx RA/4 Diaphragm Pacing System was originally developed for patients with respiratory insufficiency and diaphragm paralysis secondary to stable high spinal cord injuries. The DiPALS study will assess the effect of diaphragm pacing (DP) when used to treat patients with MND and respiratory insufficiency. Method/Design 108 patients will be recruited to the study at 5 sites in the UK. Patients will be randomised to either receive NIV (current standard care) or receive DP in addition to NIV. Study participants will be required to complete outcome measures at 5 follow up time points (2, 3, 6, 9 and 12 months) plus an additional surgery and 1 week post operative visit for those in the DP group. 12 patients (and their carers) from the DP group will also be asked to complete 2 qualitative interviews. Discussion The primary objective of this trial will be to evaluate the effect of Diaphragm Pacing (DP) on survival over the study duration in patients with MND with respiratory muscle weakness. The project is funded by the National Institute for Health Research, Health Technology Assessment (HTA) Programme (project number 09/55/33) and the Motor Neurone Disease Association and the Henry Smith Charity. Trial Registration: Current controlled trials ISRCTN53817913. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health

Safety and efficacy of diaphragm pacing in patients with respiratory insufficiency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial

Background: Non-invasive ventilation is part of the standard of care for treatment of respiratory failure in patients with amyotrophic lateral sclerosis (ALS). The NeuRx RA/4 Diaphragm Pacing System has received Humanitarian Device Exemption approval from the US Food and Drug Administration for treatment of respiratory failure in patients with ALS. We aimed to establish the safety and efficacy of diaphragm pacing with this system in patients with respiratory muscle weakness due to ALS. Methods: We undertook a multicentre, open-label, randomised controlled trial at seven specialist ALS and respiratory centres in the UK. Eligible participants were aged 18 years or older with laboratory supported probable, clinically probable, or clinically definite ALS; stable riluzole treatment for at least 30 days; and respiratory insufficiency. We randomly assigned participants (1:1), via a centralised web-based randomisation system with minimisation that balanced patients for age, sex, forced vital capacity, and bulbar function, to receive either non-invasive ventilation plus pacing with the NeuRx RA/4 Diaphragm Pacing System or non-invasive ventilation alone. Patients, carers, and outcome assessors were not masked to treatment allocation. The primary outcome was overall survival, defined as the time from randomisation to death from any cause. Analysis was by intention to treat. This trial is registered, ISRCTN number 53817913. Findings: Between Dec 5, 2011, and Dec 18, 2013, we randomly assigned 74 participants to receive either non-invasive ventilation alone (n=37) or non-invasive ventilation plus diaphragm pacing (n=37). On Dec 18, 2013, the Data Monitoring and Ethics Committee (DMEC) recommended suspension of recruitment on the basis of overall survival figures. Randomly assigned participants continued as per the study protocol until June 23, 2014, when the DMEC advised discontinuation of pacing in all patients. Follow-up assessments continued until the planned end of the study in December, 2014. Survival was shorter in the non-invasive ventilation plus pacing group than in the non-invasive ventilation alone group (median 11·0 months [95% CI 8·3-13·6] vs 22·5 months [13·6-not reached]; adjusted hazard ratio 2·27, 95% CI 1·22-4·25; p=0·009). 28 (76%) patients died in the pacing group and 19 (51%) patients died in the non-invasive ventilation alone group. We recorded 162 adverse events (5·9 events per person-year) in the pacing group, of which 46 events were serious, compared with 81 events (2·5 events per person-year) in the non-invasive ventilation alone group, of which 31 events were serious. Interpretation: Addition of diaphragm pacing to standard care with non-invasive ventilation was associated with decreased survival in patients with ALS. Our results suggest that diaphragmatic pacing should not be used as a routine treatment for patients with ALS in respiratory failure

The Cholecystectomy As A Day Case (CAAD) Score: A Validated Score of Preoperative Predictors of Successful Day-Case Cholecystectomy Using the CholeS Data Set

Background Day-case surgery is associated with significant patient and cost benefits. However, only 43% of cholecystectomy patients are discharged home the same day. One hypothesis is day-case cholecystectomy rates, defined as patients discharged the same day as their operation, may be improved by better assessment of patients using standard preoperative variables. Methods Data were extracted from a prospectively collected data set of cholecystectomy patients from 166 UK and Irish hospitals (CholeS). Cholecystectomies performed as elective procedures were divided into main (75%) and validation (25%) data sets. Preoperative predictors were identified, and a risk score of failed day case was devised using multivariate logistic regression. Receiver operating curve analysis was used to validate the score in the validation data set. Results Of the 7426 elective cholecystectomies performed, 49% of these were discharged home the same day. Same-day discharge following cholecystectomy was less likely with older patients (OR 0.18, 95% CI 0.15–0.23), higher ASA scores (OR 0.19, 95% CI 0.15–0.23), complicated cholelithiasis (OR 0.38, 95% CI 0.31 to 0.48), male gender (OR 0.66, 95% CI 0.58–0.74), previous acute gallstone-related admissions (OR 0.54, 95% CI 0.48–0.60) and preoperative endoscopic intervention (OR 0.40, 95% CI 0.34–0.47). The CAAD score was developed using these variables. When applied to the validation subgroup, a CAAD score of ≤5 was associated with 80.8% successful day-case cholecystectomy compared with 19.2% associated with a CAAD score >5 (p < 0.001). Conclusions The CAAD score which utilises data readily available from clinic letters and electronic sources can predict same-day discharges following cholecystectomy

Certification schemes and the impacts on forests and forestry

Certification schemes have emerged in recent years to become a significant and innovative venue for standard setting and governance in the environmental realm. This review examines these schemes in the forest sector where, arguably, their development is among the most advanced of the sustainability labeling initiatives. Beginning with the origins, history, and features of schemes, the review synthesizes and assesses what we know about the direct effects and broader consequences of forest certification. Bearing in mind underlying factors affecting producers' decisions to certify, direct effects are examined by describing the uptake of schemes, the improvements to management of audited forests, and the ameliorative potential of certification for landscape-level concerns such as deforestation and forest protection. In assessing broader consequences, we look beyond the instrument itself to detail positive and negative unintended consequences, spillover effects, and longer-term and slow-moving effects that flow from the emergence of the certification innovation

Effects of EU illegal logging policy on timber-supplying countries: A systematic review

The EU's Forest Law Enforcement, Governance and Trade Action Plan (FLEGT) adopted in 2003 includes bilateral trade agreements known as Voluntary Partnership Agreements (VPAs) signed between the EU and timber-supplying countries. The EU has invested more than 1.5 billion euros in VPAs; however, only one of the seven concerned countries has managed to complete all the necessary requirements to expire FLEGT licences. Since there is no research that comprehensively integrates the scientific evidence regarding the effects of this policy, this study systematically reviews all empirical scientific studies on the effects of VPAs. We found that almost all relevant studies are case reports that use qualitative data and focus on only one country at a time, mainly Ghana, Cameroon, or Indonesia. The evidence suggests that while VPAs have contributed to the establishment of governance structures, tools, and procedures they have not been able to solve social problems (i.e., inequality and injustice) and have potentially harmed the economies of EU timber suppliers. Evidence on the effects of VPAs on illegal logging and trade and the environment remains limited. Thus, future research should focus on more countries; use a greater range of methods, including comparative experimental designs; explore possible intended effects on under-researched categories; and systematically investigate unintended effects on other categories within and outside the forestry sector