Towards an evidence-informed value scale for surgical and radiation oncology: a multi-stakeholder perspective.

Surgery and radiotherapy, two locoregional cancer treatments, are essential to help improve cancer outcomes, control, and palliation. The continued evolution in treatment processes, techniques, and technologies-often at substantially increased costs-demands for direction on outcomes that are most valued by patients, and the evidence that is required before clinical adoption of these practices. Three recently introduced frameworks-the European Society for Medical Oncology Magnitude of Clinical Benefit Scale, the American Society of Clinical Oncology Value Framework, and the National Comprehensive Cancer Network Blocks-which all help define the value of oncology treatments, were appraised with a focus on their methods and definition of patient benefit. In this Review, we investigate the applicability of these frameworks to surgical and radiotherapy innovations. Findings show that these frameworks are not immediately transferable to locoregional cancer treatments. Moreover, the lack of emphasis on patient perspective and the reliance on traditional, trial-based endpoints such as survival, disease-free survival, and safety, calls for a new framework that includes real-world evidence with focus on the whole spectrum of patient-centred endpoints. Such an evidence-informed value scale would safeguard against the proliferation of low-value innovation while simultaneously increasing access to treatments that show significant improvements in the outcomes of cancer care.

Consensus on molecular imaging and theranostics in prostate cancer.

Rapid developments in imaging and treatment with radiopharmaceuticals targeting prostate cancer pose issues for the development of guidelines for their appropriate use. To tackle this problem, international experts representing medical oncologists, urologists, radiation oncologists, radiologists, and nuclear medicine specialists convened at the European Association of Nuclear Medicine Focus 1 meeting to deliver a balanced perspective on available data and clinical experience of imaging in prostate cancer, which had been supported by a systematic review of the literature and a modified Delphi process. Relevant conclusions included the following: diphosphonate bone scanning and contrast-enhanced CT are mentioned but rarely recommended for most patients in clinical guidelines; MRI (whole-body or multiparametric) and prostate cancer-targeted PET are frequently suggested, but the specific contexts in which these methods affect practice are not established; sodium fluoride-18 for PET-CT bone scanning is not widely advocated, whereas gallium-68 or fluorine-18 prostate-specific membrane antigen gain acceptance; and, palliative treatment with bone targeting radiopharmaceuticals (rhenium-186, samarium-153, or strontium-89) have largely been replaced by radium-223 on the basis of the survival benefit that was reported in prospective trials, and by other systemic therapies with proven survival benefits. Although the advances in MRI and PET-CT have improved the accuracy of imaging, the effects of these new methods on clinical outcomes remains to be established. Improved communication between imagers and clinicians and more multidisciplinary input in clinical trial design are essential to encourage imaging insights into clinical decision making.

Growth rates of black soldier fly larvae fed on fresh human faeces and their implication for improving sanitation.

OBJECTIVES: To determine the capacity of black soldier fly larvae (BSFL) (Hermetia illucens) to convert fresh human faeces into larval biomass under different feeding regimes, and to determine how effective BSFL are as a means of human faecal waste management. METHODS: Black soldier fly larvae were fed fresh human faeces. The frequency of feeding, number of larvae and feeding ratio were altered to determine their effects on larval growth, prepupal weight, waste reduction, bioconversion and feed conversion rate (FCR). RESULTS: The larvae that were fed a single lump amount of faeces developed into significantly larger larvae and prepupae than those fed incrementally every 2 days; however, the development into pre-pupae took longer. The highest waste reduction was found in the group containing the most larvae, with no difference between feeding regimes. At an estimated 90% pupation rate, the highest bioconversion (16-22%) and lowest, most efficient FCR (2.0-3.3) occurred in groups that contained 10 and 100 larvae, when fed both the lump amount and incremental regime. CONCLUSION: The prepupal weight, bioconversion and FCR results surpass those from previous studies into BSFL management of swine, chicken manure and municipal organic waste. This suggests that the use of BSFL could provide a solution to the health problems associated with poor sanitation and inadequate human waste management in developing countries.

Surgeon choice in the use of postdischarge antibiotics for prophylaxis following mastectomy with and without breast reconstruction.

Multiple guidelines recommend discontinuation of prophylactic antibiotics <24 hours after surgery. In a multicenter, retrospective cohort of 2,954 mastectomy patients ± immediate breast reconstruction, we found that utilization of prophylactic postdischarge antibiotics varied dramatically at the surgeon level among general surgeons and was virtually universal among plastic surgeons.

Characteristics, behaviors, and attitudes of men bypassing the healthcare system when obtaining phosphodiesterase type 5 inhibitors.

INTRODUCTION: Men may choose to bypass the healthcare system to obtain a phosphodiesterase type 5 inhibitor (PDE5i). AIM: Evaluate the characteristics and purchasing patterns of men obtaining a PDE5i without prior healthcare professional (HCP) interaction. MAIN OUTCOME MEASURES: Prior HCP interaction, defined as having a prescription for any PDE5i, having a PDE5i sample from a physician, or buying the PDE5i in a retail pharmacy; and erectile dysfunction (ED, the Massachusetts Male Aging Study single-item question) were assessed. A multivariate regression analysis determined predictive factors for PDE5i purchase without prior HCP interaction. Methods. A Web-based observational study was conducted in the United Kingdom, Germany, and Italy. RESULTS: Of the 11,899 participants, 1,252 (10.5% [95% CI, 10.0-11.1%]) reported PDE5i use in the last 6 months. PDE5is were obtained without prior HCP interaction by 403 users (32.3% [95% CI, 29.6-34.8%]); 65.5% of them had ED. Overall prevalence of men using PDE5is without HCP interaction was 3.0% (95% CI, 2.6-3.5%), 4.1% (95% CI, 3.5-4.6%), and 2.8% (95% CI, 2.1-3.5%) for men aged 18-34, 35-50, and >50 years, respectively (P = 0.0045). Predictive factors for obtaining a PDE5i without prior HCP interaction were embarrassment to speak to a physician (P = 0.0009) and the perception that this would be the cheapest way to get the medicine (P = 0.03). CONCLUSIONS: Based on these findings, it can be estimated that approximately 6 million men in Europe might currently bypass the healthcare system to obtain a PDE5i. In addition to the risks associated with use of PDE5is from uncontrolled sources, because most of these men have ED, they also miss the opportunity for important health information or medical follow-up. HCPs should actively address ED and offer treatment to discourage men from seeking uncontrolled sources of ED medicines.

Postdischarge antibiotic use for prophylaxis following spinal fusion.

OBJECTIVE: Despite recommendations to discontinue prophylactic antibiotics after incision closure or <24 hours after surgery, prophylactic antibiotics are continued after discharge by some clinicians. The objective of this study was to determine the prevalence and factors associated with postdischarge prophylactic antibiotic use after spinal fusion. DESIGN: Multicenter retrospective cohort study. PATIENTS: This study included patients aged ≥18 years undergoing spinal fusion or refusion between July 2011 and June 2015 at 3 sites. Patients with an infection during the surgical admission were excluded. METHODS: Prophylactic antibiotics were identified at discharge. Factors associated with postdischarge prophylactic antibiotic use were identified using hierarchical generalized linear models. RESULTS: In total, 8,652 spinal fusion admissions were included. Antibiotics were prescribed at discharge in 289 admissions (3.3%). The most commonly prescribed antibiotics were trimethoprim/sulfamethoxazole (22.1%), cephalexin (18.8%), and ciprofloxacin (17.1%). Adjusted for study site, significant factors associated with prophylactic discharge antibiotics included American Society of Anesthesiologists (ASA) class ≥3 (odds ratio [OR], 1.31; 95% CI, 1.00-1.70), lymphoma (OR, 2.57; 95% CI, 1.11-5.98), solid tumor (OR, 3.63; 95% CI, 1.62-8.14), morbid obesity (OR, 1.64; 95% CI, 1.09-2.47), paralysis (OR, 2.38; 95% CI, 1.30-4.37), hematoma/seroma (OR, 2.93; 95% CI, 1.17-7.33), thoracic surgery (OR, 1.39; 95% CI, 1.01-1.93), longer length of stay, and intraoperative antibiotics. CONCLUSIONS: Postdischarge prophylactic antibiotics were uncommon after spinal fusion. Patient and perioperative factors were associated with continuation of prophylactic antibiotics after hospital discharge.

Increased Cerebrospinal Fluid Amyloid-ß During Sleep Deprivation in Healthy Middle-Aged Adults Is Not Due to Stress or Circadian Disruption.

BACKGROUND: Concentrations of soluble amyloid-ß (Aß) oscillate with the sleep-wake cycle in the interstitial fluid of mice and cerebrospinal fluid (CSF) of humans. Further, the concentration of Aß in CSF increases during sleep deprivation. Stress and disruption of the circadian clock are additional mechanisms hypothesized to increase CSF Aß levels. Cortisol is a marker for stress and has an endogenous circadian rhythm. Other factors such as glucose and lactate have been associated with changes in sleep-wake activity and/or Aß. OBJECTIVE: In this exploratory study, we used samples collected in a previous study to examine how sleep deprivation affects Aß, cortisol, lactate, and glucose in plasma and CSF from healthy middle-aged adults (N = 11). METHODS: Eleven cognitively normal participants without evidence of sleep disturbance were randomized to sleep deprivation or normal sleep control. All participants were invited to repeat the study. Cortisol, lactate, glucose, and Aß were measured in 2-h intervals over a 36-h period in both plasma and CSF. All concentrations were normalized to the mean prior to calculating mesor, amplitude, acrophase, and other parameters. RESULTS: One night of sleep deprivation increases the overnight concentration of Aß in CSF approximately 10%, but does not significantly affect cortisol, lactate, or glucose concentrations in plasma or CSF between the sleep-deprived and control conditions. CONCLUSION: These data suggest that sleep deprivation-related changes in CSF Aß are not mediated by stress or circadian disruption as measured by cortisol.

ECCO Essential Requirements for Quality Cancer Care: Prostate cancer.

BACKGROUND: ECCO Essential Requirements for Quality Cancer Care (ERQCC) are written by experts representing all disciplines involved in cancer care in Europe. They give oncology teams, patients, policymakers and managers an overview of essential care throughout the patient journey. PROSTATE CANCER: Prostate cancer is the second most common male cancer and has a wide variation in outcomes in Europe. It has complex diagnosis and treatment challenges, and is a major healthcare burden. Care must only be a carried out in prostate/urology cancer units or centres that have a core multidisciplinary team (MDT) and an extended team of health professionals. Such units are far from universal in European countries. To meet European aspirations for comprehensive cancer control, healthcare organisations must consider the requirements in this paper, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis, to treatment, to survivorship.

Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot Program.

The advent of patient-focused drug development (PFDD) has underscored the priority of engaging the "voice of the patient" in therapy development. Industry sponsors are working to enhance engagement of patients early, particularly within decision making for design and execution of clinical trials. This trend is especially significant within oncology, as industry leaders partner with patient advocacy organizations, individual patients, and clinicians to enhance patient-centricity. These partnerships often require a willingness to change attitudes, approaches, and processes to reshape traditional models of drug development. In 2016, Bayer Oncology launched a pilot program called the Patient Advocate Advisory Council (PAAC), to design and execute a program whereby patients join clinical development teams. The PAAC, composed of experienced patient advocates from the US and Europe, worked closely with company leaders to design and execute a pilot in an ongoing clinical development program. The PAAC and Bayer teams have identified important learnings from the first phase of the program, emphasizing earlier engagement of patient advisors, launching the enhanced training platform, and recruiting additional PAAC members to expand the initiative's reach across the cancer community. A critical success factor is having champions for patient engagement within the company to ensure that activities are streamlined and standardized as patient engagement becomes more common. This is particularly important given that patient engagement should be a long-term investment with sufficient and sustained resources. PAAC members and Bayer have committed to sharing learnings, to advance opportunities for successful patient engagement in drug development throughout the oncology therapeutic landscape.

Multi-Modal Home Sleep Monitoring in Older Adults.

The gold standard for sleep monitoring is attended in-lab polysomnography; however, this method may be cost-prohibitive and inconvenient for patients and research participants. Home sleep testing has gained momentum in the field of sleep medicine due to its convenience and lower cost, as well as being more naturalistic. The accuracy and quality of home sleep testing, however, may be variable because studies are not monitored by sleep technologists. There has been some success in improving the accuracy of home sleep studies by having trained sleep technicians assist participants inside their homes with putting on the devices, but this can be intrusive and time-consuming for those involved. In this protocol, participants undergo at-home sleep monitoring with multiple devices: 1) a single-channel EEG device; 2) a home sleep test for sleep-disordered breathing and periodic limb movements; 3) actigraphy; and 4) sleep logs. A major challenge of this study is obtaining high-quality sleep monitoring data on the first attempt in order to minimize participant burden. This protocol describes the implementation of educational manuals with step-by-step instructions and photos. The goal is to improve the quality of home sleep testing.

ECCO Essential Requirements for Quality Cancer Care: Primary care.

BACKGROUND: ECCO Essential Requirements for Quality Cancer Care (ERQCC) are checklists and explanations of organisation and actions that are necessary to give high-quality care to cancer patients. They are written by European experts representing all disciplines involved in cancer care. This paper concerns the integration of primary care into care for all cancers in Europe. Primary care integration.

Mapping the cancer patient information landscape: A comparative analysis of patient groups across Europe and North America.

AIM: Little is known about how patient groups provide information for patients. We invited 838 patient groups from Europe and North America to participate in an online survey. METHODS: The survey covered: (i) availability, accessibility and quality of information provided; (ii) methods by which patient groups communicate; (iii) ways in which patient groups acquire information and confirm its veracity/accuracy; (iv) how people access information online. RESULTS: European patient groups were significantly less effective in providing medical-related information than their North American counterparts in: clinical trials, potential causes of cancer, medical research, diagnosis/screening, symptoms, treatments (all p < 0.0001); Recommendations of best practice/care (p < 0.03), healthcare services(p = 0.029) and complimentary medicine (p = 0.01). Clinical trials (p = 0.0006), medical research (p = 0.006) and diagnosis/screening (p = 0.0024) were also areas where North American patients were more likely to require medical-related information. Similar patterns emerged for non-medical information with nutrition (<0.0001), watchful waiting (p = 0.0003), self-management of care (p = 0.0003), prevention (p = 0.002) and emotional issues (p = 0.016) being less effectively communicated by European patient groups. Nutrition was also an area where North American patients were more likely to require non-medical-related information. The main barriers in accessing online information which showed differences between European and North American patients were: perceived lack of need, mainly due to faith in their doctors (p = 0.0001); limited access to the internet (p = 0.0005), limited computer skills (p = 0.02); and lower income (p = 0.027). CONCLUSION: These results emphasise the more mature nature of cancer patient engagement/information provision in North America, providing valuable insights and guidance to inform development of more robust and effective cancer patient information communication platforms in Europe.