Homecare Encounters: An Organizational Response to Innovative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation During COVID-19.

BACKGROUND: Healthcare delivery has been significantly changed because of the COVID-19 pandemic. Patients undergoing hematopoietic stem cell transplantation (HSCT) are vulnerable to infections because of their immunocompromised status. The risk of nosocomial infection may be reduced by providing care to patients at home. OBJECTIVES: This article describes one cancer center's approach for delivering safe patient care through homecare encounters, the benefits of home care for HSCT, and future directions. METHODS: Patients received detailed information on home encounters. Advanced practice providers visited patients daily and then returned to the clinic to formulate a plan of care with the interprofessional care team. Transplantation RNs visited patients on the same day to provide the prescribed care. FINDINGS: Based on evaluations from 32 patients and 12 providers, the results indicated that home care was safe, feasible, and beneficial for patient care post-HSCT during the COVID-19 pandemic.

Medical management of adrenocortical carcinoma: Current recommendations, new therapeutic options and future perspectives.

Adrenocortical carcinoma is a rare malignant tumor of poor prognosis, frequently requiring additional treatments after initial surgery. Due to its adrenolytic action, mitotane has become the first-line medical treatment in patients with aggressive adrenocortical carcinoma. Over the last 2years, apart from the classical chemotherapy based on etoposide and platinum salts, several studies reported the use of drugs such as temozolomide, tyrosine kinase inhibitors or immunotherapy, with more or less convincing results. The aim of this review is to give further insights in the use of these drugs, and to describe potential therapeutic perspectives based on recent pangenomic studies, for the future management of these still difficult to treat tumors.

Development of a clinical scale for assessment of patients with diffuse intrinsic pontine glioma (DIPG) receiving experimental therapy: the PONScore.

PURPOSE: Monitoring neurological side-effects in experimental therapy for diffuse intrinsic pontine glioma (DIPG) can be challenging. We aimed to develop a neurological scale that could be used by non-specialists to quantify neurological changes during experimental treatment of DIPG. METHODS: We developed the Pontine Observational Neurological Score (PONScore) to measure signs and symptoms of DIPG by adapting validated assessment scales of neurological signs and symptoms in children. We developed a prototype score, taught it to paediatric intensive care nursing staff, who used the Score to assess children receiving awake pontine infusion of chemotherapy for treatment of DIPG. We used their feedback to develop the PONScore. Points are allocated for headache, ophthalmoplegia, facial and tongue weakness, dysarthria, paraesthesia, limb weakness and dysmetria with increasing scores reflecting increasing disability. The PONScore was administered every hour during awake pontine infusion. Correlation and agreement calculations between nursing staff, as non-specialists, and a specialist rater were performed in 30 infusions in 6 children (aged 8-11). Changes in PONScore versus volume of infusion are described in a further 55 infusions in 8 children (aged 3-11). RESULTS: The PONScore demonstrated excellent intra-rater reliability with an intra-class co-efficient of 0.98 (95% CI 0.97-0.99; p-value < 0.001) between a specialist and non-specialist raters with strong correlation between scores and a Spearman correlation coefficient of 0.985 (p < 0.001). PONScores increased from 3.3 to 5.7 (p-value < 0.001) during infusion reflecting accumulation of neurological signs and symptoms during infusion. CONCLUSIONS: We describe a novel neurological scale that can be used by non-specialists to describe acute neurological changes in children receiving experimental therapy for DIPG. Prospective validation as part of a clinical trial is required.

Appraising the uptake and use of the IDEAL Framework and Recommendations: A review of the literature.

INTRODUCTION: Evaluation of new surgical innovations is complex and variably regulated, and historically the quality of surgical studies has been criticized. The IDEAL (Idea, Development, Exploration, Assessment, Long-term monitoring) Framework was established to provide a pathway for evaluating surgical innovations at each stage of their development in order to produce high quality surgical research. Since the inception of IDEAL in 2009, there has been no assessment of its use. In this review, we look at the uptake and usage of IDEAL by examining the published literature. METHODS: We conducted a literature search to identify all of the publications that cited IDEAL and included only those papers that intentionally used IDEAL as part of the study methodology. We then characterized these publications by year of publication, specialty, and geographical location. We performed a critical appraisal of Stage 1, 2a, and 2b studies in order to assess the degree to which authors have correctly followed the Framework and Recommendations. RESULTS: We found 790 citations of IDEAL publications, and after abstract and full-text screening, 38 prospective studies for a surgical innovation that used IDEAL remained. We saw an overall increase in the uptake of IDEAL, with a predominance in urology and origin in the United Kingdom. The critical appraisal showed that although authors identified their project as using IDEAL, they often failed to include key IDEAL characteristics; this was especially true for the features unique to IDEAL Stages 2a and 2b. CONCLUSION: It is evident from the large number of studies citing IDEAL that the importance and challenges of reporting surgical research is well recognized among researchers. There is growing enthusiasm for using IDEAL but the current level of understanding of the Recommendations is low. Clearer and more comprehensive explanation of the application of the IDEAL Framework and Recommendations is needed to guide surgical researchers undertaking IDEAL based studies of surgical innovations.

Recent developments and obstacles in the treatment of melanoma with BRAF and MEK inhibitors.

Metastatic melanoma is a least common form of cancer as it accounts only for 1% of all cancer cases. But, it is most deadly in nature and is haunting mankind for long emotionally as well as economically. The sites for the onset of the disease are pigment-producing cells of the skin, mucosa, eye etc. It has the potential to spread other sites like subcutaneous tissue, lymph nodes, lungs, liver, bone and brain. The United States Food & Drug Administration has approved various drug molecules from time to time. The molecules (Dabrafenib-BRAF inhibitor and Trametinib-MEK inhibitor) have proved their credentials alone and in combination as well. These molecules have demonstrated good results for various end points like median progression free survival, overall survival, objective response etc. The median progression free survival for patients using dabrafenib and trametinib were 5.1 and 4.8 months, respectively (administered singly). It has increased to 11.4 months in the combination treatment "dabrafenib + trametinib", which is approximately 104% and 138% greater than dabrafenib and trametinib treated groups alone. Similarly, the overall survival rate and objective response rate for the patients administered with "dabrafenib + trametinib" have been increased by 72% 64%, respectively. All these increments in these parameters were for a short period of time as the molecules were unable to withstand the pressure of resistance developed in the patients. So, the current review suggests the use of BRAF and MEK inhibitors as intermittent therapy along with heat shock protein 90 (HSP90) molecules.

Committee Opinion No 674 Summary: Guiding Principles for Privileging Of Innovative Procedures in Gynecologic Surgery.

New or emerging surgical procedures and technologies continue to be developed at a rapid rate and must be implemented safely into clinical practice. Additional privileging may be required if substantively new technical or cognitive skills are required to implement an innovative procedure or technology. Guiding principles for privileging should include cognitive and technical assessment to ensure appropriate patient selection and performance of the new procedure. Implementation also should include pertinent institutional and staff support as needed. A dynamic process for assessment and maintenance of current competency will enhance the safety of implementation and continued application of emerging procedures and technologies. The number of cases needed to demonstrate cognitive and technical proficiency will vary depending on many factors, including the health care provider's baseline expertise and technical acumen.

Anti-angiogenic drugs for second-line treatment of NSCLC patients: just new pawns on the chessboard?

Tumor angiogenesis is one of the main pathways targeted to treat cancer. Bevacizumab added survival benefit when combined with platinum-based chemotherapy in NSCLC. Recently, Phase III trials showed survival benefit when anti-angiogenic drugs are added to docetaxel as second-line treatment for NSCLC. These anti-angiogenic agents include nintedanib and ramucirumab, a tyrosine-kinase inhibitor and a monoclonal antibody, respectively, which target receptors involved in angiogenesis. These studies have some similarities and differences. We propose a new algorithm for treatment sequences in performance status 0-1 patients with non-oncogene-addicted NSCLC type adenocarcinoma. Indeed clearer scientific evidences are available for this subgroup of patients.

Getting Clearer About Surgical Innovation: A New Definition and a New Tool to Support Responsible Practice.

OBJECTIVES: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. BACKGROUND: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. METHODS: Using conceptual analysis, this article synthesizes findings from relevant literature, and from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. RESULTS: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation (newness and degree of change), is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something "new." CONCLUSIONS: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations.

Systematic review of surgical innovation reporting in laparoendoscopic colonic polyp resection.

BACKGROUND: The IDEAL framework (Idea, Development, Exploration, Assessment, Long-term study) proposes a staged assessment of surgical innovation, but whether it can be used in practice is uncertain. This study aimed to review the reporting of a surgical innovation according to the IDEAL framework. METHODS: Systematic literature searches identified articles reporting laparoendoscopic excision for benign colonic polyps. Using the IDEAL stage recommendations, data were collected on: patient selection, surgeon and unit expertise, description of the intervention and modifications, outcome reporting, and research governance. Studies were categorized by IDEAL stages: 0/1, simple technical preclinical/clinical reports; 2a, technique modifications with rationale and safety data; 2b, expanded patient selection and reporting of both innovation and standard care outcomes; 3, formal randomized controlled trials; and 4, long-term audit and registry studies. Each stage has specific requirements for reporting of surgeon expertise, governance details and outcome reporting. RESULTS: Of 615 abstracts screened, 16 papers reporting outcomes of 550 patients were included. Only two studies could be put into IDEAL categories. One animal study was classified as stage 0 and one clinical study as stage 2a through prospective ethical approval, protocol registration and data collection. Studies could not be classified according to IDEAL for insufficient reporting details of patient selection, relevant surgeon expertise, and how and why the technique was modified or adapted. CONCLUSION: The reporting of innovation in the context of laparoendoscopic colonic polyp excision would benefit from standardized methods.

Assessing Awareness and Implementation of a Recommendation for Surgical Innovation Committees: A Survey of Academic Institutions.

OBJECTIVE: In 2008, a Position Statement of the Society of University Surgeons (SUS) recommended the creation of institutional surgical innovation committees (SICs) to ensure appropriate oversight of surgical innovations. The purpose of this study was to determine the level of awareness of the position statement, and how innovations are handled in academic departments of surgery. METHODS: An electronic survey was designed to determine the level of awareness of the SUS recommendations among members of the Society of Surgical Chairs; the existence and characteristics of SICs; and alternative means of oversight of surgical innovations. RESULTS: The survey was distributed to 150 persons, and 65 (43%) surveys were returned; 84% reported their institution promoted innovative surgery as a strength, but 55% were unaware of the SUS recommendations; 23% reported that their institution has an SIC, and 20% said their institution has discussed or plans an SIC. Existing SICs have a median of 7 members; 57% reviewed 3 or fewer procedures in the prior year; and only 7% reviewed 10 or more. The majority of respondents reported alternative mechanisms of oversight, including morbidity/mortality conferences (88%), peer review (77%), and outcomes registries (51%). CONCLUSIONS: A minority of Surgery Department Chairs is aware of the SUS Position Statement. Although most reported surgical innovation was an institutional strength, only 23% had an SIC and most rely on other mechanisms of oversight. It is unclear whether academic surgical departments are committed to providing education and awareness of the appropriate development and implementation of surgical innovations.

[Academic cell therapy facilities are challenged by European regulation on advanced therapy medicinal products]. / Les unités de thérapie cellulaire à l'épreuve de la réglementation sur les médicaments de thérapie innovante.

Regulation (EC) n° 1394/2007 from the European Parliament and the Council describes a new category of health products termed « Advanced Therapy Medicinal Products ¼ (ATMPs). ATMPs derive from cell engineering, tissue engineering or genetic manipulations, and can in some instances be combined with medical devices. ATMPs are distributed and administered to patients, after biotechnology or pharmaceutical companies have obtained a marketing authorization that is granted by the European Commission on the basis of the European Medicines Agency (EMA) assessment. Seven years after the publication of the regulation, few of these therapies have received a marketing authorization, and even fewer have met commercial success, suggesting that a number of medical and economic issues still need to be sorted out in order to achieve sustainability in this field. The coexistence of three sets of rules for three categories of health products that are biologically and medically related - ATMPs, ATMPs produced under the hospital exemption rule, and cell therapy products (CTPs) (a specific legal category in France) that have long been used in hematopoietic cell transplantation - constitutes a complex regulatory framework. This situation raises significant issues for historical as well as emerging operators in this moving field that are discussed thereafter.

Innovation in pediatric surgery: the surgical innovation continuum and the ETHICAL model.

Innovations are indispensable to the practice and advancement of pediatric surgery. Children represent a special type of vulnerable population and must be protected since they do not have legal capacity to consent, and their parent's judgment may be compromised in circumstances when the child is very ill or no adequate therapy exists. In an effort to protect patients, legislators could pass and enforce laws that prohibit or curtail surgical innovations and thus stifle noble advancement of the practice. The goals of this paper are, 1) To clearly define the characteristics of surgical innovation types so interventions may be classified into 1 of 3 distinct categories along a continuum: Practice Variation, Transition Zone, and Experimental Research, and 2) To propose a practical systematic method to guide surgeon decision-making when approaching interventions that fall into the "Transition Zone" category on the Surgical Intervention Continuum. The ETHICAL model allows those that know the intricacies and nuances of pediatric surgery best, the pediatric surgeons and professional pediatric surgical societies, to participate in self-regulation of innovation in a manner that safeguards patients without stifling creativity or unduly hampering surgical progress.