Which medical device and/or which local treatment are to be used, as of 2012, in patients with infected pressure sore? Developing French guidelines for clinical practice

This paper provides a systematic review of over 350 publications that document specific medical device examples in which the design and manufacturing relied on additive manufacturing processes (more popularly referred to as “3d Printing”). Existing reviews on 3d printing for medical device design focus on the range of clinical applications and potential uses for this technology. However, existing work tends to omit key medical device development and regulatory requirements pertaining to the use of 3d printing for technology translation. These omissions often present a skewed view of each device’s potential for rapid translation to commercialization and common clinical practice. To fill gaps in existing literature, this review includes medical device journal articles and identifies each article’s country of origin, the product development stage in which 3d printing was used, and the device’s specific type and classification under the U.S. Food and Drug Administration. The findings from this systematic review provide a detailed international snapshot of current additive manufacturing research and its near term potential for changing clinical practice.

Download Full-text

Functional Requirements and Quality Assurance Necessary for Successful Incorporation of Electroporation-Based Therapies Into Clinical Practice

Journal of Medical Devices ◽

10.1115/1.4045837 ◽

2020 ◽

Vol 14 (1) ◽

Author(s):

Eva Pirc ◽

Matej Reberšek ◽

Damijan Miklavčič

Keyword(s):

Quality Assurance ◽

Clinical Practice ◽

Medical Device ◽

Development Process ◽

Functional Requirements ◽

Socioeconomically Disadvantaged ◽

Pulse Parameters ◽

Disadvantaged Populations ◽

Safety Guidelines

Abstract Electroporation-based therapies have a huge potential for implementation into clinical practice in socioeconomically disadvantaged populations. Currently, the price of electroporators and electrodes is relatively high, but custom low budget devices can be developed. In the paper, we describe three most established applications in medicine, with the focus on the basic mechanisms, which should be taken into account during the development process of a clinical electroporator. Also, typical pulse parameters used in each of the described applications are defined. In the second part of the paper, we describe technical functional requirements for a clinical electroporator and safety guidelines, with the focus on medical device standard. At the end of the paper, the focus moves to a more general problematic, such as quality assurance and the importance of measurement during the pulse delivery, which we firmly believe is necessary for successful electroporation.

Download Full-text

Criteria for indication and treatment modification in a cohort of patients with prostate cancer treated with hormone therapy

Therapeutic Advances in Urology ◽

10.1177/1756287218808496 ◽

2018 ◽

Vol 10 (12) ◽

pp. 365-376 ◽

Cited By ~ 1

Author(s):

Thierry Lebret ◽

Alain Ruffion ◽

Igor Latorzeff ◽

Marc Zerbib ◽

Jean-Luc Moreau ◽

...

Keyword(s):

Prostate Cancer ◽

Clinical Practice ◽

Hormone Therapy ◽

Predictive Factors ◽

Primary Endpoint ◽

Locally Advanced ◽

Local Treatment ◽

Routine Clinical Practice ◽

Gnrh Analogue ◽

Treatment Modification

Background: No published studies have specifically assessed whether treatment modifications to androgen deprivation therapy (ADT) for prostate cancer (PCa) are frequently carried out in routine clinical practice. The current study was conducted to determine what proportion of patients who had initiated hormone therapy with a gonadotropin-releasing hormone (GnRH) analogue then had their treatment regimen modified during the first 24 months. Methods: A prospective, noninterventional study was carried out in routine clinical practice in France. Patients with locally advanced or metastatic PCa were followed up for 2 years after treatment initiation with a GnRH analogue. The primary endpoint was the proportion of patients with a modification to their initial hormone therapy. Results: In total, 1301 patients were enrolled into the study by 204 physicians, and the primary endpoint could be evaluated for 891 patients. The GnRH analogue treatment was initiated for metastatic PCa (24.2%), locally advanced PCa without planned local treatment (20.6%), locally advanced PCa in association with radiotherapy (31.6%), and biochemical recurrence after local treatment (21.4%). Hormonal treatment was modified in 43.8% (390/891) of patients during the 24-month follow-up period after GnRH analogue initiation. In 61.3% of cases (239/390), the type of modification involved a change of GnRH analogue formulation or switch to another GnRH analogue. A total of five significant predictive factors for GnRH analogue treatment modification were identified: metastatic stage; physician sector; physician speciality; presence or absence of urinary symptoms; and intermittent versus continuous ADT. Conclusions: This study shows that in 43.8% of the patients with advanced PCa, ADT is modified in the first 2 years after initiation in routine clinical practice. Predictive factors for alteration of ADT were metastatic stage and the choice of an intermittent schedule.

Download Full-text

The role of a multidisciplinary approach in the treatment of hepatocellular carcinoma

Modern Oncology ◽

10.26442/18151434.2019.4.190694 ◽

2020 ◽

Vol 21 (4) ◽

pp. 10-14

Author(s):

Oleg I. Kit ◽

Liubov Iu. Vladimirova ◽

Anna E. Storozhakova ◽

Tatiana A. Snezhko ◽

Elena A. Kalabanova ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Clinical Practice ◽

Targeted Therapy ◽

Surgical Treatment ◽

Viral Hepatitis ◽

Multidisciplinary Approach ◽

Local Treatment ◽

Treatment Methods ◽

Viral Hepatitis C ◽

Advanced Stages

Aim. Evaluation of treatment options and efficacy in patients with hepatocellular carcinoma based on data from the FSBI Rostov Cancer Research Institute using a multidisciplinary approach to the problem. Materials and methods. 124 cases of hepatocellular carcinoma were analyzed. In 79.8% of patients (average age of 61.4 years) the disease was diagnosed at advanced stages (IIIIV). Antibodies to viral hepatitis B were detected in 18 (14.5%) patients, and antibodies to viral hepatitis C in 35 (28.2%) patients. Liver cirrhosis occurred in 38 (30.6%) cases, and ChildPugh class A in 20 (16.1%) cases. In the FSBI RCRI, a multidisciplinary approach has been introduced into clinical practice; decision on treatment tactics is made with a close cooperation of several specialists. The use of special treatment methods was available in 67 (54%) patients. 32 patients with Barcelona Clinic Liver Cancer (BCLC) stage A (early) or stage B (intermediate), had surgical treatment or hepatic arterial chemoembolization (HACE) with lipiodol or microspheres using various cytostatics (18 and 14 patients, respectively). 35 patients with advanced stage C were given a systemic therapy with various cytostatics (gemcitabine, oxaliplatin, doxorubicin) or targeted therapy with sorafenib. The treatment efficacy was assessed according to mRECIST. Results. The best median overall survival (OS) up to 21 months was in the group of patients (n=18) who underwent volume resection surgery. In this group, sorafenib was prescribed to 2 patients after surgery. When performing HACE, the median OS was 14.2 months. In 6 patients, HACE was performed 2 or more times. Among the 14 patients who had HACE, sorafenib was prescribed in 8 cases, and the median OS in this group was 16.3 months. 20 patients were given targeted therapy with sorafenib. Following 3 months of taking the drug, 16 patients achieved stabilization of the disease according to the mRECIST, in 1 patient a partial response, in 3 patients disease progression. Median OS was 9.1 months; progression-free survival among patients treated with sorafenib was 5.4 months. Conclusions. The use of a multidisciplinary approach in clinical practice makes it possible to choose the optimal treatment option for hepatocellular carcinoma and contributes to the improvement in OS. The combination of local treatment methods (surgical treatment, HACE) with effective drug therapy is the most optimal approach to treating patients with advanced stages of hepatocellular carcinoma.

Download Full-text

Real-world application of next generation sequencing to guide therapeutic options in lymphoma.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e14645 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e14645-e14645

Author(s):

Molly Tokaz ◽

Anthony Scott ◽

Maryann Shango ◽

Sumana Devata ◽

Shannon Carty ◽

...

Keyword(s):

Clinical Practice ◽

Next Generation Sequencing ◽

Precision Medicine ◽

Real World ◽

Local Treatment ◽

Therapeutic Targets ◽

Therapeutic Options ◽

Next Generation ◽

Considerable Uncertainty ◽

Generation Sequencing

e14645 Background: Despite the increasing availability of targeted and novel therapies, successful treatment of many relapsed/refractory lymphomas remains a challenge. Tumor sequencing is becoming an increasingly available technique to identify potential therapeutic targets; however, there remains considerable uncertainty about the successful application of this data in a “real world” clinical setting. Methods: Herein, we describe 91 lymphoma patients who underwent DNA & RNA sequencing of tumor biopsies via the MIONCOSEQ protocol to identify actionable therapeutic targets. Their charts were reviewed for the clinical use of MIONCOSEQ recommendations. Results: Among the 91 patients were 13 Lymphoma subtypes. Most patients had Stage III/IV disease (68%) at diagnosis, underwent an average of 4 treatments before sequencing (range 0-16) and had approximately 47 distinct molecular alterations (range 2-447). Of the cohort, 60 patients (65%) had actionable targets identified of which 11 ultimately received treatment based on MIONCOSEQ recommendations. The remaining patients did not receive treatment due to multiple reasons: prior CR or on surveillance not requiring treatment (10); death (12); trial ineligibility (4); trial unavailability at the institution (8); patient preference for local treatment (6); and already on alternative treatments (9). Taken as a whole, sequencing late in the disease course and a lack of available clinical trials were identified as barriers for the incorporation of MIONCOSEQ data into clinical practice. Therefore, earlier sequencing and strategies to bolster the availability of targeted therapies may significantly increase the application of genomic data and precision medicine in clinical practice. Conclusions: While next generation sequencing (NGS) is a powerful tool for advancing precision medicine, meaningful clinical application of these results remains a challenge. Our study indicates that early sequencing and improved trial availability could be beneficial in increasing real-world therapeutic options for relapsed/refractory lymphoma. Further research is needed to determine the extent to which a personalized approach, informed by NGS data, improves outcomes.

Download Full-text

PIN46 Assessment of Economic Efficiency of the Diagnostic Medical Device "Lifering" in the Clinical Practice of Russian Federation.

Value in Health ◽

10.1016/j.jval.2020.08.887 ◽

2020 ◽

Vol 23 ◽

pp. S552

Author(s):

V. Dombrovskiy ◽

A. Margieva

Keyword(s):

Clinical Practice ◽

Medical Device ◽

Russian Federation ◽

Economic Efficiency

Download Full-text

Initial Management of Noncastrate Advanced, Recurrent, or Metastatic Prostate Cancer: ASCO Guideline Update

Journal of Clinical Oncology ◽

10.1200/jco.20.03256 ◽

2021 ◽

pp. JCO.20.03256

Author(s):

Katherine S. Virgo ◽

R. Bryan Rumble ◽

Ronald de Wit ◽

David S. Mendelson ◽

Thomas J. Smith ◽

...

Keyword(s):

Prostate Cancer ◽

Clinical Practice ◽

Clinical Practice Guidelines ◽

Practice Guidelines ◽

Metastatic Prostate Cancer ◽

Expert Panel ◽

Locally Advanced ◽

Local Treatment ◽

Phase Iii ◽

Standards Of Care

PURPOSE Update all preceding ASCO guidelines on initial hormonal management of noncastrate advanced, recurrent, or metastatic prostate cancer. METHODS The Expert Panel based recommendations on a systematic literature review. Recommendations were approved by the Expert Panel and the ASCO Clinical Practice Guidelines Committee. RESULTS Four clinical practice guidelines, one clinical practice guidelines endorsement, 19 systematic reviews with or without meta-analyses, 47 phase III randomized controlled trials, nine cohort studies, and two review papers informed the guideline update. RECOMMENDATIONS Docetaxel, abiraterone, enzalutamide, or apalutamide, each when administered with androgen deprivation therapy (ADT), represent four separate standards of care for noncastrate metastatic prostate cancer. Currently, the use of any of these agents in any particular combination or series cannot be recommended. ADT plus docetaxel, abiraterone, enzalutamide, or apalutamide should be offered to men with metastatic noncastrate prostate cancer, including those who received prior therapies, but have not yet progressed. The combination of ADT plus abiraterone and prednisolone should be considered for men with noncastrate locally advanced nonmetastatic prostate cancer who have undergone radiotherapy, rather than castration monotherapy. Immediate ADT may be offered to men who initially present with noncastrate locally advanced nonmetastatic disease who have not undergone previous local treatment and are unwilling or unable to undergo radiotherapy. Intermittent ADT may be offered to men with high-risk biochemically recurrent nonmetastatic prostate cancer. Active surveillance may be offered to men with low-risk biochemically recurrent nonmetastatic prostate cancer. The panel does not support use of either micronized abiraterone acetate or the 250 mg dose of abiraterone with a low-fat breakfast in the noncastrate setting at this time. Additional information is available at www.asco.org/genitourinary-cancer-guidelines .

Download Full-text

An industrial oriented workflow for 3D printed, patient specific orthopedic cast

SN Applied Sciences ◽

10.1007/s42452-021-04816-w ◽

2021 ◽

Vol 3 (11) ◽

Author(s):

Mario Formisano ◽

Luigi Iuppariello ◽

Antonio Casaburi ◽

Pasquale Guida ◽

Fabrizio Clemente

Keyword(s):

Clinical Practice ◽

Medical Device ◽

Medical Devices ◽

Quality Standards ◽

Patient Specific ◽

Clinical Use ◽

Production Flow ◽

Medical Device Design ◽

Voluntary Standards ◽

3D Printed

AbstractThe clinical use of 3D printed patient specific orthopaedic cast is of wide interest. However, design and production have problems such as production time, which can take up to 35 h, and standardized procedure considering that there are medical devices that must comply mandatory and/or voluntary standards. Moreover, the proposed procedures do not fully consider the traceability of this innovative medical device design to comply with standards and industrial proposes. The aim of this work is to propose a semi-automatic workflow for the production of the 3D printed orthopaedic casts. The procedure is oriented towards a reduction time in different phases (as scan setting, designing technique, printing orientation) of the production flow. The workflow is compliant with recognized quality standards for the production of additive manufactured medical devices. This approach offers the possibility to introduce new 3D printed medical devices in clinical practice as well as to design an optimized industrial workflow.

Download Full-text