scholarly journals Evidence Based Perioperative Management —Importance of Clinical Trial on Surgery—

2017 ◽  
Vol 78 (7) ◽  
pp. 1433-1440
Keyword(s):  
Clinical Trial ◽  
Perioperative Management ◽  
Evidence Based

Craniectomy with microvascular flap reconstruction in a patient taking infliximab for vasculitis

2020 ◽  
Vol 13 (12) ◽  
pp. e238614
Author(s):  
Ogonna N Nnamani Silva ◽  
Audrey B Nguyen ◽  
William Y Hoffman
Keyword(s):  
Diabetes Mellitus ◽  
Latissimus Dorsi ◽  
Perioperative Management ◽  
Large Cell ◽  
Evidence Based ◽  
Flap Reconstruction ◽  
Biologic Drugs ◽  
Temporal Arteries ◽  
Immune Mediated ◽  
Microvascular Flap

For patients whose vasculitis is managed with biologic medications, no reports or evidence-based guidance exists regarding the perioperative management of microvascular flaps. We present a case of a 78-year-old patient with Takayasu’s arteritis (TA) and diabetes mellitus who was taking infliximab and underwent wide local excision of squamous cell carcinoma, craniectomy and reconstruction with a latissimus dorsi flap. TA, an immune-mediated large cell vasculitis characterised by granuloma formation, tends to affect larger vessels and aortic branches. The typical localisation of this condition raises concerns about potentially compromised pedicle and recipient vessels (ie, superficial temporal arteries), which could hinder postoperative flap success. Discontinuation of infliximab 4 weeks before surgery and resumption 6 weeks after led to favourable results. This case addresses the gap in the literature concerning stopping and restarting biologic drugs in the perioperative setting and documents a successful course of a microvascular procedure in a patient with vasculitis.

Perioperative management of acetabular and pelvic fractures: evidence-based recommendations

2021 ◽  
Author(s):  
Ramakanth R. Yakkanti ◽  
Neil V. Mohile ◽  
Wayne B. Cohen-Levy ◽  
Sagie Haziza ◽  
Matthew J. Lavelle ◽  
...  
Keyword(s):  
Perioperative Management ◽  
Pelvic Fractures ◽  
Evidence Based

scholarly journals Elements of a clinical trial protocol for medical devices

2017 ◽  
Vol 7 (6) ◽  
pp. 65
Author(s):  
Raymond P. Briggs ◽  
Lois Ramer
Keyword(s):  
Clinical Trial ◽  
Medical Device ◽  
De Novo ◽  
Evidence Based ◽  
Trial Protocol ◽  
Risk Class ◽  
Clinical Trial Protocol ◽  
Fda Approval ◽  
Near Future

Based on a Class 2 limited risk hospital based clinical trial, and a subsequent project retrospective, Briggs and Ramer propose an expanded clinical trial protocol.  Such an expanded protocol would be especially helpful for evaluating De Novo devices:  new inventions which require new processes for full hospital integration.  Since these new processes would often require training of nurses and supporting professionals, Briggs and Ramer suggest that nurse investigators could be very effective in carrying out such expanded protocol studies.  We briefly describe the FDA approval process, the role of the nurse in evidence based medical device evaluation, the Ramer, et al. clinical trial, the proposed expanded clinical trial protocol, and candidate categories of devices that might employ the limited risk Class 2 Medical Device clinical trial protocol.  The investigators look forward to carrying out such a medical device clinical trial in the near future.

scholarly journals The Effect of Patient Navigators on Health-Related Quality of Life in Sickle Cell Anemia: The SHIP-HU Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2168-2168
Author(s):  
Wally R Smith ◽  
Donna k McClish ◽  
Shirley Johnson ◽  
Richard Lottenberg ◽  
India Sisler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sickle Cell ◽  
Evidence Based ◽  
Health Related Quality ◽  
Patient Navigators ◽  
Related Quality ◽  
Health Related ◽  
Pain Crisis

Background: Hydroxyurea (HU) therapy in sickle cell anemia (SCA) improves health care utilization, slows organ failure, and prolongs life. Implementation of evidence-based, comprehensive care has been shown to improve health-related quality of life (HRQOL). Case management by community health workers (CHWs) is an evidence-based health management strategy. We therefore hypothesized that HU-eligible SCA adults exposed to patient navigators (PN), CHWs specially trained as case managers for SCA, would have improved HRQOL compared with controls. Methods: We enrolled 224 patients eligible for HU into the Start Healing in Patients with Hydroxyurea (SHIP-HU) Randomized Controlled Trial. All patients received care from trained physicians who implemented use of a standardized HU prescribing protocol using NIH guidelines. Pateints were randomized to either PN intervention (which included case management and education through home, telephone, and/or other visits from PNs) plus standard care by their treating physician (Experimental, E), or standard care by their physician alone (Control, C). Study physicians were blinded to study arm. At baseline, 6 and 12 months we assessed 4 psychosocial HRQOL variables-- ASCQ-Me emotional impact (EMOT), social impact (SOCI), PROMIS global mental (GMENT) and satisfaction with social roles (ROLE); 6 Physical HRQOL variables-- ASCQ-Me Sleep impact (SLEP) and Stiffness (STIFF), PROMIS global physical (GPHYS), Physical health (PHYS), Fatigue (FATG), and sleep/Wake disturbance (WAKE), and 4 pain HRQOL variables-- PROMIS pain behavior (PAINB), and ASCQ-ME-Pain crisis frequency (PAINF), Pain crisis severity (PAINS), and Pain impact (PAIN). Main analyses consisted of mixed model analysis of variance of follow-up visits, controlling for site and baseline value of outcome variable. Any missing baseline values for subjects were imputed. Results: 181 of 224 randomized patients had at least one HRQOL measure at follow-up. Patients had mean age 30.3, 45.3% were male, 81.2% were on HU at baseline. No HRQOL measures were different between groups E and C in any domain (Table, variables grouped by domain). Conclusions: In our sample, there were no differences in HRQOL among patients who were exposed to PNs vs those who weren't. These findings require further analyes before firm conclusions can be made about the isolated effect of PNs on HRQOL. PN dose of intervention was likely variable. HU use and adherence has been associated with higher HRQOL, and we did not predict high baseline HU uptake and adherence which may have led to minimal improvement despite adequate PN intervention. PNs were not allowed to work with MDs, nor did they work with the remainder of the health care team to improve HRQOL. Analyses are underway to examine these and other possible influences on HRQOL. Table. Disclosures Smith: Novartis: Consultancy, Honoraria. Villella:Emmaus: Membership on an entity's Board of Directors or advisory committees; Pfizer: Other: Site PI for the Rivipansel Clinical Trial. Liles:Novartis: Other: PI on clinical trial Sickle cell ; Shire: Other: PI on clinical trial Sickle cell ; Imara: Other: PI on Clinical trial- Sickle cell .

The future of clinical trials

2010 ◽  
pp. 45-47
Author(s):  
Perry Nisen ◽  
Patrick Vallance
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Alternative Medicine ◽  
20Th Century ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
Scientific Evaluation ◽  
New Treatments ◽  
Based Medicine ◽  
Short Section

Clinical trials are the bedrock of evidence-based medicine. Introduced in the mid 20th century, they heralded a move away from opinion and anecdote to a more scientific evaluation of new treatments. Indeed, it could be argued that it is the clinical trial and the application of scientific method to determine which treatments work that distinguishes ‘medicine’ from ‘alternative medicine’. The aim of this short section is to outline the way in which clinical trials are likely to evolve over the next few years....

scholarly journals Indications for hyperthermic intraperitoneal chemotherapy with cytoreductive surgery: a clinical practice guideline

2020 ◽  
Vol 27 (3) ◽  
Author(s):  
R.C. Auer ◽  
D. Sivajohanathan ◽  
J. Biagi ◽  
J. Conner ◽  
E. Kennedy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peritoneal Carcinomatosis ◽  
Standard Of Care ◽  
Evidence Based ◽  
Research Protocol ◽  
Newly Diagnosed ◽  
Insufficient Evidence ◽  
Peritoneal Carcinoma ◽  
Ongoing Research ◽  
Primary Peritoneal Carcinoma

ObjectiveThe purpose of this present review was to provide evidence-based guidance regarding the provision of CRS with HIPEC in the treatment of peritoneal cancers. MethodsThe guideline was developed by Cancer Care Ontario’s Program in Evidence-Based Care, together with the Surgical Oncology Program, through a systematic review of relevant literature, patient and caregiver-specific consultation and internal and external reviews. Recommendation 1aFor patients with newly diagnosed, primary stage III epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, HIPEC should be considered for those with at least stable disease following neoadjuvant chemotherapy at the time of interval CRS if complete or optimal cytoreduction is achieved. Recommendation 1bThere is insufficient evidence to recommend the addition of HIPEC when primary CRS is performed for patients with newly diagnosed, primary advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma outside of a clinical trial. Recommendation 2There is insufficient evidence to recommend HIPEC with CRS in patients with recurrent ovarian cancer outside the context of a clinical trial. Recommendation 3There is insufficient evidence to recommend HIPEC with CRS in patients with peritoneal colorectal carcinomatosis outside of a clinical trial. Recommendation 4There is insufficient evidence to recommend HIPEC with CRS for the prevention of peritoneal carcinomatosis in CRC outside of a clinical trial; however HIPEC using oxaliplatin is not recommended.Recommendation 5There is insufficient evidence to recommend HIPEC with CRS for the treatment of gastric peritoneal carcinomatosis outside of a clinical trial. Recommendation 6There is insufficient evidence to recommend HIPEC with CRS for the prevention of gastric peritoneal carcinomatosis outside of a clinical trial. Recommendation 7There is insufficient evidence to recommend HIPEC with CRS in patients with malignant peritoneal mesothelioma as a standard of care; however, patients should be referred to HIPEC specialty centres for assessment for treatment as part of an ongoing research protocol. Recommendation 8There is insufficient evidence to recommend HIPEC with CRS in patients with disseminated mucinous neoplasm in the appendix as a standard of care; however, patients should be referred to HIPEC specialty centres for assessment for treatment as part of an ongoing research protocol.

Sign in / Sign up

Export Citation Format

Share Document