Surgical Safety in Canada: Detailed Analysis Report

Report.pdf

Background

Purpose

Methods

Limitations

Results

CIHI data on pan-Canadian health system performance

Resources for safe surgical care

Patient safety glossary

Medico-legal glossary

Reference

 

 

Background

In January 2014, the Canadian Patient Safety Institute (CPSI), in conjunction with key healthcare stakeholders, formed the National Patient Safety Consortium to create an Integrated Patient Safety Action Plan. The action plan identified four priority areas: safe surgical care, medication safety, home care safety, and infection

prevention and control.

A strategy to advance a national surgical care safety action plan was the focus of the March 2014 Surgical Care Safety Summit. The summit was attended by over 30 stakeholder representatives that included professional associations, provincial ministries, health authorities, quality councils, and patient safety groups. The summit

report, A Surgical Care Safety Action Plan, outlined seven themes: measurement and analysis, access to care, best practices, patient engagement, teamwork and communication, quality improvement infrastructure, and learning from surgical patient safety incidents. The action plan identified the need for a retrospective analysis of surgical incident data and the publication of these findings in a report to be circulated nationally.1

The Consortium requested that the Canadian Medical Protective Association (CMPA), which provides medical liability protection for most Canadian physicians, and the Healthcare InsuranceReciprocal of Canada (HIROC), which provides liability insurance for healthcare organizations and their employees, conduct a retrospective analysis of Canadian surgical incident data. While providing medical liability protection for different groups, the two organizations are engaged in a broad and comprehensive effort to analyze data derived from their experiences and advance learning from these cases. Indeed, the CMPA and HIROC are dedicated to using their expertise in the medico-legal domain for advancing collaborative efforts in shared learning and identifying priority areas for health system improvements......

 

Using Bundled Interventions to Reduce Surgical Site Infection After Major Gyn Cancer Surgery

abstract
 

OBJECTIVE:

To investigate whether implementing a bundle, defined as a set of evidence-based practices performed collectively, can reduce 30-day surgical site infections.

METHODS:

Baseline surgical site infection rates were determined retrospectively for cases of open uterine cancer, ovarian cancer without bowel resection, and ovarian cancer with bowel resection between January 1, 2010, and December 31, 2012, at an academic center. A perioperative bundle was prospectively implemented during the intervention period (August 1, 2013, to September 30, 2014). Prior established elements were: patient education, 4% chlorhexidine gluconate shower before surgery, antibiotic administration, 2% chlorhexidine gluconate and 70% isopropyl alcohol coverage of incisional area, and cefazolin redosing 3-4 hours after incision. New elements initiated were: sterile closing tray and staff glove change for fascia and skin closure, dressing removal at 24-48 hours, dismissal with 4% chlorhexidine gluconate, and follow-up nursing phone call. Surgical site infection rates were examined using control charts, compared between periods using χ or Fisher exact test, and validated against the American College of Surgeons National Surgical Quality Improvement Program decile ranking.

RESULTS:

The overall 30-day surgical site infection rate was 38 of 635 (6.0%) among all cases in the preintervention period, with 11 superficial (1.7%), two deep (0.3%), and 25 organ or space infections (3.9%). In the intervention period, the overall rate was 2 of 190 (1.1%), with two organ or space infections (1.1%). Overall, the relative risk reduction in surgical site infection was 82.4% (P=.01). The surgical site infection relative risk reduction was 77.6% among ovarian cancer with bowel resection, 79.3% among ovarian cancer without bowel resection, and 100% among uterine cancer. The American College of Surgeons National Surgical Quality Improvement Program decile ranking improved from the 10th decile to first decile; risk-adjusted odds ratio for surgical site infection decreased from 1.6 (95% confidence interval 1.0-2.6) to 0.6 (0.3-1.1).

CONCLUSION:

Implementation of an evidence-based surgical site infection reduction bundle was associated with substantial reductions in surgical site infection in high-risk cancer procedures.

Salpingectomy With Delayed Oophorectomy in BRCA1/2 Mutation Carriers: Estimating Ovarian Cancer Risk

abstract

OBJECTIVE:

To estimate BRCA1/2 mutation carriers' cumulative ovarian cancer risks after risk-reducing salpingectomy at various ages with delayed oophorectomy several years later compared with risk-reducing salpingo-oophorectomy.

METHODS:

A literature search was performed on cumulative ovarian cancer risks and effects of risk-reducing salpingo-oophorectomy and salpingectomy. Results were used in a modeling study to estimate cumulative ovarian cancer risks for various scenarios of salpingectomy with delayed oophorectomy and risk-reducing salpingo-oophorectomy using Cox proportional hazard models.

RESULTS:

Estimated cumulative ovarian cancer risks at age 70 years for risk-reducing salpingectomy with delayed oophorectomy are highest for BRCA1 mutation carriers undergoing surgeries at higher age. Maximum increase in point estimates (from 1.8% to 4.1%) occurs in 40-year-old BRCA1 mutation carriers undergoing oophorectomy at age 45 years after nonprotective salpingectomy instead of salpingo-oophorectomy at age 40 years. In the best-case scenario, assuming 65% risk reduction by salpingectomy and 96% by salpingo-oophorectomy, point estimates increase (from 1.8% to 2.6%) or decrease (from 3.4% to 3.3%) depending on age. In the worst-case scenario for BRCA2, point estimates maximally increase from 0.6% to 1.8% in 45-year-old carriers when oophorectomy is performed at age 50 years instead of risk-reducing salpingo-oophorectomy at age 45 years. In the best-case scenario, point estimates increase (from 1.3% to 1.5%) or decrease (from 1.5 to 1.3%).

CONCLUSION:

Differences in estimated ovarian cancer risks between risk-reducing salpingo-oophorectomy and salpingectomy with delayed oophorectomy are small, even if salpingectomy is ineffective. Presented estimated ovarian cancer risks can be used in counseling BRCA1/2 mutation carriers, thereby facilitating a personalized and well-informed choice for either strategy.

Utilization/Outcomes of Chemotherapy in Women With Intermediate-Risk, Early-Stage Ovarian Cancer

abstract:
Utilization and Outcomes of Chemotherapy in Women With Intermediate-Risk, Early-Stage Ovarian Cancer.

OBJECTIVE:

To examine utilization and efficacy of chemotherapy for stage I ovarian cancer.

METHODS:

We conducted a retrospective cohort study using the National Cancer Data Base to identify women with stage I ovarian cancer treated from 1998 to 2012. Patients were classified into three groups based on grade and stage: stage IA or IB grade 1 (low risk); stage IA or IB grade 2 (intermediate risk); and stage IA or IB grade 3 or any stage IC (high risk). Multivariable models were developed to examine predictors of chemotherapy use and survival.

RESULTS:

We identified 21,758 patients including 4,196 (19.3%) low-risk, 3,777 (17.4%) intermediate-risk, and 13,785 (63.4%) high-risk women. The median follow-up of the cohort was 63.9 months. Use of chemotherapy within the groups was 15.5%, 39.5%, and 69.8%, respectively (P<.001). Among low-risk patients, chemotherapy was not associated with a change in survival (adjusted hazard ratio [HR] 1.10, 95% confidence interval [CI] 0.85-1.42), whereas chemotherapy was associated with reduced mortality for high-risk patients (adjusted HR 0.78, 95% CI 0.71-0.85). For intermediate-risk patients (stage IA-IB grade 2), chemotherapy was associated with a 26% reduction in mortality (adjusted HR 0.74, 95% CI 0.62-0.89). The association between chemotherapy and improved survival among intermediate-risk patients remained significant when limited to patients who underwent staging lymphadenectomy (adjusted HR 0.77, 95% CI 0.62-0.97).

CONCLUSION:

There is widespread variation in the patterns of care for early-stage ovarian cancer. Chemotherapy was associated with improved survival for stage IA-IB grade 2 patients.

Mismatch Repair Deficiency in Colorectal Cancers: Is Somatic Genomic Testing the Grab-Bag for All Answers?

Editorial: full.pdf

......It is important to highlight that, currently, there is a significant knowledge and technology gap in most laboratories using MMR IHC and/or MSI testing for the assessment of MMR status versus laboratories using NGS panels across the country and globally. At present, because of the increasing numbers of clinical trials and oncology treatments that rely on companion molecular diagnostics, the implementation of genomic technology may heighten existing global health disparities instead of narrowing them.

  See accompanying (abstract) article:
 Reliable Detection of Mismatch Repair Deficiency in Colorectal Cancers Using Mutational Load in Next-Generation Sequencing Panels

 Conclusion A cutoff for mutational load can be identified via multigene NGS tumor profiling, which provides a highly accurate means of screening for MMR-D in the same assay that is used for tumor genotyping.
 

Factors Influencing Readmission after Elective Ureteroscopy

abstract- The Journal of Urology
 

Purpose

Ureteroscopy is increasingly used to manage nephrolithiasis, upper urinary tract urothelial carcinoma and other urological conditions. In this study we determine the rate of readmission and emergency department visits after ureteroscopy in an underserved population, as well as factors associated with these unplanned visits.

Materials and Methods

A retrospective chart review from 2010 to 2014 of all elective ureteroscopies was conducted at a single tertiary hospital serving an underserved population in a major metropolis. Demographic, operative and discharge characteristics were collected and analyzed.

Results

A total of 276 ureteroscopies were performed with 15.6% presenting to the emergency department within 30 days. Overall 5.8% were readmitted. Readmitted patients were more likely to have hypertension (OR 3.64, p=0.02), asthma or chronic obstructive pulmonary disease (OR 5.54, p=0.001), 2 or more comorbidities (OR 3.65, p=0.12), or a complication associated with ureteroscopy (OR 7.27, p=0.007). The patients who sought care in the emergency department after ureteroscopy were less likely to have had a ureteral stent in place before ureteroscopy (OR 0.35, p=0.017) or an endoscopic urological procedure within the last 30 days (OR 0.35, p=0.045). About two-thirds of patients who presented to the emergency department complained of pain alone, while the most common complaints for readmitted patients were fever and pain (43.8%).

Conclusions

The majority of emergency department visits after ureteroscopy were due to pain. These patients were less likely to have a preoperative ureteral stent placed or a history of recent urological procedures. Readmission rates were associated with overall comorbidities and complications.

Last Week Tonight with John Oliver (comedian): Scientific Studies (19:27 min)(HBO) - YouTube

Scientific Studies (HBO) - YouTube

Published on May 8, 2016

John Oliver discusses how and why  media outlets so often report untrue or incomplete information as science.

 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
 Visit our official site for all that other stuff at once:
http://www.hbo.com/lastweektonight

• Category

  • Entertainment

Closely Guarded Secrets

Correspondence - open access

  ....Recently the Feds had to go to great lengths (maybe to Israel) to find someone who could crack open an iPhone belonging to the San Bernardino terrorist. So it seems like some texts are pretty darn safe. Another colleague told me that her institution prohibits her from handing a patient their own laboratory or imaging results. She's supposed to send them to medical records so they can formally request it. That sounds like a lot of fun after you've just spent a few hours getting your chemotherapy....

Refusal of Recommended Chemotherapy for Ovarian Cancer: NCI (abstract)

 abstract

(open access - now restricted to subscribers)

 Release date: May 12, 2016; Expiration date: May 12, 2017

 Refusal of Recommended Chemotherapy for Ovarian Cancer: Risk Factors and Outcomes; a National Cancer Data Base Study

 A total of 147,713 patients were identified, of whom 2,707 (1.8%) refused chemotherapy.

 One encouraging finding from this study is the lack of geographic or facility distance factor on the patient refusal, suggesting that physical parameters may be less of a barrier to care for patients with ovarian cancer compared with other cancers.

Conclusions

The goal of this study was to identify patients who are at increased risk of refusing chemotherapy, a standard treatment with known efficacy in patients with ovarian cancer. Further research could focus on what therapies, if any, are received by patients who refuse chemotherapy, and the efficacy and tolerance of those treatments. Further research is also needed to identify individualized best practices for this high-risk subgroup. Consideration should be given for low-volume centers to refer patients refusing chemotherapy for second opinion at a higher-volume facility. The study results suggest that improved health care access and individualized counseling may improve care delivery, thereby providing patients with all treatment options and improved outcomes.

Clinical Application of Poly(ADP-Ribose) Polymerase Inhibitors in High-Grade Serous Ovarian Cancer

abstract

Published online before print March 28, 2016

High-grade serous ovarian cancer is characterized by genomic instability, with one half of all tumors displaying defects in the important DNA repair pathway of homologous recombination. Given the action of poly(ADP-ribose) polymerase (PARP) inhibitors in targeting tumors with deficiencies in this repair pathway by loss of BRCA1/2, ovarian tumors could be an attractive population for clinical application of this therapy. PARP inhibitors have moved into clinical practice in the past few years, with approval from the Food and Drug Administration (FDA) and European Medicines Agency (EMA) within the past 2 years. The U.S. FDA approval of olaparib applies to fourth line treatment in germline BRCA-mutant ovarian cancer, and European EMA approval to olaparib maintenance in both germline and somatic BRCA-mutant platinum-sensitive ovarian cancer. In order to widen the ovarian cancer patient population that would benefit from PARP inhibitors, predictive biomarkers based on a clear understanding of the mechanism of action are required. Additionally, a better understanding of the toxicity profile is needed if PARP inhibitors are to be used in the curative, rather than the palliative, setting.

Cytoreductive Surgery Plus Platinum-Based HIPEC in Epithelial Ovarian Cancer...

open access:
Cytoreductive Surgery Plus Platinum-Based Hyperthermic Intraperitoneal Chemotherapy in Epithelial Ovarian Cancer: A Promising Integrated Approach to Improve Locoregional Control

 First Published Online March 23, 2016

....Finally, in a recent critical appraisal [16], it was hypothesized that, as reported in colorectal cancer [38], a disappearance of the HIPEC-related survival benefits might be possible with a long-term follow-up. In this context, the results of our recently published 7-year analysis demonstrating a very favorable postrelapse survival of approximately 60 months does not support such a hypothesis [35], and our data also appear reasonable considering the relevant differences between ovarian and colorectal cancer in terms of sensitivity to cytotoxic agents.

In conclusion, because ovarian cancer remains the biggest challenge for gynecologic oncologists, it is important for the scientific community to actively investigate and fully exploit every novel promising therapeutic strategy. The addition of HIPEC to cytoreductive surgery is supported by a solid biological and clinical rationale, with preliminarily encouraging safety and survival data, particularly in patients with platinum-sensitive recurrent disease. The rigorous analysis of the results from ongoing phase III randomized clinical trials will clarify in the future whether, and how, this therapeutic approach should be introduced into routine clinical practice.

 

HIPEC in Ovarian Cancer: Where Do We Go From Here? (Opinion)

open access

 First Published Online March 23, 2016

 In the view of this commentator, the ongoing debate regarding a potential role for hyperthermic intraperitoneal chemotherapy (HIPEC) in the management of ovarian cancer represents an excellent example of the rarely publicly discussed fundamental clash between the requirements of so-called evidence-based (e.g., randomized phase III trial data) medicine versus the roles of both clinical innovation in advancing therapeutic paradigms and a focus on optimizing care for the individual patient. Furthermore, the discussion emphasizes the genuine difficulty associated with distinguishing excellent clinical judgment from selection bias in the conduct of prospective nonrandomized clinical trials or the analysis of retrospective reports of institutional experiences.
 

A Very Brief Review and Discussion of the Background of This Debate

HIPEC

The Role of Surgical Cytoreduction in Ovarian Cancer

Intraperitoneal Chemotherapy in the Management of Ovarian Cancer

Conclusion

 

 

566 New Drugs in Pipeline for Orphan Diseases (25 matches ovarian cancer)

medicines-in-development-drug-list-rare-diseases.pdf


May 9th, 2016
 
A report by an industry group says 566 drugs designed to treat rare diseases are now in clinical testing by pharmaceutical companies. The report, prepared by Pharmaceutical Research and Manufacturers of America, or PhRMA, and the ALS Association, credits many of these new drugs to incentives in legislation encouraging research and development on treatments for rare diseases.
These 7,000 rare disorders, also known as orphan diseases, each affect less than 200,000 individuals in the U.S. But taken together, says the report, orphan diseases affect about 30 million, or 1 in 10, Americans. Because of the small numbers — sometimes just a few hundred people — affected by each disease, diagnostics and development of new drugs are difficult. Few clinicians have experience with these diseases, and the biological pathways for treating the disorders are often complicated. In addition, the small numbers of potential patients make it difficult to recruit participants for clinical trials.....

Life insurance companies deny coverage to those with cancer genes like BRCA (U.S.) Genetic Literacy Project

Genetic Literacy Project

 
....Studies do show people are more likely to apply for long term care and life insurance after genetic testing reveals that they carry disease risk genes. Boston-based geneticist Robert Green found that people who found out they have the Alzheimers-related  APOE gene variant are five times more likely to purchase long-term care insurance. That could sway the pool of potential insurance purchasers to be a sicker lot, and undermine how insurers balance their pools with more healthy participants who rarely make a claim in order to stay profitable.  Green writes in the New England Journal of Medicine:

Thus far, we have collectively decided that it is inequitable to discriminate against employees or in the pricing of health insurance but more acceptable to discriminate for products such as life, disability, and long-term care insurance. In defending the right to such discriminatory underwriting, insurers have claimed that if applicants have relevant information that isn’t available to insurers, such as robust genetic risk information, low-risk consumers will drop out of the mix and higher-risk consumers will disproportionately purchase coverage, forcing companies to raise prices and causing a “death spiral” of adverse selection.....

Lynch syndrome, Muir Torre variant: 2 cases (Peru)

abstract

Lynch syndrome (LS) is an autosomal-dominant inherited cancer predisposition syndrome caused by germline mutations in DNA mismatch repair genes (MLH1, MSH2, MSH6 or PMS2). Muir-Torre syndrome (MTS) is a phenotypic variant of LS that includes a predisposition to sebaceous glands tumors and keratoacanthomas. We report two patients with MTS, with more than one LS-related cancer, skin lesions, family history of cancer and microsatellite instability and immunohistochemistry analysis.

Nine years of censorship : Canadian scientists/prior federal government

Nine years of censorship

 It could take years for Canadian scientists to recover from heavy funding cuts, low morale and tight control over communication. Looking back over what happened, Macdonald [a biogeochemical oceanographer] remembers something his grandmother once told him. “It takes ten years to make a good garden, but you can wreck it in six months,” he says. “It’s like that with science.”

A case of mesothelioma masquerading pre-operatively as ovarian cancer/brief review of the literature

open access

Highlights

•

Malignant peritoneal mesothelioma can masquerade as ovarian epithelial neoplasm.

•

Due to similar presenting clinical symptoms, differential diagnosis can be difficult.

•

The key to differentiating between these two diagnoses lies in tissue pathology.

•

Family, social, and occupational exposure histories are crucial if suspected ovarian malignancy

•

Importance of considering broad differential when ovarian malignancy is suspected.

Quantitative evaluation of an information leaflet to increase prompt help-seeking for gyn cancer symptoms

(UK) Quantitative evaluation of an information leaflet to increase prompt help-seeking for gynaecological cancer symptoms | BMC Public Health | Full Text

 Due to the progressive nature of cancer, much effort has been put into understanding what contributes to a shorter patient interval – the time taken for an individual to notice and interpret a new symptom as worthy of medical attention and to seek medical advice [8]. Shorter patient intervals could lead to earlier-stage diagnoses and improved survival [9, 10]. Studies of women’s levels of awareness of gynaecological cancer symptoms show that free recall of symptoms is low and, although prompted recognition is higher, most women still do not recognise all symptoms [11, 12, 13]. Furthermore some symptoms (e.g., abdominal pain) are well-recognised by women as important, while others (e.g., feeling full quickly and difficulty eating) are less well-known as possible symptoms of ovarian cancer [12]. When women experience these symptoms, they typically attribute them to benign causes rather than cancer [14], and may not seek a medical opinion promptly.

Conclusions

When developing written information aimed at changing behaviour, it is essential to carry out thorough testing in the target population to demonstrate the impact of the intervention on behavioural intention, and to understand the mechanism for that impact. This study shows that useful information can be gathered through the under-used step of quantitative evaluation of a leaflet and as such indicates a method through which more effective patient information documents could be created. Improving rates of early diagnosis of cancer in the UK depends, in part, on ensuring the patient interval is kept as brief as possible. This study has shown that, as a minimum, intentions to seek help for gynaecological cancer symptoms can be improved through information leaflets which also address barriers to help-seeking and provide a tool with which the woman can approach her GP.

Efforts should now be focussed on trialling the leaflet in primary care settings and assessing its impact on help-seeking behaviours in the real world.

Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer | BMC Cancer | Full Text

open access:
(Canada) Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer | BMC Cancer | Full Text

BMC Cancer 2016 16:291

Published on: 25 April 2016

 

Participant recruitment

We are recruiting 144 BC or GC survivors from four hospital sites: Princess Margaret Hospital and Mount Sinai Hospital in Toronto, Ontario, the Ottawa Hospital in Ottawa, Ontario, and the Jewish General Hospital in Montreal, Quebec.

 Trial registration

Dr. Christine Maheu registered the trial with ISRCTN registry (Registration number: ISRCTN83539618, date assigned 03/09/2014).

Condition category

Cancer

Date applied

31/07/2014

Date assigned

03/09/2014

Last edited

27/04/2016

Prospective/Retrospective

Prospectively registered

Overall trial status

Ongoing

Recruitment status

Recruiting

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Canadian Cancer Society grant # 702985

 

Background

Clinically significant levels of fear of cancer recurrence (FCR) affect up to 49 % of cancer survivors and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased use of medical resources. Despite its prevalence, FCR is poorly addressed in clinical care. To address this problem, we first developed, and pilot tested a 6-week, 2 h, Cognitive-existential group intervention therapy that targeted FCR in survivors of breast or gynecological cancer. Following the positive outcome of the pilot, we are now testing this approach in a randomized clinical trial (RCT).

Goal and hypotheses: This multicenter, prospective RCT aims to test the efficacy of the intervention. The study hypotheses are that, compared to a control group, cancer survivors participating in the intervention (1) will have less FCR, (2) will show more favorable outcomes on the following measures: cancer-specific distress, quality of life, illness uncertainty, intolerance of uncertainty, perceived risk of cancer recurrence, and coping skills. We further postulate that the between-group differences will persist three and 6 months post-intervention.

Methods Sixteen groups of seven to nine women are being allocated to the intervention or the control group. The control group receives a 6-week, 2 h, structurally equivalent support group. We are recruiting 144 cancer survivors from four hospital sites in three Canadian cities. The sample size was based on the moderate pre/post-test changes found in our pilot study and adjusted to the drop-out rates.  

Measurements: The primary outcome, FCR, is measured by the Fear of Cancer Recurrence Inventory. Secondary outcomes measured include cancer-specific distress, perceived risk of cancer recurrence, illness uncertainty, intolerance of uncertainty, coping, and quality of life. We use reliable and recognized valid scales. Participants are to complete the questionnaire package at four times: before the first group session (baseline), immediately after the sixth session, and 3 and 6 months post-intervention. Analysis: In the descriptive analysis, comparison of group equivalent baseline variables, identification of confounding/intermediate variables and univariate analysis are planned. Each participant’s trajectory is calculated using Generalized Estimating Equation models to determine the time and group effects, after considering the correlation structures of the groups. An intent-to-treat analysis approach may be adopted.

Discussion Our Fear of Recurrence Therapy (FORT) intervention has direct implications for clinical service development to improve the quality of life for patients with breast (BC) and gynecological cancer (GC). Based on our pilot data, we are confident that the FORT intervention can guide the development of effective psychosocial cancer survivorship interventions to reduce FCR and improve psychological functioning among women with BC or GC.

Trial registration

Dr. Christine Maheu registered the trial with ISRCTN registry (Registration number: ISRCTN83539618, date assigned 03/09/2014).

Oral versus transdermal estrogens and VT postmenopausal women: what is new since 2003?

Editorial (partial view 1st page (w/o subscription $$)

My Mom (as a young girl)

AUA2016: Characterization of upper tract urothelial carcinoma in patients with clinical suspicion of Lynch syndrome

AUA2016 Annual Meeting

 Saturday, May 7, 2016 8:00 AM-10:00 AM
SDCC: Room 30DE

Bladder Cancer: Upper Tract Transitional Cell Carcinoma I
Funding: None

PD13-07: Characterization of upper tract urothelial carcinoma in patients with clinical suspicion of Lynch syndrome
  Abstract: PD13-07
 
Introduction and Objectives
Lynch syndrome (LS) is the only known hereditary cancer syndrome associated with upper tract urothelial carcinoma (UTUC). Patients with LS have a reported 14-fold increase in relative risk of developing UTUC compared to the general population. The prevalence and clinical implications of potential hereditary UTUC are not well understood due to the rarity of this clinical entity and the lack of awareness among urologists. The goal of this study was to evaluate the prevalence and outcome of UTUC in patients with LS-associated cancers.

Methods
We analyzed UTUC cases (primary site codes C65.9 and 66.9 with transition cell carcinoma histology) in the Surveillance, Epidemiology, and End Results (SEER-17) database. LS-associated cancers were identified in patients with UTUC. Based on the revised Bethesda Guidelines for Lynch Syndrome, LS-associated cancers include colorectal, endometrial/uterine, gastric, ovarian, small bowel, glioblastoma, sebaceous adenocarcinoma, biliary tract, and pancreatic cancers. UTUC-specific survival was compared between patients with UTUC alone and those with LS-associated cancers.

Results
Between 1973 and 2011, 26,819 cases of UTUC were reported in SEER. A total of 1731 (6.4%) of cases of UTUC also had at least one LS-associated cancer. Colorectal, uterine, and ovarian cancers were the most prevalent LS-associated cancers, accounting for 4.3%, 2.2%, and 0.7% of UTUC cases respectively. Compared to UTUC-only cases, those with LS-associated cancers have higher UTUC-specific survival when controlled for disease stage and age of diagnosis (p<0.0001).

Conclusions
The risk of developing UTUC in LS may be underappreciated. Patients with potential hereditary UTUC may have a different clinical course and survival outcomes compared to those with UTUC without LS-associated cancers. Further study and genetic evaluation are warranted.

Date & Time: May 7, 2016 8:00 AM-10:00 AM
Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma I
Sources of Funding: None

AUA2016 Annual Meeting - abstracts

AUA2016 Annual Meeting

AUA2016 Annual Meeting - search results 'ureter' (keyword search)

AUA2016 abstracts

You searched for "ureter" .
The following 308 abstracts matched your keyword search

AUA: Treatment of severe radiation-induced ureteral strictures to be debated

AUA Daily News (conference)

Oophorectomy Linked To Increased Risk of Colon Cancer

MedicalResearch (interview - text - Dr. Segelman)


MedicalResearch.com: What should readers take away from your report?

Dr. Segelman: Reduced endogenous estrogen and androgen levels may be involved in the increased risk of colorectal cancer seen after oophorectomy in the current study. The findings highlights that prophylactic resection of normal ovaries should be reserved for women with a clear indication, such as a hereditary increased risk of ovarian cancer. Possible negative side-effects of the procedure should always be taken into account and discussed with the women preoperatively.


Citation:
Br J Surg. 2016 Apr 26. doi: 10.1002/bjs.10143. [Epub ahead of print]
Population-based analysis of colorectal cancer risk after oophorectomy.
Segelman J¹, Lindström L¹, Frisell J¹, Lu Y^1,2.

P value: definition of p value by Medical dictionary

definition

 p value

Also found in: Dictionary, Thesaurus, Legal, Financial, Encyclopedia, Wikipedia.
Related to p value: confidence interval

value

 [val´u]

1. a measure of worth or efficiency.

2. a quantitative measurement of the activity, concentration, or some other quality of something.

3. an operational belief; an ideal, custom, institution of a society toward which the members of the group have an affective regard; any object or quality desirable as a means or as an end in itself. In exchange theory, the benefits received through an exchange minus the price paid in return.

biological value the quality of a protein expressed on a scale of 1 to 100; the higher the number the better the quality.

cultural v's prevailing and persistent guides influencing the thinking and action of members of a cultural group. Values direct one's perceptions of others and serve as the basis for a person's opinions. Individuals belonging to groups with different cultural values may clash on health and illness behavior.

normal v's the range in concentration of specific substances found in normal healthy tissues, secretions, and so on.

P value (p value) the probability of obtaining by chance a result at least as extreme as that observed, even when the null hypothesis is true and no real difference exists; when P &lt; 0.05 the sample results are usually deemed significant at a statistically important level and the null hypothesis rejected. See also Type I error.

reference v's a set of values of a quantity measured in the clinical laboratory that characterize a specified population in a defined state of health. The values obtained from a statistical sample are used to establish a reference interval that covers 95 per cent of the values of the healthy general population or of specific subpopulations differing in age and sex. These concepts were originally and are still widely referred to as “normal values” and the “normal range,” but the use of these terms is now discouraged because of their implication that values falling outside of the reference interval are “abnormal” or “unhealthy,” which has led to much confusion. It must be remembered that, by definition, 5 per cent of healthy individuals fall outside of the reference interval.

Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. © 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved.

P value

(in research) the statistical probability of the occurrence of a given finding by chance alone in comparison with the known distribution of possible findings, considering the kinds of data, the technique of analysis, and the number of observations. The P value may be noted as a decimal: P <.01 means that the likelihood that the phenomena tested occurred by chance alone is less than 1%. The lower the P value, the less likely the finding would occur by chance alone.

Mosby's Medical Dictionary, 9th edition. © 2009, Elsevier.

p value

The probability that a finding has occurred randomly rather than as a result of a treatment or other intervention. In a research study that compares a treated group of patients with a control group exposed only to a placebo, investigators may find that the treated population experienced benefits or suffered more side effects than the controls. Was the observed effect real, or did it occur by chance? The p value of the study helps researchers tell the difference. A p value of 0.5 suggests that there is a 50-50 chance that the findings of the study are significant. A p value of 0.05 (the value customarily used to suggest that research results are statistically significant) means that there is a 5% chance that the results of the study occurred by chance alone. The lower the value, the greater the degree of confidence in the findings: a p value of 0.01, for example, creates more confidence than a p value of 0.05.

Medical Dictionary, © 2009 Farlex and Partners

significance 

In statistics, an indication that the results of an investigation on a population (e.g. patients) differ from those of another population (e.g. general) by an amount that could not happen by chance alone. This is evaluated by establishing a significance level, that is the probability, called p value, which leads us to reject or accept the null hypothesis H_o (there is no significant difference between two populations and the difference is attributed to chance) and accept or reject the alternative hypothesis H₁ that there is a statistically significant difference between two populations. A p value p < 0.05 is often considered significant, but the lower this figure, the stronger the evidence. See randomized controlled trial.

Millodot: Dictionary of Optometry and Visual Science, 7th edition. © 2009 Butterworth-Heinemann

Statistical controversies in clinical research: statistical significance—too much of a good thing …

open access

problems with statistical significance

Fisher's caveats notwithstanding, P values have become an obsession in clinical research, with the magic ‘P < 0.05’ seemingly dominating all other considerations, at least in the regulatory context of granting new therapeutics market authorization. We argue here that P values per se are not the problem, but rather an excessive reliance on P values to dichotomize reality between ‘no treatment effect’ and ‘some treatment effect’. The P value is the probability of observing data as extreme as the data observed in the absence of any real treatment effect. The P value is often misunderstood or abused, in particular to make exaggerated claims about an effect of interest [5]....

 statistical significance going forward
In randomized clinical trials, prespecified criteria to gauge statistical significance should not be so broad as to be fuzzy, nor so strict as to be silly. Going forward, the proper use of statistical significance may well be just as Fisher intended it, as a pragmatic guide to inform evaluation rather than as a strict binary boundary that separates real treatment effects from lack thereof.....

Happy Mother's Day

Superficial coverage of medical errors could leave erroneous impression with readers

HealthNewsReview.org

 

Is aspirin use associated with a decreased risk of ovarian cancer?

abstract 
Is aspirin use associated with a decreased risk of ovarian cancer? A systematic review and meta-analysis of observational studies with dose-response analysis.

OBJECTIVE:

Currently available epidemiologic evidences concerning the chemopreventive effect of aspirin on ovarian cancer are inconsistent. Therefore, we aimed to further explore the association by synthesizing evidence from population-based studies.

METHODS:

We searched PubMed, EMBASE, Web of Science, and Scopus using key words and controlled vocabularies. Title/abstract screening, full-text review, data extraction, and quality assessment were performed independently by reviewers, and a random-effects model was utilized for meta-analysis. Subgroup analysis was conducted based on study locale, and sensitivity analysis was performed by synthesizing studies that adjusted for certain covariates or studies with good quality. Dose-response relation was assessed by a two-stage linear dose-response model. Statistical heterogeneity was evaluated by the I-squared value and a chi-squared test for the Cochrane Q statistic.

RESULTS:

We identified 8 cohort studies and 15 case-control studies......

CONCLUSION:

In summary, our study suggests that aspirin can reduce the risk of ovarian cancer. In addition, we observed a possible dose-response relation between frequency of use and ovarian cancer risk, but further studies are needed to examine this association.

Evaluation of ACMG-Guideline-Based Variant Classification of Cancer Susceptibility and Non-Cancer-Associated Genes in Families Affected by Breast Cancer

abstract
Evaluation of ACMG-Guideline-Based Variant Classification of Cancer Susceptibility and Non-Cancer-Associated Genes in Families Affected by Breast Cancer
 Author information

Abstract

Sequencing tests assaying panels of genes or whole exomes are widely available for cancer risk evaluation. However, methods for classification of variants resulting from this testing are not well studied. We evaluated the ability of a variant-classification methodology based on American College of Medical Genetics and Genomics (ACMG) guidelines to define the rate of mutations and variants of uncertain significance (VUS) in 180 medically relevant genes, including all ACMG-designated reportable cancer and non-cancer-associated genes, in individuals who met guidelines for hereditary cancer risk evaluation. We performed whole-exome sequencing in 404 individuals in 253 families and classified 1,640 variants. Potentially clinically actionable (likely pathogenic [LP] or pathogenic [P]) versus nonactionable (VUS, likely benign, or benign) calls were 95% concordant with locus-specific databases and Clinvar. LP or P mutations were identified in 12 of 25 breast cancer susceptibility genes in 26 families without identified BRCA1/2 mutations (11%). Evaluation of 84 additional genes associated with autosomal-dominant cancer susceptibility identified LP or P mutations in only two additional families (0.8%). However, individuals from 10 of 253 families (3.9%) had incidental LP or P mutations in 32 non-cancer-associated genes, and 9% of individuals were monoallelic carriers of a rare LP or P mutation in 39 genes associated with autosomal-recessive cancer susceptibility. Furthermore, 95% of individuals had at least one VUS. In summary, these data support the clinical utility of ACMG variant-classification guidelines. Additionally, evaluation of extended panels of cancer-associated genes in breast/ovarian cancer families leads to only an incremental clinical benefit but substantially increases the complexity of the results.
2016 The American Society of Human Genetics

MEK Inhibitor (binimetinib) Misses Mark in Phase III Ovarian Cancer Study

MEK Inhibitor 

About that Johns Hopkins study on medical errors (podcast)

MedCity News

 Frank Federico, a vice president at the Institute for Healthcare Improvement — the Cambridge, Massachusetts-based organization founded by Dr. Donald M. Berwick — has plenty of thoughts on this study and those questions. He shares them in this podcast.

World Ovarian Cancer Day - May 8th, 2016

World Ovarian Cancer Day

 

A long-term surviving patient with recurrent low-grade serous ovarian carcinoma treated with the MEK1/2 inhibitor, selumetinib

A long-term surviving patient with recurrent low-grade serous ovarian carcinoma treated with the MEK1/2 inhibitor, selumetinib | Gynecologic Oncology Research and Practice | Full Text

Case Presentation

In this case report, we present a patient with recurrent LGSOC with KRAS mutation whose tumor has not progressed and who has maintained a good general condition without severe toxicities following treatment with selumetinib for more than 7 years. Next generation sequencing of her tumor revealed a G12V mutation in KRAS. MAPK signaling inhibition plays a role in the biology of LGSOC.

Ovarian cancer and talc: Did junk science cost Johnson (media)

media

Molecular status of PI3KCA, KRAS and BRAF in ovarian clear cell carcinoma: an analysis of 63 patients

abstract:Journal of Clinical Pathology

Aims To evaluate the incidence of PI3KCA, KRAS and BRAF mutations in primary ovarian clear cell carcinoma (OCCC).

Methods 63 consecutive patients, with a proven diagnosis of OCCC, according to WHO criteria, were included into the study. Pyrosequencing analysis of all three genes hotspot regions were performed on 2.5 µm sections of formalin-fixed paraffin-embedded tissue from primary OCCC.

Results PI3KCA mutations were found in 20/63 (32%) cases; KRAS mutations were found in 8/63 (13%); no BRAF V600 mutations were found. In particular, 12/20 mutations (60%) of PI3KCA were found in the exon 20, whereas the remaining eight cases presented mutations in exon 9 (8/20; 40%). KRAS pyrosequencing analysis revealed higher incidence of codon 12 mutations (7/8; 90%) than codon 13 mutations (1/8; 10%). In five cases (5/66; 8%), synchronous mutations, affecting PI3KCA and KRAS genes, were found. No differences were found in the distribution of hotspot mutations, according to the stage.

Conclusions The high frequency of PI3KCA mutations, the low rate of mutations in KRAS and the absence of mutations in BRAF, indicate a molecular signature of OCCCs different from other ovarian carcinomas. Detection of driver mutations, such as PI3KCA and KRAS, may be the basis for a targeted therapy, although the clinical and therapeutic implications of these findings have to be supported by further studies.

 

Detecting Ovarian Cancer: Study Suggests a Role for CA 125 - May 05, 2016

Markman (Opinion)

 Hello. I'm Dr Maurie Markman from Cancer Treatment Centers of America in Philadelphia. I want to briefly discuss a very interesting paper,^[1] that appeared recently in the Lancet, entitled "Ovarian Cancer Screening and Mortality in the UK Collaborative Trial of Ovarian Screening (UKCTOCS): A Randomized Controlled Trial."...

Japan Society of Gynecologic Oncology guidelines 2015 for the treatment of ovarian cancer including primary peritoneal cancer and fallopian tube cancer

abstractJapan Society of Gynecologic Oncology guidelines 2015 for the treatment of ovarian cancer including primary peritoneal cancer and fallopian tube cancer
 

The fourth edition of the Japan Society of Gynecologic Oncology guidelines for the treatment of ovarian cancer including primary peritoneal cancer and fallopian tube cancer was published in 2015. The guidelines contain seven chapters and six flow charts. The major changes in this new edition are as follows—(1) the format has been changed from reviews to clinical questions (CQ), and the guidelines for optimal clinical practice in Japan are now shown as 41 CQs and answers; (2) the ‘flow charts’ have been improved and placed near the beginning of the guidelines; (3) the ‘basic points’, including tumor staging, histological classification, surgical procedures, chemotherapy, and palliative care, are described before the chapter; (4) the FIGO surgical staging of ovarian cancer, fallopian tube cancer, and primary peritoneal cancer was revised in 2014 and the guideline has been revised accordingly to take the updated version of this classification into account; (5) the procedures for examination and management of hereditary breast and ovarian cancer are described; (6) information on molecular targeting therapy has been added; (7) guidelines for the treatment of recurrent cancer based on tumor markers alone are described, as well as guidelines for providing hormone replacement therapy after treatment.