Does receiving high or low breast cancer risk estimates produce a reduction in subsequent breast cancer screening attendance? Cohort study

Risk-stratified breast cancer screening may improve the balance of screening benefits to harms.We assess a potential new harm: reduced screening attendance in women receiving below average-risk (false reassurance) or higher-risk results (screening avoidance). Following initial screening, 26,668 women in the PROCAS study received breast cancer risk estimates, with attendance recorded for two subsequent screening rounds. First-screen attendance was slightly reduced in below-average (85.6%) but not higher-risk women, compared to other women (86.4%). Second-screen attendance increased for women at higher-risk (89.2%) but not below-average, compared to other women (78.8%). Concerns about this potential harm of risk-stratified screening therefore appear unfounded.     

Does frailty predict increased risk of falls and fractures? A prospective population-based study

Summary

A frailty concept that includes psychological and cognitive markers was prospectively shown to be associated with increased risk of multiple falls and fractures among 1,509 community dwelling older adults, especially in those aged 75 and over. The predictive ability of frailty is not superior to falls history.

Introduction

The concept of frailty has been defined with or without psychological and cognitive markers. Falls are associated with multiple risk factors, including cognitive and mood disorders. The purpose of this study was to investigate the association of a comprehensive concept of frailty and its components with falls and fractures in community-dwelling older adults and to compare its predictive ability with having a history of falls.

Methods

One thousand five hundred nine participants in the Longitudinal Aging Study Amsterdam aged ≥65 were assessed to determine fall history and the prevalence of nine frailty markers, including cognitive and psychological factors. The number of falls and time to second fall were prospectively registered for 1 year. Fractures were registered for 6 years.

Results

Frailty was significantly associated with time to second fall: hazard ratio of 1.53 [95 % confidence interval (CI), 1.07–2.18] and area under the receiver operating characteristic curve (AUC) of 0.58 (CI, 0.53–0.62). In participants aged ≥75, frailty was associated with ≥2 falls: odds ratio (OR) of 1.74 (CI, 1.19–2.55) and AUC of 0.62 (CI, 0.55–0.68). Frailty, adjusted for age and sex, was significantly associated with ≥2 fractures: OR of 3.67 (CI, 1.47–9.15). The AUCs for falls history (aged ≥75) ranged from 0.62 (CI, 0.58–0.67) for ≥1 falls to 0.67 (CI, 0.59–0.74) for ≥3 falls.

Conclusions

A concept of frailty including psychological and cognitive markers is associated with both multiple falls and fractures. However, frailty is not superior to falls history for the selection of old persons at increased risk of recurrent falls.     

Does use of a colonoscopy imaging device improve performance? A cohort study

Background

Magnetic endoscopic imagers (MEIs) are being introduced during colonoscopy, principally for training. They aid recognition and resolution of loops. This has potential to improve technique resulting in increased completion rates and better patients?? experience.

Objective

To determine whether the use of a MEI improves colonoscopists?? performance.

Design

Cohort study.

Settings

Endoscopy unit in a district general hospital.

Patients

Consecutive patients undergoing colonoscopy during a 33?month period were studied.

Intervention

Patients underwent colonoscopy with or without the use of a magnetic endoscopic imager.

Main outcome measures

Patient comfort and colonoscopy completion rates with and without the use of a magnetic endoscopic imager. Other data recorded included sedation and analgesia doses, patient age and gender, bowel preparation quality, antispasmodic dose, time of day, and consciousness level.

Results

A total of 5,879 colonoscopies were performed. A magnetic endoscopic imager was used for 4,873. A greater proportion of patients in the imager group had the lowest discomfort score (56.2 vs. 39.8?%, logistic regression; p?=?0.005). Doses of midazolam were similar in both groups (1.93 vs. 2.14?mg for imager and nonimager groups respectively). Completion rates were 94.5?% with an imager and 91?% without (logistic regression; p?=?0.088). Logistic regression analysis showed that buscopan improved completion rate but detrimental factors included increasing patient age, discomfort, poor bowel preparation, and an afternoon procedure. Factors not influencing completion included gender, sedation and analgesia doses, and consciousness level. There was no correlation between documented reason for failure and use of the imager.

Limitations

This was a nonrandomized trial although improved with logistic regression analysis.

Conclusions

Magnetic endoscopic imager use improves patient comfort during colonoscopy but has not been shown to improve completion.     

Palliative systemic therapy and overall survival of 1,395 patients with advanced breast cancer – Results from the prospective German TMK cohort study

Data on treatment and outcome of advanced breast cancer in routine practice are rare, especially concerning recurrent disease, but important to complement the results from clinical trials and to improve the standard of care. We present data on choice of systemic first-line treatment, number of treatment lines, and survival of patients treated by medical oncologists in Germany.1395 patients recruited by 124 sites at start of first-line therapy into the ongoing, prospective German clinical cohort study TMK (Tumour Registry Breast Cancer) between February 2007 and October 2015 were analysed.The median OS was 33.8 months (95% CI 30.2–40.2) for HR-positive/HER2-negative, 38.2 months (95% CI 31.3–43.0) for HER2-positive and 16.8 months (95% CI 11.5–22.0) for triple negative breast cancer. Patients with triple negative tumours more often died before start of a third-line therapy than patients with HR-positive or HER2-positive tumours (44% vs. 25%). Use of taxane-based chemotherapies has increased since 2007, with 65% of all first-line chemotherapy-treatments containing taxanes in 2013–15 (60% HR-positive/HER2-negative, 75% HER2-positive, 56% triple negative). 52% of the patients with HR-positive/HER2-negative tumours received first-line endocrine therapy in 2013–15; when restricted to patients with only non-visceral metastases this percentage increased to 63%.To our knowledge, this is the first cohort study showing systemic first-line therapy for all subtypes of advanced breast cancer. Overall survival in the TMK is comparable to that reported by clinical trials despite the inclusion of older and comorbid patients.     

Does the use of pretreatment MRI change the management of patients with newly diagnosed breast cancer?

Breast MRI plays a critical role in the diagnosis and management of breast cancer. The purpose of this study is to evaluate the effect of preoperative breast MRI on the management of a large cohort of breast cancer patients at our institution. This study is a retrospective chart review of all newly diagnosed breast cancer patients who underwent preoperative breast MRI at our institution between January 1, 2004 and December 31, 2009. 1352 patients comprised the study population. 241 (17.8%) patients underwent a change in surgical management as a result of preoperative MRI. Patients with tumors in the lower inner quadrant and the central breast and those with pathology of invasive lobular carcinoma were significantly more likely to have their management changed by preoperative MRI. There was also a significant trend for larger tumors to be associated with a change in surgical management. No statistically significant association was found between breast density and change in management. This study supports the recommendation for the use of preoperative breast MRI in the majority of newly diagnosed breast cancer patients, especially those with larger tumors, pathology of invasive lobular carcinoma, and tumors in the lower inner quadrant. Preoperative breast MRI is a useful tool for the evaluation of additional disease that led to a change in the surgical management of 17.8% of patients.     

Is nicotine replacement therapy for smoking cessation effective in the “real world”? Findings from a prospective multinational cohort study

BACKGROUND: Increasing smoking cessation rates is an important goal in preventing lung cancer and chronic obstructive pulmonary disease. Nicotine replacement therapy (NRT) has been found in clinical trials to improve the chances of success at stopping, but recent cross-sectional survey data have raised doubts as to whether it is effective when used by smokers making quit attempts unsupervised outside clinical trials. Because of biases inherent in cross-sectional surveys, this issue can only be adequately addressed using longitudinal studies. This paper reports the first study of its kind to examine the issue. METHODS: The ATTEMPT cohort is a multinational cohort study with data collection by the internet which recruited smokers of > or = 5 cigarettes per day aged 35-65 years who were intending to stop smoking within the next 3 months. Phase 1 began in spring 2003 and involved 2009 smokers from the USA, UK, Canada and France. Phase 2 involved 3645 smokers and included the same countries plus Spain. Follow-up assessments were carried out every 3 months. 492 smokers who made a quit attempt without formal behavioural support or bupropion in the first 3-month follow-up period were identified from phase 1, 357 of whom were followed up for a further 6 months. The phase 2 sample involved 906 smokers making quit attempts, 732 of whom were followed up. At baseline, demographic characteristics, smoking history and nicotine dependence were assessed. Smokers who made quit attempts were questioned on methods used to aid them. The main outcome measure was self-report of complete abstinence throughout both the 3-month periods following the quit date. RESULTS: 35.6% of smokers followed up in phase 1 and 29.6% of those followed up in phase 2 used NRT. The odds ratios comparing abstinence for 6 months in those using and those not using NRT, adjusting for nicotine dependence, were 3.0 (95% CI 1.2 to 7.5) for the phase 1 sample and 2.1 (95% CI 1.0 to 4.1) for the phase 2 sample. The difference in success rates between those using NRT and those not using it, adjusted for the Fagerstrom test for nicotine dependence (FTND) score, was 6% in the phase 1 sample and 3.7% in the phase 2 sample. The improved odds of success were not explicable in terms of motivation to use some form of aid to cessation or differential loss to follow-up. CONCLUSION: NRT use by smokers making self-initiated quit attempts without formal behavioural support is associated with improved long-term abstinence rates.     

Does pregnancy increase the risk of cholecystectomy following bariatric surgery? A cross-sectional cohort study

BackgroundReproductive-aged women constitute a substantial proportion of patients who undergo weight loss procedures. While the risk of gallstone disease after such procedures has been addressed extensively, the impact of pregnancy on gallstone disease after bariatric procedures has not been reported.ObjectivesTo explore the effects of pregnancy on cholecystectomy rates after laparoscopic sleeve gastrectomy (LSG).SettingA university hospital.MethodsA cross-sectional cohort study of reproductive aged women (18–45 yr) who underwent LSG. The association between pregnancy and cholecystectomy was evaluated with Cox regression analysis.ResultsOf 1056 women of childbearing age who underwent LSG during 2006–2017, 128 (12.1%) subsequently experienced a pregnancy. Median follow-up durations were 3.9 and 4.9 years for women who did and did not conceive, respectively (P < .001). The median time from procedure to conception was 509 (374–1031) days. Overall, 117 (11.1%) women underwent cholecystectomy after LSG. The rate of cholecystectomy among those who conceived was higher than among those who did not (18.8% versus 10.0%, P = .005). In an unadjusted analysis, pregnancy was associated with an increased risk of cholecystectomy (hazard ratio [95% confidence interval]: 3.97 [2.58, 6.09], P < .0001). The association between pregnancy and cholecystectomy persisted after controlling for confounding factors (hazard ratio [95% confidence interval]: 3.82 [2.47, 5.92], P < .0001). Among those who experienced pregnancy, lower gestational weight gain was the only factor found to be associated with cholecystectomy after surgery (P = .05).ConclusionsPregnancy is associated with a 4-fold increased risk of cholecystectomy after LSG. Thus, the desire for future pregnancy should be considered before LSG.     

Can a surgeon predict the risk of postoperative hypoparathyroidism during thyroid surgery? A prospective study on self-assessment by experts

Background

Thyroid surgery can cause postoperative hypocalcemia (POH) and permanent hypoparathyroidism (PEH). Surgeons implicitly assess the risk and adapt their surgical strategy accordingly.

Methods

The outcome of this intraoperative decision-making process (the surgeons' ability to predict the risk of POH and PEH on a numerical rating scale and their actual incidence) was studied prospectively in 2,558 consecutive thyroid operations.

Results

POH and PEH occurred in 723 and 64 patients, respectively. In multivariate analysis, the surgeons' risk assessment score was an independent predictive factor for both complications (P < .05). Surgeons' differed significantly (P = .015) in their rates of POH but not of PEH (P = .062). Six and 3 (of 9) surgeons correctly predicted an increased risk of PEH and POH (adjusted odds ratios 1.67 to 2.21 and 1.47 to 12.73), respectively.

Conclusion

The risk for hypoparathyroidism can be estimated, but surgeons differ substantially in this ability and in the extent to which this implicit knowledge is translated into lower complication rates.     

Observations on the use of TachoSil® in cholecystectomy - a multicentre, prospective, single-arm cohort study

An observational study on TachoSil? as used in the gall bladder surgery and an analysis of the experience obtained by employing a haemostatic agent in one of the most common procedures in general and visceral surgery have been carried out. The aim of the study was to answer the following questions. When is TachoSil? in routine use? Does TachoSil? have a positive effect on the perioperative course? Is TachoSil? suitable for the routine application in difficult cholecystectomy? In the present single-arm prospective cohort study only departments with specialisation in general and visceral surgery of 40?clinics in Germany participated. Although 500 planned interventions were to be documented in 2007, only 169?operations were actually reported. The numerical results were statistically analysed and summarised. Before the operation was carried out a classification according to the bleeding history was performed. The surgery was performed in the open, laparoscopic or converted modes. During the intervention the surgeon decided about the application of TachoSil? on the basis of a risk index. According to the collected data, it was significant that TachoSil? was used more frequently when either a cholecystectomy was performed in the open mode or on conversion from laparoscopic to the open mode. Also it was significant that TachoSil? was chosen when a patient had a defect in blood coagulation or when the cholecystectomy was part of a multivisceral resection. 59.7% of the patients where TachoSil? was used had a known risk of haemorrage. 12.4?% of the patients where TachoSil was used underwent at least one intervention to compensate intraoperative blood loss before (10.1?% blood transfusion, 4.7?% blood substitutes). In 97?% TachoSil? was used as a haemostatic agent, in 30.2?% it was chosen to prevent a biliary leak and in 11.24?% to?augment vulnerable tissue (multiple answers possible). Concerning laparoscopic cholecystectomy, it was significant that the surgeons decided to take middle-sized patches (4.8?×?4.8?cm) more frequently. Only in 6 cases were the small-sized patches (3?×?2.5?cm) chosen. 90.5?% of the patches were placed in the liver bed. In 5.3?% of the cases the position was not documented. In 4.1?% the patch was placed upon the hepatoduodenal ligament or a suture of the bile duct. To conclude, in difficult cholecystectomies and cholecystectomies as part of multivisceral resection, the use of TachoSil? is an option for experts to secure the seam, to prevent a bile leakage and to control bleeding in the surgical areas.     

Does using a laparoscopic approach to cholecystectomy decrease the risk of surgical site infection?

OBJECTIVE: To assess the impact of laparoscopy on surgical site infections (SSIs) following cholecystectomy in a large population of patients. SUMMARY BACKGROUND DATA: Previous investigations have demonstrated that laparoscopic cholecystectomy is associated with a shorter postoperative stay and fewer overall complications. Less is known about the impact of laparoscopy on the risk for SSIs. METHODS: Epidemiologic analysis was performed on data collected during a 7-year period (1992-1999) by participating hospitals in the National Nosocomial Infections Surveillance (NNIS) System in the United States. RESULTS: For 54,504 inpatient cholecystectomy procedures reported, use of the laparoscopic technique increased from 59% in 1992 to 79% in 1999. The overall rate of SSI was significantly lower for laparoscopic cholecystectomy than for open cholecystectomy. Overall, infecting organisms were similar for both approaches. Even after controlling for other significant factors, the risk for SSI was lower in patients undergoing the laparoscopic technique than the open technique. CONCLUSIONS: Laparoscopic cholecystectomy is associated with a lower risk for SSI than open cholecystectomy, even after adjusting for other risk factors. For interhospital comparisons, SSI rates following cholecystectomy should be stratified by the type of technique.     

Is the increasing rate of local excision for stage I rectal cancer in the United States justified?: a nationwide cohort study from the National Cancer Database

OBJECTIVE: Determine rates of local excision (LE) over time, and test the hypothesis that LE carries increased oncologic risks but reduced perioperative morbidity when compared with standard resection (SR). SUMMARY BACKGROUND DATA: Despite the lack of level I/level II evidence supporting its oncologic adequacy, LE is performed for stage I rectal cancer. METHODS: Surgical therapy for 35,179 patients with stage I rectal cancer diagnosed in 1989 to 2003 was examined over time, utilizing the National Cancer Database. A special study then analyzed perioperative outcomes, local recurrence and survival in 2124 patients diagnosed between 1994 and 1996, including 765 (T1, 601; T2, 164) treated by LE and 1359 (T1, 493; T2, 866) treated by SR. RESULTS: From 1989 to 2003, the use of LE has increased (T1, 26.6-43.7%; T2, 5.8-16.8%; P < 0.001 both). The special study demonstrated significantly lower 30-day morbidity after LE versus SR (5.6% vs. 14.6%; P < 0.001). After adjusting for patient and tumor characteristics, the 5-year local recurrence after LE versus SR was 12.5 versus 6.9% (P = 0.003; hazard ratio = 0.38; 95% CI, 0.23-0.62) for T1 tumors, and 22.1 versus 15.1% (P = 0.01; hazard ratio = 0.69; 95% CI, 0.44-1.07) for T2 tumors. The 5-year overall survival (T1, 77.4% vs. 81.7%, P = 0.09; T2, 67.6% vs. 76.5%, P = 0.01) was influenced by age and comorbidities but not the type of surgery. CONCLUSIONS: This study provides the best evidence for both the increasing use and the associated risks of LE versus SR. For each individual patient, the benefits of LE must be balanced against the heightened risk of local failure.     

Does pathological sub stratification of T2 bladder cancer predict outcome in a contemporary pure urothelial carcinoma cohort?

IntroductionStudies evaluating outcomes in bladder cancer sub stratified into T2a and T2b pathologic staging have demonstrated inconsistent results. Survival outcomes in a cohort of pure urothelial carcinoma patient undergoing radical cystectomy were evaluated to determine the prognostic value of T2 sub staging.MethodsUsing our prospectively maintained institutional cystectomy database, we identified patients with pure urothelial carcinoma of the bladder, either pT2aN0 or pT2bN0. We excluded any patients with variant histology, patients that underwent neoadjuvant chemotherapy, and patients that had margin positive disease. Demographic and clinicopathologic data were collected, and Cox proportional hazard regression assessed overall survival (OS), cancer specific survival (CSS), and recurrence free survival (RFS).ResultsFrom 2001 to 2019, we identified 1,929 patients that underwent radical cystectomy, 61 patients had pT2a and 65 had pT2b pure urothelial carcinoma that met inclusion criteria. Only age (P = 0.02) and the initial transurethral resection of bladder tumor pathology (P < 0.01) were notably different when comparing the clinical characteristics of patients with pT2a and pT2b. No differences were noted in OS, CSS, or RFS between the 2 groups on Kaplan-Meier analysis. On univariate Cox regression analysis, age, TURBT stage, cystectomy pathology stage, carcinoma in situ, and lymphovascular invasion status, and Bacillus Calmette-Guérin therapy status was not found to be significant factors for OS, CSS, or RFS between patients with pT2aN0 or pT2bN0 tumors.ConclusionPrior studies have sub stratified pT2a and pT2b, studying survival outcomes with equivocal results. Many of these studies included variant histology or use of chemotherapy in the analysis. Here, we identified a pure urothelial cohort to compare survival outcomes between pT2a and pT2b and found no difference in OS, CSS, and RFS.     

Does ventral hernia defect length,width, or area predict postoperative quality of life? Answers from a prospective,international study

Background

The goal of this study was to determine if ventral hernia defect length, width, or area predict postoperative pain and quality of life following ventral hernia repair (VHR).

Methods

The International Hernia Mesh Registry, a prospective database from 40 institutions worldwide, was queried for patients undergoing VHR from October 2007 to June 2012. Laparoscopic and open VHR were evaluated separately. Width and length were stratified into large, ≥10 cm and small, <10 cm, along with area as large, ≥100 cm² and small, <100 cm².

Results

In total, 865 International Hernia Mesh Registry patients underwent VHR. Large defect width, length, and area had no association with hernia recurrence or reoperation in both open and laparoscopic VHR. There was a significant increase in operating room time and length of stay for large compared with small width, length, and area for open and laparoscopic VHR patients (P < 0.05). Large area was associated with increased seroma and ileus in open and laparoscopic VHR (P < 0.05). There was greater pain and activity limitation at 1 mo for large versus small width and area whether repaired laparoscopically or open (P < 0.05). When comparing large to small length, there was no difference in pain for all follow-up time points when repaired laparoscopically, but there is significantly increased odds of pain and activity limitation at 1, 6, and 12 mo when repaired open (P < 0.05).

Conclusions

Patients undergoing laparoscopic or open VHR with large defect widths and total area have a greater chance of pain and activity limitation at 1-mo follow-up, but not long term. Large defect lengths are associated with increased early and chronic discomfort in open VHR only.     

The use of symptoms to predict colorectal cancer site. Can we reduce the pressure on our endoscopy services?

Objective Our objective was to determine the value of gastrointestinal symptoms and signs in predicting the site of colorectal cancer (CRC). These symptoms can subsequently be used in determining first‐line investigation with either sigmoidoscopy or colonoscopy. Method We interrogated the endoscopic and CRC databases (‘Infoflex’), for patients diagnosed with CRC between April 2005 and March 2006 inclusive. These patients were cross‐referenced with the pathology database and patient records. Information gathered from these databases include: age, gender, symptoms, site of cancer, histology, Duke’s grading, blood parameters, diagnostic tool and treatment. Results One hundred fifty‐three patients were diagnosed with CRC between April 2005 and March 2006. One hundred twenty‐six were initially seen in the out‐patient department, of whom 38 (29%) were right‐sided (proximal to the splenic flexure), and 88 (70%) were left‐sided (splenic flexure and beyond). Change in bowel habit (diarrhoea and constipation) and rectal bleeding were significantly associated with left‐sided cancers (P < 0.0024 and P < 0.0001, respectively). Haemoglobin (P < 0.0001) and mean corpuscular volume (P < 0.0001) were significantly lower in right‐sided cancers. Weight loss, pain and obstruction were not associated with cancer site. C‐reactive protein, albumin and carcinoembryonic antigen are not predictive of cancer site, Duke’s stage or influenced by patient age or gender. Discussion Symptoms can accurately predict site of cancer, allowing investigations to be tailored accordingly. We would recommend that patients with altered bowel habit and/or rectal bleeding, and no other symptoms, risk factors or anaemia, can be investigated with a flexible sigmoidoscopy to confirm or refute a diagnosis of colorectal cancer.