Comparison between single-incision and conventional three-port laparoscopic appendectomy: a meta-analysis from eight RCTs

Purpose

To assess the efficacy and safety of single-incision laparoscopic appendectomy (SILA), we conducted a meta-analysis of randomized controlled trials (RCTs) comparing conventional three-port laparoscopic appendectomy (CTLA).

Methods

RCTs comparing the effects of SILA and CTLA were searched for in PubMed, the Cochrane Central Register of Controlled Trials, and Embase. Operative time, the pain visual analogue scales scores (VAS scores), dose of analgesics, postoperative complications, hospital charges, and duration of postoperative hospitalization in SILA and CTLA were pooled and compared by meta-analysis. Odds ratios and weighted mean differences (WMDs) were calculated with 95 % confidence intervals (CIs) to evaluate the effect of SILA.

Result

Eight original RCTs investigating 760 adults and 684 children, 1,444 patients in total, of whom 721 received SILA only and 723 received CTLA only, met the inclusion criteria. Both in adults and children, the mean operative time was significantly longer in SILA than CTLA (WMD5.45, 95 % CI 2.15 to 8.75, p?=?0.01). Compared with CTLA, in children, SILA have higher analgesic consumption (WMD 0.69, 95 % CI 0.08 to 1.3, p?=?0.03) and greater hospital charges (WMD 0.87, 95 % CI 1.26 to 1.48, p?=?0.005), which was not statistically different in adults (p?>?0.05). Pooling the results for SILA and CTLA revealed no significant difference in VAS scores, wound infection rate, overall complications, and postoperative hospital stay.

Conclusion

SILA failed to show any obvious advantages over CTLA in perioperative and postoperative outcomes. Therefore, it represents a possible alternative to conventional three-port laparoscopic appendectomy.     

Cryoablation versus radiofrequency ablation of atrioventricular nodal reentrant tachycardia

Background

Ablation of the slow pathway is an established cure for atrioventricular nodal reentrant tachycardia (AVNRT). Periprocedural damage to the conduction system is a major concern during AVNRT ablation, and cryoablation (CRYO) has been suggested to improve the procedural safety compared to standard radiofrequency (RF) ablation, without reducing the procedural success.

Objective

We performed a systematic review and meta-analysis of studies comparing CRYO with RF ablation of AVNRT.

Methods

We searched PubMed, CENTRAL, the BioMed Central, EMBASE, CardioSource, clinicaltrials.gov, and ISI Web of Science (January 1980 to July 2013). No language restriction was applied. Two independent reviewers screened titles and abstracts to identify studies that compared the procedural outcomes of AVNRT ablation with either CRYO or RF energy. Two independent reviewers assessed the risk of bias according to the Cochrane Collaboration, and extracted patient, study characteristics, and procedural outcome data. Results are expressed as odds ratio (OR) or as weighted mean difference (WMD) with their 95 % confidence interval (CI).

Results

Fourteen studies (5 prospective randomized and 9 observational) with 2,340 patients (mean age range 13 to 53 years, 1,522 (65 %) females) were included in the analysis. RF ablation was performed in 1,262 (54 %) patients, while CRYO in 1,078 (46 %) patients. Acute success (abolition of dual atrioventricular node physiology or single echo beats) was achieved in 88 % of patients treated with RF versus 83 % of those treated with CRYO (OR?=?0.72, 95 % CI 0.46 to 1.13; P?=?0.157). RF ablation was associated with shorter total procedure time (WMD?=??13.7 min, 95 % CI ?23 to ?4.3 min; P?=?0.004), but slightly longer fluoroscopy time (WMD?=?+4.6 min 95 % CI +1.7 to +7.6 min; P?=?0.002). Permanent atrioventricular block occurred in 0.87 % RF cases and in no CRYO case (OR?=?3.60, 95 % CI 1.09 to 11.81; P?=?0.035). Over a median follow-up of 10.5 months (range 6 to 12 months), freedom from recurrent AVNRT was 96.5 % in the RF group versus 90.9 % in the CRYO group (OR?=?0.40, 95 % CI 0.28 to 0.58; P?<?0.001). At meta-regression analysis, no clinical or procedural variable had a significant interaction with the results above.

Conclusions

In patients undergoing AVNRT ablation, RF significantly reduces the risk of long-term arrhythmia recurrence compared to CRYO, but is associated with a higher risk of permanent atrioventricular block.     

Single-incision laparoscopic versus traditional multiport laparoscopic colorectal surgery—a cumulative meta-analysis and systematic review

Purpose

The published data on the evaluation of feasibility and safety of single-incision laparoscopic colorectal surgery (SILC) compared with traditional multiport laparoscopic colorectal surgery (MLC) remained controversial. The present cumulative meta-analysis and systematic review were performed to provide a more objective and precise estimate.

Materials and methods

PubMed, the Cochrane Library, and also, manual searches were employed to identify potentially eligible studies which were published before June 7, 2012. The association was assessed by odds ratio (OR) and means with 95 % confidence intervals (CI).

Results

A total of 20 comparative studies were included, with 670 patients underwent SILC and 838 patients underwent MLC. For overall pooled estimates, no evidence of between trial differences was found in overall conversion rate (OR, 1.7; 95 % CI, 0.97 to 3.01), overall complication rate (OR, 0.82; 95 % CI, 0.63 to 1.08), and operative time (mean, ?3.59; 95 % CI, ?10.95 to 3.77); significantly between trial differences were found in estimated blood loss (mean, ?18.61; 95 % CI, ?31.33 to ?5.90) and post-operative hospital stay (mean, ?0.54; 95 % CI, ?0.95 to ?0.12). The cumulative meta-analysis identified a potentially increased conversion rate of SILC compared with MLC with the increased percentage of malignancies, but no significant differences could be identified in overall complication rate.

Conclusion

This meta-analysis suggested the feasibility and safety of SILC performed by experienced hands, though potentially higher overall conversion rate occurred in malignancies. SILC will benefit the patients much more with its superiority over MLC.     

Angiotensin-converting enzyme gene polymorphism in north Indian population with obstructive sleep apnea

Background

A deletion of 287-bp Alu repeat of angiotensin-converting enzyme (ACE) insertion/deletion (I/D) gene is associated with hypertension.

Purpose

The aim of this study is to determine the frequency of ACE (I/D) polymorphism in patients with obstructive sleep apnea (OSA).

Methods

Genotyping of ACE (I/D) gene polymorphism and estimation of serum angiotensin-converting enzyme (SACE) activity were done in 813 subjects who underwent polysomnography. Of these, 395 were apneics and 418 were non-apneics.

Results

The frequencies of II genotype (OR = 1.8, 95 % CI 1.26–2.60, p?=?0.001) and I allele (OR = 1.4, 95 % CI 1.13–1.69, p?=?0.001) of ACE gene were found to be significantly increased in patients with OSA as compared to patients without OSA. Frequency of II genotype was significantly decreased (OR = 0.46, 95 % CI 0.28–0.77, p?=?0.003) in OSA patients with hypertension. In contrast, the frequencies of ID (OR?=?1.80, 95 % CI 1.08–2.99, p?=?0.024) and DD genotypes (OR?=?2.15, 95 % CI 1.30–3.57, p?=?0.003) were significantly increased in this group. The activity of SACE was significantly decreased in the apneic group as compared to the non-apneic group (OR?=?0.99, 95 % CI 0.98–1.00, p?=?0.04).

Conclusions

The findings suggest that II genotype confers susceptibility towards development of OSA whereas DD genotype confers susceptibility towards hypertension irrespective of OSA.     

The short- and long-term outcomes of laparoscopic versus open surgery for colorectal cancer: a meta-analysis

Purpose

The aim of the study was to compare short- and long-term outcomes of laparoscopic surgery and conventional open surgery for colorectal cancer.

Methods

Published randomized controlled trial (RCT) reports of laparoscopic surgery and open surgery for colorectal cancer were searched, and short- and long-term factors were extracted to perform meta-analysis.

Results

A total of 15 RCT reports (6,557 colorectal cancer patients) were included in this study. Blood loss of laparoscopic surgery was less by 91.06 ml than open surgery (p?=?0.044). Operation time was longer by 49.34 min (p?=?0.000). The length of hospital stay was shorter by 2.64 days (p?=?0.003). Incisional length was shorter by 9.23 cm (p?=?0.000). Fluid intake was shorter by 0.70 day (p?=?0.001). Bowel movement was earlier by 0.95 day (p?=?0.000). Incidence of complications, blood transfusion, and 30 days death were significantly lower in laparoscopic surgery than in open surgery (p?=?0.011, 0.000, 0.01). But there was no significant difference in lymph nodes (p?=?0.535) and anastomotic leak (p?=?0.924). There was also no significant difference in 3 and 5 years overall survival (p?=?0.298, 0.966), disease-free survival (p?=?0.487, 0.356), local recurrence (p?=?0.270, 0.649), and no difference in 5 years distant recurrence (p?=?0.838).

Conclusions

Laparoscopic surgery is a mini-injured approach which can cure colorectal cancer safely and radically, and it is not different from conventional open surgery in long-term effectiveness, so laparoscopic surgery can be tried to widely use in colorectal cancer.     

Variants associated with type 2 diabetes identified by the transethnic meta-analysis study: assessment in American Indians and evidence for a new signal in LPP

Aim/hypothesis

A recent genome-wide trans-ancestry meta-analysis identified seven new loci associated with type 2 diabetes. We assessed the replication of the seven lead single nucleotide polymorphisms (SNPs) and evaluated these loci for additional signals in American Indians.

Methods

Seven SNPs were genotyped in 7,710 individuals from a longitudinally studied American Indian population, and associations with type 2 diabetes, BMI and related phenotypes were assessed. Previous genome-wide association study (GWAS) data from these individuals were used to screen for additional type 2 diabetes signals at these loci. A variant independent of the trans-ancestry meta-analysis was identified within LPP, and its replication was assessed in an additional 3,106 urban American Indians.

Results

SNP rs6813195 near to TMEM154 was nominally associated with type 2 diabetes (p?=?0.01, OR 1.12 [95% CI 1.03, 1.22]) and adiposity: the type 2 diabetes risk allele was associated with a lower percentage body fat (β?=??1.451%, p?=?4.8?×?10^?4). Another SNP, rs3130501 near to POU5F1–TCF19, was associated with BMI (β?=??0.012, p?=?0.004), type 2 diabetes adjusted for BMI (p?=?0.02, OR 1.11 [95% CI 1.02, 1.22]), 2 h glucose concentrations (β?=?0.080 mmol/l, p?=?0.02) and insulin resistance estimated by homeostatic model (β?=?0.039, p?=?0.009). The independent variant identified at the LPP locus in our American Indian GWAS for type 2 diabetes was replicated in the additional samples (all American Indian meta-analysis, p?=?8.9?×?10^?6, OR 1.29 [95% CI 1.15, 1.45]).

Conclusions/interpretation

For two of the seven newly identified variants, there was nominal evidence for association with type 2 diabetes and related traits in American Indians. Identification of an independent variant at the LPP locus suggests the existence of more than one type 2 diabetes signal at this locus.     

Diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration for solid pancreatic lesion: a systematic review

Objective

To summarize EUS-FNA test performance in suspected pancreatic malignancy with meta-analysis.

Method

Two reviewers searched MEDLINE (PubMed and Ovid from January 2002 to January 2012) database to identify relevant studies. The reference lists of the trials were manually searched. Included studies used histopathology or clinical and morphological (CT and MRI and US) follow-up as the “gold standard” and provided sufficient data to construct a diagnostic 2?×?2 table. A statistical program of Meta-Disc was used to calculate the pooled sensitivity, specificity, positive LR, negative LR, DOR, and the SROC curve. Subgroup analysis and meta-regression were calculated to evaluate potential sources of heterogeneity.

Result

A total of 15 studies with 1860 patients were included for the analysis. The pooled sensitivity and specificity of EUS-FNA were 92?% (95?% CI?=?91–93?%, p?I ²?=?69.6?%) and 96?% (95?% CI?=?93–98?%, p?=?0.006, I ²?=?54.9?%), respectively. The positive LR and negative LR were 14.24 (95?% CI?=?7.78–26.07) and 0.09 (95?% CI?=?0.07–0.13), respectively. The area under the curve was 0.974. The subgroup analysis of six studies with rapid on-site evaluation (ROSE) showed a pooled sensitivity of 95 % (95?% CI?=?93–96?%), with p value equal 0.622 and I ²?=?0. The sensitivity analysis of ten high-quality studies (a score of ≥4) showed a pooled sensitivity of 94?% (95?% CI?=?93–96?%, p?=?0.144, I ²?=?33.1?%), and the pooled specificity was 0.95 (95?% CI, 0.91–0.97).

Conclusion

EUS-FNA had overall excellent specificity and sensitivity in accurately diagnosing solid pancreatic masses. ROSE could help to improve the accuracy of diagnostic test.     

Prevalence of irritable bowel syndrome and functional dyspepsia,overlapping symptoms,and associated factors in a general population of Bangladesh

Background

This community-based survey aimed to find out the prevalence of irritable bowel syndrome (IBS), functional dyspepsia (FD), overlapping symptoms, and associated factors for overlap.

Method

By cluster sampling method, 3,000 (1,523 male) randomly selected adult subjects in the Sylhet district of Bangladesh were interviewed by a questionnaire based on ROME III criteria. Multivariate logistic regression analyses were done to find out the factors for overlap with significance level set at ≤0.05.

Results

The mean age of the study population was 33.9?±?16.4 years. Prevalence of IBS and FD and IBS-FD were 12.9 % (n?=?387), 8.3 % (n?=?249), and 3.5 % (n?=?105), respectively. Approximately 27.1 % of IBS patients and 42.1 % of FD patients had overlapping IBS-FD. The odds ratio for IBS-FD overlap was 6.3 (95 % CI, 4.8–8.4). Mean age (p?=?0.011) and epigastric pain (p?=?0.002) were more in overlap patients than FD alone, whereas epigastric pain syndrome subtype (p?<?0.009) was more prevalent in lone FD subjects. In the multivariate logistic analysis, early satiety (OR, 3.0; 95 % CI, 1.2–7.5; p?=?0.018) and epigastric pain (OR, 14.5; 95 % CI, 5.0–42.1; p?=?0.000) in FD patients appeared as independent risk factors for overlap. Bloating (p?=?0.026), <3 stools per week (p?=?0.050), abdominal pain reduced by defecation (p?=?0.002), abdominal pain severity score (p?=?0.004), and overall symptom frequency score (p?=?0.000) were more in overlap patients than IBS-alone patients. In IBS patients, bloating (OR, 3.6; CI, 2.0–6.5; p?=?0.000) was found as potential symptom associated with IBS-FD overlap.

Conclusion

FD was a less prevalent disorder than IBS in our community, and significant overlap existed between the two disorders. Early satiety, epigastric pain, and bloating were important factors associated with overlap.     

Predictive value of total atrial conduction time measured with tissue Doppler imaging for postoperative atrial fibrillation after coronary artery bypass surgery

Objective

Postoperative atrial fibrillation (POAF) complicating coronary artery bypass grafting surgery (CABG) increases morbidity and stroke risk. Total atrial conduction time (PA-TDI duration) has been identified as an independent predictor of new-onset atrial fibrillation (AF). We aimed to assess whether PA-TDI duration is a predictor of AF after CABG.

Methods

In 128 patients who had undergone CABG, preoperative clinical and echocardiographic data were compared between patients with and without POAF. The PA-TDI duration was assessed by measuring the time interval between the beginning of the P wave on the surface ECG and point of the peak A wave on TDI from left atrium (LA) lateral wall just over the mitral annulus.

Results

Patients with POAF (38/128, 29.6 %) were older (68.1?±?11.1 vs. 59.3?±?10.2 years; p?<?0.001), had higher LA maximum volume, had prolonged PA-TDI duration, and had lower ejection fraction compared with patients without POAF. PA-TDI duration was found to be significantly increased in POAF group (134.3?±?19.7 vs. 112.5?±?17.7 ms; p?=?0.01). On multivariate analysis, age (95 % CI?=?1.03–1.09; p?=?0.003), LA maximum volume (95 % CI?=?1.01–1.06; p?=?0.03), and prolonged PA-TDI duration (95 % CI, 1.02–1.05; p?=?0.001) were found to be the independent risk factors of POAF.

Conclusions

In this study, LA maximum volume and PA-TDI duration were found to be the independent predictors of the development of POAF after CABG. Echocardiographic predictors of left atrial electromechanical dysfunction may be useful in risk stratifying of patients in terms of POAF development after CABG.     

Efficacy of vildagliptin versus sulfonylureas as add-on therapy to metformin: comparison of results from randomised controlled and observational studies

Aims/hypothesis

Randomised control trials (RCTs) do not always reflect real-life outcomes for glucose-lowering drugs. In this work we compared RCT and real-life data on the efficacy of the dipeptidyl peptidase-IV (DPP-4) inhibitor vildagliptin or sulfonylureas when added to metformin.

Methods

Data were pooled from five RCTs examining vildagliptin (n?=?2,788) and sulfonylureas (glimepiride [n?=?1,259] or gliclazide [n?=?433]), added to metformin. For real-life conditions, data were extracted from an observational study examining vildagliptin (n?=?7,002) or sulfonylureas (n?=?3,702), added to metformin monotherapy. Linear regression analyses were performed between the baseline HbA_1c and the change in HbA_1c (Δ HbA_1c) after 24 weeks.

Results

Baseline HbA_1c correlated to Δ HbA_1c (r ²?=?0.36, slope?=??0.54 [95% CI ?0.55, ?0.53; p?<?0.0001]) for both treatments. With sulfonylureas, the slope of the correlation was steeper in the observational study than in RCTs (interaction coefficient?=??0.327, p?<?0.001), whereas for vildagliptin, the slope was virtually identical in the observational study and the RCTs (interaction coefficient?=?0.024, p?=?0.175). For any given baseline HbA_1c, Δ HbA_1c with sulfonylureas was smaller in real life than in RCTs, whereas Δ HbA_1c with vildagliptin was the same.

Conclusions/interpretations

When comparing RCT to real-life data, the decrease in HbA_1c from baseline with sulfonylurea treatment is smaller in real life than in RCTs, whereas the reduction with vildagliptin is essentially the same, suggesting that the full power of treatment is retained in real life for vildagliptin but not for sulfonylureas, possibly due to fear of hypoglycaemia.     

Metformin treatment is associated with a low risk of mortality in diabetic patients with heart failure: a retrospective nationwide cohort study

Aims/hypothesis

The safety of metformin in heart failure has been questioned because of a perceived risk of life-threatening lactic acidosis, though recent studies have not supported this concern. We investigated the risk of all-cause mortality associated with individual glucose-lowering treatment regimens used in current clinical practice in Denmark.

Methods

All patients aged ≥30 years hospitalised for the first time for heart failure in 1997–2006 were identified and followed until the end of 2006. Patients who received treatment with metformin, a sulfonylurea and/or insulin were included and assigned to mono-, bi- or triple therapy groups. Multivariable Cox proportional hazard regression models were used to assess the risk of all-cause mortality.

Results

A total of 10,920 patients were included. The median observational time was 844 days (interquartile range 365–1,395 days). In total, 6,187 (57%) patients died. With sulfonylurea monotherapy used as the reference, adjusted hazard ratios for all-cause mortality associated with the different treatment groups were as follows: metformin 0.85 (95% CI 0.75–0.98, p?=?0.02), metformin?+?sulfonylurea 0.89 (95% CI 0.82–0.96, p?=?0.003), metformin?+?insulin 0.96 (95% CI 0.82–1.13, p?=?0.6), metformin?+?insulin?+?sulfonylurea 0.94 (95% CI 0.77–1.15, p?=?0.5), sulfonylurea?+?insulin 0.97 (95% CI 0.86–1.08, p?=?0.5) and insulin 1.14 (95% CI 1.06–1.20, p?=?0.0001).

Conclusions/interpretation

Treatment with metformin is associated with a low risk of mortality in diabetic patients with heart failure compared with treatment with a sulfonylurea or insulin.     

Prognostic value of treatment-related factors in metastatic colorectal cancer using a stop-and-go strategy

Purpose

The purpose of this study is to identify treatment-related factors prognostic of survival in a cohort of patients with metastatic colorectal cancer (mCRC) receiving a palliative, stop-and-go chemotherapy regimen.

Methods

Consecutive patients receiving first-line treatment with biweekly FLIRI plus bevacizumab were included. The outcome was overall survival. Cox regression analysis was used to identify predictors of outcome. We analysed reduction in chemotherapy dosage (no vs. ≤25 or >25 % reduction), bevacizumab administrated to <50, or ≥50 % to chemotherapy treatments, best response during the first 24 weeks of treatment, and local treatment of metastases.

Results

We included 257 patients. Median survival was 23.6 months. Chemotherapy reduction did not influence outcome. Bevacizumab administrations (≥50 %) were associated with improved outcome: hazard ratios (HR) 0.56 (95 % confidence interval (CI) 0.34–0.90, p?=?0.018). Partial response (PR) vs. no change (NC) was borderline significant: HR 0.66 (95 % CI 0.43–0.99, p?=?0.048), whereas progressive disease (PD) vs. NC increased mortality HR 2.48 (95 % CI 1.19–5.19, p?=?0.016). Local treatment of metastases improved outcome: HR 0.30 (95 % CI 0.15–0.61, p?=?0.001).

Conclusions

In a cohort of mCRC patients, receiving a palliative, stop-and-go regimen, administration of bevacizumab to ≥50 % of chemotherapy treatments and local treatment of metastases were associated with better survival. PR improved outcome compared to NC, whereas PD was prognostic of increased mortality.     

Inner lumen mapping catheter-facilitated big cryoballoon treatment for atrial fibrillation shortens procedural duration and fluoroscopic exposure with comparable mid-term efficacy

Purpose

This study aims to investigate whether the use of a novel inner lumen circular mapping catheter (IMC) can shorten the procedural duration and fluoroscopic exposure of the single transseptal big cryoballoon (CB) pulmonary vein isolation (PVI) procedures in patients with atrial fibrillation (AF).

Methods

This is a prospective non-randomized case–control study. Forty-two patients (28 men, mean age 55.7?±?12.1) with drug-refractory paroxysmal or persistent AF and underwent CB PVI procedures were divided into Group A (conventional single transseptal big CB approach, n?=?21) and Group B (IMC-facilitated approach, n?=?21). They were compared in the co-primary endpoints: (1) procedural duration and (2) fluoroscopic exposure and secondary endpoints: (1) 6-month AF-free survival and (2) number of cryo-applications.

Results

Both the procedural duration (162?±?26 vs. 215?±?25 min; p?<?0.001) and fluoroscopic exposure (44.1?±?10.4 vs. 56.8?±?11.7 min; p?=?0.001) were significantly shorter in Group B than Group A patients. With multivariate stepwise regression, only the use of IMC was an independent predictor for procedural duration (β?=??59; 95 % CI, ?84.1 to ?33.8; p?<?0.001) and fluoroscopic exposure (β?=??16.9; 95 % CI, ?28.4 to ?5.4; p?=?0.006). The number of cryo-applications was significantly fewer in Group B than Group A patients (median 8 vs. 11; p?=?0.001). There was no significant difference in the 6-month AF-free survival between the two approaches (57 % vs. 71 %; p?=?0.351).

Conclusions

Compared to conventional single transseptal big CB PVI procedures, the use of IMC may reduce procedural duration, fluoroscopic exposure and the number of cryo-applications with comparable mid-term efficacy.     

High circulating VEGF level predicts poor overall survival in lung cancer

Purpose

Vascular endothelial growth factor (VEGF) is considered as the best-validated key regulator of angiogenesis, while the prognostic role of circulating VEGF in lung cancer remains controversial. We conducted a meta-analysis to evaluate the prognostic role of circulating VEGF.

Methods

Nineteen studies with a total number of 2,890 patients were analyzed in our meta-analysis. Hazard ratios (HRs) and their 95 % confidence intervals (CIs) were used to quantify the predictive ability of circulating VEGF on survival.

Results

The pooled HR of all 17 studies evaluating overall survival (OS) was 1.29 (95 % CI 1.19–1.40, p < 0.001), indicating high circulating VEGF predicted poor OS. When grouped by disease stages, the pooled HRs were 0.97 (95 % CI 0.47–1.47, p < 0.001) for operable stage and 1.34 (95 % CI 1.18–1.49, p < 0.001) for inoperable stage. The pooled HRs were 1.28 (95 % CI 1.15–1.42, p < 0.001) for serum and 1.31 (95 % CI 1.13–1.49, p < 0.001) for plasma, when categorized by blood sample. Meta-analysis of circulating VEGF related to progression-free survival (PFS) was performed in 7 studies, and the pooled HR was 1.03 (95 % CI 0.96–1.09).

Conclusions

Our results indicate that high level of circulating VEGF predicts poor OS in lung cancer, yet it does not predict poor PFS.     

Key Barriers to Medication Adherence in Survivors of Strokes and Transient Ischemic Attacks

BACKGROUND

Even though medications can greatly reduce the risk of recurrent stroke, medication adherence is suboptimal in stroke survivors.

OBJECTIVE

To identify key barriers to medication adherence in a predominantly low-income, minority group of stroke and transient ischemic attack (TIA) survivors.

DESIGN

Cross-sectional study.

PARTICIPANTS

Six hundred stroke or TIA survivors, age ≥ 40 years old, recruited from underserved communities in New York City.

MAIN MEASURES

Medication adherence was measured using the 8-item Morisky Medication Adherence Questionnaire. Potential barriers to adherence were assessed using validated instruments. Logistic regression was used to test which barriers were independently associated with adherence. Models were additionally controlled for age, race/ethnicity, income, and comorbidity.

KEY RESULTS

Forty percent of participants had poor self-reported medication adherence. In unadjusted analyses, compared to adherent participants, non-adherent participants had increased concerns about medications (26 % versus 7 %, p?<?0.001), low trust in their personal doctor (42 % versus 29 %, p?=?0.001), problems communicating with their doctor due to language (19 % versus 12 %, p?=?0.02), perceived discrimination from the health system (42 % versus 22 %, p?<?0.001), difficulty accessing health care (16 % versus 8 %, p?=?0.002), and inadequate continuity of care (27 % versus 20 %, p?=?0.05). In the fully adjusted model, only increased concerns about medications [OR 5.02 (95 % CI 2.76, 9.11); p?<?0.001] and perceived discrimination [OR 1.85 (95 % CI 1.18, 2.90); p?=?0.008] remained significant barriers.

CONCLUSIONS

Increased concerns about medications (related to worry, disruption, long-term effects, and medication dependence) and perceived discrimination were the most important barriers to medication adherence in this group. Interventions that reduce medication concerns have the greatest potential to improve medication adherence in low-income stroke/TIA survivors.     

Clinical implication of additional selective lateral lymph node excision in patients with locally advanced rectal cancer who underwent preoperative chemoradiotherapy

Purpose

To identify the indication and prognostic significance of lateral lymph node (LLN) excision in locally advanced rectal cancer patients underwent preoperative chemoradiotherapy.

Methods

Included were 67 consecutive patients with suspicious LLN metastasis who underwent chemoradiotherapy and surgery including selective LLN excision (82 excisions). The excisions were grouped according to the presence of LLN metastasis and compared in terms of the clinicopathological findings and oncological results. The correlation between the largest short-axis diameter of LLN measured by imaging and metastasis rates was explored.

Results

LLN metastases were identified in 32 excisions (40.0 %). The calculated short-axis LLN diameter predicting metastasis was 11.7 mm (before chemoradiotherapy) and 11.4 mm (before surgery). LLN metastasis was observed more frequently in the low rectum (p?=?0.031) and associated with higher CEA levels (p?=?0.048). The 3-year overall survival rates for patients with and without LLN metastasis were 60.3 % and 90.3 % (p?=?0.048), while the 3-year disease-free survival rates were 31.4 % and 70.5 % (p?=?0.009). The hazard ratio of LLN metastasis for recurrence was 2.938 (95 % CI?=?1.258–6.863).

Conclusions

LLN metastasis in rectal cancer patients underwent chemoradiotherapy was a distinct poor prognostic factor. Selective LLN excision based on imaging studies may have a role for such patients.     

Umbilical incision laparoscopic colectomy with one additional port for colorectal cancer

Background

Recently, laparoscopic colorectal surgery using a single incision usually made at the umbilical area has emerged as a tool to minimize the numbers of scars and provide better cosmetic results. But experience in laparoscopic skills is needed to maintain the oncologic principles of colorectal cancer surgery with the restricted operating field during the procedure. Adding an additional port to single-incision laparoscopic colorectal surgery (SILS) may be a bridge between conventional multiport laparoscopic surgery and SILS. The present study was undertaken to investigate whether umbilical incision laparoscopic colorectal cancer surgery with one additional port (ULAP) could be performed in a similar manner to conventional multiport surgery.

Methods

One hundred and sixty-three patients with colorectal adenocarcinoma underwent laparoscopic colectomy between February 2011 and August 2011. Forty of these patients underwent ULAP and were compared with the other 123 patients who had conventional laparoscopic surgery. Demographic, intraoperative, and postoperative data were analyzed.

Results

Both groups were similar in age (p = 0.438), gender (p = 0.818), body mass index (p = 0.149), American Society of Anesthesiologists (ASA) scores (p = 0.417), history of previous abdominal operation (p = 0.503), and tumor location (p = 0.051). Operation time was longer in the ULAP group (255.5 min) than in the conventional laparoscopic surgery group (144.6 min) (p < 0.001). No significant differences were evident between groups for estimated blood loss (p = 0.263), transfusion requirements (p = 0.841), conversion to open procedures (p = 0.40), length of umbilical incisions (4.6 vs. 4.4 cm, p = 0.628), postoperative hospital stay (p = 0.862), tumor size (p = 0.455), number of harvested lymph nodes (p = 0.203), proximal margins (p = 0.189), and distal resection margins (p = 0.151). Postoperative morbidity (p = 0.736) was similar in both groups. There was no mortality postoperatively.

Conclusions

Umbilical incision laparoscopic colorectal cancer surgery with an additional port is a feasible and safe approach, although it is more time consuming than conventional laparoscopic colectomy.     

Comparative-Effectiveness of Revascularization Versus Routine Medical Therapy for Stable Ischemic Heart Disease: A Population-Based Study

BACKGROUND

Randomized studies have shown optimal medical therapy to be as efficacious as revascularization in stable ischemic heart disease (IHD). It is not known if these efficacy results are reflected by real-world effectiveness.

OBJECTIVE

To evaluate the comparative effectiveness of routine medical therapy versus revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in stable IHD.

DESIGN

Observational cohort study.

PATIENTS

Stable IHD patients from 1 October 2008 to 30 September 2011, identified using a Registry of all angiography patients in Ontario, Canada.

INTERVENTION

Revascularization, defined as PCI/CABG within 90 days after index angiography.

MAIN MEASURES

Death, myocardial infarction (MI) or repeat PCI/CABG. Revascularization was compared to medical therapy using a) multivariable Cox-proportional hazard models with therapy strategy treated as a time-varying covariate; and b) a propensity score matched analysis. Post-angiography medication use was determined.

KEY RESULTS

We identified 39,131 stable IHD patients, of whom 15,139 were treated medically, and 23,992 were revascularized (PCI?=?15,604; CABG?=?8,388). Mean follow-up was 2.5 years. Revascularization was associated with fewer deaths (HR 0.76; 95 % CI 0.68–0.84; p?<?0.001) ,MIs (HR 0.78; 95 % CI 0.72–0.85; p?<?0.001) and repeat PCI/CABG (HR 0.59; 95 % CI 0.50–0.70; p?<?0.001) than medical therapy. In the propensity-matched analysis of 12,362 well–matched pairs of revascularized and medical therapy patients, fewer deaths (8.6 % vs 12.7 %; HR 0.75; 95 % CI 0.69–0.81; p?<?0.001) , MIs (11.7 % vs 14.4 %; HR 0.84; 95 % CI 0.77–0.93 p?<?0.001) and repeat PCI/CABG ( 17.4 % vs 24.1 %;HR 0.67; 95 % 0.63–0.71; p?<?0.001) occurred in revascularized patients, over the 4.1 years of follow-up. The revascularization patients had higher uptake of clopidogrel (70.3 % vs 27.2 %; p?<?0.001), β-blockers (78.2 % vs 76.7 %; p?=?0.010), and statins (94.7 % vs 91.5 %, p?<?0.001) in the 1-year post-angiogram.

CONCLUSIONS

Stable IHD patients treated with revascularization had improved risk-adjusted outcomes in clinical practice, potentially due to under-treatment of medical therapy patients.     

Short-term follow-up after laparoscopic versus conventional total mesorectal excision for low rectal cancer in a large teaching hospital

Purpose

Laparoscopic resection for low rectal cancer remains controversial, and large randomized studies on oncologic outcome are lacking. The objective of this study was to analyze the short-term results of laparoscopic resection versus conventional total mesorectal excision (TME) for low rectal cancer (≤10 cm from the anal verge).

Methods

The institutional colorectal surgery database was reviewed, and 166 consecutive patients operated for low rectal cancer between 2006 and 2011 were included in this analysis which focuses on the first 18 months of follow-up.

Results

Eighty patients underwent conventional TME, whereas 86 patients underwent laparoscopic TME. Patient characteristics were comparable between groups. Conversion rate was 17 %. Laparoscopic rectal resection resulted in significantly less blood loss (200 versus 475 ml, p?=?<0.001) and a 3-day shorter hospital stay (median, 7 versus 10 days; p?=?0.06). Oncologic results from resected specimens were comparable, although significantly more lymph nodes were harvested in laparoscopic resections (median, 13 versus 11; p?=?0.005). Disease-free survival after curative resection was better in the laparoscopic group (p?=?0.04), but this was no longer significant after correction for potential confounders.

Conclusions

This analysis of short-term results of laparoscopic versus conventional TME for low rectal cancer demonstrates that laparoscopic surgery is feasible and safe, resulting in similar oncologic outcomes with less blood loss, a trend towards less postoperative complications and shorter duration of hospital stay. Further randomized studies are needed to attribute to the body of evidence of equivalence or even superiority of laparoscopic resections compared to conventional resections for distal rectal cancer.     

Clinic-Based Versus Outsourced Implementation of a Diabetes Health Literacy Intervention

BACKGROUND

We compared two implementation approaches for a health literacy diabetes intervention designed for community health centers.

METHODS

A quasi-experimental, clinic-randomized evaluation was conducted at six community health centers from rural, suburban, and urban locations in Missouri between August 2008 and January 2010. In all, 486 adult patients with type 2 diabetes mellitus participated. Clinics were set up to implement either: 1) a clinic-based approach that involved practice re-design to routinely provide brief diabetes education and counseling services, set action-plans, and perform follow-up without additional financial resources [CARVE-IN]; or 2) an outsourced approach where clinics referred patients to a telephone-based diabetes educator for the same services [CARVE-OUT]. The fidelity of each intervention was determined by the number of contacts with patients, self-report of services received, and patient satisfaction. Intervention effectiveness was investigated by assessing patient knowledge, self-efficacy, health behaviors, and clinical outcomes.

RESULTS

Carve-out patients received on average 4.3 contacts (SD?=?2.2) from the telephone-based diabetes educator versus 1.7 contacts (SD?=?2.0) from the clinic nurse in the carve-in arm (p?<?0.001). They were also more likely to recall setting action plans and rated the process more positively than carve-in patients (p?<?0.001). Few differences in diabetes knowledge, self-efficacy, or health behaviors were found between the two approaches. However, clinical outcomes did vary in multivariable analyses; carve-out patients had a lower HbA1c (β?=??0.31, 95 % CI ?0.56 to ?0.06, p?=?0.02), systolic blood pressure (β?=??3.65, 95 % CI ?6.39 to ?0.90, p?=?0.01), and low-density lipoprotein (LDL) cholesterol (β?=??7.96, 95 % CI ?10.08 to ?5.83, p?<?0.001) at 6 months.

CONCLUSION

An outsourced diabetes education and counseling approach for community health centers appears more feasible than clinic-based models. Patients receiving the carve-out strategy also demonstrated better clinical outcomes compared to those receiving the carve-in approach. Study limitations and unclear causal mechanisms explaining change in patient behavior suggest that further research is needed.