The sensitivity and specificity of methylene blue dye as a single agent in sentinel lymph node biopsy for early breast cancer

Introduction: Axillary lymph node dissection (ALND), although associated with significant morbidity, has been the standard procedure for axillary staging for breast cancer in many hospitals in Malaysia. The limited resources for radioisotope tracer and nuclear medicine service, coupled with insufficient number of trained surgeons, have been the major obstacles to perform sentinel lymph node biopsy (SLNB). Materials and Methods: This study looks into the application of 1% methylene blue dye (MBD) as a single agent for SLNB and observes the outcome and any associated complication. Thirty-four patients with early breast cancer were enrolled. Two millilitres (ml) of 1% MBD was diluted with saline to a total volume of 5 ml. After induction of general anaesthesia, 3 ml of the diluted 1% MBD is injected subdermally at the upper outer quadrant of the breast followed by 5 minutes of massage. Sentinel nodes are identified as blue nodes or lymph nodes with a blue-stained lymphatic channel and were surgically removed. All patients then underwent tumour excision, either mastectomy or breast-conserving surgery, and ALND. The sentinel nodes were categorized to positive or negative for metastases and were compared with axillary lymph nodes for diagnostic value assessment. Results: Identification rate of sentinel nodes was 91.2%. The mean number of removed sentinel nodes was 2 (SD=1) and the mean number of axillary nodes was 16 (SD=6). Sentinel node metastasis was found in 13 (41.9%) cases. There were two false-negative cases, resulting in a sensitivity of 86.7% (95%CI: 62.1-96.3). The negative predictive value of sentinel nodes to predict axillary metastasis was 88.9% (95%CI: 67.296.9). There were no complications observed. Conclusion: Although inferior to the standard dual-tracer technique, the usage of MBD as a single agent in SLNB for early breast cancer still offers favourable accuracy and identification rate. With continuous training and improved surgeons experience, performing SLNB with blue dye alone is feasible in order to reduce the risks and morbidities associated with ALND

Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study

Background: Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. Methods: This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231. Findings: Between Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p < 0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05–2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p < 0·001). Interpretation: Countries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication

The sensitivity and specificity of methylene blue dye as a single agent in sentinel lymph node biopsy for early breast cancer

Introduction: Axillary lymph node dissection (ALND), although associated with significant morbidity, has been the standard procedure for axillary staging for breast cancer in many hospitals in Malaysia. The limited resources for radioisotope tracer and nuclear medicine service, coupled with insufficient number of trained surgeons, have been the major obstacles to perform sentinel lymph node biopsy (SLNB)

Impact of Patient Navigation on Timeliness of Diagnosis and Treatment, and Adherence to Treatment in Middle Income Asian Country

PURPOSE Women in low to middle-income countries (LMICs), such as in Malaysia, face complex barriers to healthcare because of social, economic, geographic, and other interrelated factors, which can limit their access to timely, affordable, and effective breast cancer care. Patient Navigation has emerged as a cost-effective and impactful approach to enable women to access care. METHODS We have established a hospital-based partnership model between a non-profit organization and national healthcare service to address the barriers faced by low-income women to improve the timeliness of diagnosis and treatment and reduce poor adherence to treatment. The navigation team provides resources required to overcome financial and logistic barriers, counseling to address knowledge and emotional needs and to ensure treatment adherence. RESULTS To determine the effectiveness of the program, timeliness of diagnosis and treatment, and rates of treatment adherence were compared with a historical cohort from the same hospital. The proportion of patients who met the healthcare system's targets for timeliness to cancer diagnosis increased from 50.4% to 67.3% ( P &lt; .05) and that for initiation of primary treatment increased from 36.5% to 49.5% ( P &lt; .05). The overall treatment default rates reduced from 8.6% to 2.6% ( P &lt; .05). CONCLUSION In summary, Patient Navigation is feasible and potentially effective for addressing barriers to cancer care and could be a key element of cancer control in LMICs. </jats:sec

Presentation of Breast Cancer and Impact of Patient Navigation on Timeliness of Diagnosis and Treatment and on Adherence to Treatment Recommendations in a Multicenter Network in Malaysia

PURPOSEBreast cancer deaths disproportionately affect women living in low- and middle-income countries (LMICs). Patient navigation has emerged as a cost-effective and impactful approach to enable women with symptoms or suspicious mammogram findings to access timely diagnosis and patients with breast cancer to access timely and appropriate multimodality treatment. However, few studies have systematically evaluated the impact of patient navigation on timeliness of diagnosis and treatment in LMICs.METHODSWe established a nurse- and community-navigator-led navigation program in breast clinics of four public hospitals located in Peninsular and East Malaysia and evaluated the impact of navigation on timeliness of diagnosis and treatment.RESULTSPatients with breast cancer treated at public hospitals reported facing barriers to accessing care, including having a poor recognition of breast cancer symptoms and low awareness of screening methods, and facing financial and logistics challenges. Compared with patients diagnosed in the previous year, patients receiving navigation experienced timely ultrasound (84.0% v 65.0%; P < .001), biopsy (84.0% v 78.0%; P = .012), communication of news (63.0% v 40.0%; P < .001), surgery (46% v 36%; P = .008), and neoadjuvant therapy (59% v 42%, P = .030). Treatment adherence improved significantly (98.0% v 87.0%, P < .001), and this was consistent across the network of four breast clinics.CONCLUSIONPatient navigation improves access to timely diagnosis and treatment for women presenting at secondary and tertiary hospitals in Malaysia

Surgical site infection after gastrointestinal surgery in children : an international, multicentre, prospective cohort study

Introduction Surgical site infection (SSI) is one of the most common healthcare-associated infections (HAIs). However, there is a lack of data available about SSI in children worldwide, especially from low-income and middle-income countries. This study aimed to estimate the incidence of SSI in children and associations between SSI and morbidity across human development settings. Methods A multicentre, international, prospective, validated cohort study of children aged under 16 years undergoing clean-contaminated, contaminated or dirty gastrointestinal surgery. Any hospital in the world providing paediatric surgery was eligible to contribute data between January and July 2016. The primary outcome was the incidence of SSI by 30 days. Relationships between explanatory variables and SSI were examined using multilevel logistic regression. Countries were stratified into high development, middle development and low development groups using the United Nations Human Development Index (HDI). Results Of 1159 children across 181 hospitals in 51 countries, 523 (45 center dot 1%) children were from high HDI, 397 (34 center dot 2%) from middle HDI and 239 (20 center dot 6%) from low HDI countries. The 30-day SSI rate was 6.3% (33/523) in high HDI, 12 center dot 8% (51/397) in middle HDI and 24 center dot 7% (59/239) in low HDI countries. SSI was associated with higher incidence of 30-day mortality, intervention, organ-space infection and other HAIs, with the highest rates seen in low HDI countries. Median length of stay in patients who had an SSI was longer (7.0 days), compared with 3.0 days in patients who did not have an SSI. Use of laparoscopy was associated with significantly lower SSI rates, even after accounting for HDI. Conclusion The odds of SSI in children is nearly four times greater in low HDI compared with high HDI countries. Policies to reduce SSI should be prioritised as part of the wider global agenda.Peer reviewe

Management and Outcomes Following Surgery for Gastrointestinal Typhoid: An International, Prospective, Multicentre Cohort Study

Background: Gastrointestinal perforation is the most serious complication of typhoid fever, with a high disease burden in low-income countries. Reliable, prospective, contemporary surgical outcome data are scarce in these settings. This study aimed to investigate surgical outcomes following surgery for intestinal typhoid. Methods: Two multicentre, international prospective cohort studies of consecutive patients undergoing surgery for gastrointestinal typhoid perforation were conducted. Outcomes were measured at 30 days and included mortality, surgical site infection, organ space infection and reintervention rate. Multilevel logistic regression models were used to adjust for clinically plausible explanatory variables. Effect estimates are expressed as odds ratios (ORs) alongside their corresponding 95% confidence intervals. Results: A total of 88 patients across the GlobalSurg 1 and GlobalSurg 2 studies were included, from 11 countries. Children comprised 38.6% (34/88) of included patients. Most patients (87/88) had intestinal perforation. The 30-day mortality rate was 9.1% (8/88), which was higher in children (14.7 vs. 5.6%). Surgical site infection was common, at 67.0% (59/88). Organ site infection was common, with 10.2% of patients affected. An ASA grade of III and above was a strong predictor of 30-day post-operative mortality, at the univariable level and following adjustment for explanatory variables (OR 15.82, 95% CI 1.53–163.57, p = 0.021). Conclusions: With high mortality and complication rates, outcomes from surgery for intestinal typhoid remain poor. Future studies in this area should focus on sustainable interventions which can reduce perioperative morbidity. At a policy level, improving these outcomes will require both surgical and public health system advances

Stoma-free survival after anastomotic leak following rectal cancer resection: worldwide cohort of 2470 patients

Background: The optimal treatment of anastomotic leak after rectal cancer resection is unclear. This worldwide cohort study aimed to provide an overview of four treatment strategies applied. Methods: Patients from 216 centres and 45 countries with anastomotic leak after rectal cancer resection between 2014 and 2018 were included. Treatment was categorized as salvage surgery, faecal diversion with passive or active (vacuum) drainage, and no primary/secondary faecal diversion. The primary outcome was 1-year stoma-free survival. In addition, passive and active drainage were compared using propensity score matching (2: 1). Results: Of 2470 evaluable patients, 388 (16.0 per cent) underwent salvage surgery, 1524 (62.0 per cent) passive drainage, 278 (11.0 per cent) active drainage, and 280 (11.0 per cent) had no faecal diversion. One-year stoma-free survival rates were 13.7, 48.3, 48.2, and 65.4 per cent respectively. Propensity score matching resulted in 556 patients with passive and 278 with active drainage. There was no statistically significant difference between these groups in 1-year stoma-free survival (OR 0.95, 95 per cent c.i. 0.66 to 1.33), with a risk difference of -1.1 (95 per cent c.i. -9.0 to 7.0) per cent. After active drainage, more patients required secondary salvage surgery (OR 2.32, 1.49 to 3.59), prolonged hospital admission (an additional 6 (95 per cent c.i. 2 to 10) days), and ICU admission (OR 1.41, 1.02 to 1.94). Mean duration of leak healing did not differ significantly (an additional 12 (-28 to 52) days). Conclusion: Primary salvage surgery or omission of faecal diversion likely correspond to the most severe and least severe leaks respectively. In patients with diverted leaks, stoma-free survival did not differ statistically between passive and active drainage, although the increased risk of secondary salvage surgery and ICU admission suggests residual confounding