Clean Cut (adaptive, multimodal surgical infection prevention programme) for low-resource settings: a prospective quality improvement study.

BACKGROUND: Clean Cut is an adaptive, multimodal programme to identify improvement opportunities and safety changes in surgery by enhancing outcomes surveillance, closing gaps in surgical infection prevention standards, and strengthening underlying processes of care. Surgical-site infections (SSIs) are common in low-income countries, so this study assessed a simple intervention to improve perioperative infection prevention practices in one. METHODS: Clean Cut was implemented in five hospitals in Ethiopia from August 2016 to October 2018. Compliance data were collected from the operating room focused on six key perioperative infection prevention standards. Process-mapping exercises were employed to understand barriers to compliance and identify locally driven improvement opportunities. Thirty-day outcomes were recorded on patients for whom intraoperative compliance information had been collected. RESULTS: Compliance data were collected from 2213 operations (374 at baseline and 1839 following process improvements) in 2202 patients. Follow-up was completed in 2159 patients (98·0 per cent). At baseline, perioperative teams complied with a mean of only 2·9 of the six critical perioperative infection prevention standards; following process improvement changes, compliance rose to a mean of 4·5 (P < 0·001). The relative risk of surgical infections after Clean Cut implementation was 0·65 (95 per cent c.i. 0·43 to 0·99; P = 0·043). Improved compliance with standards reduced the risk of postoperative infection by 46 per cent (relative risk 0·54, 95 per cent c.i. 0·30 to 0·97, for adherence score 3-6 versus 0-2; P = 0·038). CONCLUSION: The Clean Cut programme improved infection prevention standards to reduce SSI without infrastructure expenses or resource investments.

Is contact between men who have sex with men and non-governmental organizations providing harm reduction associated with improved HIV outcomes?

OBJECTIVES: There is a high prevalence of HIV (5.2% in 2018) among men who have sex with men (MSM) in Ukraine. HIV testing, condom provision and facilitated linkage to HIV treatment have been funded by various bodies through non-governmental organizations (NGOs). We investigated whether contact with these NGOs was associated with improved prevention and treatment outcomes among MSM in Ukraine. METHODS: Data were taken from four rounds of integrated bio-behavioural surveys among MSM in Ukraine (2011, N = 5950; 2013, N = 8101; 2015, N = 4550; 2018, N = 5971) including HIV testing combined with questionnaire responses. Data were analysed using mixed-effect regression models, which estimated associations between being an NGO client and behavioural, HIV testing and HIV treatment outcomes, adjusted for demographic factors. RESULTS: Those MSM who were NGO clients were more likely than non-clients to have been HIV tested in the last year [adjusted odds ratio (aOR) = 7.01, 95% confidence interval (CI): 6.45-7.62] or ever (aOR = 11.00, 95% CI: 9.77-12.38), to have used a condom for the last anal sex act (aOR = 1.32, 95% CI: 1.21-1.43), and to have recently either bought or received condoms (aOR = 21.27, 95% CI: 18.01-25.12). HIV-positive MSM were more likely to have contact with NGOs (aOR = 1.61, 95% CI: 1.39-1.86). Among the HIV-positive MSM, those who were NGO clients were more likely to be registered at an AIDS centre (aOR = 2.24, 95% CI: 1.61-3.11) and to be on antiretroviral treatment (aOR = 2.20, 95% CI: 1.51-3.20). CONCLUSIONS: In Ukraine, being in contact with MSM-targeted NGOs is associated with better outcomes for HIV prevention, testing and treatment, suggesting that NGO harm reduction projects for MSM have had a beneficial impact on reducing HIV transmission and morbidity.

Therapeutic mammaplasty is a safe and effective alternative to mastectomy with or without immediate breast reconstruction.

BACKGROUND: Therapeutic mammaplasty (TM) may be an alternative to mastectomy, but few well designed studies have evaluated the success of this approach or compared the short-term outcomes of TM with mastectomy with or without immediate breast reconstruction (IBR). Data from the national iBRA-2 and TeaM studies were combined to compare the safety and short-term outcomes of TM and mastectomy with or without IBR. METHODS: The subgroup of patients in the TeaM study who underwent TM to avoid mastectomy were identified, and data on demographics, complications, oncology and adjuvant treatment were compared with those of patients undergoing mastectomy with or without IBR in the iBRA-2 study. The primary outcome was the percentage of successful breast-conserving procedures in the TM group. Secondary outcomes included postoperative complications and time to adjuvant therapy. RESULTS: A total of 2916 patients (TM 376; mastectomy 1532; mastectomy and IBR 1008) were included in the analysis. Patients undergoing TM were more likely to be obese and to have undergone bilateral surgery than those having IBR. However, patients undergoing mastectomy with or without IBR were more likely to experience complications than the TM group (TM: 79, 21·0 per cent; mastectomy: 570, 37·2 per cent; mastectomy and IBR: 359, 35·6 per cent; P < 0·001). Breast conservation was possible in 87·0 per cent of patients who had TM, and TM did not delay adjuvant treatment. CONCLUSION: TM may allow high-risk patients who would not be candidates for IBR to avoid mastectomy safely. Further work is needed to explore the comparative patient-reported and cosmetic outcomes of the different approaches, and to establish long-term oncological safety.

ANTECEDENTES: La mamoplastia terapéutica (therapeutic mammaplasty, TM) puede ser una alternativa a la mastectomía, pero hay pocos estudios bien diseñados que hayan evaluado el éxito de esta estrategia o hayan comparado los resultados a corto plazo de la TM con la mastectomía con o sin (+/-) reconstrucción mamaria inmediata (immediate breast reconstruction, IBR). Para comparar la seguridad y los resultados a corto plazo de la TM y la mastectomía +/- IBR se combinaron los datos de los estudios nacionales iBRA-2 y TeaM. MÉTODOS: En el estudio TeaM se identificó el subgrupo de pacientes al que se realizó una TM para evitar la mastectomía y se compararon los datos demográficos, las complicaciones, los resultados oncológicos y el tratamiento adyuvante con las pacientes sometidas a mastectomía +/- IBR del estudio iBRA-2. La variable principal fue el porcentaje de éxito de la cirugía conservadora de mama en el grupo TM. Las variables secundarias fueron las complicaciones postoperatorias y el intervalo de tiempo hasta el inicio del tratamiento adyuvante. RESULTADOS: Se incluyeron en el análisis 2.916 pacientes (TM n = 376; mastectomía n = 1.532; IBR n = 1.008). La TM era más frecuente en pacientes obesas o en las sometidas a cirugía bilateral en comparación con las pacientes con IBR. Sin embargo, las pacientes sometidas a una mastectomía +/- IBR tenían más probabilidades de desarrollar complicaciones que las del grupo TM (TM n = 79, 21,0%; mastectomía n = 570, 37,2%; mastectomía y IBR n = 359, 35,6%; P < 0,001). La conservación de la mama fue posible en el 87% de las pacientes con TM y el procedimiento no retrasó el inicio del tratamiento adyuvante. CONCLUSIÓN: La TM puede permitir que pacientes de alto riesgo que no serían candidatas a IBR eviten la mastectomía de una forma segura. Se necesitan más trabajos para comparar los resultados percibidos por las pacientes y los estéticos de las diferentes estrategias terapéuticas y establecer la seguridad oncológica a largo plazo.

Surgery, stomas, and anxiety and depression in inflammatory bowel disease: a retrospective cohort analysis of privately insured patients.

AIM: Patients with inflammatory bowel disease (IBD) are diagnosed with anxiety/depression at higher rates than the general population. We aimed to determine the frequency of anxiety/depression among IBD patients and the temporal association with abdominal surgery and stoma formation. METHOD: We conducted a retrospective cohort study in adult patients with IBD using difference-in-difference methodology and a large commercial claims database (2003-2016). Outcomes were anxiety/depression diagnoses before and after major abdominal surgery or stoma formation. RESULTS: We identified 10 481 IBD patients who underwent major abdominal surgery, 18.8% of whom underwent stoma formation, and 41 924 nonsurgical age- and sex-matched IBD controls who were assigned random index dates. Rates of anxiety and depression increased among all cohorts (P < 0.001). Surgical patients had higher odds of anxiety [one surgery, adjusted OR 6.90 (95% CI 6.11-7.79), P < 0.001; two or more surgeries, 7.53 (5.99-9.46), P < 0.001] and depression [one surgery, 6.15 (5.57-6.80), P < 0.001; two or more surgeries, 6.88 (5.66-8.36), P < 0.001] than nonsurgical controls. Undergoing multiple surgeries was associated with a significant increase in depression from 'pre' to 'post' time periods [1.43 (1.18-1.73), P < 0.001]. Amongst surgical patients, stoma formation was independently associated with anxiety [1.40 (1.17-1.68), P < 0.001] and depression [1.23 (1.05-1.45), P = 0.01]. New ostomates experienced a greater increase in postoperative anxiety [1.24 (1.05-1.47), P = 0.01] and depression [1.19 (1.03-1.45), P = 0.01] than other surgical patients. CONCLUSION: IBD patients who undergo surgery have higher rates of anxiety and depression than nonsurgical patients. Rates of anxiety and depression increase following surgery. Stoma formation represents an additional risk factor. These findings suggest the need for perioperative psychosocial support services.

Clustering of hepatitis C virus antibody positivity within households and communities in Punjab, India.

To better understand hepatitis C virus (HCV) epidemiology in Punjab state, India, we estimated the distribution of HCV antibody positivity (anti-HCV+) using a 2013-2014 HCV household seroprevalence survey. Household anti-HCV+ clustering was investigated (a) by individual-level multivariable logistic regression, and (b) comparing the observed frequency of households with multiple anti-HCV+ persons against the expected, simulated frequency assuming anti-HCV+ persons are randomly distributed. Village/ward-level clustering was investigated similarly. We estimated household-level associations between exposures and the number of anti-HCV+ members in a household (N = 1593 households) using multivariable ordered logistic regression. Anti-HCV+ prevalence was 3.6% (95% confidence interval 3.0-4.2%). Individual-level regression (N = 5543 participants) found an odds ratio of 3.19 (2.25-4.50) for someone being anti-HCV+ if another household member was anti-HCV+. Thirty households surveyed had ⩾2 anti-HCV+ members, whereas 0/1000 (P < 0.001) simulations had ⩾30 such households. Excess village-level clustering was evident: 10 villages had ⩾6 anti-HCV+ members, occurring in 31/1000 simulations (P = 0.031). The household-level model indicated the number of household members, living in southern Punjab, lower socio-economic score, and a higher proportion having ever used opium/bhuki were associated with a household's number of anti-HCV+ members. Anti-HCV+ clusters within households and villages in Punjab, India. These data should be used to inform screening efforts.

Current practice and short-term outcomes of therapeutic mammaplasty in the international TeaM multicentre prospective cohort study.

BACKGROUND: Therapeutic mammaplasty, which combines breast reduction and mastopexy techniques with tumour excision, may extend the boundaries of breast-conserving surgery and improve outcomes for patients, but current practice is unknown and high-quality outcome data are lacking. This prospective multicentre cohort study aimed to explore the practice and short-term outcomes of the technique. METHODS: Consecutive patients undergoing therapeutic mammaplasty at participating centres between 1 September 2016 and 30 June 2017 were recruited to the study. Demographic, preoperative, operative, oncological and complication data were collected. The primary outcome was unplanned reoperation for complications within 30 days of surgery. Secondary outcomes included re-excision rates and time to adjuvant therapy. RESULTS: Overall, 880 patients underwent 899 therapeutic mammaplasty procedures at 50 centres. The most common indications were avoidance of poor cosmetic outcomes associated with standard breast-conserving surgery (702 procedures, 78·1 per cent) or avoidance of mastectomy (379, 42·2 per cent). Wise-pattern skin incisions were the most common (429 of 899, 47·7 per cent), but a range of incisions and nipple-areola pedicles were used. Immediate contralateral symmetrization was performed in one-third of cases (284 of 880, 32·3 per cent). In total, 205 patients (23·3 per cent) developed a complication, but only 25 (2·8 per cent) required reoperation. Median postoperative lesion size was 24·5 (i.q.r. 16-38) mm. Incomplete excision was seen in 132 procedures (14·7 per cent), but completion mastectomy was required for only 51 lesions (5·7 per cent). Median time to adjuvant therapy was 54 (i.q.r. 42-66) days. CONCLUSION: Therapeutic mammaplasty is a safe and effective alternative to mastectomy or standard breast-conserving surgery. Further work is required to explore the impact of the technique on quality of life, and to establish cost-effectiveness.

The burden of hepatitis C virus infection in Punjab, India: A population-based serosurvey.

INTRODUCTION: Hepatitis C virus (HCV) infection prevalence is believed to be elevated in Punjab, India; however, state-wide prevalence data are not available. An understanding of HCV prevalence, risk factors and genotype distribution can be used to plan control measures in Punjab. METHODS: A cross-sectional, state-wide, population-based serosurvey using a multi-stage stratified cluster sampling design was conducted October 2013 to April 2014. Children aged ≥5 years and adults were eligible to participate. Demographic and risk behavior data were collected, and serologic specimens were obtained and tested for anti-HCV antibody, HCV Ribonucleic acid (RNA) on anti-HCV positive samples, and HCV genotype. Prevalence estimates and adjusted odds ratios for risk factors were calculated from weighted data and stratified by urban/rural residence. RESULTS: 5,543 individuals participated in the study with an overall weighted anti-HCV prevalence of 3.6% (95% Confidence Interval [CI]: 3.0%-4.2%) and chronic infection (HCV Ribonucleic acid test positive) of 2.6% (95% CI: 2.0%-3.1%). Anti-HCV was associated with being male (adjusted odds ratio 1.52; 95% CI: 1.08-2.14), living in a rural area (adjusted odds ratio 2.53; 95% CI: 1.62-3.95) and was most strongly associated with those aged 40-49 (adjusted odds ratio 40-49 vs. 19-29-year-olds 3.41; 95% CI: 1.90-6.11). Anti-HCV prevalence increased with each blood transfusion received (adjusted odds ratio 1.36; 95% CI: 1.10-1.68) and decreased with increasing education, (adjusted odds ratio 0.37 for graduate-level vs. primary school/no education; 95% CI: 0.16-0.82). Genotype 3 (58%) was most common among infected individuals. DISCUSSION: The study findings, including the overall prevalence of chronic HCV infection, associated risk factors and demographic characteristics, and genotype distribution can guide prevention and control efforts, including treatment provision. In addition to high-risk populations, efforts targeting rural areas and adults aged ≥40 would be the most effective for identifying infected individuals.

Risk of post-operative surgical site infections after vedolizumab vs anti-tumour necrosis factor therapy: a propensity score matching analysis in inflammatory bowel disease.

BACKGROUND: Perioperative vedolizumab (VDZ) and anti-tumour necrosis factor (TNFi) therapies are implicated in causing post-operative complications in inflammatory bowel disease (IBD). AIM: To compare the risk of surgical site infections (SSIs) between VDZ- and TNFi-treated IBD patients in propensity-matched cohorts. METHODS: The Optum Research Database was used to identify IBD patients who received VDZ or TNFi within 30 days prior to abdominal surgery between January 2015 and December 2016. The date of IBD-related abdominal surgery was defined as the index date. SSIs were determined by ICD-9/10 and CPT codes related to superficial wound infections or deep organ space infections after surgery. Propensity score 1:1 matching established comparable cohorts based on VDZ or TNFi exposure before surgery based on evidence-based risk modifiers. RESULTS: The propensity-matched sample included 186 patients who received pre-operative biologic therapy (VDZ, n = 94; TNFi, n = 92). VDZ and TNFi cohorts were similar based on age, gender, IBD type, concomitant immunomodulator exposure, chronic opioid or corticosteroid therapy, Charlson Comorbidity Index and malnutrition. VDZ patients were more likely to undergo an open bowel resection with ostomy. After propensity score matching, there was no significant difference in post-operative SSIs (TNFi 12.0% vs VDZ 14.9%, P = 0.56). Multivariable analysis indicated that malnutrition was the sole risk factor for developing SSI (OR 3.1, 95% CI 1.11-8.71) regardless of the type of biologic exposure. CONCLUSION: In the largest, risk-adjusted cohort analysis to date, perioperative exposure to VDZ therapy was not associated with a significantly higher risk of developing an SSI compared to TNFi therapy.

Evaluation of an intervention to reduce tidal volumes in ventilated ICU patients.

BACKGROUND: There is considerable evidence that the use of tidal volumes <6 ml kg(-1) predicted body weight (PBW) reduces mortality in mechanically ventilated patients. We evaluated the effectiveness of using a large screen displaying delivered tidal volume in ml kg(-1) (PBW) for reducing tidal volumes. METHODS: We assessed the intervention in two 6-month periods. A qualitative study was undertaken after the intervention period to examine staff interaction with the intervention. The study was conducted in a mixed medical and surgical intensive care unit at University Hospitals Bristol, UK. Consecutive patients requiring controlled mechanical ventilation for more than 1 h were included. Alerts were triggered when tidal volume breached predetermined targets and these alerts were visible to ICU clinicians in real time. RESULTS: A total of 199 patients with 7640 h of data were observed during the control time period and 249 patients with 10 656 h of data were observed in the intervention period. Time spent with tidal volumes <6 ml kg(-1) PBW increased from 17.5 to 28.6% of the period of controlled mechanical ventilation. Time spent with a tidal volume <8 ml kg(-1) PBW increased from 60.6 to 73.9%. The screens were acceptable to staff and stimulated an increase in attendance of clinicians at the bedside to adjust ventilators. CONCLUSIONS: Changing the format of data and displaying it with real-time alerts reduced delivered tidal volumes. Configuring information in a format more likely to result in desired outcomes has the potential to improve the translation of evidence into practice.

Colectomy without mechanical bowel preparation in the private practice setting.

BACKGROUND: Despite randomized trials and meta-analyses demonstrating the safety of omitting mechanical bowel preparation (MBP) before colorectal surgery, private practice surgeons may hesitate to eliminate MBP for fear of being outside community standards. This study evaluated the safety of eliminating MBP before colectomy in a private practice setting. METHODS: This prospective observational study included elective abdominal colorectal operations from one surgeon's practice from October 2008 to June 2011. MBP was not routinely utilized after November 2009. Postoperative 30-day complication rates and length of hospital stay were compared in patients with and without MBP. Multivariable regression models were developed to compare outcomes among study groups, adjusting for demographics, diagnoses, procedures, and year. RESULTS: A total of 165 patients were analyzed. Demographics were similar between groups. Laparoscopic procedures were more common in patients without MBP due to increased laparoscopy over time (43 vs. 61 %, p = 0.03). As regards complications, infection rates were similar between groups (MBP 10.5 % vs. no MBP(NMBP) 11.4 %, adj p = 0.57). Patients without MBP had a shorter length of hospital stay (median: 6 vs. 5 days, p = 0.01), but those differences were not statistically significant after adjustment (p = 0.14). CONCLUSIONS: Private practice surgeons should embrace evidence-based practice changes and make efforts to quantitatively evaluate the safety of those changes. Omission of MBP for most elective colectomy procedures appears to be safe with no significant increase in complications or length of hospital stay. Because MBP has substantial drawbacks, there is little justification for its routine use in the majority of elective abdominal colorectal procedures.