Enhanced Recovery After Surgery (ERAS®) Society Consensus Guidelines for Emergency Laparotomy Part 3: Organizational Aspects and General Considerations for Management of the Emergency Laparotomy Patient.

BACKGROUND: This is Part 3 of the first consensus guidelines for optimal care of patients undergoing emergency laparotomy using an enhanced recovery after surgery (ERAS) approach. This paper addresses organizational aspects of care. METHODS: Experts in management of the high-risk and emergency general surgical patient were invited to contribute by the International ERAS® Society. PubMed, Cochrane, Embase, and MEDLINE database searches were performed for ERAS elements and relevant specific topics. Studies were selected with particular attention to randomized clinical trials, systematic reviews, meta-analyses and large cohort studies, and reviewed and graded using the Grading of Recommendations, Assessment, Development and Evaluation system. Recommendations were made on the best level of evidence, or extrapolation from studies on elective patients when appropriate. A modified Delphi method was used to validate final recommendations. RESULTS: Components of organizational aspects of care were considered. Consensus was reached after three rounds of a modified Delphi process. CONCLUSIONS: These guidelines are based on best current available evidence for organizational aspects of an ERAS® approach to patients undergoing emergency laparotomy and include discussion of less common aspects of care for the surgical patient, including end-of-life issues. These guidelines are not exhaustive but pull together evidence on important components of care for this high-risk patient population. As much of the evidence is extrapolated from elective surgery or emergency general surgery (not specifically laparotomy), many of the components need further evaluation in future studies.

Consensus Guidelines for Perioperative Care for Emergency Laparotomy Enhanced Recovery After Surgery (ERAS®) Society Recommendations Part 2-Emergency Laparotomy: Intra- and Postoperative Care.

BACKGROUND: This is Part 2 of the first consensus guidelines for optimal care of patients undergoing emergency laparotomy (EL) using an Enhanced Recovery After Surgery (ERAS) approach. This paper addresses intra- and postoperative aspects of care. METHODS: Experts in aspects of management of high-risk and emergency general surgical patients were invited to contribute by the International ERAS® Society. PubMed, Cochrane, Embase, and Medline database searches were performed for ERAS elements and relevant specific topics. Studies on each item were selected with particular attention to randomized clinical trials, systematic reviews, meta-analyses, and large cohort studies and reviewed and graded using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. Recommendations were made on the best level of evidence, or extrapolation from studies on elective patients when appropriate. A modified Delphi method was used to validate final recommendations. Some ERAS® components covered in other guideline papers are outlined only briefly, with the bulk of the text focusing on key areas pertaining specifically to EL. RESULTS: Twenty-three components of intraoperative and postoperative care were defined. Consensus was reached after three rounds of a modified Delphi Process. CONCLUSIONS: These guidelines are based on best available evidence for an ERAS® approach to patients undergoing EL. These guidelines are not exhaustive but pull together evidence on important components of care for this high-risk patient population. As much of the evidence is extrapolated from elective surgery or emergency general surgery (not specifically laparotomy), many of the components need further evaluation in future studies.

They Can Have Our Cake - But Can We Eat It? Access to Raw Genomic Data under Australian Privacy Law.

There is an increasing demand for the return of raw genomic data by research participants in translational genomic research. This article discusses the scope and application of privacy and freedom of information legislative provisions in Australia. Whether there is a right to access a copy of such data under Australian privacy legislation is contingent on whether raw genomic data can identify an individual and this article explores the opportunities for genomic data to be linked to individuals. We conclude that despite the complexity and overlapping nature of privacy laws in Australia, there is a clear right on the part of research participants to access their raw genomic data.

Legal Liability of Clinical Ethics Services in Australia: "Should I Be More Worried Than I Am?"

A key function of clinical ethics services (CESs) is to provide decision-making support to health care providers in ethically challenging cases. Cases referred for ethics consultation are likely to involve diverging views or conflict, or to confront the boundaries of appropriate medical practice. Such cases might also attract legal action due to their contentious nature. As CESs become more prevalent in Australia, this article considers the potential legal liability of a CES and its members. With no reported litigation against a CES in Australia, we look to international experience and first principles. We consider the prospects of a claim in negligence, the most likely legal action against a CES, through application of legal principles to a hypothetical case scenario. We conclude that, although unlikely to be successful at this time, a CES could face answerable claims in negligence brought by patients (and families) who are the subject of ethics case consultation.

Health-related quality of life among cervical cancer survivors at a tertiary hospital in Ghana.

INTRODUCTION: Cervical cancer is the second most common female cancer in Ghana. The disease and its treatment significantly affect survivors' health-related quality of life (HRQoL). We determined the overall quality of life (QoL) and identified its predictors among cervical cancer survivors after treatment. MATERIALS AND METHODS: A hospital-based cross-sectional analytical study was conducted on 153 disease-free cervical cancer survivors who completed curative treatment between January 2004 and December 2018 at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana. We used the European Organization for Research and Treatment of Cancer core-30 item (EORTC QLQ-C30) and cervical cancer module (EORTC QLQ-CX24) to assess the survivors' overall QoL. QoL domain scores were dichotomised as affected or unaffected by disease and its treatment. Significant differences between the affected and unaffected groups within each QoL domain were determined using the student T-test. We used Kruskal-Wallis and Dunn's tests to examine the difference in QoL domains between treatment types, with significance based on Bonferroni corrections. Multivariable logistic regression was performed to identify predictors of overall QoL. A p-value of less than 0.05 was considered statistically significant. RESULTS: One hundred and fifty-three (153) women having a mean age of 58.3 (SD 11.4) years were studied. The overall QoL score was 79.6 (SD 16.0), and 74.5% of survivors reported good QoL score within the median follow up time of 41.8 months (interquartile range [IQR], 25.5-71.1 months) after cervical cancer diagnosis. Although the majority (66.0-84.3%) of the QoL functioning scale were unaffected, about a fifth (22.2%) to a third (34.5%) of the subjects had perceptual impairment in cognitive and role functioning. Financial difficulties, peripheral neuropathy and pain were most common symptoms reported as affected. A third of the survivors were worried that sex would be painful, and 36.6% indicated that their sexual activity as affected. The overall QoL scores for survivors who had surgery, chemoradiation and radiation-alone were 86.1 (SD 9.7), 76.9 (SD 17.7), and 80.7 (SD 14.7), respectively (p = 0.025). The predictors of survivor's overall QoL were loss of appetite [Adjusted Odd Ratio (AOR) = 9.34, 95% Confidence Interval (CI) = 2.13-35.8, p = 0.001], pain (AOR = 3.53, 95% CI = 1.25-9.31, p = 0.017) and body image (AOR = 5.89, 95% CI = 1.80-19.27, p = 0.003). CONCLUSION: About 75% of the survivors had a good overall quality of life. Primary surgical treatment affords the best prospects for quality of life with the least symptom complaints and financial burden. Loss of appetite, pain or diminution in body image perception predicted the overall quality of life of cervical cancer survivors after treatment.

Ethical Design and Use of Robotic Care of the Elderly.

The Australian Royal Commission into Aged Care Quality and Safety acknowledged understaffing and substandard care in residential aged care and home care services, and recommendations were made that that the Australian Government should promote assistive technology within aged care. Robotic care assistants can provide care and companionship for the elderly-both in their own homes and within health and aged care institutions. Although more research is required into their use, studies indicate benefits, including enabling the elderly to live independently at home, assistance with medication and monitoring of safety. Nevertheless, there are inherent ethical challenges in the use of robots as carers, including loss of privacy, unwarranted restrictions on autonomy, lack of dignity, deception, and the exacerbation of loneliness. Ethics by design can counter these issues in development of robotics and clinical ethics committees have been put forward as a way of dealing with the ethical use of robotic care in healthcare institutions. In this paper I outline the ethical challenges of robotic care assistants and how these may be mediated in their design and use.

Determinants of cervical cancer screening uptake among women with access to free screening: A community-based study in peri-urban Ghana.

OBJECTIVE: Cervical cancer can be prevented by regular screening; however, screening rates are low in developing countries. We evaluated the proportion of women screened, modalities of screening utilized, and factors influencing uptake among Ghanaian women with access to free screening services. METHODS: Participants were women aged 25-65 in Asokore-Mampong, Ghana. A structured questionnaire collected socio-demographic characteristics, risk factors, knowledge of, and utilization of cervical cancer screening. Adjusted logistic regression evaluated predictors of screening. RESULTS: Of 710 participants, the majority had heard of cervical cancer (64.6%) and screening (57.7%). Screening utilization was 24.6%. Visual inspection with acetic acid was the most common screening method (97.1%). For those who had never been screened, common reasons were believing they were healthy (21.7%), fearing pain (12.9%), lacking awareness of screening (11.8%), and being too busy (11.6%). Participants who were aged 35-44 (aOR 1.82; 95% CI 1.09-3.03; p = 0.023), married (aOR 3.98; 95% CI 1.68-9.40; p = 0.002), formally employed (aOR 9.31; 95% CI 2.86-30.35; p <0.001), and had higher cervical cancer knowledge (aOR 3.98; 95% CI 2.64-6.02; p <0.001) were more likely to have been screened. CONCLUSION: Despite geographic proximity to a health center that provides free cervical cancer screening, screening uptake among Ghanaian women remains low.

Factors associated with late-stage presentation of cervical cancer in Ghana.

Objective: To explore factors associated with late clinical presentation among Ghanaian women with cervical cancer. Design: This is a cross-sectional survey using a paper questionnaire. Setting: Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana. Participants: Participants were women presenting for cervical cancer care at KATH. Inclusion criteria were histologically diagnosed cervical cancer and age ≥18 years. The exclusion criteria was age <18. All women presenting from August 2018-August 2019 were recruited. Main outcome measures: The primary outcome was the proportion of participants presenting with late-stage cervical cancer, defined as stage II or higher. Results: Of 351 total participants, 33.6% were unemployed, 35.3% had no formal education, and 96.6% had an average monthly income of less than five hundred Ghana cedis ($86 USD). Time from symptoms to seeing a doctor ranged from fewer than two weeks (16.0%) to more than twelve months (8.6%). Participants' most common barrier in seeking healthcare was financial constraints (50.0%). Most participants presented at late-stage cervical cancer (95.2%, n=334), with only 4.8% (n=17) presenting at stage I. Of participants presenting with late-stage cervical cancer, the vast majority had never had a Papanicolaou (Pap) smear (99.1%) nor a recent gynecologic exam (99.3%). After adjusting for age, parity, and distance to a healthcare facility, a late-stage presentation was associated with lower income and living in a rural area. Conclusions: In Ghana, 95% of women with cervical cancer seek care at a late clinical stage, defined as stage II or greater, when the cancer is inoperable. Funding: None declared.

Good enough? Parental decisions to use DIY looping technology to manage type 1 diabetes in children.

People are using innovative internet of things technologies to gain individualised management of their type 1 diabetes. The #WeAreNotWaiting movement supports them to build their own hybrid closed loop systems and access their real time blood sugar data via any web connected device. A small number of parents in Australia use such DIY looping systems to manage their child's type 1 diabetes, but these systems have not been approved by the Therapeutic Goods Administration in Australia, creating ethical dilemmas for clinicians about how to respond to the use of medical devices that are not registered on the Australian Register of Therapeutic Goods. This article considers whether the use of DIY looping is in the best interests of the child and, if not, whether intervention in parental decision making is justified to prevent harm to the child. It addresses the ongoing duty of healthcare professionals to provide care to children who are 'looping.' Reference is made to findings from a study, Personalised Closed Loop Systems for Childhood Diabetes, to illustrate stakeholders' perceptions of benefits and harms of DIY looping systems. I conclude that the decision of parents to use DIY looping technology could be considered to be in a child's best interests, broadly defined, and falls within the Zone of Parental Discretion, however healthcare practitioners who support parents may have professional concerns in doing so.

Nurse-Family Partnership nurses' attitudes and confidence in identifying and responding to intimate partner violence: An explanatory sequential mixed methods evaluation.

AIMS: To evaluate the effect of an intimate partner violence intervention education component on nurses' attitudes in addressing intimate partner violence; complementary aims included understanding nurses' perceptions of the education and how it influenced their attitudes and confidence to address intimate partner violence in practice. DESIGN: An explanatory sequential mixed methods design embedded within a 15-site cluster randomized clinical trial that evaluated an intimate partner violence intervention within the Nurse-Family Partnership programme. METHODS: Data were collected between February 2011 and September 2016. Quantitative assessment of nurses' attitudes about addressing intimate partner violence was completed by nurses in the intervention (n = 77) and control groups (n = 101) at baseline, 12 months and at study closure using the Public Health Nurses' Responses to Women Who Are Abused Scale. Qualitative data were collected from nurses in the intervention group at two timepoints (n = 14 focus groups) and focused on their perceptions of the education component. Data were analysed using content analysis. RESULTS: Nurses in the intervention group reported large improvements in their thoughts, feelings and perceived behaviours related to addressing intimate partner violence; a strong effect of the education was found from baseline to 12 months and baseline to study closure timepoints. Nurses reported that the education component was acceptable and increased their confidence to address intimate partner violence. CONCLUSION: Nurses reported improved attitudes about and confidence in addressing intimate partner violence after receiving the education component. However, these findings need to be considered together with trial results showing no main effects for clients, and a low level of intervention fidelity. IMPACT: These evaluation findings underscore that improvement in nurses' self-reported educational outcomes about addressing intimate partner violence cannot be assumed to result in adherence to intervention implementation or improvement in client outcomes. These are important considerations for developing nurse education on intimate partner violence.

Two rare presentations of embryonal rhabdomyosarcoma of the cervix in teenagers at a low-resource teaching hospital in Ghana: A case series.

We report two cases of embryonal rhabdomyosarcoma (ERMS) of the cervix in teenagers presenting to Komfo Anokye Teaching Hospital in Kumasi, Ghana within one month of each other. Between October and November 2019, two patients presented with ERMS of the cervix. They both underwent fertility-sparing surgery followed by chemotherapy with vincristine, actinomycin-D, and cyclophosphamide. Preoperative workup for the two patients was minimal due to limited availability and high cost of imaging in a low-resource setting. Both patients were discussed at a multidisciplinary tumor board meeting to guide best management practices. Both patients had local surgical resection with histological confirmation of ERMS and negative margins, followed by six cycles of vincristine, actinomycin-D, and cyclophosphamide. Neither of the patients had perioperative complications or received radiation therapy. At the time of publication, both patients are currently alive and without evidence of recurrence. Fertility-sparing surgery followed by chemotherapy for patients with ERMS of the cervix is accessible in low-income countries.

Gynecologic Oncology Sub-Specialty Training in Ghana: A Model for Sustainable Impact on Gynecologic Cancer Care in Sub-Saharan Africa.

African women have double the risk of dying from cancer than women in high-income countries. In Ghana, most women with gynecological malignancies present with advanced-stage disease when treatment is less effective. Barriers to improved cancer outcomes include the availability of cancer screening, affordability of treatment, and access to gynecologic oncology specialists. In response to a paucity of gynecologic oncology providers, an in-country fellowship training program was established at Komfo Anokye Teaching Hospital (KATH) in 2013. Historically, Ghanaian resident physicians were sent to other countries for fellowship training and were unlikely to repatriate. The establishment of an in-country training program not only addresses the challenge of "brain drain," but also builds local capacity in gynecologic oncology education and emphasizes culturally relevant and accessible healthcare. The four-years gynecologic oncology fellowship program at KATH was developed as part of a longitudinal multi-decade partnership between the University of Michigan and academic medical centers in Ghana. The fellowship trains obstetricians and gynecologists to provide subspecialist clinical and surgical care to patients with gynecologic malignancies. Fellows collaborate with the radiation, oncology and pathology departments, participate in monthly inter-institutional tumor board meetings, conduct research, advise on health policy issues, and train subsequent cohorts. This fellowship is representative of emerging twenty-first-century trends in which subspecialty training programs in low-income countries are strengthened by international collaborations. Providing specialized training in gynecologic oncology can help develop and maintain resources that will improve clinical outcomes for women in low-resources settings.

Phase II clinical trial of metformin as a cancer stem cell-targeting agent in ovarian cancer.

BACKGROUNDEpidemiologic studies suggest that metformin has antitumor effects. Laboratory studies indicate metformin impacts cancer stem-like cells (CSCs). As part of a phase II trial, we evaluated the impact of metformin on CSC number and on carcinoma-associated mesenchymal stem cells (CA-MSCs) and clinical outcomes in nondiabetic patients with advanced-stage epithelial ovarian cancer (EOC).METHODSThirty-eight patients with stage IIC (n = 1)/III (n = 25)/IV (n = 12) EOC were treated with either (a) neoadjuvant metformin, debulking surgery, and adjuvant chemotherapy plus metformin or (b) neoadjuvant chemotherapy and metformin, interval debulking surgery, and adjuvant chemotherapy plus metformin. Metformin-treated tumors, compared with historical controls, were evaluated for CSC number and chemotherapy response. Primary endpoints were (a) a 2-fold or greater reduction in aldehyde dehydrogenase-positive (ALDH+) CD133+ CSCs and (b) a relapse-free survival at 18 months of more than 50%.RESULTSMetformin was well tolerated. Median progression-free survival was 18.0 months (95% CI 14.0-21.6) with relapse-free survival at 18 months of 59.3% (95% CI 38.6-70.5). Median overall survival was 57.9 months (95% CI 28.0-not estimable). Tumors treated with metformin had a 2.4-fold decrease in ALDH+CD133+ CSCs and increased sensitivity to cisplatin ex vivo. Furthermore, metformin altered the methylation signature in CA-MSCs, which prevented CA-MSC-driven chemoresistance in vitro.CONCLUSIONTranslational studies confirm an impact of metformin on EOC CSCs and suggest epigenetic change in the tumor stroma may drive the platinum sensitivity ex vivo. Consistent with this, metformin therapy was associated with better-than-expected overall survival, supporting the use of metformin in phase III studies.TRIAL REGISTRATIONClinicalTrials.gov NCT01579812.

Phase II Trial of Cabozantinib in Recurrent/Metastatic Endometrial Cancer: A Study of the Princess Margaret, Chicago, and California Consortia (NCI9322/PHL86).

PURPOSE: The relevance of the MET/hepatocyte growth factor pathway in endometrial cancer tumor biology supports the clinical evaluation of cabozantinib in this disease. PATIENTS AND METHODS: PHL86/NCI#9322 (NCT01935934) is a single arm study that evaluated cabozantinib (60 mg once daily) in women with endometrial cancer with progression after chemotherapy. Coprimary endpoints were response rate and 12-week progression-free-survival (PFS). Patients with uncommon histology endometrial cancer (eg, carcinosarcoma and clear cell) were enrolled in a parallel exploratory cohort. RESULTS: A total of 102 patients were accrued. Among 36 endometrioid histology patients, response rate was 14%, 12-week PFS rate was 67%, and median PFS was 4.8 months. In serous cohort of 34 patients, response rate was 12%, 12-week PFS was 56%, and median PFS was 4.0 months. In a separate cohort of 32 patients with uncommon histology endometrial cancer (including carcinosarcoma), response rate was 6% and 12-week PFS was 47%. Six patients were on treatment for >12 months, including two for >30 months. Common cabozantinib-related toxicities (>30% patients) included hypertension, fatigue, diarrhea, nausea, and hand-foot syndrome. Gastrointestinal fistula/perforation occurred in four of 70 (6%) patients with serous/endometrioid cancer and five of 32 (16%) patients in exploratory cohort. We observed increased frequency of responses with somatic CTNNB1 mutation [four partial responses (PRs) in 10 patients, median PFS 7.6 months] and concurrent KRAS and PTEN/PIK3CA mutations (three PRs in 12 patients, median PFS 5.9 months). CONCLUSIONS: Cabozantinib has activity in serous and endometrioid histology endometrial cancer. These results support further evaluation in genomically characterized patient cohorts.

Hospital-level evaluation of the effect of a national quality improvement programme: time-series analysis of registry data.

BACKGROUND AND OBJECTIVES: A clinical trial in 93 National Health Service hospitals evaluated a quality improvement programme for emergency abdominal surgery, designed to improve mortality by improving the patient care pathway. Large variation was observed in implementation approaches, and the main trial result showed no mortality reduction. Our objective therefore was to evaluate whether trial participation led to care pathway implementation and to study the relationship between care pathway implementation and use of six recommended implementation strategies. METHODS: We performed a hospital-level time-series analysis using data from the Enhanced Peri-Operative Care for High-risk patients trial. Care pathway implementation was defined as achievement of >80% median reliability in 10 measured care processes. Mean monthly process performance was plotted on run charts. Process improvement was defined as an observed run chart signal, using probability-based 'shift' and 'runs' rules. A new median performance level was calculated after an observed signal. RESULTS: Of 93 participating hospitals, 80 provided sufficient data for analysis, generating 800 process measure charts from 20 305 patient admissions over 27 months. No hospital reliably implemented all 10 processes. Overall, only 279 of the 800 processes were improved (3 (2-5) per hospital) and 14/80 hospitals improved more than six processes. Mortality risk documented (57/80 (71%)), lactate measurement (42/80 (53%)) and cardiac output guided fluid therapy (32/80 (40%)) were most frequently improved. Consultant-led decision making (14/80 (18%)), consultant review before surgery (17/80 (21%)) and time to surgery (14/80 (18%)) were least frequently improved. In hospitals using ≥5 implementation strategies, 9/30 (30%) hospitals improved ≥6 care processes compared with 0/11 hospitals using ≤2 implementation strategies. CONCLUSION: Only a small number of hospitals improved more than half of the measured care processes, more often when at least five of six implementation strategies were used. In a longer term project, this understanding may have allowed us to adapt the intervention to be effective in more hospitals.

Quality improvement and emergency laparotomy care: what have we learnt from recent major QI efforts?

More than 1.53 million adults undergo inpatient surgery in the UK NHS. Patients undergoing emergency abdominal surgery have a much greater risk of death than patients admitted for elective surgery. Widespread variations in key standards of care between hospitals exist and are associated with differences in mortality rates.Recently there have been three large-scale initiatives to improve quality of care for emergency laparotomy patients: the National Emergency Laparotomy Audit, the enhanced perioperative care for high-risk patients trial and the Emergency Laparotomy Collaborative. Here we provide a critical review of what we currently know about the use of structured methods for improving the quality of healthcare services, with reference to the three initiatives. We find that using structured methods to improve care is the hallmark of quality improvement but attention must too be paid to the context in which these methods are used.

Disclosure of Genetic Results to At-risk Relatives without Consent: Issues for Health Care Professionals in Australia.

Disclosure of genetic information without consent of the patient (proband) challenges the legal frameworks of privacy and confidentiality. Changes to privacy legislation enable and provide guidelines for undertaking disclosure, with the purpose of reducing the harm to genetic relatives who, armed with such information, may seek predictive testing themselves. Nevertheless, significant uncertainty remains for health care professionals in the application of the discretion to disclose genetic information to at-risk relatives. First, jurisdictional inconsistencies in privacy legislation present challenges for the provision of genetic services across the country. Second, the current guidelines provide insufficient clarity regarding the justification for disclosure of genetic information to reduce psychological harm to relatives. Third, the implications of a potential expansion of a legal duty of care to inform genetic relatives in some circumstances indicates that such a duty would be unduly burdensome for health care professionals, and suggests that revision of the threshold for use - rather than disclosure - of depersonalised genetic information may represent a pragmatic way forward.