Outcomes of Rituximab-abbs versus Rituximab in Patients with Diffuse Large B-Cell Lymphoma in a Noninferiority Study.

BACKGROUND: Rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is one of the first line treatments for diffuse large B-cell lymphoma (DLBCL). Rituximab comprises most of the treatment cost for this regimen; therefore, biosimilars, such as rituximab-abbs are crucial to provide affordable care. Although rituximab-abbs was studied primarily in follicular lymphoma, the Food and Drug Administration (FDA) approved this drug for all indications of the reference product on the basis of extrapolation. Effectiveness and safety data surrounding the use of rituximab-abbs in DLBCL is lacking. OBJECTIVE: To evaluate the effectiveness and safety of rituximab-abbs and reference product rituximab as R-CHOP treatment for patients with DLBCL. PATIENTS AND METHODS: This noninferiority (NI) study compared the 2-year overall survival (OS), overall response rate (ORR), and incidence of adverse events (AEs) between rituximab-abbs and its reference product (RP) in R-CHOP among adult patients with newly diagnosed DLBCL. The study inclusion period was from 1 January 2019 to 31 December 2020. Analyses were performed on the basis of a noninferiority lower limit of 10% for OS and ORR, and an upper limit of 10% for serious AEs. RESULTS: There were 240 patients who received RP rituximab, while 295 patients received rituximab-abbs. The cohort had a mean age of 63.7±12.2 years and 43% were female. The 2-year OS was 81.0% and 79.6% (NI p < 0.01) while the ORR was 80.0% and 69.6% (NI p < 0.01), among the rituximab-abbs and rituximab groups, respectively. The incidence of infusion reaction AEs (NI p < 0.01) and noninfusion reaction AEs (NI p < 0.01) also met noninferiority. CONCLUSIONS: We demonstrated that rituximab-abbs was noninferior to rituximab in both effectiveness and safety among patients receiving R-CHOP for DLBCL in this study. Long-term follow-up would be needed to confirm these results.

Failures in communication and information transfer across the surgical care pathway: interview study.

BACKGROUND AND OBJECTIVES: Effective communication is imperative to safe surgical practice. Previous studies have typically focused upon the operating theatre. This study aimed to explore the communication and information transfer failures across the entire surgical care pathway. METHODS: Using a qualitative approach, semi-structured interviews were conducted with 18 members of the multidisciplinary team (seven surgeons, five anaesthetists and six nurses) in an acute National Health Service trust. Participants' views regarding information transfer and communication failures at each phase of care, their causes, effects and potential interventions were explored. Interviews were recorded, transcribed verbatim, and submitted to emergent theme analysis. Sampling ceased when categorical and theoretical saturation was achieved. RESULTS: Preoperatively, lack of communication between anaesthetists and surgeons was the most common problem (13/18 participants). Incomplete handover from the ward to theatre (12/18) and theatre to recovery (15/18) were other key problems. Work environment, lack of protocols and primitive forms of information transfer were reported as the most common cause of failures. Participants reported that these failures led to increased morbidity and mortality. Healthcare staff were strongly supportive of the view that standardisation and systematisation of communication processes was essential to improve patient safety. CONCLUSIONS: This study suggests communication failures occur across the entire continuum of care and the participants opined that it could have a potentially serious impact on patient safety. This data can be used to plan interventions targeted at the entire surgical pathway so as to improve the quality of care at all stages of the patient's journey.

An observational study of teamwork skills in shift handover.

BACKGROUND: Clinical handover (handoff, sign out) is frequently implicated as a cause of adverse events in hospitalised patients. Complex social interactions such as handover are subject to the teamwork skills of the participants and there is increasing evidence that the quality of teamwork in handover affects outcome. Teamwork skills have been assessed in one-to-one handovers but the applicability of these measurement tools to healthcare team shift handovers remains unproven. This study aimed to assess the feasibility of measurement of teamwork skills in shift handover and the applicability of adapted teamwork skills rating scales to a shift handover environment. METHODS: Morning surgical shift handovers were assessed for completeness of information transfer, duration, interruptions and handover attendance. Handover teamwork skills were evaluated using two validated rating scales, adapted from one-to-one handovers and intra-operative teamwork skill measurement. RESULTS: 50 handovers, including 306 patients were observed. Communication checklist completion was 97% but the quality of teamwork skills varied widely between handovers. There was very good concurrent validity between the two teamwork skill rating scales (Spearman's rho = 0.67, p < 0.001). There was no significant correlation between content completion, duration, interruptions or attendance and teamwork skill ratings. CONCLUSIONS: Teamwork skills vary widely between handovers and can be consistently scored using both rating scales. It is feasible to use adapted teamwork skill rating scales in shift handover and they appear to measure different constructs to traditional handover measures such as interruptions and communication checklist completion. The assessment of teamwork skills is a necessary complement to the assessment of completeness of information transfer when evaluating the overall quality of handover.

Quantitative analysis of intraoperative communication in open and laparoscopic surgery.

BACKGROUND: Communication is important for patient safety in the operating room (OR). Several studies have assessed OR communications qualitatively or have focused on communication in crisis situations. This study used prospective, quantitative observation based on well-established communication theory to assess similarities and differences in communication patterns between open and laparoscopic surgery. METHODS: Based on communication theory, a standardized proforma was developed for assessment in the OR via real-time observation of communication types, their purpose, their content, and their initiators/recipients. Data were collected prospectively in real time in the OR for 20 open and 20 laparoscopic inguinal hernia repairs. Assessors were trained and calibrated, and their reliability was established statistically. RESULTS: During 1,884 min of operative time, 4,227 communications were observed and analyzed (2,043 laparoscopic vs 2,184 open communications). The mean operative duration (laparoscopic, 48 min vs open, 47 min), mean communication frequency (laparoscopic, 102 communications/procedure vs open, 109 communications/procedure), and mean communication rate (laparoscopic, 2.13 communications/min vs open, 2.23 communications/min) did not differ significantly across laparoscopic and open procedures. Communications were most likely to be initiated by surgeons (80-81 %), to be received by either other surgeons (46-50%) or OR nurses (38-40 %), to be associated with equipment/procedural issues (39-47 %), and to provide direction for the OR team (38-46%) in open and laparoscopic cases. Moreover, communications in laparoscopic cases were significantly more equipment related (laparoscopic, 47 % vs open, 39 %) and aimed significantly more at providing direction (laparoscopic, 46 % vs open, 38 %) and at consulting (laparoscopic, 17 % vs open, 12 %) than at sharing information (laparoscopic, 17 % vs open, 31 %) (P < 0.001 for all). CONCLUSIONS: Numerous intraoperative communications were found in both laparoscopic and open cases during a relatively low-risk procedure (average, 2 communications/min). In the observed cases, surgeons actively directed and led OR teams in the intraoperative phase. The lack of communication between surgeons and anesthesiologists ought to be evaluated further. Simple, inexpensive interventions shown to streamline intraoperative communication and teamworking (preoperative briefing, surgeons' mental practice) should be considered further.

Teamwork and team performance in multidisciplinary cancer teams: development and evaluation of an observational assessment tool.

AIM: Team performance is important in multidisciplinary teams (MDTs), but no tools exist for assessment. Our objective was to construct a robust tool for scientific assessment of MDT performance. MATERIALS AND METHODS: An observational tool was developed to assess performance in MDTs. Behaviours were scored on Likert scales, with objective anchors. Five MDT meetings (112 cases) were observed by a surgeon and a psychologist. The presentation of case history, radiological and pathological information, chair's effectiveness, and contributions to decision-making of surgeons, oncologists, radiologists, pathologists and clinical nurse specialists (CNSs) are analysed via descriptive statistics, a comparison of average scores (Mann-Whitney U) to test interobserver agreement and intraclass correlation coefficients (ICCs) to further assess interobserver agreement and learning curves. RESULTS: Contributions of surgeons, chair's effectiveness, presentation of case history and radiological information were rated above average (p ≤ 0.001). Contributions of histopathologists and CNS were rated below average (p ≤ 0.001), and others average. The interobserver agreement was high (ICC = 0.70+) for presentation of radiological information, and contribution of oncologists, radiologists, pathologists and CNSs; adequate for case history presentation (ICC = 0.68) and contribution of surgeons (ICC = 0.69); moderate for chairperson (ICC = 0.52); and poor for pathological information (ICC = 0.31). Average differences were found only for case-history presentation (p ≤ 0.001). ICCs improved significantly in assessment of case history, and Oncologists, and ICCs were consistently high for CNS, Radiologists, and Histopathologists. CONCLUSIONS: Scientific observational metrics can be reliably used by medical and non-medical observers in cancer MDTs. Such robust assessment tools provide part of a toolkit for team evaluation and enhancement.

Information needs in operating room teams: what is right, what is wrong, and what is needed?

BACKGROUND: Safe surgical care requires effective information transfer between members of the operating room (OR) team. The present study aims to assess directly, systematically, and comprehensively, information needs of all OR team-members. METHODS: Thirty-three OR team-members (16 surgeons/anesthesiologists, 17 nurses) took part in a mixed-method interview. Participants indicated what information they need, their problems accessing it, and potential interventions to improve information transfer. They also rated the importance of different sources of information and the quality (accuracy, availability, timeliness, completeness, and clarity) of the information that they typically receive. Theme extraction and statistical analyses (descriptive and inferential) were used to analyze the data. RESULTS: The patient emerged as the top source of information. Surgeons and anesthesiologists relied more on information from fellow clinicians, as well as information originating from diagnostic and imaging labs. They were also more critical about the quality of the information than nursing personnel. Anesthesiologists emerged as the most reliable source of information, whereas information coming from surgeons was deemed lacking in quality (even by surgeons themselves). Finally, the more time participants had spent working in ORs, the more negative views they had about the information that they receive-an unexpected finding. Communication skills training, standardized communication protocols, and information technology (IT) systems to function as a central information repository were the top three proposed interventions. CONCLUSIONS: This study comprehensively maps information sources, problems, and solutions expressed by OR end-users. Recent developments in skills training modules and patient safety interventions for the OR (Surgical Safety Checklist) are discussed as potential interventions that will ameliorate communication in ORs, with a view to enhance patient safety and surgical care.

Postoperative handover: problems, pitfalls, and prevention of error.

OBJECTIVE: To identify the information transfer and communication problems in postoperative handover and to develop and validate a novel protocol for standardizing this communication. BACKGROUND: Effective clinical handover ensures continuity of patient care. Patient handovers within surgical units are largely informal. A thorough understanding of the problem is vital to develop standardized protocols. METHODS: A qualitative semistructured interview study was conducted with 18 healthcare professionals to uncover the problems with postoperative handover and to identify solutions, including components of a postoperative handover protocol. Interviews were recorded, transcribed verbatim, and submitted to emergent theme analysis. Multiple blind coders were used to ensure triangulation and reliability of the coding process. A Delphi method was used to elicit consensus from a group of 50 surgical professionals so as to validate the handover protocol. RESULTS: Many of the information transfer and communication failures at the postoperative phase are deemed to be due to an incomplete handover. All the interviewed healthcare professionals agreed that postoperative handover should be structured in the form of a standardized protocol so as to prevent omissions of any critical information. Based on this, 28 items were submitted to the Delphi process. Of these, 21 items had a mean importance score greater than 4.0 and were included in the final postoperative handover proforma under the following headings: patient-specific information, surgical information, and anesthetic information. CONCLUSION: The present study identified that the postoperative handover is informal, unstructured and inconsistent with often incomplete information transfer. Based on end-user input, a handover protocol was successfully developed and validated. Use of this may facilitate standardization of this critical activity and thereby improve the quality of patient care.

Entry screening to delay local transmission of 2009 pandemic influenza A (H1N1).

BACKGROUND: After the WHO issued the global alert for 2009 pandemic influenza A (H1N1), many national health agencies began to screen travelers on entry in airports, ports and border crossings to try to delay local transmission. METHODS: We reviewed entry screening policies adopted by different nations and ascertained dates of official report of the first laboratory-confirmed imported H1N1 case and the first laboratory-confirmed untraceable or 'local' H1N1 case. RESULTS: Implementation of entry screening policies was associated with on average additional 7-12 day delays in local transmission compared to nations that did not implement entry screening, with lower bounds of 95% confidence intervals consistent with no additional delays and upper bounds extending to 20-30 day additional delays. CONCLUSIONS: Entry screening may lead to short-term delays in local transmission of a novel strain of influenza virus. The resources required for implementation should be balanced against the expected benefits of entry screening.