Striving towards access to essential medicines for human and animal health; a situational analysis of access to and use of antifungal medications for histoplasmosis in Ethiopia.

Antifungal medications are vital in combatting fungal diseases that affect over a billion people annually. Antifungal medications for people and equids are scarce in Ethiopia, where lack of resources to treat fungal infection, in particular histoplasmosis, is a major health challenge. Histoplasmosis is endemic within the equine population in Ethiopia, where it is estimated that one in five horses are infected. This disease has far reaching impacts on equine welfare and the socio-economic wellbeing of families. The burden of histoplasmosis in people in Ethiopia is currently unknown, representing a blind spot in public health surveillance. Previous research has identified contact with wildlife, and domestic animal species as possible transmission pathways for histoplasmosis however, questions remain about the role of equids in human histoplasmosis. Given the close proximity of people and animals in this setting, the high level of endemic disease among equids, and the common sources of anti-fungals in Ethiopia, our study adopted a One-Health approach to examine how systemic issues affect access to, and use of antifungals to treat histoplasmosis among people and equids. A qualitative study was conducted in 6 urban regions of Oromia, Ethiopia in December 2018, incorporating semi-structured face-to-face interviews and focus group discussions. Twenty-seven individual interviews were held with doctors (n = 7), pharmacists (n = 12), veterinarians (n = 5), para-veterinarians (n = 2) and an equid owner (n = 1). Eleven focus groups were conducted with equid owners (n = 42), 3 with veterinarians (n = 6), 1 with para-veterinarians (n = 2) and 1 with pharmacists (n = 2). Transcripts were analysed using thematic analysis, and dimensions of key themes conceptualised and compared. Two overarching themes namely, 'Structural', and 'Human factors', summarised the main limitations to access to antifungal medications. 'Structural factors' included the national reliance on importation of medicines or pharmaceutical ingredients, inaccurate demand forecasting due to poor recording of the shortfall within the pharmaceutical supply chain, deficiencies in diagnostic capacity for fungal disease and, a healthcare system funded with a significant component of out-of-pocket expenditure. 'Human factors' that influenced access to antifungals included the perception of the expense of antifungals compared with competing needs such as food and education, the social stigma attached to histoplasmosis that could lead to delays in treatment seeking and, readily available home remedies or alternative treatment options. Furthermore, it was reported that trust in healthcare and veterinary provisions was undermined by a perceived lack of efficacious medications. Access to antifungals remains an urgent public health and animal welfare concern in Ethiopia. Key points within the supply and distribution chain that affect access to anti-fungals are identified, and policies that facilitate anti-fungal procurement and distribution should be reviewed. This paper highlights the structural, socio-economic and cultural factors influencing the management of infection with histoplasmosis, including how it is understood, identified and treated. This study identifies areas where further cross-sectorial work is needed to address these factors to improve disease control and clinical outcomes observed in human and animal histoplasmosis within Ethiopia.

Metal-citrate complex transport in Kineococcus radiotolerans.

The growth of an organism is highly dependent on the acquisition of carbon and metals, and availability of these nutrients in the environment affects its survival. Organisms can obtain both nutrients simultaneously through proteins of the CitMHS superfamily. Bioinformatic studies suggested a CitMHS gene (Accession number ABS03965.1) in Kineococcus radiotolerans. Radio flux assays following 14-C radiolabelled citrate, either free or complexed to a variety of metal ions, in K. radiotolerans demonstrated internalization of the citrate when bound to select metal ions only, primarily in the form of calcium-citrate. A pH response was also observed, consistent with a permease (ATP independent) mechanism as noted for other CitMHS family members, with greater uptake at pH 7 compared to pH 10. These results confirm the ability of K. radiotolerans to transport complexed citrate.

Intentional Rounding: a staff-led quality improvement intervention in the prevention of patient falls.

AIMS AND OBJECTIVES: This study designed and evaluated the use of a specific implementation strategy to deliver a nursing staff-led Intentional Rounding intervention to reduce inpatient falls. BACKGROUND: Patient falls are a common cause of harm during hospital treatment. Intentional Rounding has been proposed as a potential strategy for prevention, but has not received much objective evaluation. Previous work has suggested that logical interventions to improve patient care require an integrated implementation strategy, using teamwork training and systems improvement training, to instigate positive change and improvement. METHODS: Customised Intentional Rounding was implemented and evaluated as part of a staff-led quality improvement intervention to reduce falls on a neuroscience ward. Intentional Rounding was instigated using a prespecified implementation strategy, which comprised of: (1) engagement and communication activities, (2) teamwork and systems improvement training, (3) support and coaching and (4) iterative Plan-Do-Check-Act cycles. Process (compliance with hourly visiting to patients by staff) and outcome (incidence of falls) measures were recorded pre- and postintervention. Falls measured on the active ward were compared with incidence of falls in 50 wards across the rest of the same Trust. RESULTS: There was a 50% reduction in patient falls on the active ward vs. a minimal increase across the rest of the Trust (3·48%). Customised Intentional Rounding, designed by staff specifically for the context, appeared to be effective in reducing patient falls. CONCLUSIONS: Improvement programmes based on integrating teamwork training and staff-led systems redesign, together with a preplanned implementation strategy, can deliver effective change and improvement. RELEVANCE TO CLINICAL PRACTICE: This study demonstrates, through the implementation of a specific strategy, an effective improvement intervention to reduce patient falls. It provides insight into the effective design and practical implementation of integrated improvement programmes to reduce risk to patients at the frontline.

Lean Participative Process Improvement: Outcomes and Obstacles in Trauma Orthopaedics.

OBJECTIVES: To examine the effectiveness of a "systems" approach using Lean methodology to improve surgical care, as part of a programme of studies investigating possible synergy between improvement approaches. SETTING: A controlled before-after study using the orthopaedic trauma theatre of a UK Trust hospital as the active site and an elective orthopaedic theatre in the same Trust as control. PARTICIPANTS: All staff involved in surgical procedures in both theatres. INTERVENTIONS: A one-day "lean" training course delivered by an experienced specialist team was followed by support and assistance in developing a 6 month improvement project. Clinical staff selected the subjects for improvement and designed the improvements. OUTCOME MEASURES: We compared technical and non-technical team performance in theatre using WHO checklist compliance evaluation, "glitch count" and Oxford NOTECHS II in a sample of directly observed operations, and patient outcome (length of stay, complications and readmissions) for all patients. We collected observational data for 3 months and clinical data for 6 months before and after the intervention period. We compared changes in measures using 2-way analysis of variance. RESULTS: We studied 576 cases before and 465 after intervention, observing the operation in 38 and 41 cases respectively. We found no significant changes in team performance or patient outcome measures. The intervention theatre staff focused their efforts on improving first patient arrival time, which improved by 20 minutes after intervention. CONCLUSIONS: This version of "lean" system improvement did not improve measured safety processes or outcomes. The study highlighted an important tension between promoting staff ownership and providing direction, which needs to be managed in "lean" projects. Space and time for staff to conduct improvement activities are important for success.

Assessing the Nontechnical Skills of Surgical Trainees: Views of the Theater Team.

OBJECTIVE: This study aims to explore the views of members of theater teams regarding the proposed introduction of a workplace-based assessment of nontechnical skills of surgeons (NOTSS) into the Intercollegiate Surgical Curriculum Programme in the United Kingdom. In addition, the previous training and familiarity of the members of the surgical theater team with the concept and assessment of NOTSS would be evaluated. DESIGN: A regional survey of members of theater teams (consultant surgeons, anesthetists, scrub nurses, and trainees) was performed at 1 teaching and 2 district general hospitals in South Yorkshire. RESULTS: There were 160 respondents corresponding to a response rate of 81%. The majority (77%) were not aware of the NOTSS assessment tool with only 9% of respondents reporting to have previously used the NOTSS tool and just 3% having received training in NOTSS assessment. Overall, 81% stated that assessing NOTSS was as important as assessing technical skills. Trainees attributed less importance to nontechnical skills than the other groups (p ≤ 0.016). Although opinion appears divided as to whether the presence of a consultant surgeon in theater could potentially make it difficult to assess a trainee's leadership skills and decision-making capabilities, overall 60% agree that the routine use of NOTSS assessment would enhance safety in the operating theater and 80% agree that the NOTSS tool should be introduced to assess the nontechnical skills of trainees in theater. However, a significantly lower proportion of trainees (45%) agreed on the latter compared with the other groups (p = 0.001). CONCLUSIONS: Our survey demonstrates acceptability among the theater team for the introduction of the NOTSS tool into the surgical curriculum. However, lack of familiarity highlights the importance of faculty training for assessors before such an introduction.

The Safer Delivery of Surgical Services Program (S3): Explaining Its Differential Effectiveness and Exploring Implications for Improving Quality in Complex Systems.

OBJECTIVE: To analyze the challenges encountered during surgical quality improvement interventions, and explain the relative success of different intervention strategies. SUMMARY BACKGROUND DATA: Understanding why and how interventions work is vital for developing improvement science. The S3 Program of studies tested whether combining interventions addressing culture and system was more likely to result in improvement than either approach alone. Quantitative results supported this theory. This qualitative study investigates why this happened, what aspects of the interventions and their implementation most affected improvement, and the implications for similar programs. METHODS: Semistructured interviews were conducted with hospital staff (23) and research team members (11) involved in S3 studies. Analysis was based on the constant comparative method, with coding conducted concurrently with data collection. Themes were identified and developed in relation to the program theory behind S3. RESULTS: The superior performance of combined intervention over single intervention arms appeared related to greater awareness and ability to act, supporting the S3 hypothesis. However, we also noted unforeseen differences in implementation that seemed to amplify this difference. The greater ambition and more sophisticated approach in combined intervention arms resulted in requests for more intensive expert support, which seemed crucial in their success. The contextual challenges encountered have potential implications for the replicability and sustainability of the approach. CONCLUSIONS: Our findings support the S3 hypothesis, triangulating with quantitative results and providing an explanatory account of the causal relationship between interventions and outcomes. They also highlight the importance of implementation strategies, and of factors outside the control of program designers.

Quality Improvement in Surgery Combining Lean Improvement Methods with Teamwork Training: A Controlled Before-After Study.

BACKGROUND: To investigate the effectiveness of combining teamwork training and lean process improvement, two distinct approaches to improving surgical safety. We conducted a controlled interrupted time series study in a specialist UK Orthopaedic hospital incorporating a plastic surgery team (which received the intervention) and an Orthopaedic theatre team acting as a control. STUDY DESIGN: We used a 3 month intervention with 3 months data collection period before and after it. A combined teamwork training and lean process improvement intervention was delivered by an experienced specialist team. Before and after the intervention we evaluated team non-technical skills using NOTECHS II, technical performance using the glitch rate and WHO checklist compliance using a simple 3 point scale. We recorded complication rate, readmission rate and length of hospital stay data for 6 months before and after the intervention. RESULTS: In the active group, but not the control group, full compliance with WHO Time Out (T/O) increased from 14 to 71% (p = 0.032), Sign Out attempt rate (S/O) increased from 0% to 50% (p<0.001) and Oxford NOTECHS II scores increased after the intervention (P = 0.058). Glitch rate decreased in the active group and increased in the control group (p = 0.001). Complications and length of stay appeared to rise in the control group and fall in the active group. CONCLUSIONS: Combining teamwork training and systems improvement enhanced both technical and non-technical operating team process measures, and were associated with a trend to better safety outcome measures in a controlled study comparison. We suggest that approaches which address both system and culture dimensions of safety may prove valuable in reducing risks to patients.

The effect of teamwork training on team performance and clinical outcome in elective orthopaedic surgery: a controlled interrupted time series study.

OBJECTIVES: To evaluate the effectiveness of aviation-style teamwork training in improving operating theatre team performance and clinical outcomes. SETTING: 3 operating theatres in a UK district general hospital, 1 acting as a control group and the other 2 as the intervention group. PARTICIPANTS: 72 operations (37 intervention, 35 control) were observed in full by 2 trained observers during two 3-month observation periods, before and after the intervention period. INTERVENTIONS: A 1-day teamwork training course for all staff, followed by 6 weeks of weekly in-service coaching to embed learning. PRIMARY AND SECONDARY OUTCOME MEASURES: We measured team non-technical skills using Oxford NOTECHS II, (evaluating the whole team and the surgical, anaesthetic and nursing subteams, and evaluated technical performance using the Glitch count. We evaluated compliance with the WHO checklist by recording whether time-out (T/O) and sign-out (S/O) were attempted, and whether T/O was fully complied with. We recorded complications, re-admissions and duration of hospital stay using hospital administrative data. We compared the before-after change in the intervention and control groups using 2-way analysis of variance (ANOVA) and regression modelling. RESULTS: Mean NOTECHS II score increased significantly from 71.6 to 75.4 in the active group but remained static in the control group (p=0.047). Among staff subgroups, the nursing score increased significantly (p=0.006), but the anaesthetic and surgical scores did not. The attempt rate for WHO T/O procedures increased significantly in both active and control groups, but full compliance with T/O improved only in the active group (p=0.003). Mean glitch rate was unchanged in the control group but increased significantly (7.2-10.2/h, p=0.002) in the active group. CONCLUSIONS: Teamwork training was associated with improved non-technical skills in theatre teams but also with a rise in operative glitches.

A combined teamwork training and work standardisation intervention in operating theatres: controlled interrupted time series study.

BACKGROUND: Teamwork training and system standardisation have both been proposed to reduce error and harm in surgery. Since the approaches differ markedly, there is potential for synergy between them. DESIGN: Controlled interrupted time series with a 3 month intervention and observation phases before and after. SETTING: Operating theatres conducting elective orthopaedic surgery in a single hospital system (UK Hospital Trust). INTERVENTION: Teamwork training based on crew resource management plus training and follow-up support in developing standardised operating procedures. Focus of subsequent standardisation efforts decided by theatre staff. MEASURES: Paired observers watched whole procedures together. We assessed non-technical skills using NOTECHS II, technical performance using glitch rate and compliance with WHO checklist using a simple quality tool. We measured complication and readmission rates and hospital stay using hospital administrative records. Before/after change was compared in the active and control groups using two-way ANOVA and regression models. RESULTS: 1121 patients were operated on before and 1100 after intervention. 44 operations were observed before and 50 afterwards. Non-technical skills (p=0.002) and WHO compliance (p<0.001) improved significantly after the intervention in the active versus the control group. Glitch count improved in both groups and there was no significant effect on clinical outcomes. DISCUSSION: Combined training in teamwork and system improvement causes marked improvements in team behaviour and WHO performance, but not technical performance or outcome. These findings are consistent with the synergistic hypothesis, but larger controlled studies with a strong implementation strategy are required to test potential outcome effects.

Effectiveness of facilitated introduction of a standard operating procedure into routine processes in the operating theatre: a controlled interrupted time series.

BACKGROUND: Standard operating procedures (SOPs) should improve safety in the operating theatre, but controlled studies evaluating the effect of staff-led implementation are needed. METHODS: In a controlled interrupted time series, we evaluated three team process measures (compliance with WHO surgical safety checklist, non-technical skills and technical performance) and three clinical outcome measures (length of hospital stay, complications and readmissions) before and after a 3-month staff-led development of SOPs. Process measures were evaluated by direct observation, using Oxford Non-Technical Skills II for non-technical skills and the 'glitch count' for technical performance. All staff in two orthopaedic operating theatres were trained in the principles of SOPs and then assisted to develop standardised procedures. Staff in a control operating theatre underwent the same observations but received no training. The change in difference between active and control groups was compared before and after the intervention using repeated measures analysis of variance. RESULTS: We observed 50 operations before and 55 after the intervention and analysed clinical data on 1022 and 861 operations, respectively. The staff chose to structure their efforts around revising the 'whiteboard' which documented and prompted tasks, rather than directly addressing specific task problems. Although staff preferred and sustained the new system, we found no significant differences in process or outcome measures before/after intervention in the active versus the control group. There was a secular trend towards worse outcomes in the postintervention period, seen in both active and control theatres. CONCLUSIONS: SOPs when developed and introduced by frontline staff do not necessarily improve operative processes or outcomes. The inherent tension in improvement work between giving staff ownership of improvement and maintaining control of direction needs to be managed, to ensure staff are engaged but invest energy in appropriate change.

Interventions employed to improve intrahospital handover: a systematic review.

BACKGROUND: Modern medical care requires numerous patient handovers/handoffs. Handover error is recognised as a potential hazard in patient care, and the information error rate has been estimated at 13%. While accurate, reliable handover is essential to high quality care, uncertainty exists as to how intrahospital handover can be improved. This systematic review aims to evaluate the effectiveness of interventions aimed at improving the quality and/or safety of the intrahospital handover process. METHODS: We searched for articles on handover improvement interventions in EMBASE, MEDLINE, HMIC and CINAHL between January 2002 and July 2012. We considered studies of: staff knowledge and skills, staff behavioural change, process change or patient outcomes. RESULTS: 631 potentially relevant papers were identified from which 29 papers were selected for inclusion (two randomised controlled trials and 27 uncontrolled studies). Most studies addressed shift-change handover and used a median of three outcome measures, but there was no outcome measure common to all. Poor study design and inconsistent reporting methods made it difficult to reach definite conclusions. Information transfer was improved in most relevant studies, while clinical outcome improvement was reported in only two of 10 studies. No difference was noted in the likelihood of success across four types of intervention. CONCLUSIONS: The current literature does not confirm that any methodology reliably improves the outcomes of clinical handover, although information transfer may be increased. Better study designs and consistency of the terminology used to describe handover and its improvement are urgently required.

Oxford NOTECHS II: a modified theatre team non-technical skills scoring system.

BACKGROUND: We previously developed and validated the Oxford NOTECHS rating system for evaluating the non-technical skills of an entire operating theatre team. Experience with the scale identified the need for greater discrimination between levels of performance within the normal range. We report here the development of a modified scale (Oxford NOTECHS II) to facilitate this. The new measure uses an eight-point instead of a four point scale to measure each dimension of non-technical skills, and begins with a default rating of 6 for each element. We evaluated this new scale in 297 operations at five NHS sites in four surgical specialities. Measures of theatre process reliability (glitch count) and compliance with the WHO surgical safety checklist were scored contemporaneously, and relationships with NOTECHS II scores explored. RESULTS: Mean team Oxford NOTECHS II scores was 73.39 (range 37-92). The means for surgical, anaesthetic and nursing sub-teams were 24.61 (IQR 23, 27); 24.22 (IQR 23, 26) and 24.55 (IQR 23, 26). Oxford NOTECHS II showed good inter-rater reliability between human factors and clinical observers in each of the four domains. Teams with high WHO compliance had higher mean Oxford NOTECHS II scores (74.5) than those with low compliance (71.1) (p = 0.010). We observed only a weak correlation between Oxford NOTECHS II scores and glitch count; r = -0.26 (95% CI -0.36 to -0.15). Oxford NOTECHS II scores did not vary significantly between 5 different hospital sites, but a significant difference was seen between specialities (p = 0.001). CONCLUSIONS: Oxford NOTECHS II provides good discrimination between teams while retaining reliability and correlation with other measures of teamwork performance, and is not confounded by technical performance. It is therefore suitable for combined use with a technical performance scale to provide a global description of operating theatre team performance.

Capturing intraoperative process deviations using a direct observational approach: the glitch method.

OBJECTIVES: To develop a sensitive, reliable tool for enumerating and evaluating technical process imperfections during surgical operations. DESIGN: Prospective cohort study with direct observation. SETTING: Operating theatres on five sites in three National Health Service Trusts. PARTICIPANTS: Staff taking part in elective and emergency surgical procedures in orthopaedics, trauma, vascular and plastic surgery; including anaesthetists, surgeons, nurses and operating department practitioners. OUTCOME MEASURES: Reliability and validity of the glitch count method; frequency, type, temporal pattern and rate of glitches in relation to site and surgical specialty. RESULTS: The glitch count has construct and face validity, and category agreement between observers is good (κ=0.7). Redundancy between pairs of observers significantly improves the sensitivity over a single observation. In total, 429 operations were observed and 5742 glitches were recorded (mean 14 per operation, range 0-83). Specialty-specific glitch rates varied from 6.9 to 8.3/h of operating (ns). The distribution of glitch categories was strikingly similar across specialties, with distractions the commonest type in all cases. The difference in glitch rate between specialty teams operating at different sites was larger than that between specialties (range 6.3-10.5/h, p<0.001). Forty per cent of glitches occurred in the first quarter of an operation, and only 10% occurred in the final quarter. CONCLUSIONS: The glitch method allows collection of a rich dataset suitable for analysing the changes following interventions to improve process safety, and appears reliable and sensitive. Glitches occur more frequently in the early stages of an operation. Hospital environment, culture and work systems may influence the operative process more strongly than the specialty.