The combination of personal protective equipment (PPE) together with donning and doffing protocols was designed to protect British and Canadian military medical personnel in the Kerry Town Ebola Treatment Unit (ETU) in Sierra Leone. The PPE solution was selected to protect medical staff from infectious risks, notably Ebola virus, and chemical (hypochlorite) exposure. PPE maximized dexterity, enabled personnel to work in hot temperatures for periods of up to 2 h, protected mucosal membranes when doffing outer layers, and minimized potential contamination of the doffing area with infectious material by reducing the requirement to spray PPE with hypochlorite.The ETU was equipped to allow medical personnel to provide a higher level of care than witnessed in many existing ETUs. This assured personnel working as part of the international response that they would receive as close to Western treatment standards as possible if they were to contract Ebola virus disease (EVD). PPE also enabled clinical interventions that are not seen routinely in West African EVD treatment regimens, whilst providing a robust protective barrier. Competency in using PPE was developed during a nine-day pre-deployment training programme. This allowed over 60 clinical personnel per deployment to practice skills in PPE in a simulated ETU and in classrooms. Overall, the training provided: (i) an evidence base underpinning the PPE solution chosen; (ii) skills in donning and doffing of PPE; (iii) personnel confidence in the selected PPE; and (iv) quantifiable testing of each individual's capability to don PPE, perform tasks and doff PPE safely. Ebola virus is found in body fluids such as blood, sweat, vomit and diarrhoea of patients in the acute phase of infection Serious gaps in implementing infection prevention and control (IPC) standards were reported in the settings where transmission likely took place or where infected HCWs were employed. Among these, the most frequently reported were deficiencies in administrative, engineering and environmental controls, inappropriate use or lack of personal protective equipment (PPE), defective IPC practice and behaviour, and poor employment conditions and social determinants The Ministry of Defence (MoD) Kerry Town Ebola Treatment Unit (ETU) was developed to provide the highest possible standards of care, including interventions such as peripheral and central venous catheters, urinary catheters and blood product transfusions. During the period from admission of the first patient in November 2014 to discharge of the last patient in December 2015, the unit admitted 125 patients, 44 of whom had a final diagnosis of EVD. It was important that IPC standard precautions were maintained to reduce the risk of healthcare-associated infections for medical staff and patients.In September 2014, specialists from Public Health England, the National Ambulance Resilience Unit and the Ministry of Defence (MoD) worked together to identify the combination of PPE and donning and doffing protocols for PPE worn by military medical personnel working in a 12-bedded ETU in Kerry Town, Sierra Leone. PPE comprised both single-use and re-usable items. It needed to be available in a variety of sizes; to be resistant to heat, sweat and chemicals; to minimise loss of dexterity; and to maximize movement. Furthermore, the items needed to be procured during a time when many countries were seeking to stockpile PPE, making development of a sustainable solution critical to allow for continuity and the establishment of reliable supply.The rationale behind the PPE solution was to allow for care to be delivered whilst protecting those working within the ETU, providing a barrier against nosocomial infection.PPE was doffed in a designated area, prior to exit into the green zone Cotton scrubs were chosen as the base layer. Consideration was given to disposable scrubs but these were rejected on the basis of comfort, material degradation and additional clinical waste. Cotton scrubs offered a comfortable, absorbent base that could be bleached, laundered and re-used. Due to the risk of malaria, long-sleeved tops would have been preferred as they offer greater protection against mosquito bites; however, these proved to be significantly more difficult to source within the time frames available.Rubber boots were chosen as the footwear for the clinical zone as they are both chemical and ultraviolet resistant; the boots needed to be decontaminated by soaking in hypochlorite (5000 ppm) for at least 10 min, rinsed in water and left inverted, exposed to direct sunlight, before being transferred to the green zone changing room for re-use. Rubber boots are flexible and comfortable for wearers, and seamless boots were preferred to aid decontamination. White or bright colours (not red) were the preferred option as contamination could be seen easily. The sole and upper area of the boot needed to be resistant to both cuts and punctures. Furthermore, the sole needed to meet EN13287 SRA and SATRA TM144 standards in order to be slip resistant, whilst not having a deep tread which could be difficult to decontaminate. Immersion foot can be caused by wearing damp socks and shoes for less than one day Despite the final choice of coverall suits, back fastening gowns were initially considered as part of the overall PPE solution due to their established use for infectious work. Gowns can be removed away from the wearer and may assist with temperature regulation in a warm environment. However, in this circumstance, a continuous suit that extends to cover the head, torso, arms and legs of the wearer was preferred. Coveralls are produced to suit a variety of settings, and water-resistant coveralls made of a breathable material with taped seams were selected to reduce the possibility of liquid penetration and contamination of exposed areas under the coverall.The single-use coveralls chosen and tested were made of polyethrine and polypreprine . These materials had a lower thermodynamic specification compared with other PPE available on the market, which potentially allowed for a longer working time in the red zone. Coveralls with finger loops were selected as these anchored the sleeve and prevented it from sliding up. Loops were worn on the middle finger as this minimized loss of dexterity. Integrated booties could potentially cause a trip hazard so were not preferred.Aprons were included within the PPE solution to increase protection to the front of the wearer, as this area was considered to be at high risk of splashes/spills of contaminated material and, in addition, the coverall zip was set into permeable material. The properties stipulated were: length (below knee), plastic and lightweight design , fluid repellent and disposable. The apron chosen was adjustable, and so could cover the zip completely, irrespective of body shape, and helped to minimize heat stress whilst giving the necessary protection. The recommendation was to change aprons and gloves between patients in order to reduce the risk of cross-contamination between patients.From the outset, double gloving was the agreed standard practice to allow outer gloves to be changed between patients whilst still protecting the HCW. Tactility and dexterity through two pairs of gloves was of key importance. In addition to complying with European standard EN 374-2:2003 for resistance to penetration by chemicals and micro-organisms, avoidance of allergic reactions was considered from both a patient and wearer perspective. These factors led to the choice of 400-mm nitrile, powder-free gloves.These long gloves gave additional coverage to the arm, coupled with a secure elasticized coverall fitting around the wrist; this, together with the coveralls' attached finger loops, held the coverall cuffs in place and minimized the risk of exposure of the hands, wrists and lower arms. The first pair was worn under the cuff of the coverall, with the second pair worn over the cuff and extending up the arm. The guidance of the US Centers for Disease Control and Prevention The use of goggles was initially considered but, following assessment of the environment and the level of care that would be delivered, it was decided that goggles would be too restrictive and the vision range would be too poor.A disposable filtered face piece 2 (FFP2), non-valved mask was selected to be worn under a face visor. Although the Ebola virus is not spread via the airborne route, it was essential to protect the eyes, mouths and noses of HCWs from droplets and splashes. An FFP2 mask in combination with a full face visor was considered to be sufficient to control the risk of fluid splash. Non-valved or shrouded valve FFP2 masks were preferred as these offer a greater level of protection from splashes. The masks chosen were suitable for use in hot and humid conditions, and were compatible with the face visors. Additionally, the shape of the masks and the way they were donned made the removal process safe.Two types of multi-use adjustable visors were chosen as these could fit the diversity of personnel deployed comfortably and securely. Repeated decontamination of visors in high levels of hypochlorite solution led to delamination and clouding of the visors and rusting of metal supports, so both types of visors had replaceable acetate screens and plastic adjustable head pieces. After 10 min of soaking in 5000 ppm hypochlorite, the visors were rinsed in water, dried and returned for re-use. The visors provided good head movement and a greater vision range, thereby increasing situational awareness. A clear full face visor also meant that patients could see the clinician's face, allowing better communication and reassurance. Staff reported that the visors reduced the feelings of claustrophobia, and allowed air movement and a cooling effect.Two layers of disposable head wear were worn: a surgical cap, to aid with coverage of the front of the head and prevent hair falling in front of an individual's eyes; and the hood of the coverall suit. The hood of the coverall suit was worn over the upper edge of the visor, allowing the hood to be removed prior to the visor in the doffing stage, thus maintaining protection of the mucosal membranes for longer during the doffing procedure. Fluid-repellent caps were preferred; however, surgical caps of several styles were found to be suitable. Most clinical PPE were single-use items, apart from scrubs, face visors and boots. Re-usable items were cleaned and decontaminated by the wash team prior to re-use.Personnel suffering from stress, fatigue, heat degradation and dehydration are at a higher risk of making errors The donning and doffing procedures were adapted from the systems already in use, and were familiar to those used by ambulance hazardous area response teams when wearing the civilian responder (CR1) suit. Whilst this equipment was unfamiliar to military personnel, similar procedures are used with the military Mark 1V chemical biological radiological and nuclear protection suit, and the training reflected this. A stepwise approach  was devePersonnel decontaminated their gloves  and then changed their gloves and aprons between tasks and patients, as per UK best practice The doffing procedure worked on a stepwise approach under instruction from PPE monitors . This enTraining was delivered in a graduated manner in line with MoD practices; this aided familiarity for the personnel, allowed them to understand the process and adopt it safely in situ and at regular intervals to ensure that they were confident and competent with the protocols once in West Africa. This continued in order to maintain competence until the outbreak was declared over and the facility closed down.Refresher training was given to staff The ETU concept and doctrine that was developed was designed to offer up to high-dependency level care for HCWs in a resource-limited West African setting. It was well resourced with medical and nursing staff, with a nurse:patient ratio of 1:1–1:2 depending on occupancy levels. For each 60-day clinical deployment period, up to 50 HCWs provided clinical care in the red zone. The initial 12 beds (later increased to 20-bed capacity) provided a suspected EVD area, with four single-occupancy rooms with dedicated individual toilets. There was no cohorting of suspected EVD patients and no cases of nosocomial transmission to suspected EVD patients. The tents and surrounding areas had closed-circuit television to allow remote monitoring of staff and patients, and were temperature controlled.nd Field Hospital as part of Operation GRITROCK between November 2014 and June 2015. A large number of personnel used PPE, and the combination of equipment chosen could be adapted to fit all the deploying personnel.The PPE solution described for the MoD-led ETU at Kerry Town was used by personnel deployed with the 22et al. Lamb Temperatures in Sierra Leone typically reached 31 °C, which caused people wearing PPE to perspire heavily. Some batches of gloves degraded on contact with perspiration, visibility could be reduced by condensation on the visors, and sweat could pool in the rubber boots. This was managed by limiting the amount of time that staff spent in the red zone to a maximum of 2 h. There was a protocol for heat stress and emergencies in the red zone, allowing safe extraction of staff should the need arise.The quality of PPE was monitored and any failures were managed using a formal reporting mechanism. Issues with insufficient thickness of aprons, delamination of visor screens, perspiration-sensitive gloves and variability between batches of coveralls were identified and addressed in this way. Faulty batches of PPE were disposed of and replacements were sourced quickly.Observed breaches in PPE included rips in coveralls caused by catching on door handles or rubbing against rough wooden balustrades. This was mitigated by removing door handles where possible, and wrapping the balustrades in cushioned material. Other breaches in PPE included the coverall hoods or headwear slipping off within the red zone. The headwear protected the user from chlorine dripping off the tent flaps, and contact from patients who occasionally patted medical staff on the head as they leant over. If the headwear was displaced, the wearer proceeded to the doffing station immediately, but the risk of contracting Ebola from this was considered low and so did not result in quarantining of the individual.et al. PPE was designed to protect the wearer primarily from infectious risks, but also from the high concentrations of hypochlorite used. These levels caused the re-usable PPE (boots and visors) to disintegrate and glaze/delaminate, respectively. Rinsing in fresh water and wiping followed by air drying helped to reduce the degradation of this equipment. During the deployment, one individual contracted EVD via an unknown route. As discussed in the paper by Lamb Furthermore, two individuals undertook precautionary medical evacuation following needlestick incidents which, when investigated, were not attributed to a failure in PPE. PPE was not designed to protect the wearer from sharps, and therefore strict protocols were used to protect against this hazard.The robust military management style helped to ensure that donning and doffing drills were followed accurately and consistently. This was further enforced by the role of PPE monitors who ensured that the doffing area was well managed, and instructed and observed each person through the doffing procedure and checked for any breaches in PPE. During the deployment, small, authorized changes were made to the protocols defined pre-deployment in order to speed up the doffing process whilst not compromising IPC, and the protocols described here are those used and tested in Sierra Leone.et al. et al. Developing a PPE solution for those deploying to the ETU was a critical stage in the UK MoD response because PPE, protocols and the use of disinfectant were the major infection prevention controls. The personnel who would be manning the treatment centre had to be assured and confident in the selection of equipment and the training provided as the situation facing them was unique and not comparable to other military deployments. The use of ultraviolet tracer during training revealed no cross-contamination, unlike recent reports by Casanova A range of subject matter experts, including experienced emergency responders, and clinical, scientific, laboratory and military staff, worked together to develop and deliver an intense nine-day training course that encompassed the predicted environment that would be faced during deployment. When transferred to the field environment, initial training could then be supplemented and any issues faced fed back to the UK team, allowing for amendments to be made to protocols if required. This continuous feedback loop ensured that the most up-to-date protocols were used for training, and provided a quality control aspect.The PPE solution chosen was robust and implemented successfully within the ETU in Sierra Leone. However, limitations in the PPE selected have been described, and the authors would lobby for further improvements in PPE design. Such improvements would lead to decreased heat stress for the user and a more simple doffing solution, whilst not compromising infection control methods and maintaining protection from direct and indirect contamination.None declared.Wellcome Trust (104480/Z/14/Z) and the UK MoD.No specific funding. TF is funded by the


An Acute Oncology Service (AOS) is paramount to providing timely and improved pathways of care for patients who are admitted to hospital with cancer-related problems or suspected cancer.To establish an AOS pilot study to decide how best to implement such a service locally.The AOS, which included collaboration between the oncology and palliative care teams at the Northern General Hospital in Sheffield, UK, ensured that the majority of oncology patients in the region received timely assessment by an oncologist if they became acutely unwell as a result of their cancer or its treatment. The AOS consisted of a thrice-weekly ward round, and daily telephone advice service.We report on patient data during the first 12 months of the pilot study. Delivery of the AOS enhanced communication between the services and provided inter-professional education and support, resulting in earlier oncological team involvement in the management of patients with cancer admitted under other teams, as well as provision of advice to patients and their caregivers and families. Provision of the AOS shortened the mean length of hospital stay by 6 days. Two case studies are presented to illustrate the typical challenges faced when managing these patients.Establishment of the AOS enabled effective collaboration between the oncology and other clinical teams to provide a rapid and streamlined referral pathway of patients to the AOS. Locally, this process has been supported by the development of acute oncology protocols, which are now in use across the local cancer network.Journal of Comorbidity 2012;2:10–17 In the UK, the incidence of the most common cancers, including breast, lung, colorectal and prostate cancer, is strongly associated with increasing age, and, therefore, many patients who have cancer also have other comorbidities . OncologAcute oncology is a subspeciality, which has evolved relatively recently, that focuses on the prompt management of patients who are admitted to hospital because of symptoms caused by their cancer or its treatment. This includes patients for whom a new diagnosis of cancer is established following admission to hospital with symptoms that may suggest a malignant cause, such as anaemia or dysphagia. The impetus behind the creation of this subspeciality was the findings from two reports commissioned to assess the safety and quality of chemotherapy services in England; findings which highlighted the often less-than-optimal care of such patients.In 2008, the National Confidential Enquiry into Patient Outcome and Death (NCEPOD) published the report of their study of patients who died within 30 days of receiving systemic anticancer therapies (SACT) . One of Following this report, the National Chemotherapy Advisory Group (NCAG) was asked to address the concerns raised by NCEPOD. Their report, published in August 2009, recommended, amongst other things, that all hospitals with an Accident and Emergency (A&E) department establish an Acute Oncology Service (AOS), with representation from A&E, general medicine, clinical and medical oncology, haematology, oncology nursing, and oncology pharmacy .In April 2011, the peer-reviewed Acute Oncology Measures were published . One stiThe Weston Park Hospital (WPH) in Sheffield, UK, is one of only four specialist cancer hospitals in the country, serving a population of 1.8 million in South Yorkshire and North Derbyshire. Almost all oncology services in Sheffield, including the delivery of radiotherapy and systemic anticancer therapies, are concentrated at the purpose-built cancer centre at the WPH. The site also includes the Cancer Clinical Trials Centre where patients receive treatment in the context of clinical trials. Satellite chemotherapy units also provide a limited range of SACT in the wider region. Geographically distinct from the WPH, the NGH in Sheffield currently has 1,354 beds, and admitted 15,475 patients in the financial year ending March 31, 2011. It receives all acutely unwell adult patients in the city via the sole adult A&E department. Prior to September 2010, oncology input at the NGH was limited to one outpatient clinic and two multidisciplinary team meetings per week. There was no provision for the assessment of inpatients at the NGH by an oncologist.In response to the NCEPOD and NCAG reports, an acute oncology pilot study was initiated in September 2010 to provide dedicated oncology input for inpatients at the NGH. For the first 7 months of the pilot study, a consultant clinical oncologist provided expertise via an acute oncology ward round for one-half day per week. This service was increased to two-and-a-half days per week in total, spread over 3 days, for the final 5 months of the pilot study by the addition of a medical oncology specialist registrar to the acute oncology team. The service was advertised repeatedly via email to all of the consultants at the NGH, with details of how to refer patients to the service.At the same time, an AOS was also established at the WPH, where the majority of patients on anticancer therapy in the region are admitted if they become acutely unwell as a result of their cancer or its treatment. The AOS at the WPH consists of a daily consultant ward round to ensure that all newly admitted patients are seen by a consultant within 24 hours of admission, and the availability of a consultant for telephone advice for clinicians from other specialities 24 hours per day, 7 days a week.During the first 12 months of the pilot at the NGH, 136 patients were seen. Of these, 122 sets of notes were available for analysis, although a limited amount of information was available for some of those patients for whom the notes were not available. Patient outcomes were censored on 05/09/11. Two thirds of the patients were previously known to have a diagnosis of cancer . The remainder were newly diagnosed with cancer during their admission. Of the patients known to have a diagnosis of cancer, Of the patients who received a new diagnosis of cancer during this admission, almost all  were diagnosed radiologically following investigations for new symptoms. The tumour sites involved are illustrated in We assessed the impact of increasing the frequency of the AOS from one-half day per week to two-and-a-half days per week in terms of mean length of hospital stay (LOS). By increasing the frequency of the service, we significantly reduced the mean LOS by 6 days, from 26 to 19.8 days. The average daily income received by the trust for the patients we saw was approximately £200 per patient. A theoretical extension of their inpatient stay by 6 days would attract a much lower additional income of between £57 and £101 per night. In other words, an additional LOS by 6 days attracts little extra income for the trust, while costs continue to increase.The two case histories described below illustrate the typical challenges we faced when contributing to the management of these patients, many of whom were receiving care from several specialist teams in addition to the oncology team.A 79-year-old man was referred to the AOS by the admitting general physicians on 14/07/11 and was seen on the same day. He was known to have metastatic malignant melanoma at the time of admission to the NGH, but was not previously under the care of an oncologist. He had been admitted on 12/07/11 with general deterioration, and had been found to have acute kidney injury (AKI) with a serum creatinine of 603 μmol/L on routine biochemistry. A computed tomography (CT) scan performed prior to this admission on 21/06/11 showed extensive pelvic nodal metastases from his melanoma, which were now presumed to have caused urinary tract obstruction resulting in AKI. Prior to the involvement of the AOS, the admitting team had sought the advice of the renal physicians as to the suitability of renal dialysis for this man. It was concluded that dialysis was not appropriate. The admitting team then requested advice from the urologists regarding the use of nephrostomies. The urologists had given advice over the telephone, as urology services are based at another hospital in the city. They had advised that nephrostomies were a possible option, but prior to insertion the patient would require re-imaging with a non-contrast CT scan to firmly establish the presumed cause of the AKI. After receiving this advice, the admitting team contacted the AOS for an opinion to help decide the best management. We discovered a patient who had a performance status of 4, who was therefore not sufficiently fit to receive any systemic treatment for his underlying melanoma, the presumed cause of his AKI. It also became clear after speaking to the patient that he did not wish to have any further intervention. Our opinion was therefore that any further investigations, and the insertion of nephrostomies, were not appropriate. We recommended that the team responsible for this man’s care discuss his medical problems and grave prognosis with the patient and his family, and instigate palliative care to manage any symptoms as appropriate. He died peacefully in hospital 6 days later.This case illustrates some of the complexities involved in healthcare decisions, which often include opinions from several different medical and surgical specialities. Obtaining an opinion from the relevant teams can be time-consuming, and clinicians are often obliged to make assessments and give opinions without the benefit of actually seeing the patient. This can lead to them giving their “gold-standard” advice, which is often not appropriate for individual patients. It then falls to another clinician, usually the consultant under whose care the patient has been admitted, to co-ordinate the patient’s care, and decide on a management plan for their patient, having noted the advice received.A 61-year-old man not previously known to have cancer was referred to the AOS 7 days after his admission to the NGH under the care of the orthopaedic surgeons. He had been transferred from a local district general hospital for a biopsy of a vertebral lesion, which had been found on a magnetic resonance imaging scan after he presented with back pain. On arrival at the NGH, the patient had normal neurological function. Whilst the results of the biopsy were awaited, the patient developed bilateral leg weakness and sensory loss. Surgery was not thought to be appropriate. He was seen by the AOS team, treatment with radiotherapy was discussed, and the patient was transferred to the WPH later that same day for radiotherapy, which was commenced the following day. Subsequent investigations did not reveal a primary tumour, although bone biopsies confirmed metastatic adenocarcinoma. He therefore had a diagnosis of carcinoma of unknown primary. Following his radiotherapy, he was deemed too unwell for chemotherapy and received best supportive care. He died 10 weeks after his initial diagnosis.The NGH has a palliative care hospital support team that aims to manage the symptoms of patients with potentially life-limiting conditions, including cancer. During the Sheffield AOS pilot study, the oncology and palliative care teams worked in collaboration. The main benefit was timely communication between the services; which is particularly important given the poor prognosis of this patient group. Other advantages included inter-professional education and support. Other centres in Europe have also found that despite the presence of a hospital palliative care team, oncologists require training in symptom management, as they are often involved in the end-of-life care of patients with cancer . MansourDespite the fact that many of the patients referred to the AOS were deemed too unwell to receive or continue SACT, they and their relatives found reassurance from a specialist oncology opinion. Those with a pre-existing diagnosis of cancer had often developed longstanding relationships with oncologists that they wanted to continue. That is, the presence of the AOS relieved psychological distress. Many patients were referred by the AOS to the palliative care team for specialist symptom control and advanced care planning. Conversely, palliative care specialists referred patients to the AOS for consideration of oncological treatment for the control of refractory symptoms, for example, radiotherapy for bone cancer pain. For those with a new diagnosis of cancer, the AOS perspective on potential anticancer treatment options and likely prognosis facilitated clinical decision-making. Finally, effective teamwork allowed accurate, consistent information to be communicated to both patients and their families.The use of chemotherapy and other SACT has increased dramatically over recent years, with an increase of approximately 60% in the amount of chemotherapy delivered over a 4-year period . In addiIn our experience, communication between teams is essential in order to minimize repetition of work and to establish more clearly the respective roles of the various clinicians contributing to the care of the patient. In the USA, sentinel events occurring in the healthcare settings are reported voluntarily, or via the complaints process, to the Joint Commission. When this occurs, the healthcare organization is required to share its root-cause analysis, which, in turn, is reviewed by a Joint Commission clinician. Breakdown in communication is one of the leading root causes of medical adverse events reported to the Joint Commission . This brOur observations also show that such communication between healthcare professionals and patients is often suboptimal. Directly asking the patient about their wishes regarding further intervention is a simple, but often overlooked, way in which treatment decisions can be made collaboratively. In their document “Treatment and care towards the end of life: good practice in decision making”, the General Medical Council states that doctors should, “Respect patients’ right to reach decisions with you about their treatment and care” . During Our experience shows that patients who have cancer and require emergency admission to hospital, or who have symptoms requiring admission to hospital – which are subsequently found to be due to cancer – tend to be elderly, and have poor outcomes. Prior to the AOS pilot study in Sheffield, individual oncologists were in direct communication with a limited range of clinicians from other specialities when attending tumour site-specific multidisciplinary team meetings. During the pilot study, we have received referrals from numerous sources, necessitating clear communication between clinical teams who did not previously have established links. The AOS provides a platform from which non-oncologists can be informed about the toxicities of SACT, thus encouraging a more streamlined referral pathway of such patients to the AOS. Locally, this process has been supported by the development of acute oncology protocols, which are now in use across the local cancer network.In addition, patients were referred to us who had a newly diagnosed, often un-investigated primary, when historically, oncologists would only have received referrals of patients who have undergone the traditional “work-up”, including radiological and histological assessment. Our data show that the majority of these patients are elderly, and have comorbidities, and few go on to receive any specific oncological intervention. By becoming involved in the care of such patients at a much earlier stage than would traditionally have been the case, we have been able to help direct their management, which in two-thirds of cases was towards best supportive care. Thus, we hope to have avoided unnecessary investigations for patients who have a poor performance status and are therefore not sufficiently fit to receive anticancer therapy. King and Leonard report similar findings from The Whittington Hospital in London, UK, where the introduction of an AOS resulted in fewer blood tests, biopsies and endoscopies, and also reduced the LOS in these patients , 15. By


The Demand-Driven Evaluations for Decisions (3DE) programme was piloted in Zambia and Uganda in 2012–2015. It aimed to answer evaluative questions raised by policymakers in Ministries of Health, rapidly and with limited resources. The aim of our evaluation was to assess whether the 3DE model was successful in supporting and increasing evidence-based policymaking, building capacity and changing behaviour of Ministry staff.Using mixed methods, we compared the ex-ante theory of change with what had happened in practice, why and with what results (intended and unintended), including a qualitative assessment of 3DE’s contribution. Data sources included a structured quality assessment of the five impact evaluations produced, 46 key informant interviews at national and international levels, structured extraction from 170 programme documents, a wider literature review of relevant topics, and a political economy analysis conducted in Zambia.We found that 3DE had a very limited contribution to changing evidence-based policymaking, capacity and behaviour in both countries as a result of having a number of aspirations not all compatible with one another. Co-developing evaluation questions was more time-consuming than anticipated, Ministry evidence needs did not fit neatly into questions suitable for impact evaluations and constricted timeframes for undertaking trials did not necessarily produce the most effective results and value for money. The evaluation recommended a focusing of objectives and a more strategic approach to strengthening evaluative demand and capacity.Lessons emerge that are likely to apply in other low- and middle-income settings, such as the importance of supporting evaluative thinking and capacity within wider institutions, of understanding the political economy of evidence use and its uptake, and of allowing for some flexibility in terms of programme targets. Fixating on one type of evidence is unhelpful in the context of institutions like ministries of health, which require a wide range of evidence to plan and deliver programmes. In addition, having success tied to indicators, such as number of ‘policy decisions made’, provides potentially perverse incentives and neglects arguably more important aspects such as incremental programmatic adjustments and improved implementation.The online version of this article (doi:10.1186/s12961-017-0250-4) contains supplementary material, which is available to authorized users. Evidence can shape policy decisions in a variety of ways. Our primary interest is often in understanding whether and under what circumstances robust evidence directly contributes to a policy decision. Yet, as Johnson describes , the appThe literature suggests that the extent of uptake of evaluation evidence  in policy is often relatively modest. A comprehensive report on relevance, quality and influence of impact evaluations conducted by the World Bank Group found that, while impact evaluation evidence was observed in some cases to make a positive contribution to development practice and policy debate, systematic use of evidence was weakened by a number of constraints, such as lack of government demand or champions . This coBoth reviews note that detecting or measuring the extent of evidence uptake is challenging, especially given that some of the broader level influences on how knowledge is used in the policy process may be intangible such as relationships between researchers, departments and wider stakeholders , 6, 7. HIn order to be relevant, information presented to policymakers should be salient (relevant to the problem), credible  and legitimate  , 9. One Some policy questions that governments are concerned with are also not well suited to ostensibly rigorous evaluation techniques such as randomised controlled trials (RCTs) , 14, eitSecondly, evaluation evidence is often not available when policy decisions need to be made , 10, 11.A third factor identified in the literature is that empirical evidence is not well communicated to policymakers since reports may be excessively technical , 15 or tThe failure of some evaluators to deliver high quality, timely, policy-relevant and appropriately communicated findings to policymakers points to a wider concern that the priorities of the producers and users of evaluation are not closely aligned. This is in part due to the fact that evaluations in lower- and middle-income countries tend to be commissioned by international development partners . There iA prerequisite for the actual use of evaluations in policy is that key political actors demand evidence to be made available and are receptive to the findings. Guidance produced by the World Bank Group on strengthening government capacity in generating and using M&E evidence argues that weak demand for evaluation evidence can pose an even greater limitation to the use of evaluation evidence in policy than the issues around evaluation characteristics described above , 18.There are mixed findings in the literature on whether this demand exists in different contexts. Hyder et al.  find thamaximise the likelihood of alignment between the evaluation and departmental willingness to use the findings” . ndings”  pilot was designed by the Clinton Health Access Initiative (CHAI) and IDinsight. It was based on the recognition that Ministry of Health (MoH) officials often lack evidence on the most effective and efficient ways in which to deliver known clinical interventions and services. Further, where evidence is generated, it is often not relevant to the operational needs of MoH officials or done within a period that meets decision-making timeframes. The 3DE pilot model aimed to facilitate a more demand-driven approach to the evaluation of health interventions by 1) identifying relevant, suitable and priority evaluation questions from the ministries, (2) conducting these evaluations rigorously but rapidly and in an affordable manner, and (3) catalysing the response to their findings and sharing the lessons learned from this process more widely, so as to influence future evaluation processes. Under this pilot, 3DE was expected to conduct eight (later revised to five) impact evaluations that influenced managerial decisions in six instances (later revised to four) in Uganda and Zambia. The interventions that were evaluated under the 3DE pilot are summarised in Table  identifyThis article presents findings from the evaluation of the 3DE pilot. Its main objective is to provide lessons on how to design evidence support programmes or initiatives for the health sector . It builds on the small but growing literature documenting attempts to support evidence-based policy at institutional level in low- and middle-income countries.The overall aim of the evaluation, conducted in 2015, was to assess whether the 3DE model had been successful in supporting and increasing evidence-based policymaking, building capacity and changing the behaviour of Ministry staff in terms of demanding and using evidence (as these were the 3DE objectives).As the evaluation was commissioned ex-post and there was no credible counterfactual, the evaluation took a theory-based approach, starting from the theory of change for 3DE, structured by process, outputs and outcomes Fig. . AssumptThe evaluation considered 3DE as a whole, including consideration of how it was established and the prioritisation of evaluation questions that the 3DE evaluations would seek to answer. However, each individual evaluation conducted by 3DE constituted a case study within the overall framework, which could be compared in order to generate a richer understanding of differences and similarities.As most of the work had been undertaken in Zambia, this was the focus of the evaluation; nevertheless, a modified set of questions was used in Uganda to learn from the experience there. The evaluation was therefore able to draw from evidence from two national settings and across five different evaluations.Five main sources of evidence were used for the evaluation.Given the overall objective of the intervention, the purpose of this component was to test the effectiveness of the programme in generating high quality evaluations. The quality of the 3DE evaluations was assessed against a set of specific questions, including the relevance and clarity of the evaluation questions; the extent to which contextual factors that could affect the evaluation were considered; the clarity and level of detail with which the intervention was described; the extent the evaluation considered other programmes that may have affected key indicators; the appropriateness of the evaluation methodology, including the adequacy of the sample size, and the extent to which baseline differences, spillover effects, externalities, imperfect compliance, non-response and attrition were dealt with appropriately; the appropriateness and rigour of the data sources and data collection; the rigour of the analysis including appropriate calculation of standard errors and use of sampling weights; the clarity and plausibility of the links between data, interpretation and conclusions; and the external validly of the evaluation.The assessment was applied to all five evaluations conducted by 3DE, although only three were finalised at the time of evaluation and so could be examined in relation to all quality assurance questions. Details of the assessment have been previously published .Forty-six key informant interviews were conducted, using semi-structured topic guides. The participants included a range of stakeholders internationally and in the two focal countries from government (n = 17), the 3DE programme (n = 16), and development partners and other institutions (n = 13). The interviewees were initially sampled purposefully to maximise information-rich cases augmented by snow-balling during the evaluation. The interviews were thematically coded and entered into an analysis spreadsheet, which was structured according to the key nodes in the theory of change. By reading down the columns, views from informants and evidence from 3DE programme documents could be triangulated on each topic, and a summary of evidence created.Over 170 documents of various types  were read, thematically coded and entered into the same spread sheet used for the key informants . An impoA literature review was undertaken to understand the background and wider global context for 3DE. This focused on a number of topics, including evidence on general experience and the efficacy of demand-led evaluations; evidence on evaluation use and uptake by policymakers; evidence on formal and informal barriers and enablers for conducting and using impact evaluations by policymakers/government officials; other global initiatives and experiences of demand-led evaluations; and reviews of on-going and recent impact evaluations in the health sectors of Zambia and Uganda.The body of literature reviewed included research papers, articles, theoretical discussion papers and synthesis reports drawing together the findings of other work.A political economy analysis of the health sector in Zambia was conducted to better understand the contextual factors influencing the outcomes of the 3DE model, with particular focus on resource allocation and decision-making within the two Ministries being studied, and how evidence was used in their policymaking processes.Some important limitations should be noted, including the relatively short timeframe of 3DE, which did not allow for the assessment of health outcome changes or the necessary maturation of catalysation activities. As a result, the evaluation focused on processes more than outcomes. The Ugandan experience also received more limited analysis compared to the Zambian one, given that no evaluation had yet been completed in Uganda.The theory of change of 3DE Fig.  stipulatAlthough the approach of starting from MoH questions was laudable, one challenge faced was that ministries do not generally have a prioritised set of research questions and are often institutionally divided. In Zambia, a set of ministerial research priorities had been established but it was more of a theoretical wish list and many questions were not amendable to answer by impact evaluation. In Uganda, individual disease programmes had research agendas but these had not been prioritised across the ministry as a whole. Developing options and assessing them was a much more intensive process than anticipated by the 3DE programme, and depended on strong links to specific groups within the MoH, which also biased the selection towards certain favoured programmes . In Uganda, a number of ‘false starts’ were made with different units within the MoH, which is one reason why ultimately just one impact evaluation was delivered there.Another challenge faced by 3DE implementers was identifying questions which met the rigorous criteria of the programme. These included that the intervention was feasible to implement in the timescale (9 months), had potential for wide impact, could be addressed through a rigorous experimental or quasi-experimental counterfactual-based impact evaluation, was being rolled out in a way and timeframe that could be used for the study, and where the chances of catalysing change in the future were strong. It is clear that these criteria were, in combination, very demanding, and this in part explained the difficulty of identifying successful questions in Uganda and reaching the targeted four evaluations in Zambia.3DE implementers worked closely with Ministry partners  in Zambia) to source questions, but partners found it harder to engage in the prioritisation of questions that involved more technical issues about research design. This reduced their ultimate ownership in the process.The research questions posed by the evaluations were all shown to address relevant healthcare challenges in Zambia and Uganda and, in at least one case, the evaluation was timed to meet an important opportunity . The others addressed less urgent issues and took longer to conduct than originally prescribed. The rationale for the particular interventions evaluated in each study, including a description of underlying challenges and how the intervention mechanism was expected to address them, was not always well described in the evaluation reports.The overall quality of the design of the 3DE evaluations was assessed as variable, with some weaknesses stemming from the constraints placed on the evaluations in terms of timeframes and budgets.One aspect of the evaluation design that was consistently conducted well was the choice of primary outcome given the available study period. The evaluations all focused on measures that could be plausibly expected to change over a period of months if the intervention was effective. Although all evaluations did make an appropriate choice of primary outcome, there were some issues with the indicators used to track these outcomes. The evaluations were also well designed to make efficient use of the available budget and were organised to minimise additional workload for health staff by being aligned to a large degree with current practices in health facilities.The overriding concern with the design of 3DE evaluations was that the findings were not easily generalisable to other contexts . Many of the evaluations were only able to cover a limited geographic area and a small sample due to the relatively low budget and timeframe to implement the evaluation. There was also a concern that some of the 3DE evaluations may not have delivered sufficient internal validity despite their randomised design, given the small size of the treatment groups. The time and budget constraints also affected the implementation of the interventions themselves, which in some cases may have been too ambitious for the short evaluation period.In view of some of these concerns it was not clear that the choice of a given RCT always made the best use of the available budget. In some cases, a simple operational pilot or process study might have provided sufficient evidence around the implementation of interventions to help guide future programming decisions. This was particularly the case for interventions that sought to reinforce existing practices rather than providing new and previously untested solutions (such as the Early Infant Diagnosis simple intervention and the decongestion intervention).The evaluations appeared to have collected good data using appropriate techniques. Where the data-collection processes were reported on, these processes were assessed as good. Sample sizes were an issue for some of the evaluations. Quantitative findings were for the most part presented well. The explanation and interpretation of results could, however, have been further developed, with the overall findings better situated within a broader discussion of the context and likely mechanisms involved.We concluded that 3DE generally had a good awareness of entry points as well as of key stakeholders and disseminated evaluation findings well to key stakeholders, mostly to the implementers of the interventions they were evaluating. However, in order to provide rapid feedback, presentations preceded the finalisation of reports, which was problematic when final findings later changed. The ensuing ‘policy decisions’  took the form of advisory notes. The implications of the evaluations were largely managerial, rather than implying larger changes in programming or resource allocation. There was also limited scope for ‘catalysation’ work  and uptake had been limited at the time of evaluation. There was no resourcing for 3DE to follow-up on what had happened after ‘policy decisions’ were taken.3DE did not have a specific capacity-building plan beyond working closely through the stages of the programme with MoH/MCDMCH partners. Interviews indicated that individuals who worked closely with 3DE did benefit in terms of capacity development. More broadly, there was an expression of latent demand for evidence, although not necessarily for evaluations specifically. Both ministries (MoH and MCDMCH) lacked a wider strategic approach to evidence and research, and there was no indication that this had changed as a result of 3DE.Key stakeholders did not always have a clear understanding of the findings and raised questions about the external validity of results for other areas of the country and in ‘normal’ health system conditions. Ownership of findings was partial. Limited staff time, a lack of capacity in terms of research staff in key partner agencies, and a lack of incentives for evidence use were some of the factors behind this.Although the timeframe of our evaluation did not permit assessment of outcomes, the expected impact was unlikely to be transformational. Some 3DE evaluations supported a reinforced implementation of the status quo. Others suggested potential for some cost savings, though only in some contexts in Zambia, and with careful attention to ensure replicability of results. Others suggested a potential saving but largely for donors.There were a number of issues relating to context and internal factors that contributed to the failure of the 3DE pilot to achieve its key objectives. Among the contextual factors, the lack of an effective strategic prioritisation of evidence-based decision-making within government was highlighted as a constraint, along with unclear ministry roles in Zambia (linked to the split of the MoH into two ministries in 2012).The evidence that was deemed as most in need by Ministry officials in Zambia was operations research and situation analyses to identify and rectify bottlenecks in delivery or service and research to better understand the behaviour and motivation of end-users in regard to non-utilisation, as well as synthesis of evidence from other contexts. National reports also highlight insufficient use of data at all levels of government and further note that capacity and funding for research is limited . Demand Internal programme factors included positive ones, such as a strong starting base for CHAI, which was well embedded in the MoH, as well as negative, such as an initial understaffing of the 3DE Uganda programme. The degree of involvement of the MoH Principal Investigators and co-Investigators also varied across the studies and contexts, as might be expected, according to individual time and interest; these affected ownership and legacy.This evaluation adds to a small but growing body of evidence on how to support evaluation evidence uptake in the sub-Saharan African context. Mijumbi et al. , for exaThis evaluation of the 3DE programme faced limitations in terms of the ex-post design and its timing in relation to the interventions. However, the theory-based approach, combined with triangulation of different data sources derived from mixed methods, and a collaborative relationship between the evaluation specialists based in the programme implementing partner (CHAI), the commissioning group  and the evaluation team resulted in rich results and engagement to absorb the lessons learned.The evaluation concluded that 3DE had made a very limited contribution to changing evidence-based policymaking, capacity and behaviour in both countries. The main reasons behind this limited impact were judged to be two-fold. First, 3DE’s goal was inherently over-ambitious for a 3-year pilot. The overall goal, particularly in terms of building capacity and changing behaviour, requires a longer timeframe. Secondly, the programme had a number of aspirations that were not all compatible with one another. 3DE aimed to be demand-led, focused on robust impact evaluations, rapid, responsive and affordable, as well as catalysing action. A number of tensions or trade-offs exist within and between these aspirations. The overall lesson from the pilot is that even a very professional partnership cannot deliver on all of these in a short-term project in contexts like Zambia and Uganda, which are relatively typical of low- and middle-income settings. The necessary conditions for success are laid out in the revised theory of change  .encompasses both the capacity to find, evaluate and use…different forms of evidence and the motivation to use them to make evidence-informed policy” ,policy”  also needs to be classified as a policy decision in this context, if this is what the evidence recommends.In addition, if contribution to a policy decision is used as a target, then ‘policy decision’ should be broadened to include implementation, given the implementation gap which is so common in low-income countries . A focusThe evaluation also questioned the privileging of RCT-based impact evaluations as a higher form of knowledge. Different kinds of evidence are suited for different types of questions, and the 3DE modality could have focused on trying to generate or broker evidence that was suitable for the Ministry’s priority questions rather than privileging RCTs. RCTs are less suited to understanding processes, mechanisms, how and why implementation occurred, and the influence of context. Ministries rightly look for a range of information, including on equity and sustainability of interventions. Demand-generation or evidence-supply programmes should focus on supporting and providing appropriate tools for different questions. Evidence should fit with policy needs, so there should also be more flexibility about timeframes, for example. In some cases, having a longer time period would generate more useful and valuable information for the MoH than information generated rapidly. Overall value for money is also an important consideration. This was not assessed by the team and is itself a complex question . HoweverThere is a broader question about the primary purpose of conducting evaluations. The 3DE approach viewed evaluations as tools for providing answers to policy questions. In this model, engagement with civil society and stakeholders is primarily a vehicle for improving the evidence to inform those answers. Yet, in Zambia, as in other low-income countries, civil society is generally weak. A complementary model of the evaluation process might view evaluations also as tools for engaging civil society and stakeholders around an issue, helping build local capacity to define and measure progress by creating robust and engaged evaluation processes. Thus, a stronger emphasis on the evaluation process, with the aim of building evaluative thinking and capacity, might help provide ‘answers’ that have a greater degree of legitimacy than evaluations that take a more extractive approach to citizen and stakeholder evidence.The evaluation of the 3DE programme in Uganda and Zimbabwe illustrates the complexity of the process of supporting evidence-based policymaking in healthcare, as in other sectors, and the need for clarity of focus and realism of expectations. The 3DE programme promised an ambitious set of targets, some of which were in tension with one another. It focused on producing evaluations whose characteristics would support evidence-based policymaking, while neglecting the wider context and the characteristics of evaluation users. A number of important lessons have been derived which are likely to apply in other low- and middle-income settings, such as the importance of supporting evaluative thinking and capacity within the wider institutions, of understanding the wider political economy of evidence use and its uptake, and of allowing for some flexibility in terms of programme targets. Fixating on one type of evidence is unhelpful in the context of institutions like ministries of health, which require a wide range of evidence to plan and deliver programmes. In addition, being tied to ‘policy decisions’ provides perverse incentives and neglects arguably more important aspects for evaluators, such as contributing to incremental programmatic adjustments and improved implementation.


The presence of a polymorphonuclear neutrophil infiltrate in periprosthetic tissues has been shown to correlate closely with the diagnosis of septic implant failure. The histological criterion considered by the Musculoskeletal Infection Society to be diagnostic of periprosthetic joint infection is “greater than five neutrophils per high-power field in five high-power fields observed from histologic analysis of periprosthetic tissue at ×400 magnification.” Surgeons and pathologists should be aware of the qualifications introduced by different authors during the last years in the histological techniques, samples for histological study, cutoffs used for the diagnosis of infection, and types of patients studied. Recently, immunohistochemistry and histochemistry studies have appeared which suggest that the cutoff point of five polymorphonuclear neutrophils in five high-power fields is too high for the diagnosis of many periprosthetic joint infections. Therefore, morphomolecular techniques could help in the future to achieve a more reliable histological diagnosis of periprosthetic joint infection. Periprosthetic joint infection (PJI) is one of the most common complications in hip, knee, shoulder, and ankle replacements. For many years, there were no universally accepted criteria for the definitive diagnosis of PJI; each author or scientific society used their own gold standard, which might include clinical, analytical, radiological, microbiological, or histological features. Some authors considered only cultures , while oThe presence of a polymorphonuclear neutrophil (PMN) infiltrate in periprosthetic tissues has been shown to correlate closely with the diagnosis of septic implant failure. However, the extent of the PMN infiltrate that is required to establish a diagnosis of infection is controversial . The hisThe aim of the present review is to examine the origin of the MSIS' current definition of histological PJI and to consider what morphomolecular studies can add to the histological diagnosis of PJI.In PJI, two histological techniques have been used: frozen sections for intraoperative histological assessment and paraffin sections for final or postoperative assessment . ClassicThe major objective of the definitive postoperative histology is to establish whether the prosthesis was infected. In this regard, it serves as a confirmatory test for infection a posteriori once the new prosthesis has been implanted. Postoperative histology is also useful in diagnosing those cases of PJI which were thought preoperatively, on the basis of clinical and laboratory findings, to be aseptic in nature.As a result, intraoperative histology is used to guide surgical decisions , and definitive histology, in conjunction with other data such as microbiological results , is usedP = 0.04). A possible reason for these results could be the presence of fibrosis in the pseudocapsule which hindered neutrophil infiltration or that the largest bacterial biofilm is found between implant and bone. In addition, one group [During the revision arthroplasty the surgeon can obtain various samples of periprosthetic tissue for histological analysis. The tissues available are samples of synovium/pseudocapsule, the periprosthetic membrane, and other periprosthetic tissues in which infection is suspected. The literature review  shows thne group  recentlyne group , 46 suppThe histological criterion used to diagnose whether a prosthesis is infected or not is the presence or absence of PMNs . Some au P. acnes, can cause a periprosthetic infection with a PMN infiltration rate below five [As with all diagnostic tests, if we raise the histology test's cutoff point for defining infection to ten PMNs, we reduce the sensitivity while increasing the specificity; if we lower it to one PMN, the reverse is the case. The new definition proposed by the MSIS for periprosthetic infection uses five PMNs as cutoff point, because it is the most frequently used worldwide and because several studies have shown that there is no difference between using five or ten PMNs , 17, 22.low five , 42, 47. P. acnes) or virulent infection. Most authors have tried to assess the true value of this test using the postoperative diagnosis, that is, after the definitive diagnosis of the replacement as septic or aseptic has been established. However, one author assessed the value of the histology test based on the preoperative diagnosis, the suspicion of loosening (either septic or aseptic), or whether it was the time of reimplantation of a definitive prosthesis [The type of patient studied may also introduce a major bias in the definition of the sensitivity, specificity, and positive and negative predictive values of histology tests. This is due to the difference in incidence of low-grade infection , the histology tests were positive in all except two of the 13 caused by CNS.In patients with a preoperative suspicion of septic loosening, the microorganisms responsible presented a classic distribution of chronic infection with the presence of CNS,reported –51, the reported  of 38 re P. acnes. The only two specific studies [ Candida sp.), the histology was positive in only two cases (one case caused by CNS and the other by Candida sp.). The other study [One interesting group is those recently operated patients who have a cement spacer and require the placement of the definitive prosthesis. As in the first group, positive cultures in these patients are very likely to be due to a CNS or studies , 28 of ter study  reported P. acnes and most infections in elbow prostheses are due to CNS and P. acnes. In a study [ P. acnes was the etiology in 18 cases and other microorganisms in 12. The sensitivity was lower for the P. acnes group (50%) than for the other infections group (67%).Most of these studies were performed with revision arthroplasties of the knee and hip, but recently studies of revision arthroplasties of the shoulder  and elbo a study  of 45 paFinally, there are two groups of patients in which histology produces a high rate of false positives for diagnosis of infection: patients who undergo a prosthetic replacement and have an underlying inflammatory disease   and thosAs we have seen, all the studies analysed to determine the presence of PJI have used hematoxylin-eosin histological staining and have assessed the presence of a neutrophil polymorph infiltrate in periprosthetic tissues. Sometimes it is difficult to identify neutrophils, even using Feldman et al.'s criteria . The FelKashima et al.  reported2) in five different areas of each histological section  and counted the number of PMNs in these five areas. From this, the average number of PMN per HPF was calculated and the polymorph infiltration score determined as follows: 0 means no polymorphs identified, + means fewer than two polymorphs per HPF (×400), ++ means two to five cells per HPF, and +++ means more than five cells per HPF. The ways used to count the PMNs do not seem to affect the conclusions reached by the two authors. Their results corroborate those of previous studies which stated or inferred that infections due to CNS or P. acnes might have a PMN infiltration of fewer than five per HPF.Morawietz et al.  and KashAnother strategy for developing the histological morphomolecular diagnosis in PJI is first to define the molecules that are present in infected periprosthetic tissues and absent in uninfected tissues. Recently, two studies , 56 haveCD15 has been the most important tissue biomarker used in clinical and experimental histological studies to distinguish between septic and aseptic loosening , 57. TamToll-like receptors (TLR) are other tissue biomarkers that have been studied histopathologically in PJI. Takagi et al.  and LähdSubsequent studies have tried to identify the specific TLR associated with infection and sought to distinguish between infected and noninfected tissues histologically. Tamaki et al.  reportedDespite the large number of studies in this field over the past 40 years, the current histological criterion for PJI stipulated by the MSIS (more than five PMNs in five HPF) remains the one proposed by Mirra et al.  in 1976.


In the nursing profession, leadership plays a significant role in creating motivation and thus enabling nurses to provide high quality care. Ethics is an essential component of leadership qualifications and the ethical leader can help create an ethical atmosphere, offer ethical guidance, and ensure the occupational satisfaction of personnel through prioritizing moralities. However, some issues prevent the implementation of this type of leadership by nursing leaders. The aim of this study was to identify and describe some problems and obstacles in ethical leadership faced by nursing leaders, and to help them achieve more accurate information and broader perspective in this field.The present study was conducted using a qualitative approach and content analysis. A total of 14 nursing managers and educators were selected purposefully, and deep and semi-structured interviews were conducted with them. Content analysis was performed using an inductive approach. Three main categories were obtained after data analysis: ethical, cultural and managerial problems. “Ethical problems” pertain to doubt in ethical actions, ethical conflicts and ethical distress; “cultural problems” include organizational and social culture; and “managerial problems” are connected to organizational and staff-related issues.Nursing leaders put forth various aspects of the problems associated with ethical leadership in the clinical setting. This style of leadership could be promoted by developing suitable programs and providing clear-cut strategies for removing the current obstacles and correcting the organizational structure. This can lead to ethical improvement in nursing leaders and subsequently the nurses. Today, health care organizations are subject to rapid and fundamental changes aimed at enhancing the quality of service, patient satisfaction and productivity . ParalleOne of the most powerful methods to promote ethics in health care and the nursing practice is to role model ethical performance on the managerial level . Nurses Some studies in this field have indicated that ethical leadership leads to reduced work leave and increased job satisfaction in nurses through decreasing moral distress and creating an ethical milieu . FurtherThe Islamic Republic of Iran is located in the Middle East and enjoys one of the oldest civilizations of the world. It is a developing country with specific ethical values and a population of more than seventy million people. Islam is the formal religion in this country , and a cSimilar to their peers in many other countries, Iranian nurses are dissatisfied with their jobs due to work pressure and shortage of time and resources that prevent them from proper fulfillment of their duties . FurtherIt seems that these problems are imposed by lack of leadership skills in nursing managers. Studies have revealed that task-oriented behaviors are the dominant style of health care leaders and educational systems in Iran . LeadersThe present study used conventional qualitative content analysis and purposive sampling to investigate the problems and obstacles of ethical leadership in nursing. Conventional content analysis is usually the preferred method in studies that focus on elucidating a phenomenon. This design is suitable when there are limited numbers of existing theories or sporadic literature on the phenomenon under study. In this case, the researchers avoided the application of presupposed categories and managed to distill the categories from the data. Hence, the categories are manifested through deduction . Seeing that in the qualitative approach, the phenomena must be investigated in their natural context, the hospitals and nursing schools of Tehran, Iran, were selected as the research setting. Among the formal nursing leaders, those with at least 2 years of managerial work experience who wished to participate in the study were chosen. Selection criteria for the educators included experience in teaching ethics, leadership status, and publication of books and articles in the field of leadership and ethics. These individuals possessed deep information and experience related to the subject under study (they were key informants) and could provide the researcher with much information. As decision-makers in the health care system, clinical leaders and university authorities cannot be separated from each other, and the emergence of ideas on ethics requires the participation of both; therefore, nursing educators were also involved in this research. Moreover, the participating educators had some experience in clinical settings and leadership, and a number of them were occupied in the capacity of formal leaders at the time. This study tried to cover a sample with great variety in age, gender, management level, department, and work experience. To find the more experienced participants with a richer reservoir of data, the initial sample was used, which included nursing educators with a 22-year management experience at various levels of nursing as well as teaching ethics. . As confirmed by research participants, the interviews were held in a quiet room in their workplace at hospitals and colleges.A total of 14 individual interviews were conducted. Data saturation was achieved after 11 interviews, but an additional three were carried out to reach certaintyAll interviews were conducted by the first author, a female PhD candidate in nursing, and a nursing instructor. She has received the customary training for PhD students to prepare for doctoral dissertations, and has also completed a content analysis workshop. After obtaining the approval and written informed consent from the participants, deep and semi-structured interviews were conducted to collect the data. The interviewer began with general questions and proceeded to ask, “Where is the position of ethics in your leadership?” Then, based on the goals of the study, the more detailed questions followed, for instance: “Have you ever been in a situation where you did not do what was ethical despite being aware of it? Please explain.” and “What happened that led you to behave like that?”In order to obtain more data and clarify certain issues, some probing questions were also asked, such as: “Can you give us an example? What did you mean by that? Can you explain further?”Individual interviews lasted for 35 to 90 minutes and the participants were then asked to discuss any remaining issues that came to mind. The interviews continued till data saturation was achieved so that no new code of data could be retrieved. In this study, the common points were identified, coded and categorized by using latent content analysis. In this method, the researcher searches for specific concepts and the meaning of all the data within the context, and will then design the structural model that can relate the meaningful classes with similar themes . All interviews were recorded on tape and the transcripts were typed, reviewed and coded at the end of each interview. To observe the principle of confidentiality, participants’ names were not revealed. Instead, each of them was given a specific number and their important particulars such as age, type of degree, and managerial experience were recorded. Data were analyzed simultaneously and continuously by collecting information. Semantic units were extracted in the form of initial codes or open codes from the interviews. The codes were reread several times and placed in subcategories on the basis of similarity and proportion of the participant expressing the same topic. Next, the subcategories were compared with each other and those with similar characteristics were combined to create wider categories, which were presented once more. Some of the measures taken to enhance data accuracy included prolonged involvement with the topic, confirmation of findings by the participants, and observer reviews. To ensure dependability of the data, in addition to the members of the research team, two experts out of the research team were asked to evaluate the interviews, codings and categories. As regards the conformability of the data, all research steps, including data collection and analysis, observer reviews and the research process were documented on a regular basis. To enhance transferability, the entire process of the research and all the work done in the course of the study were prepared in clear and accurate written form to enable others to track and study population characteristics.This study was approved by the Human Research Ethics Committee of Shahid Beheshti University of Medical Sciences in Tehran, Iran. In the course of the study, permission was obtained from the authorities of hospitals, departments and colleges. The interviewer began by introducing herself and explaining the purpose of the research to the participants, who were then asked to complete the demographic questionnaire and informed consent. Moreover, permission to record the interviews and take notes was obtained from the participants, and confidentiality and subjects’ freedom to participate in or withdraw from the research was observed. The participants were also assured that their names will not be revealed under any circumstances. Interview tapes are kept anonymously in a safe place and can be accessed only through codes assigned by the researcher.There were 14 participants with a mean age of 46 years and an average management experience of 12 years. In terms of managerial level, 3 were supervisors , 6 were head nurses, and 5 were nursing educators . Analysis of the handwritten notes on participants’ experiences of the problems associated with ethical leadership in nursing resulted in the formation of 73 original codes, which were reduced to 21 after merging similar codes. Eventually, three main categories and 7 subcategories emerged that are presented in From the perspective of the nursing leaders in this study, there are three major types of problems and obstacles in ethical leadership: ethical, cultural and managerial problems.Ethical problemsEthical problems were among the categories abstracted from the data. In nursing leadership, these types of problems are sophisticated and pervasive due to their far-reaching implications and varied solutions on the one hand, and uncertain events and personal impressions on the other. The reason is that acts performed by nurse leaders affect staff, patients and other people. If these acts affect others inconsistently, or harm them in an uncontrolled manner, ethical problems arise. This category consists of three subcategories of doubt in the ethical act, ethical conflict, and ethical distress.A) Doubt in the ethical act: Quite often the consequences associated with ethical choices are not clear, and this will make leaders doubt their ethical performance. Participant number 2 who has a PhD in nursing and 8.5 years of management and leadership experiences at various levels puts it this way: (Participant No.2)Some participants stated that doubt in the ethical act is a challenge in nursing leadership. For example, participant number 11, a 45-year-old nurse with 9 years of experiences in different wards says: (Participant No. 11)B) Ethical conflict: Differences in ethical values in practice will lead to ethical conflicts. Participants admitted that sometimes they are involved in situations where the needs and expectations of nurses are in conflict with each other. Participant number 6, a 38-year-old nurse with a 6-year experience in head nursing and supervisory says in this regard: (Participant No. 6) Another aspect of the conflict is that both employees have similar desires, and therefore the nurse leader experiences negative feelings as to whose needs to meet under the circumstances. Participant number 14, a master of nursing with 20 years of management experiences at various levels  says: (Participant No. 14) Participants stated that sometimes there is a conflict between their values and beliefs and those of the organization. As nursing directors, they are expected to act in accordance with organizational values and justify them for the personnel, even though they might have different opinions. Participant number 9, a 44-year-old nursing PhD with 5 years of management experiences states: (Participant No. 9)Participants believed that ethical leadership is harder and more complex in the clinical setting than other work environments such as nursing education due to a high rate of ethical conflict:  (Participant No. 2)C) Ethical distress: Participants stated that when they are faced with obstacles that force them to act against their ethical beliefs, they feel discomfort, dissatisfaction and frustration. They acknowledged that they are often involved in situations where they know the right way to do things, but organizational policies and rules and lack of support from superiors make it impossible for them to perform their duties appropriately and this causes them distress and discomfort.  (Participant No. 2)Another condition that causes ethical distress in nursing leadership is lack of adequate and skilled manpower in wards. In this regard, participant number 5, a nursing expert with a 20-year experience of head nursing in different wards says: (Participant No. 5)Similarly, participant number 9, who is a 44-year-old PhD with 5 years of management experience, states: (Participant No. 9)CulturalproblemsIn data analysis, cultural problems were abstracted as the second category. Like any other institution, hospitals and health care centers have their own beliefs and norms that determine the way of thinking, behavior and performance of employees within the organization. The beliefs and opinions of organization members reflect those of the society in which they grew up. The nursing leaders in this study noted cases that can be classified as cultural problems, including two subcategories of social culture and organizational culture.A) Social culture: Culture is a model of values, beliefs and attitudes of people in every society, and the culture of any organization, including health care centers, is therefore no exception. Lack of respect for the nursing profession and the negative public image associated with it were among the cases that the participants pointed out. This negative attitude has an impact on the self-confidence and motivation of nurses, including nursing leaders. Leaders with low levels of self-confidence and motivation cannot play their leading and supportive role as may be expected. In this regard, participant number 9 states: (Participant No. 9)The Iranian society is a family-centered one, and this creates a negative attitude towards women working late hours and night shifts. Some participants mentioned this as an obstacle to their ethical practice. For example, participant number 13 says in this regard: (Participant No. 13)B) Organizational culture: Organizational culture is a control agent that shapes the attitudes and behavior of employees, and the participants pointed out the problems in this area as one of the cases. For example, participant number 3, a 52-year-old nursing PhD with 7 years of experience in management states: (Participant No. 3)Another participant says: (Participant No. 2)Managerial problemsAnother issue in the field is connected to managerial problems. These problems revolve mainly around axes such as inappropriate procedures, guidelines and evaluations as well as the poor performance of the nursing staff. This category consists of two subcategories: issues related to the organization and issues related to staff.A) Issues related to the organization: Lack of authority in recruitment, low regard for nursing, shortage of manpower and resources, and certain clinical characteristics were mentioned by the participants in this respect. Of the above-mentioned factors, they considered the first as one of the most challenging. For example, participant number 13, 44 years old, with 15 years of management experience states: (Participant 13).Participants had also experienced a lack of respect for nurses. They said that sometimes decisions are made for the nursing department without considering their opinions. Nurses are simply asked to implement those decisions, and do not even receive explanations and clarifications on the process. For example, participant number 8 says: (Participant No. 8)One source of power for leaders is their authority, which is based on reward and punishment. In order to use these power sources fairly, it is essential to evaluate staff performance, the most important purpose of which should be the improved quality of patient care and safety. But nursing leaders believe that the common evaluation method of staff performance is not fair: (Participant No. 13)Characteristics of health care organizations and in particular clinical environments, which are a component of the nursing profession, have created challenges for ethical leadership: (Participant No. 3)B) Issues related to staff: Ethical or unethical behavior and performance of the nursing staff can trigger positive or negative consequences at the organizational level; thus, non-observance of some ethical standards is a source of concern for efficient leaders. One of the things referred to by the participants in this study was abuse and bullying on the part of nurses. Participant number 10, a specialist nurse with 18 years of management experience states: (Participant No. 10)Adherence to ethical values on the personal level is the individual dimension of ethics, and a lack thereof will cause greed, selfishness, speaking ill of others, and so on. Such behaviors will lead to an escalation of conflict in the organization. Participant number 9, a 44-year-old PhD with 5 years of management experience says: (Participant No. 9)Participants believed that members of the staff are different from each other, even if placed in similar circumstances. One challenge faced by nurse leaders was lack of acceptance of individual differences among the staff, and a sense of injustice. In this regard, participant number 7, 47 years old, with 9 years of management experience at various levels states: (Participant No. 7)The findings of the present study were similar to those of other studies on this topic. Three main categories were identified, indicating the participants’ perceptions and experiences of ethical leadership barriers and problems in the sociocultural context of the Iranian health care setting. It should be mentioned that all formal nursing leaders in this study showed a kind of positive feeling and interest with respect to this leadership style. This was to be expected as members of the nursing workforce are committed to ethical practice in their profession . Ethical problems were among the abstracted categories in this research. Nursing leaders experienced doubt in the ethical act, ethical conflicts and distress in the clinical setting. Other studies with similar findings have also mentioned these issues  - 33. The results of this study demonstrated that the unexpected outcomes of ethical behavior could cause nursing leaders to hesitate about performing ethical acts. One issue that is raised in emergence of ethical complaints is that not all criteria used to justify ethical beliefs are fair, as they are affected by the ethical beliefs of a culture or a person . In one Today, ethical conflicts and controversies are inevitable in health care organizations round the globe, and this may lead to ethical distress . The stuThe results of this study showed that obstacles such as organizational policies and rules, lack of support from superiors, and lack of sufficient and qualified manpower will weaken leaders’ capability to perform ethical acts and create ethical distress. These findings are similar to those of the study by Gaudine and Beaton. Their findings revealed that disagreement with organizational policies over employee discipline, centralized decisions, and lack of ethical resources available to nurses are among the sources of ethical distress in ethical leaders . Shirey Leadership and management are affected by cultural, social, and economical factors. Cultural problems were one of the categories extracted from the participants’ statements. The role of culture in human behavior is one of the most important concepts discussed in behavioral sciences. In the present study, participants considered cultural and professional identity as one of the factors contributing to the promotion of the profession and professional attitude. Positive or negative cultural factors can be seen in any society. For example, negative attitudes towards nurses expressed by the participants can be effective on their self-confidence, authority, professional socialization process and professional identity. These findings are approved by other studies as well , 38 - 45The participants experienced improper organizational culture such as an absence of model acceptance, which affected their ethical leadership. The cultural values of an organization are usually a reflection of the society and the environment in which it belongs. Some other studies have suggested that the organizational culture is correlated with individual and leadership efficacies. The constructive aspects of organizational culture encourage individuals to find a way for self-correction and acquiring job satisfaction . SimilarData analysis confirmed that managerial problems are obstacles for ethical leadership. Issues related to the organization such as lack of power and authority in recruitment, low regard for the nursing staff, shortage of manpower and resources, and specific clinical features were among the cases referred to by the participants. This is not consistent with the findings by Fradd, who emphasizes the important role of nursing mangers in organizational decision-making in the scope of nursing     . Of couIn this study, participants referred to behaviors on the part of the personnel that disrupted the environment and had an impact on the quality of care, thus challenging ethical leadership. For instance, mistreatment, bullying and behavioral disorders such as defamation were among the cases referred to by the participants. Behaviors such as bullying are quite common in the nursing profession, as has been reported in many studies     - 57 . IThis study showed that despite the emphasis on ethical leadership in existing research, there are some barriers and problems in the implementation of this style of leadership. These obstacles have various aspects in ethical, cultural, and managerial domains. Identification of these factors can promote the ethical dimension of leadership. Health care policy makers may utilize the findings of this study to formulate programs and clear-cut strategies to remove these barriers and improve organizational structure and thus promote this style of leadership. Moreover, development of organizational ethical codes for guiding the performance of nursing leaders in confrontation with these problems may be helpful. Ethical leadership is feasible through correction of social and organizational cultures, and securing the public confidence in nursing from organizational and extra-organizational aspects. In conclusion, nursing leaders are required to consider the individual and occupational features and characteristics of personnel when approaching these problems. Discussions about the nursing profession and nursing leaders’ conditions can improve the standards in this regard. The leaders themselves play a key role in such discussions and should make their actions clearer and more specific. The findings of this study may help with the development of an instrument for investigating the barriers and problems of ethical leadership in nursing.Further studies are required on ethics in management and research, specifically in the case of each of the obstacles, causes of ethical problems, and their frequency and severity as well as their differences in various levels of management. Presently ,there is very limited information about the values, resources and mechanisms to resolve ethical problems, and that could be the basis for future research.