COVID-19 has rapidly become a pandemic emergency, distressing health systems in each affected country. COVID-19 determines the need for healthcare in a large number of people in an extremely short time and, like a tsunami wave, overruns emergency, infectious diseases, and pneumology departments as well as intensive care units, choking healthcare services. Rehabilitation services are also affected by this epidemic which forces radical changes both in the organization and in the operating methods. In the absence of reference literature on this issue, this report aims to provide a background documentation to support physicians and healthcare personnel involved in neurorehabilitation and rehabilitation care. The spread of coronavirus disease 2019 (COVID-19—COrona VIrus Disease 2019) has become unstoppable and in the last few weeks has reached the epidemiological criteria to be declared a pandemic by the World Health Organization, having widely exceeded 400,000  infected people in the world in over 100 countries  and non-European countries, shows that the challenge is similar for everyone. Nonetheless, the absence of a common pandemic plan in Italy and Europe, with Regions and individual countries that are still adopting different methods of managing the epidemic, runs the concrete risk of dissolving the effectiveness of the stringent measures implemented in different areas or countries. This can also be observed in China, where, in the face of an internal growth of new cases equal to zero over the past few days, new infections have been recorded due to the presence of the so-called “re-entry cases.” It must also be taken into account that the epidemic spread will occur with peaks at different times and areas, within and between the various countries, so the overall consequences will be related to the effectiveness of the different health systems.Numerous mathematical models for predicting the progress of the epidemic are being proposed in Italy and in the world in an attempt to provide useful tools to decision makers . Howeverwait-and-see attitude, but should rather induce us to learn from this “temporal advantage,” promptly implementing all the social distancing measures essential to reduce the circulation of the virus.The currently still limited number of cases, albeit growing, in the central-southern regions, should teach us not to repeat the error of a One of the most worrying aspects of the COVID-19 epidemic is linked to the involvement of frail and vulnerable people, in particular the elderly, subjects who suffer from multiple comorbidities or chronic diseases and people with disabilities. For this reason, it is essential to address and focus on prevention, health interventions and care in chronically ill patients staying in health care facilities, as well as patients suffering recent functional limitation requiring rehabilitation (or admitted to rehabilitation facilities).In fact, in an extremely short time compared to the spread of the epidemic, Rehabilitation Facilities need to enact prompt remodellling of the health organization both in the internal structure and in the strategy and approach of care delivery, which presents unique peculiarities within healthcare organizations , 10.Furthermore, in some areas due to the lack of beds, rehabilitation facilities are now being occupied with other patients, with consequent difficulty in hospitalizing patients, for example, discharged from stroke units.Therefore, in the need to reorganize hospital and outpatient rehabilitation activities , 12, thiThe following indications are suggested in order to make the reorganization of rehabilitation activities homogeneous, whether they are carried out in hospitalization or outpatient settings or at home, with the main aim of limiting patient flows within the facilities and maintaining staff safety. For some structures, these indications must take into account territorial and network needs, as well as the possible increase in hospital admission in order to favor discharge from acute care facilities.The definition of dedicated territorial and local pathways for patients from acute care facilities, separating noCOVID or negative COVID patients from suspected positive or positive Covid cases.Admissions to hospital wards must be limited to only those that are essential, and in any case supervised by personnel equipped with personal protective equipment. All other accesses must be closed.Posting of notices with behavioral rules at the entrances to and within all the departments [see ]Posting of hand hygiene recommendations near hand-sanitizing gel dispensers [see ]Staff of external companies are required to comply rigorously and systematically with standard precautions in addition to those provided by air, by droplets, and by contact, as indicated in the behavioral rules.Preparation of extraordinary plans for daily cleaning and sanitization of the rooms.Preparation of plans for extraordinary sanitization and cleaning in cases of access or identification of a “suspected case.”Reorganization of work shifts  with reduction of activities in order to reduce contact and movements. Where possible, encourage staff to work from home . Obligation for everyone to report any symptoms that have arisen recently; in this case, respect home isolation.Strengthening of patient and caregiver support networks, also through information technologies.Emphasis on the role of remote assistance and/or tele-rehabilitation in particular as remote home monitoring for patients who are unable to access rehabilitation hospitals or must be discharged in advance as well as for consulting activities in hospitals or in case of consultation for out-patientsFor all, monitoring of body temperature <37.5°C—Even in the absence of fever, it is necessary to subject people to careful triage by explicitly asking for their place of origin and detecting potential contacts.Suspension of caregiver visits to hospitalized patients . Exceptional cases must be authorized by clinicians according to the rules of the health management; access in derogation will be managed by the staff in order to avoid any contact and for a limited time.Rehabilitation units will have to keep the doors closed in order to control and direct the flow . for all health personnel and visitors with permission, monitoring of body temperature <37.5°C For discharges (see rules for access in derogation and compliance with point 2)Suspension of all meeting activities, replaced by the use of telephone or email contact.Clinical interviews with family members by phone or email only.Remodeling of rehabilitation programs, identifying the most relevant goals, among the short-term achievable onesSuspension of all rehabilitation activities that require internal flow (movement between floors or to reach gyms)Carrying out of rehabilitation activities in the patients' room where possible; in the case of gym activities, strictly keep the distance of at least 2 m between the patients.Reduction of the rehabilitation team's activities Education and empowerment of all healthcare professionals involved in rehabilitation team, by means of specific targeted training For all healthcare professionals, it is recommended to “enhance hand hygiene by following the WHO instructions, before and after each patient and whenever the hands move from the patient to another surface” Remember that “Masks with greater protection  are indicated only in suspicious or full-blown cases, therefore it is suggested not to abuse these devices, so as not to reduce their availability for cases of real need”In the management of suspicious cases (cases with not deferrable treatment) , remembepatient with respiratory symptoms (no COVID19): the patient is recommended to wear the surgical mask; keep a distance of at least 1 m or wear a surgical mask;patients suspected or affected by Covid-19: the use of FFP2 or FFP3 mask, protective gown, gloves, eye protection (goggles or face shield) is recommended;patients suspected or affected by Covid-19 during the execution of procedures capable of generating aerosols: the use of FFP3 mask, protective gown, gloves, eye protection (goggles or face shield) is recommendedEven in the absence of fever, people must be subjected to careful triage by explicitly asking where they came from and detecting potential contacts.NOTE: Remember that it is possible to carry out “…respiratory physiotherapy in hospitalization and re-education settings in recent outcomes of surgery, in trauma with fractures and the immediately post-acute phase of cardiac and neurological disabling pathologies  …,” for this specific area, please refer to the joint document of the Association of Rehabilitators of Respiratory Insufficiency and the Italian Association of Physiotherapists  (update of 16/03/2020) , if they are not affected or suspected by Covid-19.with appropriate personal protective equipment due to the impossibility of maintaining a distance of <1.5 m)Patients suspected or affected by Covid-19 with neurological impairments requiring rehabilitation and according to clinical conditions  should be treated in the room  without fever and cough suggestive of Covid-19 infection.Neurorehabilitation/rehabilitation Unit located outside general and multi-disciplinary Hospitals should only admit patients with sub-acute neurological disorders negative for Covid-19 infections in order to facilitate prompt availability of intensive care unit.Suspension of all outpatient and/or Day-hospital rehabilitation activities and/or with access from the outside Suspension of all activities including those of a freelance type (re-scheduling of visits and activities)Suspension of all home rehabilitation activities except those that cannot be postponed according to clinical judgment.The greatest difficulty in applying these indications in the field of neurorehabilitation/rehabilitation is related to the need to find the right balance between the provision of services useful to the patient (in case of not deferrable treatment) and the reduction of the risk of spreading the virus. In this phase of maximum spreading speed, priority must be given to reducing the risk of spreading the infection.The carrying out of rehabilitation activities in hospital stays, and in services in general, can only be continued in compliance with the needs of the patients and the protection of the health of all staff, as activities require close contact with the patient, or with the production of aerosols and secretions as for respiratory rehabilitation interventions  . FinallyIt must be reiterated that given the specificity of Rehabilitation/Rehabilitative interventions, which necessarily have to take into account the territorial contexts, the above indications must be adapted to the specific realities, while adhering as closely as possible to the recommendations.In fact, it seems useful to reiterate that the indications and measures to be taken are valid for all and should be applied in all countries and in the different areas as simultaneously as possible, because a non-uniform alignment would also lead to the risk of an inevitable misalignment in the desirable economic restart, with heavy long-term relapses.The original contributions presented in the study are included in the article/supplementary materials, further inquiries can be directed to the corresponding author/s.MB conceived the study. MB, DI, CL, GS, SP, and MZ also on behalf of the Authors listed in the The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


This model predicted 45% of the variance in the MPTPP (p < 0.001), which corresponds to a large effect size. We developed an effective prediction model for ED MPTPP, resulting in an MPTPP of 47 min. Future studies are needed to validate our model, which could serve as a benchmark for other EDs where the MPTPP is not available.One key element for emergency department (ED) staff calculation is the mean physician time per patient (MPTPP) and its influencing factors. The aims of this study were measuring the MPTPP, identifying factors with significant influence on the MPTPP, and developing a model to predict the MPTPP. This study was a prospective trial conducted at the ED of a university hospital in Germany. The MPTPP was measured with a specifically developed app. The influence of different factors on MPTPP were first tested in univariate analysis. Then, all significant factors were used in a multivariant regression model to minimize collinearities and to develop a prediction model. In total, 202 patients treated by 32 different physicians were observed within one year. The MPTPP was 47 min (standard deviation: 34 min). Relevant factors influencing the MPTPP were treatment area, Emergency Severity Index (ESI) triage level, guiding symptom category, and physician level (all  Crowding in emergency departments (ED) increases the risk of preventable medical errors , increasDifferent models for the calculation of the optimal number of staff required can be used . For mosTo our knowledge, there is no European study which actually measured MPTPP in the emergency department. Therefore, the aims of this study were measuring the MPTPP, identifying factors with a significant influence on the MPTPP, and developing a model to predict the MPTPP.This prospective cohort study was conducted in the ED of a university hospital in Germany. The ED sees approximately 33,000 patients per year and consists of three resuscitation rooms, 14 treatment spaces with stretchers and monitoring, one procedure room, one room for casting, and eight rooms for walking patients (fast-track area), including one room with special ears-nose-throat (ENT) equipment, and one room with special ophthalmic equipment. In total, the ED employs 11 fully trained specialist physicians and 14 doctors in training. Specialty emergency medicine does not exist in Germany; thus, fully trained specialist physicians come from various backgrounds, such as internal medicine, surgery, anesthesiology, or cardiology, as well as intensive care medicine. Since the fully trained specialist physicians have worked for many years in the ED, they have gained vast knowledge in emergency medicine and have seen patients with all kinds of symptoms. The doctors in training are either in their family medicine residency and stay for 18 months in the ED, or in their internal medicine or surgery, or trauma surgery residency and stay for 6 months in the ED. All patients are seen by doctors in training regardless of the patients’ symptoms or the specialty of the doctors in training. The doctors in training are all supervised by fully trained specialist physicians of the ED. In cases of higher patient volume, fully trained specialist physicians see patients without doctors in training to speed up the process.The MPTPP was measured with a smartphone application designed especially for this study. It allowed for the simultaneous allocation of different physicians to multiple patients, which in turn allowed for the documentation of the time required by each physician to work with one patient. Whenever a physician performed a patient-related activity, the time was started and stopped accordingly. After the case was closed and no more patient-related activity was performed, the total time spent per patient was recorded as total physician time for that specific patient. The MPTPP is the sum of the treatment times each emergency physician took for one particular patient.The treatment time consists of the time needed for the following actions: taking patient history; examination; charting and documentation; ordering tests and treatments; communication with the patient, family members, or other health professionals; reviewing interviews and test results; carrying out procedures; providing direct bedside care; and looking up information and administrative functions related directly to the patient, such as searching for available beds for admission. The time needed by a consulting physician from another specialty was not measured and not included in the calculations. The MPTPP did not include the waiting time of the patient.Fully trained specialist physicians and doctors in training were included in the study. The assignment of physicians to patients was random. If a certain patient was treated by a doctor in training and a fully trained specialist physician working in the capacity of a treating physician, the total MPTPP was assigned to the physician, who spent more time with the patient. The MPTPP does not include time for supervising a doctor in training.The number of patient observations needed was calculated by the rule of ten, as suggested by Everitt . The disPrior to the study, a set of potentially relevant influencing factors was determined, based on the factors already mentioned in the literature and clinical experience. These factors included the following: the patient’s age in years; the patient’s gender; whether the patient was treated in the fast-track area or acute area; Emergency Severity Index (ESI) triage level by arrival; time of the day, with the beginning of the treatment at 00:00–07:59, 08:00–15:59 or 16:00–23:59, guiding symptom category, with guiding symptom as described in the Canadian Emergency Department Information System (CEDIS) Presenting Complaint List  and as cThe study involved no experimental treatments and posed no risk to patients, so the university ethics committee approved the study without the need for patient consent. All emergency physicians gave verbal consent for observation, time measurement, and data collection.Data was collected by the smartphone application and entered into an Excel spreadsheet. Statistical analyses were done using SPSS Statistics .p < 0.05. Depending on the parameters, different tests were performed:Mann-Whitney test for two independent, non-parametric samples;Linear regression for interval scaled variables;Kolmogorov-Smirnov Goodness-of-Fit test for the distribution analysis of an interval scaled variable;Pearson’s chi-squared test for two categorical variables to test if the frequency distribution of a non-dichotomous variable corresponds to an expected distribution;Kruskal-Wallis test for more than two independent, non-parametric samples;Dunn-Bonferroni tests as post-hoc tests after a significant Kruskal-Wallis test;Binominal test to assess if the frequency distribution of a dichotomous variable corresponds to an expected distribution;A generalized linear model to create the multivariant model used to estimate the MPTPP of a patient and to identify collinearities between significant factors.For analysis, a descriptive statistic and a significance test were carried out. Significance level was determined as First, all potentially relevant influencing factors were analyzed using a univariate analysis. In the second step, significant factors were used to create a model. Non-significant factors were excluded one after another until only significant factors remained in the model. Subsequently, the Bayesian information criterion (BIC) was used to identify factors which could be excluded to improve the goodness of fit. The lower the BIC, the better the goodness of fit .R2. It is the proportion of the variance in the dependent variable that can be predicted from the independent variables [R2, the effect size of the model can be calculated. Therefore, Cohen’s The coefficient of determination for the multivariant model is ariables . With R2ect size .In total, 32 physicians were included in the study . A total of 142 patients were seen by doctors in training, 49 patients were seen by fully trained specialist physicians, and 11 patients were seen by doctors in training and fully trained specialist physicians. In 8 of these 11 patients, doctors in training spent the majority of the time with the patients. Therefore, the total MPTPP of these 8 patients was assigned to the doctors in training. Thus, in the analysis, a total of 150 patients were seen only by doctors in training, and 52 patients were seen only by fully trained specialist physicians.The overall MPTPP was 47 min (SD: 34 min).The following factors showed statistically significant differences in MPTPP : treatmeIn the multivariant regression model in the first step, the following factors were excluded due to a lack of significance: patient age, arrival time, and necessity of consultation. This lack of significance is mostly caused by collinearities between the factors. In the second step, the factor day of the week was excluded, reducing the BIC (from 1931 to 1920) and improving the goodness of fit. The following regression equation was derived from these data:Our study found an MPTPP of 47 min for ED patients, with treatment area, ESI triage level, guiding symptom category, and physician level being the most relevant factors for the MPTPP. We developed a prediction model which can calculate the MPTPP for individual EDs, taking into account the varying influence of each individual factor.To our knowledge, this is the first real-time measurement of the MPTPP for ED patients in Europe. Medical training and care delivery are not homogenous in Europe. Every country has differences in how much supervision doctors in training receive and the amount of autonomy they are allowed. Therefore, we did not include time for supervision or teaching in the MPTPP. First, the MPTPP for patient care has to be determined to be able to calculate the optimal number of staff required for safe patient care. In the next step, time for supervision and training needs to be determined, which will depend on the setting of each individual emergency department. Whereas the measured MPTPP of 52 min for doctors in training in our study reflects the MPTPP for doctors in training found in interviews in Germany and France , the meaIn our study, the factor treatment area was one of the two most relevant factors for the MPTPP. Patients in the fast-track showed a 40 min shorter MPTPP than patients in the acute area. This difference can be explained by the lower complexity and hence by the lower time investment in these patients. Though the MPTPP was shorter in the fast-track area as compared to the acute area, it has to be recognized that the occasional alert, mobile patient with normal vital signs who is seriously ill often require more clinical skill than the emergency management of those who are obviously sick. Another study found “arrival by ambulance” as strongest predictor for MPTPP . We did The other most relevant factor for the MPTPP in our study was the factor of ESI triage level 1 and 2. The ESI triage algorithm yields rapid, reproducible, and clinically relevant stratification of patients into five groups, from level 1 (most urgent) to level 5 (least urgent) . With inGuiding symptom category was another factor for the MPTPP in our study, with symptoms from the internal medicine category having the greatest impact. Although other studies did not investigate the guiding symptom category specifically, surrogate parameters for patients with symptoms from the internal medicine category, such as age and comorbidity, were also associated with longer MPTPP . InteresR2). This corresponds to a Cohen’s f2 of 0.82 which is equivalent to a large effect size [The factors included in our model explain 45% of the variance of the MPTPP (ect size . The onlFormulas for staff calculation use number of patients and workload per patient to obtain the needed number of full-time equivalents . From ouFuture studies are needed to investigate the MPTPP in various settings and types of emergency departments to identify more factors impacting the MPTPP. Such factors could include whether the hospital is a university hospital or non-university hospital, city hospital or rural hospital, and referral hospital or general hospital. Moreover, the MPTPP could be compared between states within one country or even between countries. If differences in the MPTPP are detected, factors leading to these differences need to be identified to understand how the MPTPP can be optimized.We developed an effective prediction model for ED MPTPP and identified the following relevant factors in order of decreasing effect: treatment area, ESI triage level, guiding symptom category, and physician level, resulting in an MPTPP of 47 min. The complexity of determining the MPTPP as a key element of proper staff calculation needs to be considered. Future multicentric studies are needed to validate our model, which could serve as a benchmark for other EDs where the MPTPP is not available.First of all, the study was not blinded. The physicians were aware that they were observed to measure the time used for patient diagnosis and treatment. Therefore, a willingly prolonged duration of allocated time to prove a shortage of workforce, or shorter duration of allocated time to prove efficacy of a single doctor cannot be excluded.The study was monocentric and our results may not apply to other sites. However, we are confident that we could partly overcome this limitation by including a wide range of physicians with different education levels and experience.Pediatric patients and patients with gynecological, ophthalmic, dermatologic, psychiatric, and ENT symptoms were not included in the study.Other factors, such as comorbidity and number of previous visits were not measured. Further factors should be investigated to increase the effectiveness of the study.It is possible to generate a negative MPTPP in our model. Although our model has a large effect size, some uncertainty concerning the MPTPP remains. Certain constellations of the factors included in the model will thus result in a negative MPTPP. This weakness is shared with the model developed by Innes et al. .Lastly, due to a limited number of observers, it was not possible to generate a higher number of patient observations, which prevented a validation of our results.


Undernutrition in surgical patients leads to a higher risk of postoperative complications like infections and delayed recovery of gastrointestinal functions, often resulting in a longer hospital stay and lower quality of life. Nurses at outpatient clinics can deliver nutritional care during outpatient preoperative evaluation of health status to ensure that patients are properly fed in preparation for hospital admission for surgery. However, nutritional nursing care was not determined in research yet. This paper describes the structural development of an Outpatient Nursing Nutritional Intervention (ONNI).A project group followed the steps of the Intervention Mapping. The needs assessment included assessment of delivery of nutritional care and nutritional care needs at two anaesthesia outpatient clinics of an academic and a teaching hospital. Also, outpatient clinic nurses and patients at risk for undernutrition were interviewed. Determinants resulted from these methods were matched with theories on behaviour change and nutritional support.Both patients and nurses were unaware of the consequences of undernutrition, and nurses were also unaware of their roles with regard to nutritional support. The intervention goals were: 1) enabling surgical patients to improve or maintain their nutritional status before hospital admission for surgery, and 2) enabling nurses to deliver nutritional support. The ONNI was developed for outpatients at risk for or with undernutrition. A training was developed for nurses. The ONNI included the five following components: 1) identification of the causes of undernutrition; 2) provision of a nutritional care plan including general and individually tailored advice; 3) self-monitoring of nutrient intake; 4) counselling and encouragement; and 5) support during a telephone follow-up meeting. The intervention and training were tested. A multifaceted implementation strategy was used to deliver the intervention in daily practice.Despite the unique position of the nurses at outpatient clinics, nurses were unaware of their role with regard to nutritional care. The ONNI was developed and implemented along with a training program for nurses. The test confirmed that the training can improve nurses’ knowledge, skills, and sense of responsibility for nutritional support. The intervention may empower patients to actively improve their nutritional status. Patients did not experience undernutrition as a problem for their health and recovery after surgery (see quotations).Adequately informed patients stated that they felt responsible for adequate nutritional intake.‘Well, meanwhile I know the way to maintain weight’.(Patient 7)Knowledge, skills, and self-efficacy: Patients did not know what undernutrition could mean for their recovery after surgery. They felt capable of eating a varied diet. Some patients stated that they do know what to do to maintain an adequate weight.Patients who received adequate information and advice stated that they were able to achieve adequate nutritional intake.The results of step 1 enabled the project group to define program goals for undernutrition and its behavioural and environmental causes. This was done by discussion panel with stakeholders. The stakeholder panel consisted of two patients, a nurse, a dietician (MvA), an external expert (HK) in clinical undernutrition, and two researchers . The discussion started with explaining the gap between the current situation and the ultimate goal that patients are in good nutritional condition before surgery. The current situation was explained by presenting the results of step 1. Then, the stakeholders discussed what should be accomplished to close this gap . This resulted in program goals and performance objectives. Also, they discussed which determinants needed to be changed. Then, the project group specified the performance objectives and linked these to the changeable determinants (step 1). By linking the performance objectives with the changeable determinants, the project group defined change objectives. Finally, researchers constructed a matrix of program goals, performance objectives, and relevant determinants for both patients and nurses.To close the gap between the current situation and a good nutritional condition before surgery the stakeholders and project group argued that behaviour change was needed in nurses as well as in patients. The programme goals for patients and nurses were as follows:Patients at risk for or with undernutrition and planned for surgery maintain or improve their nutritional status.Nursing staff at anaesthesia outpatient clinics support patients in achieving adequate nutritional intake, leading to maintenance or an improvement in patients’ nutritional status.The goal for patients contains ‘improve’, in order to achieve the good nutritional condition. ‘Maintain’ was also mentioned in the goal in order to prevent further decline of undernutrition if improvement is too optimistic.Matrices of both patients’ and nurses’ performance objectives, determinants, and change objectives were defined and are shown in Tables One of the performance objectives for nurses state that nurses should inform and advise patients about the causes and consequences of undernutrition, about the need of energy- and protein-rich food, and about eating healthy snacks  and the program goals (step 2). Theories regarding undernutrition, methods of nutritional support, and behaviour change theories were considered relevant. These theories and methods were studied and discussed by the project group in order to conceptualise the intervention.Theories on the following subjects were selected: a) behaviour change , 22, 23;The way we applied the theories in development of the intervention is explained in the following example: In step 1, it turned out that most of the patients were unaware of undernutrition and its consequences. When the researcher informed the patient adequately during the interview, some stated that they felt to be able to maintain their weight. Therefore, we considered awareness, attitude, self-efficacy and skills as important determinants to be changed. According to the program goal for patients , performance objectives stated that patients need to take action regarding their individual cause (s) of undernutrition and eat healthy, energy and protein enriched nutrition  prepared all versions of the intervention and presented these for comments to the rest of the project group. After three rounds of feedback, consensus was reached.The training for the outpatient-clinic nursing staff was developed to help the nurses achieve their change objectives. A researcher (GHdW) and the dietician (MvA) of the project group developed the training using the methods and applications mentioned in Table Two nurses of the outpatient clinic of the academic hospital tested the ONNI after the training in six consults to evaluate if the ONNI could work . Both nuThe ONNI and the training were evaluated using a short questionnaire and interviews. Topics covered in the semi-structured questionnaire concerned the experiences of nurses with the training and the extent of improvement on the previously identified determinants as a result of the training. The interview based on this semi-structured questionnaire was held in person with a researcher. The six consecutive patients who received the ONNI were interviewed after written informed consent. Objective was to determine the extent to which patients were exposed to different intervention components during the consults, patients’ ability to record food intake, and their awareness of nutrition and eating patterns. Patients were also questioned about their preferences regarding two types of food diaries. Notes were made after each interview and analysed through open coding.The ONNI was developed for use during outpatient pre-operative consults and consists of five components  stated that the training refreshed and updated their knowledge regarding undernutrition and that information on the intervention was clearly provided. They showed willingness to meet patients’ nutritional needs and felt responsible to improve patients’ nutritional status. The nurses felt that the intervention was complete and applicable in practice. After completing the intervention for three patients, the nurses stated that they were able to perform the full intervention adequately. They also stated that they were able to carry out the intervention in the time allocated for each patient and that they became more familiar with the ONNI.The nurses (N = 6) stated that they received all the information necessary, were able to use the food diaries, and became aware of their eating patterns by using the diaries. The patients used both the hospital food diary and the Dutch Malnutrition Steering Group food diary. After evaluation, all patients preferred the hospital version of the food diary  observed the way nurses performed the intervention. Afterwards, the researcher and the nurse discussed the performance and the researcher gave feedback to the nurse. Also, the nurses’ experiences with the intervention were discussed with the researcher who visited the outpatient clinic during weekly follow-up meetings in the implementation period. These discussions were meant to increase nurses’ skills and improve their attitudes towards nutritional support. Nurses asked the trainer more questions during the first meetings compared to the end of this period. Near the end of the implementation period, nurses started to feel familiar with the intervention.ClinicalTrial.gov Identifier, NCT02440165 [In the final step, the aim is the design of an evaluation study, which required an evaluation of the feasibility and effectiveness of the ONNI. This evaluation is not the focus of this paper and is reported separately . The stu02440165 .This paper describes the methods and end products of the application of the IM approach to develop an ONNI.Within the MRC framework for complex interventions, IM was used to structure the development phase of the complex nutritional intervention. In step 1, research identified the determinants which contributed to undernutrition or risk for undernutrition before surgery. In this phase of development, we invited patients to share their opinions and experiences. The stakeholders collaborating in the project group all had experience with nursing, undernourished patients, systematic development of interventions, or held a combination of these areas of expertise. Patients were not included in the project group. Involvement of patients was addressed in step 1 by exploring their perspectives, and also during evaluation of the intervention in step 4. Involvement of patients’ perspectives is considered as ‘consulting’ on the ladder of citizen participation . PartnerWith regard to the entire process of intervention development, we argue that although IM is time consuming, it results in an examination of the context, an evidence-based, thought-through intervention, as well as training and a set of implementation strategies. At this time, a test confirmed an improvement in nurses’ behaviour and patients’ knowledge and skills. However, the feasibility and effectiveness of the ONNI are not yet determined. The evaluation plan, step 6 of IM, is meant to determine the feasibility of the ONNI in daily practice and the effectiveness effect based on relevant nutritional outcomes . This exNurses were found to be unaware of their roles and felt incapable of providing nutritional care (step 1). This is in accordance with other studies, which demonstrated that nurses were unaware of their nutritional roles, demonstrated low self-efficacy, and lacked nutritional knowledge , 42 and In the samples of surgical outpatients (step 1), 5–7% of the patients were at risk for undernutrition, and 4–5% of patients were undernourished . This may suggest that patients are generally not well informed regarding nutrition and that all patients may benefit from nutritional advise during outpatient preoperative consultation.The ONNI comprises tailored and general advice, leaflets, counselling on eating patterns based on a food diary, encouragement for sufficient and healthy food intake, and a follow-up meeting. It is intended to be provided in anaesthesia outpatient clinics before patients’ admission for surgery. Other oral nutritional interventions include education of caregivers of dependent undernourished patients , enhanceSurgical patients with undernutrition may also have other frailty factors that increase the risk of complications. Levett, Edwards, Grocott, and Mythen (2016) discuss that preoperative prehabilitation of high-risk patients should be based on a multimodal and interdisciplinary approach . The heaThis application of the IM approach demonstrates that nurses at the outpatient clinics felt incapable and did not feel responsible for delivery of preoperative nutritional support to surgical patients at risk for or with undernutrition. Patients themselves were often unaware of their nutritional status and the increased risks for complications in case of undernutrition. The extensive IM approach resulted in an evidence-based, thoroughly-developed ONNI. The ONNI, including a training for nurses, aims to improve or maintain patients’ nutritional status. The test confirmed improved knowledge, skills, and sense of responsibility in nurses. The ONNI enables nurses to empower patients to improve their preadmission nutritional status and ultimately may improve postoperative recovery.Additional file 1. Interview guide to explore nurses’ perspectives.Additional file 2. Survey on patients’ satisfaction with general and nutritional care.Additional file 3. Interview guide for patients’ perspectives.Additional file 4. Food Diary.


The promises of improved health care and health research through data-intensive applications rely on a growing amount of health data. At the core of large-scale data integration efforts, clinical data warehouses (CDW) are also responsible for data governance, managing data access and (re)use. As the complexity of the data flow increases, greater transparency and standardization of criteria and procedures are required in order to maintain objective oversight and control. Therefore, the development of practice oriented and evidence-based policies is crucial. This study assessed the spectrum of data access and use criteria and procedures in clinical data warehouses governance internationally.We performed a systematic review of (a) the published scientific literature on CDW and (b) publicly available information on CDW data access, e.g., data access policies. A qualitative thematic analysis was applied to all included literature and policies.Twenty-three scientific publications and one policy document were included in the final analysis. The qualitative analysis led to a final set of three main thematic categories: (1) requirements, including recipient requirements, reuse requirements, and formal requirements; (2) structures and processes, including review bodies and review values; and (3) access, including access limitations.The description of data access and use governance in the scientific literature is characterized by a high level of heterogeneity and ambiguity. In practice, this might limit the effective data sharing needed to fulfil the high expectations of data-intensive approaches in medical research and health care. The lack of publicly available information on access policies conflicts with ethical requirements linked to principles of transparency and accountability.CDW should publicly disclose by whom and under which conditions data can be accessed, and provide designated governance structures and policies to increase transparency on data access. The results of this review may contribute to the development of practice-oriented minimal standards for the governance of data access, which could also result in a stronger harmonization, efficiency, and effectiveness of CDW. Digitalization in health care and biomedical research has developed at a rapid pace. What previously consisted of error-prone and time-consuming manual documentation of information, often resulting in poorly structured data, has in large part been replaced by digitally supported or fully automatized processes. Despite persistent challenges, the widespread adoption of electronic health records (EHR) is one of many examples of this digital progress , adding Much progress is expected from the reuse of such structured clinical data for secondary research purposes in a wide area of applications. Epidemiological and health economic research, comparative effectiveness research, health care quality improvement,learning health care systems (LHCS) and, last but not least, precision medicine rely on such promising developments –6. GivenOne of the cornerstones of successful data reuse is an appropriate data infrastructure. However, due to differences in local, regional and national infrastructures, the information system landscape in the health care sector is largely characterized by heterogeneity . HospitaFirst developed for industry, data warehousing has been identified as a solution to overcome this siloed infrastructure . ClinicaHowever, CDW are more than a mere technical infrastructure to integrate data. CDW hold responsibility over data stewardship , meaningAn abundance of policies, regulations and guidelines addresses the importance of sharing data and making health data accessible for research purposes, thus calling for a transparent and sustainable data access governance . For insChallenges often arise when ethical standards are implemented in practice. In the case of biobanks, for instance, a recent investigation on sample and data access governance revealed significant shortcomings: although sample and data access policies are required, they are in most cases not publicly available and the criteria for access decisions outlined in the policies lack systematization and harmonization . This isRegarding data governance and stewardship, biobanks and CDW share common responsibilities. So far, the scientific literature offers little information about the actual practice of structuring and handling the governance of data access in CDW. A review by Holmes et al. on data warehouse governance for distributed research networks found that details on governance were sparse. However, their review was limited to publications from the U.S. before July 2013, and the authors expected more relevant publications to emerge in the years following their publication .The aim of this study was to assess the spectrum of criteria and procedures applied in data access and use governance in CDW internationally.We performed a systematic review of (a) published scientific literature on CDW and (b) publicly available information on CDW data access. A protocol for this review was prepared using the PRISMA-P 2015 Checklist  and was First, to review the scientific literature, the search engines PubMed, Web of Science, ACM Digital Library, CINAHL and IEEE Xplore were queried systematically. The PRESS checklist served to ensure the inclusion of essential elements in the search strategy . The seaThe retrieved scientific literature was imported into Endnote (Version X9.1) and screened for eligibility using RAYYAN . RAYYAN After screening the first 100 references, we compared the initial results and discussed the appropriateness of the inclusion and exclusion criteria. In screening the full body of literature, 42 conflicting ratings occurred, all of which were resolved by discussion.In addition, the search engine Google Scholar was consulted using the key search term elaborated in Table Second, for the publicly available information, a web search was conducted via Google.de to identify the online presence of CDW. The first 100 hits sorted by relevance (by default) were screened for CDW websites  was included for the qualitative thematic analysis. See the PRISMA flow diagram in Fig. The primary outcome of this systematic review is a matrix containing the qualitative spectrum of criteria and procedures applied in data access and use governance in CDW , the requirements relating to the data reuse (reuse requirements) and the requirements relating to documents, policies or other formalities .The recipient requirements include various definitions of potential data recipients, organized by their formal categorization, their background, their qualifications or their relation to the CDW.Recipient categorization: Recipients can be categorized in different manners. On a general level, these categories can be divided into roles and status. Role represents a specific combination of attributes defined in detail by the respective CDW . Status describes the presence or lack of one concrete attribute .Recipient background: On a more detailed level, potential data recipients are characterized by their background. This can be a specific professional background or another background relevant to the context of the CDW.Recipient qualifications: Potential data recipients can be required to have certain qualifications in order to access the data, meaning that they have skills that enable them to use the data as required by the CDW.Recipient relation to CDW: The potential data recipient’s relationship to the CDW might play a role in the data request. Some CDW might only agree to data access when a prior relation to the CDW or to the data provided to the CDW has been established.The reuse requirements reflect different aspects of the planned data reuse that might influence access and use decisions.Reuses can be described by their intended purpose, meaning the proposed objective of the data reuse. We intentionally excluded primary uses such as treatment and the closely related purposes of payment and insurance coverage review as presented in the policy document , as thisReuse setup describes organizational and practical level preparations for the data reuse that need to be provided for a data request.Reuse risk mitigation describes the potentially required commitments of the data reuser that serve to minimize the risk to the data subject stemming from the reuse of data.Ethical soundness can be further subdivided into responsibleness, patient-centricity and non-competitiveness.Reuse values are requirements to the quality and integrity of the reuse request concerning ethical or scientific soundness, or appropriateness. Formal requirements are documents, policies and regulations which potential data recipients might need to sign, respect or agree to for a positive data access and use decision.Data reuse documents describe mutual agreements and contracts specific to the reuse of the data.This section describes fundamental laws and policies whose requirements are not specific to the CDW but more general.In contrast to the general policies and regulations, this subcategory comprises the policies and regulations where the content would be expected to vary strongly depending on the local particularities.The data access and use decisions might also rely on the potential recipient’s agreement to paying a fee.Under the main category “structure and procedures”, the governance structures and procedures are subsumed which need to be in place to provide for a review of the data request and the subsequent data access and use decision. They are divided into review bodies who are exercising the review, and review values underlying review procedures and decisions.Review bodies reflect the implementation of designated governance bodies, which is commonplace in all assessed CDW. Here, we do not distinguish between boards, groups and individual positions, as the hierarchies and directions are not always transparent.This section comprises a variety of rather general governance bodies involved in the data reuse review.As a more specialized review body type, scientific review bodies describe those dealing with research questions.Another type of specific review bodies are those where patients are involved in data access and use decisions.Review bodies might follow certain review values when deciding data access and use requests which are subsumed in the following.General values describe values driving the CDW’s overall data access governance structure and procedures.This section encompasses the measures taken to reduce bias in the data request review.Reducing investments reflects aspects that save valuable resources, such as time and effort.Managing competitiveness describes an approach that places common interest over individual interest.Under the main category “access”, we subsume data access which can be granted with varying limitations based on the previously described requirements or particularities of the CDW.Access limitations can take on different forms and restrict either data itself, location or the access time.Data access can also be limited in itself, if only a specific part of the requested data is provided, or if it is only provided in a specific form that might be reduced in its level of information.Another possible limitation in access can be the location, where data can only be accessed from specific places.Some CDW might restrict the access to data to a certain timeframe or number of accesses.This systematic review aimed to assess the spectrum of criteria and procedures that surround data access and use decisions in CDW. A core finding is the lack of concrete information available in the scientific literature and the lacking public accessibility of CDW data access policies.While there is a solid corpus of scientific literature on the implementation and maintenance of CDW, the governance of data access is only marginally addressed. In many cases, the publications retrieved mention the relevance of data access and use without clarifying the details on the handling in practice. Many of the publications instead focus on technical aspects of data governance. Since the practical aspects of data access and use only become relevant when a significant amount of data is available for sharing, it is reasonable that CDW might approach technical issues first, which also require considerable effort and resources.However, international recommendations on the ethics of health data sharing also emphasize the importance of procedural (e.g. independent review) and substantial aspects (e.g. criteria for data access decisions) of data access governance , 52. TheProcedural aspects might be comparatively straightforward. Despite the heterogeneity of the denominations and of the composition of governance bodies, based on our study such procedural aspects seem to be addressed appropriately in the scientific literature.Substantial aspects can be considered more demanding. The elaboration of concise access criteria satisfying all stakeholders and enabling all foreseen data reuses is a highly complex task. Considering the amount of public funding invested in the establishment of CDW, sharing details on the conceptualization and the access and use criteria themselves with the scientific community and the public is all the more important. This could significantly improve the efficiency of funding devoted to CDW.In publications on transparent access and use governance, we would expect to find concrete and decisive criteria on the basis of which data access requests are weighted and judged. While the existence of more concrete policies is mentioned in the publications included, they could not be retrieved in our separate search except for one.In the additional web search for publicly available access and use policy documents, our strategy was reduced to simpler search terms  and the governance of data access and use. In addition, a systematic review of data sharing networks access and use governance could offer valuable results, especially when considering developing best practice examples.Through our screening, we were able to extract potential criteria for decisions on data access and use. However, most of these criteria were not e xplicitly described as being decisive for a data request. Criteria applicable to the handling of data access requests are often provided in a rather unspecific and unstructured manner. They are not addressed in a separate designated section of the publications but are mentioned secondarily or need to be deduced from other information. Even the more explicit access and use criteria offer considerable leeway for interpretation and are therefore difficult to translate into practice. In addition, the denomination of requirements, structures and procedures varies highly between CDW and often lacks a more distinct definition. This can be detrimental to the harmonization and effectiveness of the CDW’s objectives.The need for more clarity and standards on conditions for access and use must also be considered an ethical issue. While information transparency is not an ethical principle on its own, it can certainly become ethically relevant, for example when ethical principles such as informed consent or accountability depend on that information .One could argue that individuals consenting to their data being stored and processed by a CDW rely on the CDW’s governance structures to execute the data reuse, first, according to their given consent, and second, with their best interests in mind beyond the consent. In their publication on the governance of biobanks, the German Ethics Council states that in order to compensate for the lack of precision at the time of consenting, donors should have the capacity to trace the governance of sample and data transfer. The specific purposes of reuse should therefore be publicly accessible in “a clear, generally intelligible and up-to-date account” . This shParticularly important, moreover, is the role of transparency as a requirement for setting up accountability mechanisms. Only clear conditions and attributions allow for the evaluation and execution of compliance with ethical and other norms. Ultimately, accountability also serves to increase public trust in data reuse .Increased trust in CDW is also likely to have a positive effect on the future willingness to share data . In contExpectations placed on data-driven approaches in biomedical research and health care are high. Accordingly, increased efforts are being made internationally to develop and implement IT infrastructures that facilitate high-quality data access and use. In Germany, for instance, the Medical Informatics Initiative funding scheme was launched by the Federal Ministry of Research and Education (BMBF) in 2016 and aims to foster collaborative data use by investing 150 million Euros into the development of robust IT solutions .This considerable allocation of funding, however, is generally based on the assumption of a return on public investment. Normative concepts and recommendations for the ethical conduct of data-driven approaches in medical research and health care have been developed and almost unanimously highlight the importance of data access , 59–61. Both, promoting scientific research and improving health care delivery, are very much in the public interest. While the public is supportive of the reuse of data for research purposes , it is tTo our knowledge, this is the first systematic review of data access and use in clinical data warehouses. The findings may stimulate further discussions about the appropriate governance of data access and use. Furthermore, the heterogeneity of mentioned substantial and procedural criteria that shall guide access and use decisions point to the need to develop practice-oriented standards. A certain degree of standardization may in the future contribute to more harmonization, efficiency, and effectiveness of data access and use governance. Involving all relevant stakeholders should be considered in the development and further improvement of data access and use policies in order to ensure acceptance and practice-oriented solutions. The results of this review, especially the qualitative spectrum of criteria and procedures in data access and use governance Table  can servIn the long run, more emphasis should be placed on the practice evaluation of CDW governance to assess compliance with ethical standards and to identify practical issues . The latAs digitalization and data-driven approaches in health research and health care are rapidly evolving, the current governance practices will require broader implementation, evaluation, and improvement to keep up with ongoing developments and challenges.Additional file 1: Supplement table 1. List of CDW found in the Google searchAdditional file 2: Supplement table 2. Included literature and policiesAdditional file 3: Supplement table 3. Qualitative spectrum of criteria and procedures in data access and use governance in clinical data warehouses


Public or patient versions of guidelines (PVGs) are derivative documents that “translate” recommendations and their rationale from clinical guidelines for health professionals into a more easily understandable and usable format for patients and the public. PVGs from different groups and organizations vary considerably in terms of quality of their reporting. In order to address this issue, we aimed to develop a reporting checklist for developers of PVGs and other potential users.First, we collected a list of potential items through reviewing a sample of PVGs, existing guidance for developing and reporting PVGs or other similar evidence-based patient tools, as well as qualitative studies on original studies of patients’ needs about the content and/or reporting of information in PVGs or similar evidence-based patient tools. Second, we conducted a two-round Delphi consultation to determine the level of consensus on the items to be included in the final reporting checklist. Third, we invited two external reviewers to provide comments on the checklist.We generated the initial list of 45 reporting items based on a review of a sample of 30 PVGs, four PVG guidance documents, and 46 relevant studies. After the two-round Delphi consultation, we formed a checklist of 17 items grouped under 12 topics for reporting PVGs.The RIGHT-PVG reporting checklist provides an international consensus on the important criteria for reporting PVGs.The online version contains supplementary material available at 10.1186/s13012-020-01066-z. Contributions to the literatureOur research is the first literature and consensus-based reporting checklist for public or patient versions of guidelines.The RIGHT for PVG reporting checklist can help to improve the transparency, consistency, and usability of their guidelines, which may ultimately lead to better uptake of clinical guidelines, improved shared decision-making between patients and clinicians, and improved patient health outcomes.The availability of trustworthy health-related information for patients can promote informed and shared decision-making and improve health outcomes . ClinicaInternational guideline organizations, such as the American College of Physicians (ACP), the National Institute for Health and Care Excellence (NICE), the Scottish Intercollegiate Guidelines Network (SIGN), the American Academy of Neurology (AAN), the National Comprehensive Cancer Network (NCCN), and the US Preventive Services Task Force, are aware of the importance of PVGs and have developed their own PVGs –8. HowevReporting checklists can promote transparent and rigorous reporting of guidelines . The RepThe aim of our study was to identify essential reporting items for PVGs to promote transparency, and to optimize their use and ultimately their impact on outcomes that matter to patients.The detailed methods used to develop the RIGHT for PVG have been reported previously . For theWe generated the initial list of items through systematically reviewing (1) a sample of PVGs, (2) existing guidance for conducting and reporting PVGs or similar evidence-based patient tools, and (3) original studies of patients’ needs about the content and/or reporting information of PVG or similar evidence-based patient tools, which could contribute to the checklist from the perspective of patients and the public. The detailed inclusion criteria for articles of interest can be found in the published protocol [12].We took a sample of one to two PVGs from each organization that has developed PVGs . We inclTo identify existing guidance for conducting and reporting PVGs, we searched the guidance documents for PVGs on the official websites of organizations that had published PVGs. When such a document was not available, we attempted to contact the person(s) named on the website.To identify studies on patients’ needs and studies relevant to the reporting and conducting of PVGs, we searched PubMed without language restrictions. We developed the search strategies with the assistance of an information scientist  , plain language editing, and reporting guidelines, epidemiology as well as physicians and three representatives of the public with previous experience in guideline-related work agreed to participate in the Delphi consultation  analyzed the results of the Delphi consultation without having access to the name of the Delphi panelist. We had several discussions about how to present the checklist, after which all the panelists were invited to review the checklist for further comments.We invited two external reviewers (JC and HSA) with relevant expertise in clinical guideline methods and knowledge translation of guidelines to review the checklist. Their comments are reflected in the final checklist.We generated the initial topics and relevant items from a sample of 30 PVGs. Then, we identified four PVG guidance documents and summaries from organizations developing PVGs , modality , and style . We excluded some items related to format; however, the Delphi panel prioritized one item related to format , which was deemed to have a substantial impact on the use of the guideline. Different organizations often have a unique style for their products and PVGs also need to consider the special characteristics of their target patients or public groups when choosing an optimal style, so the format and style can be expected to vary. In the second round, 17 panelists responded and four items were included. Thus, a total of 18 items were included after Delphi consultation.Based on the results of the Delphi consultation and further discussions, we finalized the checklist. Two items on the same topic were combined into one. All panelists who participated in the Delphi consultation reviewed and approved the final checklist of 17 items. The overall generation process of item selection is shown in Fig. We added one or two examples for each item and sent them for review and confirmation by the panelists in the Delphi group. Meanwhile, the two invited external reviewers commented on our draft including the checklist, resulting in further refinements. The final checklist together with examples is shown in Table We included five items in the basic information section. First, three items focus on information in the title or on the cover page that helps to identify the document as a PVG (items 1.1 to 1.3). An informative title that clearly states the topic and identifies the document as a PVG using an appropriate term can help readers locate and access the PVG effectively , 25, whiA PVG may target a specific condition or a category, for example, prevention, diagnosis, or treatment . PVGs shPVGs are derivative products of the source guidelines (the guideline being translated); however, the scope and intended use are different from the source guidelines , 27. UnlThe recommendations should indicate the specific target population and important outcomes, including both benefits, harms, and costs (if possible). If the recommendation is based on a comparison of two or more options in the source guideline, recommendations in the PVG should also report the alternative options (item 7.1). If undesirable outcomes are expected from the management options, the PVGs should describe any expected undesirable outcomes with potential management options based on what is mentioned in the source guideline (item 7.2). There is a clear need for PVGs to focus on self-management, as evidenced by results from the DECIDE  project’s focus groups and user-testing   of the evidence item 13). Technical language such as that of the source guideline can be difficult for lay people to understand , however3. TechniRecommendations in PVGs should be easily identified by users. The developers should consider highlighting the recommendations with tables, boxes, bold type, or a distinctive color.Other information proposed for reporting includes questions to ask clinicians (item 9.1), terms and abbreviations (item 10.1), funding source(s) and their roles for both PVG and the source guideline (item 11.1), and conflicts of interest of contributors to the PVG and the source guidelines (item 12.1). For the first point, a list of potential questions can encourage patient inquiries, allowing them to be more active during their healthcare visits and facilitating more effective communication and decision-making , 34. ForRIGHT-PVG is the first international consensus-based checklist for the reporting of PVGs. The checklist consists of 17 items under four domains. Application of the checklist aims to improve the transparent and understandable reporting of PVGs and facilitate their effective use among patients and the public. Use of the checklist could, in turn, promote shared decision-making and improved patient health outcomes . PotentiDuring the development process, we gathered initial items from a sample of PVGs, documents from organizations publishing PVGs, methodological publications on PVGs, and the literature on patients’ needs. This enabled us to start with a list of potential topics and considerations. With limited publications on the methodology or reporting of PVGs , the DelThere are several limitations to this work. First, we have not yet conducted any usability testing to understand how RIGHT-PVG works in practice. Second, we did not carry out face-to-face panel meetings due to a restricted budget, which might have limited the discussion among panelists. However, the two-round Delphi achieved a high level of consensus on the checklist and all panelists were in agreement with the final list of items, as were the external reviews. Third, our project mainly focused on what to report in the PVG; for issues about the style and presentation of the content, such as how to present numerical information, we suggest referring to the G-I-N public toolkit  and otheThe RIGHT for PVG reporting checklist provides an international consensus on important criteria when reporting PVGs. With this checklist, developers of PVGs can improve the transparency, consistency, and usability of their guidelines, which may ultimately lead to improved shared decision-making between patients and clinicians and improved patient health outcomes.Additional file 1.


Transactions of the Royal Society of Tropical Medicine and Hygiene with Ernest Price’s recently rediscovered collection of archival materials and explains how these have shaped recent research into the pathogenesis of the NTD podoconiosis.In the light of the refreshed strategy of the Royal Society of Tropical Medicine and Hygiene (RSTMH), this commentary addresses a condition, podoconiosis, that sits firmly within the thematic areas prioritised by the RSTMH. Podoconiosis is unique, being both a neglected tropical disease (NTD) and a non-communicable disease. It is a condition that affects some of the most disenfranchised people and communities in the world and is only now beginning to receive the attention it deserves, in part through a programme of research that has explored disease distribution, burden, aetiology, sequelae, prevention and treatment. This brief commentary links two articles from the Transactions.7 He described the aetiology, pathogenesis, clinical progression and treatment of the disease, to which he eventually attached the term podoconiosis (from the Greek words for ‘foot’ and ‘dust’).We have selected two articles written by Dr Ernest W. Price, who worked as a leprosy control officer in Ethiopia in the 1970s and 1980s. His curiosity was piqued by the large number of patients presenting to the leprosy hospital in Addis Ababa with leg swelling of undefined cause. Through the 1970s and 1980s he conducted a careful series of investigations of these patients and wrote more than 20 articles, including seven in the 5 and one from 1979.6 These compared the microparticles found in the lymph nodes of people with podoconiosis with those of unaffected barefoot comparators. The first study used light microscopy to identify birefringent particles within the lymph node macrophages and then electron microscope microanalysis to identify the most prominent elements in these particles.5 The second took the exploration a step further, through additional diffraction analysis. In both articles, groups of particles were reported within macrophages in the corticomedullary area, both within and outside lysosomes. Particles within the lysosomes were found in spherical clumps and were amorphous, whereas those outside were more often crystalline. Microanalysis confirmed the intralysosomal particles contained silicon (Si) and aluminium (Al), in the form of aluminosilicates or (in patients only) silica alone. The ratio of Si to Al was significantly different between patients and controls. Price suggested that the low pH of the lysosome might cause the crystals to disintegrate, becoming highly soluble aluminium hydroxide and insoluble silica. From this he suggested insoluble silica was the toxic agent in podoconiosis and that genetic differences in lysosome pH might cause differing susceptibility to developing the disease.6We have selected two articles, one from 1978Transactions of the Royal Society of Tropical Medicine and Hygiene archives was the ‘rediscovery’ in 2013 of several of Price’s notebooks, photographs, tissue blocks and slides. Ernest Price’s son, Michael, had stored his father’s effects since his death in 1990. When clearing his attic, he came across the boxes. He then discovered online that our group was doing research into podoconiosis, and so gifted the collection to Brighton & Sussex Medical School (BSMS). The BSMS Research Governance and Ethics Committee was alerted to the presence of the archive and offered guidance on its storage, particularly in relation to the Human Tissue Act. The Human Tissue Authority was also made aware of the archive, but agreed that further licensing was unnecessary given the HTA licence already held by BSMS.These articles are of interest in themselves, but the event that caused us to go back to the Transactions of the Royal Society of Tropical Medicine and Hygiene archive.Following cataloguing of the archive, a series of studies was planned, including investigation of the morphologic and immunophenotypic features of lymph node samples from podoconiosis patients using techniques unavailable to Price in the late 1970s. We summarise this investigation and then discuss the value of having access to the articles from the 4 was apparent in all nodes. All of the nodes we examined showed evidence of follicular hyperplasia, with an increased number of proliferative germinal centres. This is consistent with Price’s description of the nodes being enlarged4 and provides an explanation for the enlargement. An exaggerated lymphocyte population , Perls’ Prussian blue, elastic van Gieson, Masson Fontana and a range of immunohistochemical stains. The extensive fibrosis described by Priceion Fig.  was seenTransactions of the Royal Society of Tropical Medicine and Hygiene with a historical sample archive. Lymph node blocks and slides in the archive were labelled and their provenance clearly documented, enabling us to select appropriate samples. We found that most stains, including immunohistochemical stains, worked well on the archived material, although stains that included bleaching damaged the tissue, making interpretation difficult. We have been able to confirm most of Price’s descriptions and in some areas have taken them further, for example, by immunophenotyping the lymphocytic populations. We found potential discrepancies in relation to what Price identified as dilation of lymphatic vessels, which we identified as capillaries (Fig. Serendipity enabled us to link articles published in the ies Fig. , and ack