Feasibility and efficacy of combined pancreatic islet-lung transplantation in cystic fibrosis-related diabetes-PIM study: A multicenter phase 1-2 trial.

Cystic fibrosis-related diabetes (CFRD) is a common complication of cystic fibrosis (CF), and restoring metabolic control in these patients may improve their management after lung transplantation. In this multicenter, prospective, phase 1-2 trial, we evaluate the feasibility and metabolic efficacy of combined pancreatic islet-lung transplantation from a single donor in patients with CFRD, terminal respiratory failure, and poorly controlled diabetes. Islets were infused via the portal vein under local anesthesia, 1 week after lung transplantation. At 1 year, the primary outcome was transplant success as evaluated by a composite score including four parameters (weight, fasting glycemia, HbA1c, and insulin requirements). Ten participants (age: 24 years [17-31], diabetes duration: 8 years [4-12]) received a combined islet-lung transplant with 2892 IEQ/kg [2293-6185]. Transplant success was achieved in 7 out of 10 participants at 1-year post transplant. Fasting plasma C-peptide increased from 0.91 µg/L [0.56-1.29] to 1.15 µg/L [0.77-2.2], HbA1c decreased from 7.8% [6.5-8.3] (62 mmol/mol [48-67]) to 6.7% [5.5-8.0] (50 mmol/mol [37-64]), with 38% decrease in daily insulin doses. No complications related to the islet injection procedure were reported. In this pilot study, combined pancreatic islet-lung transplantation restored satisfactory metabolic control and pulmonary function in patients with CF, without increasing the morbidity of lung transplantation.

Assessing the implementation of community-based learning in public health: a mixed methods approach.

BACKGROUND: The French government has set up a community-based learning programme on health promotion for undergraduate health students to involve them in key public health objectives. At the University of Lyon, students first underwent formal instruction, including e-learning, lectures, and interactive seminars, and then became health educators for school pupils. The main objective of the present study was to assess the process of implementing this programme during the 2018-2019 academic year. METHODS: The satisfaction and perception of medical and midwife students with community-based learning experiences were assessed by a questionnaire, semi-directive interviews, and observations. Replies to the questionnaire were described by median and interquartile range or by proportion. A paired Wilcoxon-Mann-Whitney test was used to compare self-evaluated students' competence scores before and after the seminars (alpha risk of 5%). Thematic analyses using grounded theory were performed on recorded and transcribed interviews, and on transcribed notes taken during the observations. RESULTS: Over time the students have evolved from a negative perception of the community-based learning to a positive one. The students were mostly satisfied by interactive seminars that allowed them to gain confidence and competencies in health education. Their involvement in the programme increased their self-esteem. They became more aware of their educative responsibilities regarding public health issues as future professionals. CONCLUSIONS: The students had a positive perception of the implementation of a community-based learning programme in our University, as it appeared a pertinent strategy to raise their awareness of prevention and health education issues.

Ten-year outcomes of islet transplantation in patients with type 1 diabetes: Data from the Swiss-French GRAGIL network.

To describe the 10-year outcomes of islet transplantation within the Swiss-French GRAGIL Network, in patients with type 1 diabetes experiencing high glucose variability associated with severe hypoglycemia and/or with functional kidney graft. We conducted a retrospective analysis of all subjects transplanted in the GRAGIL-1c and GARGIL-2 islet transplantation trials and analyzed components of metabolic control, graft function and safety outcomes over the 10-year period of follow-up. Forty-four patients were included between September 2003 and April 2010. Thirty-one patients completed a 10-year follow-up. Ten years after islet transplantation, median HbA1c was 7.2% (6.2-8.0) (55 mmol/mol [44-64]) versus 8.0% (7.1-9.1) (64 mmol/mol [54-76]) before transplantation (p < .001). Seventeen of 23 (73.9%) recipients were free of severe hypoglycemia, 1/21 patients (4.8%) was insulin-independent and median C-peptide was 0.6 ng/ml (0.2-1.2). Insulin requirements (UI/kg/day) were 0.3 (0.1-0.5) versus 0.5 (0.4-0.6) before transplantation (p < .001). Median (IQR) ß-score was 1 (0-4) (p < .05 when comparing with pre-transplantation values) and 51.9% recipients had a functional islet graft at 10 years. With a 10-year follow-up in a multicentric network, islet transplantation provided sustained improvement of glycemic control and was efficient to prevent severe hypoglycemia in almost 75% of the recipients.

Women's dissatisfaction with inappropriate behavior by health care workers during childbirth care in France: A survey study.

BACKGROUND: Quality care during childbirth requires that health care providers have not only excellent skills but also appropriate and considerate attitudes and behavior. Few studies have examined the proportion of women in Western countries expressing dissatisfaction with such inappropriate or inconsiderate behavior. This study evaluated this proportion in a sample presumably representative of French maternity units. METHODS: This prospective multicenter study, using data from a selfadministered questionnaire, took place in 25 French maternity units during one week in September 2018. The primary outcome measure was mothers' self-reported dissatisfaction with blatantly inappropriate behavior (ie, inappropriate attitude, inadequate respect for privacy, insufficient gentleness of care, and/or inappropriate language) by health care workers in the delivery room. The secondary outcome was their self-reported dissatisfaction with these workers' inconsiderate behavior (ie, unclear and inappropriate information, insufficient participation in decision-making, or deficient consideration of pain). RESULTS: Of 803 potentially eligible women, 627 completed the questionnaire after childbirth; 5.62% (35/623, 95% CI: 3.94-7.73) reported dissatisfaction with blatantly inappropriate behaviors and 9.79% (61/623, 95% CI: 7.57-12.40) with inconsiderate behaviors. The main causes of dissatisfaction reported by women in this survey were the inadequate consideration of their pain and the failure to share decision-making. CONCLUSIONS: Most of the women were satisfied with how health care workers behaved towards them in the delivery room. Nonetheless, health care staff must be aware of women's demands for greater consideration of their expressions of pain and of their voice in decisions.

Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial.

BACKGROUND: About 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs. METHODS: A cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used. RESULTS: Sixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1-103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC95 [1.2-10.1], p = 0.02). The modification and initiation of an antihypertensive treatment were also significantly associated with the reporting of ADEs (aOR = 4.4, CI95 [1.9-10.0], p <  0.001 and aOR = 11.0, CI95 [4.6-26.4], p <  0.001, respectively). The booklet delivery also improved patient satisfaction on general practitioner communication and high blood pressure management. CONCLUSION: A booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient's health status. TRIAL REGISTRATION: Trial registry identifier NCT01610817 (2012/05/30).

Comparison of rural and urban French GPs' activity: a cross-sectional study.

INTRODUCTION: In various countries, a shortage of general practitioners (GPs) and worrying health statistics on risk factors, morbidity and mortality have been observed in rural areas. However, few comparative data are available on GP activities according to their location. The aim of this study was to analyse French GP activities according to their rural or urban practice location. METHODS: This study was ancillary to the Eléments de la COnsultation en médecine GENérale (ECOGEN) study, which was a cross-sectional, multicentre, national study conducted in 128 French general practices in 2012. Data were collected by 54 interns in training during a period of 20 working days from December 2011 to April 2012. GP practice location was classified as rural area, urban cluster or urban area. The International Classification of Primary Care (ICPC-2) was used to classify reasons for encounter, health problem assessments, and processes of care. Univariate analyses were performed for all dependent variables, then multivariable analyses for key variables, using hierarchical mixed-effect models. RESULTS: The database included 20 613 consultations. The mean yearly number of consultations per GP was higher in rural areas (p<0.0001), with a shorter consultation length (p<0.0001). No difference was found for GP sex (p=0.41), age (p=0.87), type of fees agreement (p=0.43), and type of practice (p=0.19) according to their practice location. Urban patients were younger, and there was a lower percentage of patients over 75 years (p<0.001). GPs more frequently consulted at patients' homes in rural areas (p<0.0001). The mean number of chronic conditions managed was higher in rural areas and urban clusters than in urban areas (p<0001). Hypertension (p<0.0001), type 2 diabetes (p=0.003), and acute bronchitis/bronchiolitis (p=0.01) were more frequently managed in rural areas than in urban clusters and areas. Health maintenance/prevention (p<0.0001) and no disease situations (p<0.0001) were less frequent in rural areas. Drug prescription was more frequent in rural areas than in urban clusters and areas (p<0.0001). Multivariable analysis confirmed the influence of a GP's rural practice location on the consultation length (p<0.0001), the number of chronic conditions per consultation (p<0.0001) and the number of health maintenance/prevention situations (p<0.0001), and a trend towards a higher yearly number of consultations per GP (p=0.09). CONCLUSION: French rural GPs tend to have a higher workload than urban GPs. Rural patients have more chronic conditions to be managed but are offered fewer preventive services during consultations. It is necessary to increase the GP workforce and develop cooperation with allied health professionals in rural areas.

Contours et organisations des activités de santé publique au sein des centres hospitaliers universitaires français.

PURPOSE OF RESEARCH: This study, conducted at the initiative of the French academic college of public health, aimed to describe, from the point of view of public health physicians, the outlines and organization of public health activities within French university hospitals. In the first half of 2018, a survey was sent to physicians in charge of public health specialties and to chiefs of public health divisions from the 41 French university hospitals. The survey was supplemented by 10 telephone interviews. RESULTS: Among the 33 hospitals from which we received answers, 28 had a division that encompassed the majority of public health activities, usually combined with other disciplines (occupational medicine, pharmacy…). The existence of a public health division improved the visibility of this specialty and allowed to leverage its strengths. Epidemiology, biostatistics and health information were the most represented activities. Several public health activities were shared with other divisions and directions (healthcare quality and safety, infection control, etc.), due, in part, to a lack of public health physicians. Most respondents cited health promotion, health economics and big data analytics as activities that need to be developed in their institution. CONCLUSION: While most institutions have an identified public health division, their organizations are still heterogeneous and constantly evolving. Despite several difficulties, hospital public health activities are more diversified than before, but need the collaboration of extra hospital public health departments to progress.

[General practitioners' views on cognitive disorders diagnosis: a qualitative study]. / Représentations des médecins généralistes à propos du diagnostic des troubles cognitifs.

Diagnosis of cognitive disorders is at medical and ethical stake. The aim of an qualitative study based on interviews was to explore the views of general practitioners on this diagnosis. General practitioners are ambivalent about the relevance and temporality of the diagnosis of cognitive disorders, which could be resolved by a shared decision making at each stage of the diagnostic approach.

Myocardial infarction: Economic, health, and social impacts on informal caregivers.

OBJECTIVES: The aim of the study was to measure the economic impact of informal care (IC) on caregivers assisting myocardial infarction (MI) survivors in France. Health and social impacts were also described. METHODS: Data from the prospective 2008 Health and Disabilities Households Survey (Enquête Handicap-Santé), carried out among the French general population, were used to obtain information about patients with MI and their informal caregivers. To estimate the approximate monetary value of IC, three methods were used: the proxy good method, opportunity cost method (OCM), and contingent valuation method (CVM). A multivariate analysis was performed to determine the associations of the IC duration and the existence of professional care with the health indicators stated by caregivers. RESULTS: The analysis included data from 147 caregivers. The mean value of IC ranged from €9,679 per year using the CVM to €11,288 per year using the OCM (p > .05). The mean willingness to pay for an additional hour of IC was €10.9 (SD = 8.3). A total of 46.2 percent of caregivers reported that IC negatively affected theirs physical condition, and 46.3 percent reported that it negatively affected their psychological health. In addition, 40.1 percent declared that caregiving activity made them anxious and 38.8 percent stated they felt alone. Associations were identified between the duration of IC and feeling the need to be replaced, feeling alone and making sacrifices (p < .05). CONCLUSIONS: Informal caregiver burden may be recognized in health technology assessment in order not to underestimate the cost of strategies and to facilitate the comparability of cost-effectiveness outcomes between studies.

[Organization of public health activities within university hospitals in France]. / Contours et organisations des activités de santé publique au sein des centres hospitaliers universitaires français.

Purpose of research: This study, conducted at the initiative of the French academic college of public health, aimed to describe, from the point of view of public health physicians, the outlines and organization of public health activities within French university hospitals. In the first half of 2018, a survey was sent to physicians in charge of public health specialties and to chiefs of public health divisions from the 41 French university hospitals. The survey was supplemented by 10 telephone interviews.Results: Among the 33 hospitals from which we received answers, 28 had a division that encompassed the majority of public health activities, usually combined with other disciplines (occupational medicine, pharmacy…). The existence of a public health division improved the visibility of this specialty and allowed to leverage its strengths. Epidemiology, biostatistics and health information were the most represented activities. Several public health activities were shared with other divisions and directions (healthcare quality and safety, infection control, etc.), due, in part, to a lack of public health physicians. Most respondents cited health promotion, health economics and big data analytics as activities that need to be developed in their institution.Conclusion: While most institutions have an identified public health division, their organizations are still heterogeneous and constantly evolving. Despite several difficulties, hospital public health activities are more diversified than before, but need the collaboration of extra hospital public health departments to progress.

INN or brand name drug prescriptions: a multilevel, cross-sectional study in general practice.

PURPOSE: The prescription in International Nonproprietary Names (INN) is a legal obligation for all physicians in France since January 2015. The objective of this study was to analyze the frequency and main factors of INN drug prescribing in general practice. METHODS: Multicenter cross-sectional study conducted with 11 interns acting as observers of 23 GP trainers between November 2015 and January 2016. Two evaluators analyzed all GPs' drug prescriptions to identify INN or brand name prescriptions. RESULTS: The database included 4957 drugs prescribed during 1647 visits. Of these, 1462 (29.5% [95% CI 28.2-30.8%]) were prescribed only in INN. According to the multivariate analyses, the factors favoring INN prescribing were as follows: at the drug level, its initial prescribing (OR = 1.4), a nonspecific prescribing objective (OR = 1.6), its listing in the generic drug index with (OR = 7.7) or without (OR = 2.9) efficiency objective included in the payment for public health objectives (PPHO) program, and the oral route of administration (OR from 0.4 for the percutaneous route to 0.2 for the pulmonary route); at the patient level, the male gender (OR = 1.3), the age of 15 years or more (OR = 1.9), and the absence of a long-term condition (OR = 1.3); at the physician level, the reception of a public healthcare insurance representative (OR = 4.1), the nonreception of pharmaceutical sales representatives (OR = 3.0), and the urban practice environment (OR = 2.8). CONCLUSIONS: In 2015, less than one third of drugs were prescribed in INN only in general practice. The use of various incentives and regulatory measures is likely to favor the prescription of INNs by practitioners.

Economic valuation of informal care provided to people after a myocardial infarction in France.

BACKGROUND: The aim of this study was to estimate the mean cost per caregiver of informal care during the first year after myocardial infarction event in France. METHODS: We used the Handicap-Santé French survey carried out in 2008 to obtain data about MI survivors and their caregivers. After obtaining the total number of informal care hours provided by caregiver during the first year after MI event, we estimated the value of informal care using the proxy good method and the contingent valuation method. RESULTS: For MI people receiving informal care, an annual mean cost was estimated at €12,404 (SD = 13,012) with the proxy good method and €12,798 (SD = 13,425) with the contingent valuation method per caregiver during the first year after myocardial infarction event. CONCLUSIONS: The present study suggests that informal care should be included more widely in economic evaluations in order not to underestimate the cost of diseases which induce disability.

Quality Assessment of Reporting of Economic Evaluation in Cardiac Sugery: Has it Improved?

OBJECTIVES: Cardiac surgery has seen substantial scientific progress over recent decades. Health economic evaluations have become important tools for decision makers to prioritize scarce health resources. The present study aimed to identify and critically appraise the reporting quality of health economic evaluations conducted in the field of cardiac surgery. METHODS: A literature search was performed to identify health economic evaluations in cardiac surgery. The consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement was used to assess the quality of reporting of studies. RESULTS: A total 4,705 articles published between 1981 and 2016 were identified; sixty-nine studies fulfilled the inclusion criteria. There was a trend toward a greater number of publications and reporting quality over time. Six (8.7 percent) studies were conducted between 1981 and 1990, nine (13 percent) between 1991 and 2000, twenty-four (34.8 percent) between 2001 and 2010, and thirty (43.5 percent) after 2011. The mean CHEERS score of all articles was 16.7/24; for those published between 1980 and 1990 the mean (SD) score was 10.2 (±1.4), for those published between 1991 and 2000 it was 11.2 (±2.4), between 2001 and 2010 it was 15.3 (±4.8), and after 2011 it was 19.9 (±2.9). The quality of reporting was still insufficient for several studies after 2000, especially concerning items "characterizing heterogeneity," "assumptions," and "choice of model." CONCLUSIONS: The present study suggests that, even if the quantity and the quality of health economics evaluation in cardiac surgery has increased, there remains a need for improvement in several reporting criteria to ensure greater transparency.

Clinical and Health System Determinants of Venous Thromboembolism Event Rates After Hip Arthroplasty: An International Comparison.

BACKGROUND: Routinely collected hospital data provide increasing opportunities to assess the performance of health care systems. Several factors may, however, influence performance measures and their interpretation between countries. OBJECTIVE: We compared the occurrence of in-hospital venous thromboembolism (VTE) in patients undergoing hip replacement across 5 countries and explored factors that could explain differences across these countries. METHODS: We performed cross-sectional studies independently in 5 countries: Canada; France; New Zealand; the state of California; and Switzerland. We first calculated the proportion of hospital inpatients with at least one deep vein thrombosis (DVT) or pulmonary embolism by using numerator codes from the corresponding Patient Safety Indicator. We then compared estimates from each country against a reference value (benchmark) that displayed the baseline risk of VTE in such patients. Finally, we explored length of stay, number of secondary diagnoses coded, and systematic use of ultrasound to detect DVT as potential factors that could explain between-country differences. RESULTS: The rates of VTE were 0.16% in Canada, 1.41% in France, 0.84% in New Zealand, 0.66% in California, and 0.37% in Switzerland, while the benchmark was 0.58% (95% confidence interval, 0.35-0.81). Factors that could partially explain differences in VTE rates between countries were hospital length of stay, number of secondary diagnoses coded, and proportion of patients who received lower limb ultrasound to screen for DVT systematically before hospital discharge. An exploration of the French data showed that the systematic use of ultrasound may be associated with over detection of DVT but not pulmonary embolism. CONCLUSIONS: In-hospital VTE rates after arthroplasty vary widely across countries, and a combination of clinical, data-related, and health system factors explain some of the variations in VTE rates across countries.

National cost study versus hospital cost accounting for organ recovery cost assessment in a French hospital group.

BACKGROUND: The choice of cost data sources is crucial, because it influences the results of cost studies, decisions of hospital managers and ultimately national directives of policy makers. The main objective of this study was to compare a hospital cost accounting system in a French hospital group and the national cost study (ENC) considering the cost of organ recovery procedures. The secondary objective was to compare these approaches to the weighting method used in the ENC to assess organ recovery costs. METHODS: The resources consumed during the hospital stay and organ recovery procedure were identified and quantified retrospectively from hospital discharge abstracts and the national discharge abstract database. Identified items were valued using hospital cost accounting, followed by 2010-2011 ENC data, and then weighted using 2010-2011 ENC data. A Kruskal-Wallis test was used to determine whether at least two of the cost databases provided different results. Then, a Mann-Whitney test was used to compare the three cost databases. RESULTS: The costs assessed using hospital cost accounting differed significantly from those obtained using the ENC data (Mann-Whitney; P-value < 0.001). In the ENC, the mean costs for hospital stays and organ recovery procedures were determined to be €4961 (SD €7295) and €862 (SD €887), respectively, versus €12,074 (SD €6956) and €4311 (SD €1738) for the hospital cost accounting assessment. The use of a weighted methodology reduced the differences observed between these two data sources. CONCLUSIONS: Readers, hospital managers and decision makers must know the strengths and weaknesses of each database to interpret the results in an informed context.

Organ recovery cost assessment in the French healthcare system from 2007 to 2014.

Background: Organ recovery costs should be assessed to allow efficient and sustainable integration of these costs into national healthcare budgets and policies. These costs are of considerable interest to health economists, hospitals, financial managers and policy makers in most developed countries. This study assessed organ recovery costs from 2007 to 2014 in the French healthcare system based on the national hospital discharge database and a national cost study. The secondary objective was to describe the variability in the population of deceased organ donors during this period. Methods: All stays for organ recovery in French hospitals between January 2007 and December 2014 were quantified from discharge abstracts and valued using a national cost study. Five cost evaluations were conducted to explore all aspects of organ recovery activities. A sensitivity analysis was conducted to test the methodological choice. Trends regarding organ recovery practices were assessed by monitoring indicators. Results: The analysis included 12 629 brain death donors, with 28 482 organs recovered. The mean cost of a hospital stay was €7469 (SD = €10, 894). The mean costs of separate kidney, liver, pancreas, intestine, heart, lung and heart-lung block recovery regardless of the organs recovered were €1432 (SD = €1342), €502 (SD = €782), €354 (SD = €475), €362 (SD = €1559), €542 (SD = €955), €977 (SD = €1196) and €737 (SD = €637), respectively. Despite a marginal increase in donors, the number of organs recovered increased primarily due to improved practices. Conclusion: Although cost management is the main challenge for successful organ recovery, other aspects such as organization modalities should be considered to improve organ availability.

Who Am I to Decide Whether This Person Is to Die Today? Physicians' Life-or-Death Decisions for Elderly Critically Ill Patients at the Emergency Department-ICU Interface: A Qualitative Study.

STUDY OBJECTIVE: We explored physicians' perceptions of and attitudes toward triage and end-of-life decisions for elderly critically ill patients at the emergency department (ED)-ICU interface. METHODS: This was a qualitative study with thematic analysis of data collected through semistructured interviews (15 emergency physicians and 9 ICU physicians) and nonparticipant observations (324 hours, 8 units, in 2 hospitals in France). RESULTS: Six themes emerged: (1) Physicians revealed a representation of elderly patients that comprised both negative and positive stereotypes, and expressed the concept of physiologic age. (2) These age-related factors influenced physicians' decisionmaking in resuscitate/not resuscitate situations. (3) Three main communication patterns framed the decisions: interdisciplinary decisions, decisions by 2 physicians on their own, and unilateral decisions by 1 physician; however, some physicians avoided decisions, facing uncertainty and conflicts. (4) Conflicts and communication gaps occurred at the ED-ICU interface and upstream of the ED-ICU interface. (5) End-of-life decisions were perceived as more complex in the ED, in the absence of family or of information about elderly patients' end-of-life preferences, and when there was conflict with relatives, time pressure, and a lack of training in end-of-life decisionmaking. (6) During decisionmaking, patients' safety and quality of care were potentially compromised by delayed or denied intensive care and lack of palliative care. CONCLUSION: These qualitative findings highlight the cognitive heuristics and biases, interphysician conflicts, and communication gaps influencing physicians' triage and end-of-life decisions for elderly critically ill patients at the ED-ICU interface and suggest strategies to improve these decisions.

Enhanced capture of healthcare-related harms and injuries in the 11th revision of the International Classification of Diseases (ICD-11).

The World Health Organization (WHO) plans to submit the 11th revision of the International Classification of Diseases (ICD) to the World Health Assembly in 2018. The WHO is working toward a revised classification system that has an enhanced ability to capture health concepts in a manner that reflects current scientific evidence and that is compatible with contemporary information systems. In this paper, we present recommendations made to the WHO by the ICD revision's Quality and Safety Topic Advisory Group (Q&S TAG) for a new conceptual approach to capturing healthcare-related harms and injuries in ICD-coded data. The Q&S TAG has grouped causes of healthcare-related harm and injuries into four categories that relate to the source of the event: (a) medications and substances, (b) procedures, (c) devices and (d) other aspects of care. Under the proposed multiple coding approach, one of these sources of harm must be coded as part of a cluster of three codes to depict, respectively, a healthcare activity as a 'source' of harm, a 'mode or mechanism' of harm and a consequence of the event summarized by these codes (i.e. injury or harm). Use of this framework depends on the implementation of a new and potentially powerful code-clustering mechanism in ICD-11. This new framework for coding healthcare-related harm has great potential to improve the clinical detail of adverse event descriptions, and the overall quality of coded health data.

How many diagnosis fields are needed to capture safety events in administrative data? Findings and recommendations from the WHO ICD-11 Topic Advisory Group on Quality and Safety.

OBJECTIVE: As part of the WHO ICD-11 development initiative, the Topic Advisory Group on Quality and Safety explores meta-features of morbidity data sets, such as the optimal number of secondary diagnosis fields. DESIGN: The Health Care Quality Indicators Project of the Organization for Economic Co-Operation and Development collected Patient Safety Indicator (PSI) information from administrative hospital data of 19-20 countries in 2009 and 2011. We investigated whether three countries that expanded their data systems to include more secondary diagnosis fields showed increased PSI rates compared with six countries that did not. Furthermore, administrative hospital data from six of these countries and two American states, California (2011) and Florida (2010), were analysed for distributions of coded patient safety events across diagnosis fields. RESULTS: Among the participating countries, increasing the number of diagnosis fields was not associated with any overall increase in PSI rates. However, high proportions of PSI-related diagnoses appeared beyond the sixth secondary diagnosis field. The distribution of three PSI-related ICD codes was similar in California and Florida: 89-90% of central venous catheter infections and 97-99% of retained foreign bodies and accidental punctures or lacerations were captured within 15 secondary diagnosis fields. CONCLUSIONS: Six to nine secondary diagnosis fields are inadequate for comparing complication rates using hospital administrative data; at least 15 (and perhaps more with ICD-11) are recommended to fully characterize clinical outcomes. Increasing the number of fields should improve the international and intra-national comparability of data for epidemiologic and health services research, utilization analyses and quality of care assessment.

A multifaceted risk management program to improve the reporting rate of patient safety incidents in primary care: a cluster-randomised controlled trial.

BACKGROUND: While patient safety incident reporting is of key importance for patient safety in primary care, the reporting rate by healthcare professionals remains low. This study aimed to assess the effectiveness of a risk management program in increasing the reporting rate within multiprofessional primary care facilities. METHODS: A nation-wide cluster-randomised controlled trial was performed in France, with each cluster defined as a primary care facility. The intervention included professional e-learning training, identification of a risk management advisor, and multidisciplinary meetings to address incident analysis. In the first observational period, a patient safety incident reporting system for professionals was implemented in all facilities. Then, facilities were randomised, and the program was implemented. Incidents were reported over the 15-month study period. Quasi-Poisson models were used to compare reporting rates. RESULTS: Thirty-five facilities (intervention, n = 17; control, n = 18) were included, with 169 and 232 healthcare professionals, respectively, involved. Overall, 7 out of 17 facilities carried out the entire program (41.2%), while 6 did not hold meetings (35.3%); 48.5% of professionals logged on to the e-learning website. The relative rate of incidents reported was 2.7 (95% CI = [0.84-11.0]; p = 0.12). However, a statistically significant decrease in the incident rate between the pre-intervention and post-intervention periods was observed for the control arm (HR = 0.2; 95% CI = [0.05-0.54]; p = 0.02), but not for the intervention arm (HR = 0.54; 95% CI = [0.2-1.54]; p = 0.23). CONCLUSION: This program didn't lead to a significant improvement in the patient safety incident reporting rate by professionals but seemed to sustain reporting over time. Considering that the program was fully implemented in only 41% of facilities, this highlights the difficulty of implementing such multidisciplinary programs in primary care despite its adaptation to the setting. A better understanding of how risk management is currently organized in these multiprofessional facilities is of key importance to improve patient safety in primary care. TRIAL REGISTRATIONS: The study has been registered at clinicaltrials.gov (NCT02403388) on 30 March 2015.