Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials.

OBJECTIVE: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts. SUMMARY OF BACKGROUND DATA: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence. METHODS: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory. RESULTS: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700. CONCLUSIONS: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials. ETHICAL APPROVAL: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.

The age-specific differences in histopathological tumor characteristics and TNM classification of breast carcinomas in Quality assured mamma diagnostic (QuaMaDi) program in the state of Schleswig-Holstein in Germany.

BACKGROUND: We explored the hypothesis that high-quality standards in diagnostic mammography can lead to an early diagnosis of breast cancers and identifies at risk populations outside screening programs. The histopathological features and distribution of the TNM classification were examined in relation to patient age in a large group of women with breast cancers participating in the Quality Assured Mamma Diagnostic (QuaMaDi) program of the state of Schleswig-Holstein. PATIENTS AND METHODS: Surgical pathological reports were studied for clinicopathological characteristics, receptor status, molecular subtype and tumor stage. The analysis was conducted by dividing the study population into three age groups: women under 50 years (pre-screening), 50-69 years (peri-screening) and over 70 years (post-screening). RESULTS: 7.111 biopsies and 2.887 resection specimens were included. Breast cancer was diagnosed in 4.241 (59.7%) cases, one fourth of them in women < 50 years. Elderly women (> 70 years) had more well-differentiated, estrogen receptor (ER)-positive and HER2-negative carcinomas, whereas younger women (< 50 years) tended to have more poorly differentiated, ER negative, and HER2-positive carcinomas. 47% of breast carcinoma were luminal B tumors and were most common regardless of age. 70.4% of resected specimen had pT1 stage. Nodal negative were 71.2%. CONCLUSION: In QuaMaDi breast cancer was diagnosed at an early and potentially curable stage of the disease due to high-quality standards in diagnostic mammography. In addition, regardless of age, an increased number of prognostically unfavorable molecular subtypes were detected. Thus, QuaMaDi helps to identify at risk populations. QuaMaDi significantly improves diagnostic mammography and complements mammography screening programs.

TEAM(ing): together each achiev(ing) more!

Providing medical care at the highest levels across various reproductive endocrinology and infertility settings necessitates seamless partnership among multiple people with diverse skill sets. In this introductory article for this month's Views and Reviews, the concept of teaming is presented, including the key concepts of collaboration, assembling the right team members, establishing goals, inspiring and empowering others, and encouraging new approaches to optimize outcomes. Following this introduction, thought leaders from diverse reproductive endocrinology and infertility spaces, including clinical, ambulatory surgery, laboratory, and research settings, present their experiences using teaming models to adapt team members' thinking, elevate the quality of scientific productivity, and achieve excellence in both patient care and laboratory and clinical outcomes.

Organizational Characteristics Associated with High Performance in Medicare's Comprehensive End-Stage Renal Disease Care Initiative.

BACKGROUND AND OBJECTIVES: Medicare plans to extend financial structures tested through the Comprehensive End-Stage Renal Disease Care (CEC) Initiative-an alternative payment model for maintenance dialysis providers-to promote high-value care for beneficiaries with kidney failure. The End-Stage Renal Disease Seamless Care Organizations (ESCOs) that formed under the CEC Initiative varied greatly in their ability to generate cost savings and improve patient health outcomes. This study examined whether organizational or community characteristics were associated with ESCOs' performance. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used a retrospective pooled cross-sectional analysis of all 37 ESCOs participating in the CEC Initiative during 2015-2018 (n=87 ESCO-years). Key exposures included ESCO characteristics: number of dialysis facilities, number and types of physicians, and years of CEC Initiative experience. Outcomes of interest included were above versus below median gross financial savings (2.4%) and standardized mortality ratio (0.93). We analyzed unadjusted differences between high- and low-performing ESCOs and then used multivariable logistic regression to construct average marginal effect estimates for parameters of interest. RESULTS: Above-median gross savings were obtained by 23 (52%) ESCOs with no program experience, 14 (32%) organizations with 1 year of experience, and seven (16%) organizations with 2 years of experience. The adjusted likelihoods of achieving above-median gross savings were 23 (95% confidence interval, 8 to 37) and 48 (95% confidence interval, 24 to 68) percentage points higher for ESCOs with 1 or 2 years of program experience, respectively (versus none). The adjusted likelihood of achieving above-median gross savings was 1.7 (95% confidence interval, -3 to -1) percentage points lower with each additional affiliated dialysis facility. Adjusted mortality rates were lower for ESCOs located in areas with higher socioeconomic status. CONCLUSIONS: Smaller ESCOs, organizations with more experience in the CEC Initiative, and those located in more affluent areas performed better under the CEC Initiative.

The new Care Quality Commission inspection procedures.

Emeritus Professor Alan Glasper, from the University of Southampton, discusses recent changes to the way in which the Care Quality Commission (CQC) conducts its health and social care inspections.

Integrating quality control and external quality assurance.

Effective management of clinical laboratories relies upon an understanding of Quality Control and External Quality Assurance principles. These processes, when applied effectively, reduce patient risk and drive quality improvement. In this Review, we will describe the purpose of QC and EQA and their role in identifying analytical and process error. The two concepts are linked, and we will illustrate that linkage. Some EQA providers offer far more than analytical surveillance. They facilitate training and education and extend quality improvement and identify areas where there is potential for patient harm into the pre-and post-analytical phases of the total testing process.

Systemness Taps the Power of Interdependence in Healthcare.

SUMMARY: While the term systemness has been used in the healthcare sector for decades, its definition varies from organization to organization. Still, the goals are consistent: to improve patient experience, lower costs, reduce risk, and provide insights into a wide range of care and management issues. Most health systems face similar challenges, such as margin enhancement, quality improvement, increased access, and fending off disruptive competition. Systemness is a way to address these challenges while improving the overall interdependence of the organization. Although embraced by and advantageous to healthcare organizations, systemness efforts often fail. The obstacles are surmountable when organizations thoroughly analyze the achievable scale of systemness, community resources, and current mindset regarding the good of the whole. Leaders must play a vital role in promoting systemness by providing education and a routine review of day-to-day organizational activities. Sometimes, systemness requires a change in leadership or an updating of leadership skills.Organizations must recognize and assess their culture as it relates to principles of independence versus interdependence, and refocus clinical standardization through best-practice protocols and policies as COVID-19 affects the already-fractured healthcare sector. Fortunately, current and developing artificial intelligence, wearables, at-home testing, and improved technologies promise to provide a needed break for a contracting physician field and fatigued front line, and they present an opportunity for those organizations poised to meet the systemness challenge.

Reorganization of nurse scheduling reduces the risk of healthcare associated infections.

Efficient prevention and control of healthcare associated infections (HAIs) is still an open problem. Using contact data from wearable sensors at a short-stay geriatric ward, we propose a proof-of-concept modeling study that reorganizes nurse schedules for efficient infection control. This strategy switches and reassigns nurses' tasks through the optimization of shift timelines, while respecting feasibility constraints and satisfying patient-care requirements. Through a Susceptible-Colonized-Susceptible transmission model, we found that schedules reorganization reduced HAI risk by 27% (95% confidence interval [24, 29]%) while preserving timeliness, number, and duration of contacts. More than 30% nurse-nurse contacts should be avoided to achieve an equivalent reduction through simple contact removal. Nurse scheduling can be reorganized to break potential chains of transmission and substantially limit HAI risk, while ensuring the timeliness and quality of healthcare services. This calls for including optimization of nurse scheduling practices in programs for infection control in hospitals.

El part a casa a Catalunya: una opció en evolució I transformació. Cap a on volem anar? / El parto en casa en Cataluña: una opción en evolución y transformación. ¿hacia dónde queremos ir? / Home birth in Catalonia: an evolving andt ransforming option. Where do we want to go?

El part domiciliari planificat, assistit per professionals competents I coordinades amb el sistema de salut, ha demostrat ser tan segur com el part hospitalari en gestants de baix risc. El part domiciliari a Catalunya ha esdevingut, els darrers trenta anys, l'única opció per a moltes dones d'evitar l'alt nivell d'intervencionisme en l'atenció al part hospitalari. Aquest treball revisa la bibliografia sobre el part a casa I explora I reflexiona sobre diferents aspectes de la seva situació a Catalunya. L'evidència deixa clar que amb bones guies d'actuació I sistemes de trasllat ben establerts, hi ha poc o cap risc incrementat associat directament al part domiciliari. Tanmateix, per garantir-ne la seguretat cal l'accés a l'atenció mèdica I hospitalària. La col·laboració entre tots els professionals del naixement és essencial per oferir una atenció integral que preservi els interessos de les mares I els nounats perquè el part I el naixement siguin segurs per a unes I altres, saludables a tots els nivells I satisfactoris per a tota la família. A Catalunya, cinc per cada mil dones pareixen a casa. Atès que la dona és lliure de triar on vol parir, que ho faci en les condicions òptimes de seguretat depèn de la col·laboració de tots els professionals implicats en l'atenció a les dones I els nounats, així com de les institucions responsables de la salut. L'Associació de Llevadores del Part a Casa de Catalunya (ALPACC) vol treballar, juntament amb obstetres I neonatòlegs/neonatòlogues, per aconseguir aquesta collaboració interprofessional I institucional

El parto domiciliario planificado, asistido por profesionales compe-tentes y coordinadas con el sistema de salud, ha demostrado ser tan seguro como el parto hospitalario en gestantes de bajo riesgo. El parto domiciliario en Cataluña ha sido, los últimos treinta años, la única opción para muchas mujeres de evitar el alto nivel de intervencionismo en la atención al parto hospitalario. Este trabajo revisa la bibliografía sobre el parto en casa, y explora y reflexiona sobre diferentes aspectos de su situación en Cataluña. La evidencia deja claro que, con buenas guías de actuación y sistemas de traslado bien establecidos, hay poco o ningún riesgo incrementado asociado directamente con el parto domiciliario. Sin embargo, para garantizar su seguridad, es necesario el acceso a la atención médica y hospitalaria. La colaboración entre todos los profesionales del nacimiento es esencial para ofrecer una atención integral que preserve los intereses de las madres y los recién nacidos para que el parto y el nacimiento sean seguros para ambos, saludable a todos los niveles y satisfactorio para toda la familia. En Cataluña, cinco por cada mil mujeres paren en casa. Dado que la mujer es libre de elegir dónde quiere parir, que lo haga en las condiciones óptimas de seguridad depende de la colaboración de todos los profesionales implicados en la atención a las mujeres y los recién nacidos, así como de las instituciones sanitarias. La Associació de Llevadores del Part a Casa de Catalunya (ALPACC) quiere trabajar, conjuntamente con obstetras y neonatólogos/ neonatólogas, para conseguir esta colaboración interprofesional e institucional

Well-planned home birth, assisted by trained professionals and coordinated with the health systems, has demonstrated to be as safe as hospital birth for low-risk pregnancies. Over the last 30 years in Catalonia, home birth has been the only option for women who want to avoid the high level of interventionism that characterizes hospital birth. In this article, we review the literature on home birth, and we examine its status in Catalonia. Available evidence indicates that with good management guides and well-established transportation systems, the incremental risk associated with home birth is minimal. However, in order to ensure safety, ready access to medical and hospital care is critical. The collaboration between all professionals is essential to offer comprehensive care that protects the interests and well-being of the mothers and the newborn, with the goal of creating a safe and healthy birth experience for both and to the satisfaction of the family. In Catalonia, five of every thousand females deliver at home. Given the fact that women can chose where they want to deliver, having the optimum conditions of safety depends on the collaboration of all the healthcare providers dedicated to maternal and child health, as well as the healthcare administration. The Association of Home Birth Midwives of Catalonia wants to work together with obstetricians and neonatologists to achieve this interprofessional and institutional collaboration

Home- and Community-Based Provider Preparation for Pennsylvania's Managed Long-term Services and Supports.

As Pennsylvania implements its managed long-term services and supports program, we explore how home- and community-based providers are preparing for and perceiving the transition through an online survey. We summarize responses and conduct chi-square analysis to measure differences between select provider groups. Despite high levels of uncertainty about program impact, over 84% of respondents plan to participate. We found that providers in the first implementation phase had more strategic and operational discussions with MCOs than the other two phases (p < .03). As program rollout continues, we anticipate changes in MCO-provider conversation frequency and topics based upon implementation zone.

The governance of overseas surgical collaborations - BFIRST/BSSH.

Clinical governance is the structured approach to maintaining and improving the quality of patient care and is a vital part of global surgery. BFIRST and BSSH closely collaborate with local doctors on a number of overseas projects, seeking to strengthen and develop local knowledge and skills, aiming for an independent local practice in reconstructive and upper limb surgery. Thoughts on essential requirements, improvements and pitfalls in the ethical approach to global collaboratives are presented.

Learning During and From a Crisis: The Student-Led Development of a COVID-19 Curriculum.

PROBLEM: The speed and scope of the upheaval that COVID-19 inflicted on medical education made innovation a necessity. While medical students wanted high-quality, consolidated educational resources on COVID-19, the medical school faculty who typically produced such resources were increasingly burdened with clinical, administrative, and personal commitments. However, students eager to contribute to the pandemic response were well suited to create these instructional materials for their peers. APPROACH: In mid-March 2020, a group of students at Harvard Medical School came together to synthesize the key facts and collate the best existing educational materials about the COVID-19 pandemic into a unified learning resource. The materials were faculty reviewed and shared freely online. The curriculum now contains 8 modules that are updated regularly. Throughout this process, the student authors prioritized accessibility, iterative improvement, and effective pedagogy. OUTCOMES: To date, nearly 80,000 users from 132 countries have accessed the curriculum. It has been referenced or incorporated into courses at Harvard Medical School and more than 30 other medical schools across the country. About 40% of all users are from outside the United States, and the materials have been translated into 28 languages. This effort has spurred a number of other educational initiatives led by medical student groups in the United States and abroad. NEXT STEPS: As understanding of the COVID-19 pandemic is constantly changing, the student authors' immediate goal is to keep the curriculum up to date in the months to come. They plan to maintain existing partnerships with medical schools and student groups around the world while pursuing new opportunities to expand the curriculum's reach, provide education, and build community. Students and educators alike should leverage student-driven education efforts to benefit other learners both within and, importantly, beyond their institutions.

Quality improvement for cancer multidisciplinary teams: lessons learned from the Anglian Germ Cell Cancer Collaborative Group.

Shamash and colleagues describe how their supra-regional germ cell tumour multidisciplinary team achieved standardisation of treatment and improved survival. We discuss some of the insights the study provides into prioritising complex patients, streamlining processes, the use of telemedicine, and the centrality of good data collection to continuous quality improvement.

Implementation and assessment of a telecytology quality assurance program.

INTRODUCTION: The College of American Pathologists mandates that telepathology services are included in laboratory quality management programs. The aim of this study was to assess a telecytology quality assurance (QA) process that we implemented in 2015. MATERIALS AND METHODS: Each month, a cytotechnologist randomly selected 3 telecytology fine-needle aspiration (FNA) cases from each cytopathologist on the FNA service that month. Data were recorded in a monthly worksheet and included onsite telecytology adequacy, final adequacy, concordance, onsite operator, cytopathologist, and reason for discrepancy, if present. The worksheet was reviewed monthly, discordant cases were re-examined, and feedback to cytologists was provided. For this study, worksheets from October 2015 to December 2019 were retrospectively reviewed. RESULTS: The QA program captured 488 cases, representing 25% of total cases that utilized telecytology during the evaluation period (n = 1983). The telecytology onsite assessment was concordant with the final cytologic assessment in 84% (410 of 488) of cases. The majority of discordant cases (72 of 78, 92%) were the result of an "Inadequate" onsite telecytology assessment, but a final diagnosis was able to be rendered; 92% of these cases were attributed to diagnostic material being present in cytologic preparations not available during the onsite assessment. Nine telecytology onsite interpretation errors were identified, of which 7 were provided by cytopathologists with less than 2 years of experience. CONCLUSIONS: Most telecytology cases with onsite assessment errors were evaluated by cytopathologists with less than 2 years of practice experience; therefore, careful monitoring of new staff should be considered when developing a telecytology QA program.

SPRINTing to Innovation: Children's Hospital of Philadelphia's Strategic Approach to Discovering Its Untapped Innovation Potential.

PROBLEM: There is a clear and urgent need for health care innovation in the United States. Hospital employees routinely recognize pain points that affect care delivery and are in a unique position to propose innovative and practical solutions, yet leaders rarely solicit ideas for investment and development from frontline providers and staff, revealing an untapped resource with innovation potential. APPROACH: To address these deficiencies, the Children's Hospital of Philadelphia expanded its innovation infrastructure with the competition-based SPRINT program in 2015. All hospital employees are encouraged to apply with early-stage innovative ideas, and if selected, are provided with business, legal, technical, and scientific project management support to help accelerate their projects toward commercial viability. SPRINT was modeled around 4 core tenets: (1) small, dynamic, and attentive project manager-led teams; (2) low barriers to entry; (3) emphasis on outreach; and (4) fostering innovators. OUTCOMES: Over its first 4 cycles from 2015 to 2018, 271 innovative teams applied to the SPRINT program, which led to support for 30 projects (11% acceptance rate). About a quarter of the projects each year were submitted by physician-led teams (mean 23%), a third by nonphysician clinical providers (mean 33%), and almost half were submitted by employees without direct patient contact (mean 44%). Nurses have emerged as the largest applicant group. Eleven of the SPRINT-supported projects (37%) resulted in commercial endpoints. NEXT STEPS: SPRINT has proven to be an effective model for supporting institution-wide, employee-driven health care innovation, especially among frontline clinical and nonclinical personnel. Critical next steps for the program include a formal cost-benefit analysis and the earlier participation of technology transfer and intellectual property experts to improve the commercialization roadmap for many SPRINT projects.

Planning effective mental healthcare in prisons: Findings from a national consultation on the Care Programme Approach in prisons.

The Care Programme Approach (CPA) can be an effective tool in coordinating the care and treatment needs of people with mental illness and learning disabilities. Within prisons settings, the CPA has been poorly implemented and the principles underpinning this approach have been lost. This paper presents the key themes identified as part of a consultation process to develop quality guidance on planning effective mental healthcare in prisons in relation to the CPA. It was conducted by the Quality Network for Prison Mental Health Services, a quality improvement initiative organised by the Royal College of Psychiatrists' Centre for Quality Improvement. The information derived from the consultation process indicates that there is a substantial need for standardisation and consistency in the application of the CPA process within prisons, for the purposes of enhanced care delivery, greater continuity of care, and improved patient outcomes.

[The role of Public Health as a key to the success of the neonatal screening program in the Basque Country.] / El papel de la Salud Publica como clave del éxito del Programa de Cribado Neonatal en el País Vasco.

Neonatal Screening Programs (PCN) have widely demonstrated their benefits since Dr. Guthrie published his developments on Phenylketonuria (PKU) in 1961. This paper describes how a simple and effective organization, which incorporates all the fundamental actors under the responsibility of the Public Health Directorate (DSP), has managed to ensure that the PCN of the Basque Country meets all the objectives required for a population screening. The acceptance by Basque society of the PCN allowed it to exceed 95% coverage in its second year of operation. Likewise, the limited negative social impact of PCN is evidenced by its low number of false positives and incorrect samples. Excellent response times allow every newborn with a positive result to have an early diagnosis and optimal initiation of treatment. There are two relevant experiences that support the importance of the effective exercise of the responsibility of the DSP. Congenital adrenal hyperplasia (CAH) was incorporated into the PCN in 1991 meeting all technical and clinical criteria. At the request of the experts, the DSP ordered in 1993 to cease this activity showing that it did not provide the expected benefits. The problems of organically integrating the PCN into the healthcare system were also experienced. The need to compete for resources put public health activities, including the PCN, at risk and led to their return to direct dependence on the DSP. The availability of this structure, in addition to facilitating the incorporation of other screenings, allows facing the future challenges.

Los Programas de Cribado Neonatal (PCN) han demostrado ampliamente sus beneficios desde que en 1961 el Dr. Guthrie publicó sus trabajos sobre Fenilcetonuria (PKU). En este trabajo se describe cómo una organización sencilla y eficaz, que incorpora a todos los actores fundamentales bajo la responsabilidad de la Dirección de Salud Pública (DSP), ha conseguido que el PCN del País Vasco cumpla con todos los objetivos exigibles a un cribado poblacional. La aceptación por la sociedad vasca del PCN permitió superar el 95% de cobertura en su segundo año de funcionamiento. Asimismo, el limitado impacto social negativo del PCN se evidencia por su reducido número de falsos positivos y de muestras incorrectas. Los excelentes tiempos de respuesta permiten que todo recién nacido con resultado positivo disponga de un diagnóstico temprano y de un inicio óptimo del tratamiento. Hay dos experiencias relevantes que avalan la importancia del ejercicio eficaz de la responsabilidad de la DSP. La hiperplasia adrenal congénita (HAC) se incorporó en 1991 al PCN, cumpliendo con todos los criterios técnicos y clínicos. A petición de los expertos, la DSP ordenó en 1993 cesar esta actividad al evidenciar que no aportaba los beneficios esperados. También se experimentaron los problemas de integrar orgánicamente el PCN en el sistema asistencial. La necesidad de competir por los recursos puso en riesgo las actividades de Salud Pública, incluyendo el PCN, lo que provocó su retorno a la dependencia directa de la DSP. La disponibilidad de esta estructura, además de facilitar la incorporación de otros cribados, permite afrontar los retos del futuro.

Impact of suspending minimum volume requirements for knee arthroplasty on hospitals in Germany: an uncontrolled before-after study.

BACKGROUND: In 2004, the Federal Joint Committee, supreme decision-making body in German healthcare, introduced minimum volume requirements (MVRQs) as a quality instrument. Since then, MVRQs were implemented for seven hospital procedures. This study evaluates the effect of a system-wide intermission of MVRQ for total knee arthroplasty (TKA), demanding 50 annual cases per hospital. METHODS: An uncontrolled before-after study based on federal-level data including the number of hospitals performing TKA, and TKA cases from the external hospital quality assurance programme in Germany (2004-2017). Bi- and multivariate analyses based on hospital-level secondary data of TKA cases and TKA quality indicators extracted from hospital quality reports in Germany (2006-2014). RESULTS: The number of TKAs performed in Germany decreased by 11% after suspending the TKA-MVRQ in 2011, and rose by 13% after its reintroduction in 2015. The number of hospitals with less than 50 cases rose from 10 to 25% and their case share from 2 to 5.5% during suspension. Change in hospital volume after the suspension of TKA-MVRQ was not associated with hospital size, ownership, or region. All four evaluable quality indicators increased significantly in the year after their first public reporting. Compared to hospitals meeting the TKA-MVRQ, three indicators show slight but statistically significant better quality in hospitals below the TKA-MVRQ. CONCLUSIONS: In Germany, TKA-MVRQs seem to induce in-hospital caseload adjustments rather than foster regional inter-hospital case transfers as intended.