Controlling the extrudate swell in melt extrusion additive manufacturing of 3D scaffolds: a designed experiment.

Tissue engineering using three-dimensional porous scaffolds has shown promise for the restoration of normal function in injured and diseased tissues and organs. Rigorous control over scaffold architecture in melt extrusion additive manufacturing is highly restricted mainly due to pronounced variations in the deposited strand diameter upon any variations in process conditions and polymer viscoelasticity. We have designed an I-optimal, split-plot experiment to study the extrudate swell in melt extrusion additive manufacturing and to control the scaffold architecture. The designed experiment was used to generate data to relate three responses (swell, density, and modulus) to a set of controllable factors (plotting needle diameter, temperature, pressure, and the dispensing speed). The fitted regression relationships were used to optimize the three responses simultaneously. The swell response was constrained to be close to 1 while maximizing the modulus and minimizing the density. Constraining the extrudate swell to 1 generates design-driven scaffolds, with strand diameters equal to the plotting needle diameter, and allows a greater control over scaffold pore size. Hence, the modulus of the scaffolds can be fully controlled by adjusting the in-plane distance between the deposited strands. To the extent of the model's validity, we can eliminate the effect of extrudate swell in designing these scaffolds, while targeting a range of porosity and modulus appropriate for bone tissue engineering. The result of this optimization was a predicted modulus of 14 MPa and a predicted density of 0.29 g/cm3 (porosity ≈ 75%) using polycaprolactone as scaffold material. These predicted responses corresponded to factor levels of 0.6 µm for the plotting needle diameter, plotting pressure of 2.5 bar, melt temperature of 113.5 °C, and dispensing speed of 2 mm/s. The validation scaffold enabled us to quantify the percentage difference for the predictions, which was 9.5% for the extrudate swell, 19% for the density, and 29% for the modulus.

How can healthcare standards be standardised?

International travel, medical tourism and trade have created a demand for reliable assessment of healthcare provision across borders, and for information which is accessible to patients, insurers and referring institutions. External assessment schemes for healthcare providers may be clustered into three types: statutory regulation and institutional licensing, International Standardization Organisation certification, and voluntary systems such as peer review and healthcare accreditation. Increasing complexity of healthcare provision, pressures for public accountability and expectations of professional self-governance place a burden on the inspectors and the inspected. If only to contain costs of external assessment and to increase access to reliable information for patients and insurers, the three approaches must work together rather than compete. This paper summarises the origins, aims, authority and methods of the three general models, describing current pressures and opportunities for convergence (between systems and across borders) in the UK and in Europe.

Evidence-based organization and patient safety strategies in European hospitals.

OBJECTIVE: To explore how European hospitals have implemented patient safety strategies (PSS) and evidence-based organization of care pathway (EBOP) recommendations and examine the extent to which implementation varies between countries and hospitals. DESIGN: Mixed-method multilevel cross-sectional design in seven countries as part of the European Union-funded project 'Deepening our Understanding of Quality improvement in Europe' (DUQuE). SETTING AND PARTICIPANTS: Seventy-four acute care hospitals with 292 departments managing acute myocardial infarction (AMI), hip fracture, stroke, and obstetric deliveries. Main outcome measure Five multi-item composite measures-one generic measure for PSS and four pathway-specific measures for EBOP. RESULTS: Potassium chloride had only been removed from general medication stocks in 9.4-30.5% of different pathways wards and patients were adequately identified with wristband in 43.0-59.7%. Although 86.3% of areas treating AMI patients had immediate access to a specialist physician, only 56.0% had arrangements for patients to receive thrombolysis within 30 min of arrival at the hospital. A substantial amount of the total variance observed was due to between-hospital differences in the same country for PSS (65.9%). In EBOP, between-country differences play also an important role (10.1% in AMI to 57.1% in hip fracture). CONCLUSIONS: There were substantial gaps between evidence and practice of PSS and EBOP in a sample of European hospitals and variations due to country differences are more important in EBOP than in PSS, but less important than within-country variations. Agencies supporting the implementation of PSS and EBOP should closely re-examine the effectiveness of their current strategies.

The effect of certification and accreditation on quality management in 4 clinical services in 73 European hospitals.

OBJECTIVE: To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals. DESIGN: A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways. SETTING AND PARTICIPANTS: Seventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. MAIN OUTCOME MEASURE: Four composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways. RESULTS: Accreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke). CONCLUSIONS: Accreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes.

Profiling health-care accreditation organizations: an international survey.

OBJECTIVE: To describe global patterns among health-care accreditation organizations (AOs) and to identify determinants of sustainability and opportunities for improvement. DESIGN: Web-based questionnaire survey. PARTICIPANTS: Organizations offering accreditation services nationally or internationally to health-care provider institutions or networks at primary, secondary or tertiary level in 2010. MAIN OUTCOME MEASURE: s) External relationships, scope and activity public information. RESULTS: Forty-four AOs submitted data, compared with 33 in a survey 10 years earlier. Of the 30 AOs that reported survey activity in 2000 and 2010, 16 are still active and stable or growing. New and old programmes are increasingly linked to public funding and regulation. CONCLUSIONS: While the number of health-care AOs continues to grow, many fail to thrive. Successful organizations tend to complement mechanisms of regulation, health-care funding or governmental commitment to quality and health-care improvement that offer a supportive environment. Principal challenges include unstable business (e.g. limited market, low uptake) and unstable politics. Many organizations make only limited information available to patients and the public about standards, procedures or results.

Comparison of health service accreditation programs in low- and middle-income countries with those in higher income countries: a cross-sectional study.

OBJECTIVE: The study aim was twofold: to investigate and describe the organizational attributes of accreditation programmes in low- and middle-income countries (LMICs) to determine how or to what extent these differ from those in higher-income countries (HICs) and to identify contextual factors that sustain or are barriers to their survival. DESIGN: Web-based questionnaire survey. PARTICIPANTS: National healthcare accreditation providers and those offering international services. In total, 44 accreditation agencies completed the survey. MAIN OUTCOME MEASURE(S): Income distinctions, accreditation programme features, organizational attributes and cross-national divergence. RESULTS: Accreditation programmes of LMICs exhibit similar characteristics to those of HICs. The consistent model of accreditation worldwide, centres on promoting improvements, applying standards and providing feedback. Where they do differ, the divergence is over specialized features rather than the general logic. LMICs were less likely than HICs to include an evaluation component to programmes, more likely to have certification processes for trainee surveyors and more likely to make decisions on the accreditation status based on a formulaic, mathematically oriented approach. Accreditation programme sustainability, irrespective of country characteristics, is influenced by ongoing policy support from government, a sufficient large healthcare market size, stable programme funding, diverse incentives to encourage participation in accreditation by Health Care Organizations as well as the continual refinement and improvement in accreditation agency operations and programme delivery. CONCLUSIONS: Understanding the similarities, differences and factors that sustain accreditation programmes in LMICs, and HICs, can be applied to benefit programmes around the world. A flourishing accreditation programme is one element of the institutional basis for high-quality health care.

The attitude of health care professionals towards accreditation: A systematic review of the literature.

Accreditation is usually a voluntary program, in which authorized external peer reviewers evaluate the compliance of a health care organization with pre-established performance standards. The aim of this study was to systematically review the literature of the attitude of health care professionals towards professional accreditation. A systematic search of four databases including Medline, Embase, Healthstar, and Cinhal presented seventeen studies that had evaluated the attitudes of health care professionals towards accreditation. Health care professionals had a skeptical attitude towards accreditation. Owners of hospitals indicated that accreditation had the potential of being used as a marketing tool. Health care professionals viewed accreditation programs as bureaucratic and demanding. There was consistent concern, especially in developing countries, about the cost of accreditation programs and their impact on the quality of health care services.

Strengthening organizational performance through accreditation research-a framework for twelve interrelated studies: the ACCREDIT project study protocol.

BACKGROUND: Service accreditation is a structured process of recognising and promoting performance and adherence to standards. Typically, accreditation agencies either receive standards from an authorized body or develop new and upgrade existing standards through research and expert views. They then apply standards, criteria and performance indicators, testing their effects, and monitoring compliance with them. The accreditation process has been widely adopted. The international investments in accreditation are considerable. However, reliable evidence of its efficiency or effectiveness in achieving organizational improvements is sparse and the value of accreditation in cost-benefit terms has yet to be demonstrated. Although some evidence suggests that accreditation promotes the improvement and standardization of care, there have been calls to strengthen its research base.In response, the ACCREDIT (Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork) project has been established to evaluate the effectiveness of Australian accreditation in achieving its goals. ACCREDIT is a partnership of key researchers, policymakers and agencies. FINDINGS: We present the framework for our studies in accreditation. Four specific aims of the ACCREDIT project, which will direct our findings, are to: (i) evaluate current accreditation processes; (ii) analyse the costs and benefits of accreditation; (iii) improve future accreditation via evidence; and (iv) develop and apply new standards of consumer involvement in accreditation. These will be addressed through 12 interrelated studies designed to examine specific issues identified as a high priority. Novel techniques, a mix of qualitative and quantitative methods, and randomized designs relevant for health-care research have been developed. These methods allow us to circumvent the fragmented and incommensurate findings that can be generated in small-scale, project-based studies. The overall approach for our research is a multi-level, multi-study design. DISCUSSION: The ACCREDIT project will examine the utility, reliability, relevance and cost effectiveness of differing forms of accreditation, focused on general practice, aged care and acute care settings in Australia. Empirically, there are potential research gains to be made by understanding accreditation and extending existing knowledge; theoretically, this design will facilitate a systems view of accreditation of benefit to the partnership, international research communities, and future accreditation designers."Accreditation of health-care organisations is a multimillion dollar industry which shapes care in many countries. Recent reviews of research show little evidence that accreditation increases safety or improves quality. It's time we knew about the cost and value of accreditation and about its future direction." [Professor John Øvretveit, Karolinska Institute, Sweden, 7 October 2009].

Impact of accreditation on the quality of healthcare services: a systematic review of the literature.

BACKGROUND AND OBJECTIVE: Accreditation is usually a voluntary program in which trained external peer reviewers evaluate a healthcare organization's compliance and compare it with pre-established performance standards. The aim of this study was to evaluate the impact of accreditation programs on the quality of healthcare services METHODS: We did a systematic review of the literature to evaluate the impact of accreditation programs on the quality of healthcare services. Several databases were systematically searched, including Medline, Embase, Healthstar, and Cinhal. RESULTS: Twenty-six studies evaluating the impact of accreditation were identified. The majority of the studies showed general accreditation for acute myocardial infarction (AMI), trauma, ambulatory surgical care, infection control and pain management; and subspecialty accreditation programs to significantly improve the process of care provided by healthcare services by improving the structure and organization of healthcare facilities. Several studies showed that general accreditation programs significantly improve clinical outcomes and the quality of care of these clinical conditions and showed a significant positive impact of subspecialty accreditation programs in improving clinical outcomes in different subspecialties, including sleep medicine, chest pain management and trauma management. CONCLUSIONS: There is consistent evidence that shows that accreditation programs improve the process of care provided by healthcare services. There is considerable evidence to show that accreditation programs improve clinical outcomes of a wide spectrum of clinical conditions. Accreditation programs should be supported as a tool to improve the quality of healthcare services.

Structural, chemical and electrochemical characterization of poly(3,4-ethylenedioxythiophene) (PEDOT) prepared with various counter-ions and heat treatments.

Electrochemical deposition of the conjugated polymer poly(3,4-ethylenedioxythiophene) (PEDOT) forms thin, conductive films that are especially suitable for charge transfer at the tissue-electrode interface of neural implants. For this study, the effects of counter-ion choice and annealing parameters on the electrical and structural properties of PEDOT were investigated. Films were polymerized with various organic and inorganic counter-ions. Studies of crystalline order were conducted via X-ray diffraction (XRD). Electrochemical impedance spectroscopy (EIS) and cyclic voltammetry (CV) were used to investigate the electrical properties of these films. X-ray photoelectron spectroscopy (XPS) was used to investigate surface chemistry of PEDOT films. The results of XRD experiments showed that films polymerized with certain small counter-ions have a regular structure with strong (100) edge-to-edge correlations of PEDOT chains at ~1.3 nm. After annealing at 170 °C for 1 hour, the XRD peaks attributed to PEDOT disappeared. PEDOT polymerized with LiClO(4) as a counter-ion showed improved impedance and charge storage capacity after annealing at 160 °C.

Accreditation and ISO certification: do they explain differences in quality management in European hospitals?

BACKGROUND: Hospital accreditation and International Standardisation Organisation (ISO) certification offer alternative mechanisms for improving safety and quality, or as a mark of achievement. There is little published evidence on their relative merits. OBJECTIVE: To identify systematic differences in quality management between hospitals that were accredited, or certificated, or neither. Research design ANALYSIS: of compliance with measures of quality in 89 hospitals in six countries, as assessed by external auditors using a standardized tool, as part of the EC-funded METHODS: of Assessing Response to Quality Improvement Strategies project. MAIN OUTCOME MEASURES: Compliance scores in six dimensions of each hospital-grouped according to the achievement of accreditation, certification or neither. RESULTS: Of the 89 hospitals selected for external audit, 34 were accredited (without ISO certification), 10 were certificated under ISO 9001 (without accreditation) and 27 had neither accreditation nor certification. Overall percentage scores for 229 criteria of quality and safety were 66.9, 60.0 and 51.2, respectively. Analysis confirmed statistically significant differences comparing mean scores by the type of external assessment (accreditation, certification or neither); however, it did not substantially differentiate between accreditation and certification only. Some of these associations with external assessments were confounded by the country in which the sample hospitals were located. CONCLUSIONS: It appears that quality and safety structures and procedures are more evident in hospitals with either the type of external assessment and suggest that some differences exist between accredited versus certified hospitals. Interpretation of these results, however, is limited by the sample size and confounded by variations in the application of accreditation and certification within and between countries.

Sustainable healthcare accreditation: messages from Europe in 2009.

BACKGROUND: Healthcare accreditation has grown rapidly since the 1980s but critics question the value of accreditation rather than certification or inspection. Research has focused more on evidence of impact on provider institutions than on health systems; little has been published on the determinants of growth or decline of accreditation organizations and programmes. OBJECTIVE: To describe the development of national accreditation organizations in Europe in relation to incentives, funding and market position in 2009; to identify trends over time using data from previous surveys. METHODS: Contacts in 24 countries, identified by previous surveys, were invited to complete a web-based questionnaire comprising 183 items seeking numerical data or posing multiple choice options. Preliminary results were verified with respondents and agreed for publication. MAIN OUTCOME MEASURES: National healthcare environment, incentives, government policy, legislation, regulation; programme governance, development, funding. RESULTS: The survey identified 18 active national accreditation organizations in Europe. Older ones tend to be independent, profession-dominated and self-financing; they have shown little growth in activity and coverage of the potential market. Newer ones have broad stakeholder governance, support from government policy and growth sustained by legal or financial incentives-giving wide coverage across the healthcare system. The traditional collegial model of accreditation is moving towards a semi-regulatory model of external assessment which could integrate minimal standards of licensing, public safety and accountability with aspirational standards for organizational development and improvement. CONCLUSIONS: The principal challenges to sustainable accreditation appear to be market size, consistency of policy support, programme funding and financial incentives for participation.

Assessment of the accreditation standards of the Central Board for Accreditation of Healthcare Institutions in Saudi Arabia against the principles of the International Society for Quality in Health Care (ISQua).

BACKGROUND AND OBJECTIVES: Accreditation is usually a voluntary program, in which trained external peer reviewers evaluate health care organization's compliance with pre-established performance standards. Interest in accreditation is growing in developing countries, but there is little published information on the challenges faced by new programs. In Saudi Arabia, the Central Board for Accreditation of Healthcare Institutions (CBAHI) was established to formulate and implement quality standards in all health sectors across the country. The objective of this study was to assess a developing accreditation program (CBAHI standards) against the International Society for Quality in Health Care (ISQua) principles to identify opportunities for improvement of the CBAHI standards. METHODS: A qualitative appraisal and assessment of CBAHI standards was conducted using the published ISQua principles for accreditation standards. RESULTS: The CBAHI standards did not describe the process of development, evaluation or revision of the standards. Several standards are repetitive and ambiguous. CBAHI standards lack measurable elements for each standard. CBAHI standards met only one criterion (11.1%) of the Quality Improvement principle, two criteria (22.2%) of Patient/Service User Focus principle, four criteria (40%) of the Organizational Planning and Performance principle, the majority (70%) of the criteria for the safety principle, only one criteria (7.1%) for the Standards Development principle, and two criteria (50%) of the Standards Measurement principle. CONCLUSIONS: CBAHI standards need significant modifications to meet ISQua principles. New and developing accreditation programs should be encouraged to publish and share their experience in order to promote learning and improvement of local accreditation programs worldwide.

Towards hospital standardization in Europe.

QUALITY PROBLEM: There is no simple tool to assess compliance with common national and European directives, guidance and professional advice on the management of healthcare institutions. Despite evidence of unacceptable variations in the protection of patient and staff safety little attention has been given to harmonizing the way services are organized and managed. INITIAL ASSESSMENT: Existing systems which define organizational standards, or assess compliance with them, are not in a position to extend this activity into or across national borders in Europe. Certification, accreditation and licensing programmes are too variable to provide a common basis for consistent assessment. Consensual standards would inevitably be minimal if they were to achieve acceptance by all or a majority of member state governments; they would not be standards for excellence or help the majority of organizations to improve performance. PROPOSED SOLUTION: This paper proposes the development of a framework and measurement tool, initially for hospitals, which could be used for self-assessment or peer review to demonstrate compliance with European legislation, guidance and public expectations without infringing national responsibilities. A common code of management practice could be developed through a process similar to that adopted for clinical practice guidelines by the European commission-funded project on appraisal of guidelines research and evaluation. CONCLUSIONS: In practice, the legal relationships between member states and intergovernmental organizations inhibit the harmonization of management practice across-borders. Faster progress to higher levels of performance would be achieved by voluntary, non-regulatory cooperation of enthusiasts to define, measure and improve the quality of healthcare in European hospitals.

Three-dimensional engineered bone from bone marrow stromal cells and their autogenous extracellular matrix.

Most bone tissue-engineering research uses porous three-dimensional (3D) scaffolds for cell seeding. In this work, scaffold-less 3D bone-like tissues were engineered from rat bone marrow stromal cells (BMSCs) and their autogenous extracellular matrix (ECM). The BMSCs were cultured on a 2D substrate in medium that induced osteogenic differentiation. After reaching confluence and producing a sufficient amount of their own ECM, the cells contracted their tissue monolayer around two constraint points, forming scaffold-less cylindrical engineered bone-like constructs (EBCs). The EBCs exhibited alizarin red staining for mineralization and alkaline phosphatase activity and contained type I collagen. The EBCs developed a periosteum characterized by fibroblasts and unmineralized collagen on the periphery of the construct. Tensile tests revealed that the EBCs in culture had a tangent modulus of 7.5 +/- 0.5 MPa at 7 days post-3D construct formation and 29 +/- 9 MPa at 6 weeks after construct formation. Implantation of the EBCs into rats 7 days after construct formation resulted in further bone development and vascularization. Tissue explants collected at 4 weeks contained all three cell types found in native bone: osteoblasts, osteocytes, and osteoclasts. The resulting engineered tissues are the first 3D bone tissues developed without the use of exogenous scaffolding.