Max Moldovan

IL28B is associated with response to chronic hepatitis C interferon-alpha and ribavirin therapy

Hepatitis C virus (HCV) infects 3% of the worlds population. Treatment of chronic HCV consists of a combination of PEGylated interferon-α (PEG-IFN-α) and ribavirin (RBV). To identify genetic variants associated with HCV treatment response, we conducted a genome-wide association study of sustained virological response (SVR) to PEG-IFN-α/RBV combination therapy in 293 Australian individuals with genotype 1 chronic hepatitis C, with validation in an independent replication cohort consisting of 555 individuals. We report an association to SVR within the gene region encoding interleukin 28B (IL28B, also called IFNλ3; rs8099917 combined P = 9.25 × 10−9, OR = 1.98, 95% CI = 1.57–2.52). IL28B contributes to viral resistance and is known to be upregulated by interferons and by RNA virus infection. These data suggest that host genetics may be useful for the prediction of drug response, and they also support the investigation of the role of IL28B in the treatment of HCV and in other diseases treated with IFN-α.

Narrative synthesis of health service accreditation literature

Aims To systematically identify and synthesise health service accreditation literature. Methods A systematic identification and narrative synthesis of health service accreditation literature published prior to 2012 were conducted. The search identified 122 empirical studies that examined either the processes or impacts of accreditation programmes. Study components were recorded, including: dates of publication; research settings; levels of study evidence and quality using established rating frameworks; and key results. A content analysis was conducted to determine the frequency of key themes and subthemes examined in the literature and identify knowledge-gaps requiring research attention. Results The majority of studies (n=67) were published since 2006, occurred in the USA (n=60) and focused on acute care (n=79). Two thematic categories, that is, ‘organisational impacts’ and ‘relationship to quality measures’, were addressed 60 or more times in the literature. ‘Financial impacts’, ‘consumer or patient satisfaction’ and ‘survey and surveyor issues’ were each examined fewer than 15 times. The literature is limited in terms of the level of evidence and quality of studies, but highlights potential relationships among accreditation programmes, high quality organisational processes and safe clinical care. Conclusions Due to the limitations of the literature, it is not prudent to make strong claims about the effectiveness of health service accreditation. Nonetheless, several critical issues and knowledge-gaps were identified that may help stimulate and inform discussion among healthcare stakeholders. Ongoing effort is required to build upon the accreditation evidence-base by using high quality experimental study designs to examine the processes, effectiveness and financial value of accreditation programmes and their critical components in different healthcare domains.

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.

The standard of healthcare accreditation standards: a review of empirical research underpinning their development and impact

BackgroundHealthcare accreditation standards are advocated as an important means of improving clinical practice and organisational performance. Standard development agencies have documented methodologies to promote open, transparent, inclusive development processes where standards are developed by members. They assert that their methodologies are effective and efficient at producing standards appropriate for the health industry. However, the evidence to support these claims requires scrutiny. The study’s purpose was to examine the empirical research that grounds the development methods and application of healthcare accreditation standards.MethodsA multi-method strategy was employed over the period March 2010 to August 2011. Five academic health research databases (Medline, Psych INFO, Embase, Social work abstracts, and CINAHL) were interrogated, the websites of 36 agencies associated with the study topic were investigated, and a snowball search was undertaken. Search criteria included accreditation research studies, in English, addressing standards and their impact. Searching in stage 1 initially selected 9386 abstracts. In stage 2, this selection was refined against the inclusion criteria; empirical studies (n = 2111) were identified and refined to a selection of 140 papers with the exclusion of clinical or biomedical and commentary pieces. These were independently reviewed by two researchers and reduced to 13 articles that met the study criteria.ResultsThe 13 articles were analysed according to four categories: overall findings; standards development; implementation issues; and impact of standards. Studies have only occurred in the acute care setting, predominately in 2003 (n = 5) and 2009 (n = 4), and in the United States (n = 8). A multidisciplinary focus (n = 9) and mixed method approach (n = 11) are common characteristics. Three interventional studies were identified, with the remaining 10 studies having research designs to investigate clinical or organisational impacts. No study directly examined standards development or other issues associated with their progression. Only one study noted implementation issues, identifying several enablers and barriers. Standards were reported to improve organisational efficiency and staff circumstances. However, the impact on clinical quality was mixed, with both improvements and a lack of measurable effects recorded.ConclusionStandards are ubiquitous within healthcare and are generally considered to be an important means by which to improve clinical practice and organisational performance. However, there is a lack of robust empirical evidence examining the development, writing, implementation and impacts of healthcare accreditation standards.

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.

Evaluation of current Australian health service accreditation processes (ACCREDIT-CAP): protocol for a mixed-method research project

Introduction Accreditation programmes aim to improve the quality and safety of health services, and have been widely implemented. However, there is conflicting evidence regarding the outcomes of existing programmes. The Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork-Current Accreditation Processes (ACCREDIT-CAP) project is designed to address key gaps in the literature by evaluating the current processes of three accreditation programmes used across Australian acute, primary and aged care services. Methods and design The project comprises three mixed-method studies involving documentary analyses, surveys, focus groups and individual interviews. Study samples will comprise stakeholders from across the Australian healthcare system: accreditation agencies; federal and state government departments; consumer advocates; professional colleges and associations; and staff of acute, primary and aged care services. Sample sizes have been determined to ensure results allow robust conclusions. Qualitative information will be thematically analysed, supported by the use of textual grouping software. Quantitative data will be subjected to a variety of analytical procedures, including descriptive and comparative statistics. The results are designed to inform health system policy and planning decisions in Australia and internationally. Ethics and dissemination The project has been approved by the University of New South Wales Human Research Ethics Committee (approval number HREC 10274). Results will be reported to partner organisations, healthcare consumers and other stakeholders via peer-reviewed publications, conference and seminar presentations, and a publicly accessible website.

Analysis of Australian newspaper coverage of medication errors

OBJECTIVE To investigate the frequency, style and reliability of newspaper reporting of medication errors. DESIGN Content analysis of articles discussing medication errors that were published in the 10 most widely read Australian daily newspapers between January 2005 and January 2010. Main outcome measure(s) Newspaper source, article type, article topic, leading news actors, identified causes and solutions of medication errors and cited references. RESULTS Ninety-two articles included discussion of medication errors, with the one national newspaper, The Australian, the main source of articles (n = 24). News items were the most frequent type of articles (n = 73), with the majority (n = 55) primarily focused on broader hospital problems. Government representatives, advocacy groups, researchers, health service staff and private industry groups were prominent news actors. A shortage of hospital resources was identified as the central cause of medication errors (n = 38), with efficient error reporting systems most frequently identified as a solution (n = 25). Government reports were cited on 39 occasions, with peer-reviewed publications infrequently cited (n = 4). CONCLUSION Australian newspaper reporting of medication errors was relatively limited. Given the high prevalence of errors and the potential role consumers can play in identifying and preventing errors, there is a clear argument for increasing public awareness and understanding of issues relating to medication safety. Existing coverage of this issue is unrelated to research evidence. This suggests the need for patient safety researchers and advocacy groups to engage more strongly with the media as a strategy to increase the productive public discourse concerning medication errors and gain support for evidence-based interventions.

Economic evaluation of Australian acute care accreditation (ACCREDIT-CBA (Acute)): study protocol for a mixed-method research project

Introduction The Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork—Cost–Benefit Analysis (ACCREDIT-CBA (Acute)) study is designed to determine and make explicit the costs and benefits of Australian acute care accreditation and to determine the effectiveness of acute care accreditation in improving patient safety and quality of care. The cost–benefit analysis framework will be provided in the form of an interactive model for industry partners, health regulators and policy makers, accreditation agencies and acute care service providers. Methods and design The study will use a mixed-method approach to identify, quantify and monetise the costs and benefits of accreditation. Surveys, expert panels, focus groups, interviews and primary and secondary data analysis will be used in cross-sectional and case study designs. Ethics and dissemination The University of New South Wales Human Research Ethics Committee has approved this project (approval number HREC 10274). The results of the study will be reported via peer-reviewed publications, conferences and seminar resentations and will form part of a doctoral thesis.

A multimethod research investigation of consumer involvement in Australian health service accreditation programmes: the ACCREDIT-SCI study protocol

Introduction Health service accreditation programmes are a regulatory mechanism adopted to drive improvements inpatient safety and quality. Research investigating the benefits or limitations, of consumer involvement in accreditation programmes is negligible. To develop our knowledge in this area the ACCREDIT collaboration (Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork) has developed a research plan, known as the ACCREDIT-SCI (Standards of Consumer Involvement) study protocol. Two complementary studies have been designed: one, to examine the effectiveness of a standard for consumer participation and two, to explore how patient experiences vary across a range of settings with differing accreditation results. Methods and design The research setting is the Australian healthcare system, and the two studies focus on three accreditation programmes in the primary, acute and aged care domains. The studies will use multimethods: document analysis; interviews and surveys. Participants will be stakeholders across the three domains including: policy officers; frontline healthcare professionals; accreditation agency personnel, including surveyors and healthcare consumers. Drawing on previous experience, the research team has developed purpose-designed tools. Data will be analysed using thematic, narrative and statistical (descriptive and inferential) procedures. Ethics and dissemination The University of New South Wales Human Research Ethics Committee has approved the two studies (HREC 10274). Findings will be disseminated through seminars, conference presentations, academic publications and research partner websites. The findings will be formulated to facilitate uptake by policy and accreditation agency professionals, researchers and academics, and consumers, nationally and internationally.

An empirical test of accreditation patient journey surveys: randomized trial.

OBJECTIVE To evaluate the effectiveness of utilizing the patient journey survey (PJS) method in healthcare accreditation processes. DESIGN Randomized trial of the PJS method in parallel with the current accreditation survey (CAS) method of the Australian Council on Healthcare Standards (ACHS). SETTING Acute healthcare organizations in Australia. PARTICIPANTS Seventeen organizations, 28 organizational staff, nine surveyors and 38 patients. MAIN OUTCOME MEASURES The results of each surveying method were compared. Participants provided feedback, via 18 interviews and 40 questionnaire surveys, about the benefits and disadvantages of a PJS compared to a CAS. RESULTS The PJS method is not as comprehensive as the CAS method for accreditation assessment. In matched assessments the majority of items were rated lower by the PJS method than by the CAS. PJSs were shown to be appropriate for assessing mandatory clinical criteria, but were less effective for assessing corporate and support criteria. The two methods diverged in their final assessments of which organizations met the accreditation threshold. Participants endorsed the use of PJSs within accreditation processes. CONCLUSIONS The PJS methodology complements but is not a substitute for existing accreditation methods. There is significant stakeholder support for the inclusion of the PJS method within the current accreditation programme.