Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Infants, Children, and Adolescents with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy, and their representatives to develop minimum sets of standardized outcomes and outcome measurement methods for clinical practice. Using modified Delphi consensus methods with consecutive rounds of online voting over 12 months, a core set of outcomes and corresponding measurement tool packages to capture the outcomes were identified for infants, children, and adolescents with epilepsy. Consensus methods identified 20 core outcomes. In addition to the outcomes identified for the ICHOM Epilepsy adult standard set, behavioral, motor, and cognitive/language development outcomes were voted as essential for all infants and children with epilepsy. The proposed set of outcomes and measurement methods will facilitate the implementation of the use of patient-centered outcomes in daily practice.

Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Adults with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. Therefore, the International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy and their representatives to develop minimum sets of standardized outcomes and outcomes measurement methods for clinical practice that support patient-clinician decision-making and quality improvement. Consensus methods identified 20 core outcomes. Measurement tools were recommended based on their evidence of strong clinical measurement properties, feasibility, and cross-cultural applicability. The essential outcomes included many non-seizure outcomes: anxiety, depression, suicidality, memory and attention, sleep quality, functional status, and the social impact of epilepsy. The proposed set will facilitate the implementation of the use of patient-centered outcomes in daily practice, ensuring holistic care. They also encourage harmonization of outcome measurement, and if widely implemented should reduce the heterogeneity of outcome measurement, accelerate comparative research, and facilitate quality improvement efforts.

Cost-effectiveness of an Environmental Cleaning Bundle for Reducing Healthcare-associated Infections.

BACKGROUND: Healthcare-associated infections (HAIs) remain a significant patient safety issue, with point prevalence estimates being ~5% in high-income countries. In 2016-2017, the Researching Effective Approaches to Cleaning in Hospitals (REACH) study implemented an environmental cleaning bundle targeting communication, staff training, improved cleaning technique, product use, and audit of frequent touch-point cleaning. This study evaluates the cost-effectiveness of the environmental cleaning bundle for reducing the incidence of HAIs. METHODS: A stepped-wedge, cluster-randomized trial was conducted in 11 hospitals recruited from 6 Australian states and territories. Bundle effectiveness was measured by the numbers of Staphylococcus aureus bacteremia, Clostridium difficile infection, and vancomycin-resistant enterococci infections prevented in the intervention phase based on estimated reductions in the relative risk of infection. Changes to costs were defined as the cost of implementing the bundle minus cost savings from fewer infections. Health benefits gained from fewer infections were measured in quality-adjusted life-years (QALYs). Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio and net monetary benefit of adopting the cleaning bundle over existing hospital cleaning practices. RESULTS: Implementing the cleaning bundle cost $349 000 Australian dollars (AUD) and generated AUD$147 500 in cost savings. Infections prevented under the cleaning bundle returned a net monetary benefit of AUD$1.02 million and an incremental cost-effectiveness ratio of $4684 per QALY gained. There was an 86% chance that the bundle was cost-effective compared with existing hospital cleaning practices. CONCLUSIONS: A bundled, evidence-based approach to improving hospital cleaning is a cost-effective intervention for reducing the incidence of HAIs.

Exploring the determinants of health and wellbeing in communities living in proximity to coal seam gas developments in regional Queensland.

BACKGROUND: There is some concern that coal seam gas mining may affect health and wellbeing through changes in social determinants such as living and working conditions, local economy and the environment. The onward impact of these conditions on health and wellbeing is often not monitored to the same degree as direct environmental health impacts in the mining context, but merits attention. This study reports on the findings from a recurrent theme that emerged from analysis of the qualitative component of a comprehensive Health Needs Assessment (HNA) conducted in regional Queensland: that health and wellbeing of communities was reportedly affected by nearby coal seam gas (CSG) development beyond direct environmental impacts. METHODS: Qualitative analysis was initially completed using the Framework Method to explore key themes from 11 focus group discussions, 19 in-depth interviews, and 45 key informant interviews with health and wellbeing service providers and community members. A key theme emerged from the analysis that forms the basis of this paper. This study is part of a larger comprehensive HNA involving qualitative and quantitative data collection to explore the health and wellbeing needs of three communities living in proximity to CSG development in regional Queensland, Australia. RESULTS: Communities faced social, economic and environmental impacts from the rapid growth of CSG development, which were perceived to have direct and indirect effects on individual lifestyle factors such as alcohol and drug abuse, family relationships, social capital and mental health; and community-level factors including social connectedness, civic engagement and trust. CONCLUSIONS: Outer regional communities discussed the effects of mining activity on the fabric of their town and community, whereas the inner regional community that had a longer history of industrial activity discussed the impacts on families and individual health and wellbeing. The findings from this study may inform future health service planning in regions affected by CSG in the development /construction phase and provide the mining sector in regional areas with evidence from which to develop social responsibility programs that encompass health, social, economic and environmental assessments that more accurately reflect the needs of the affected communities.

Assessment of Motivational Cognitions in Diabetes Self-Care: the Motivation Thought Frequency Scales for Glucose Testing, Physical Activity and Healthy Eating.

PURPOSE: There is a need for improved measurement of motivation for diabetes self-care. The Elaborated Intrusion Theory of Desire offers a coherent framework for understanding and identifying the cognitive-affective events that constitute the subjective experience of motivation and may therefore inform the development of such an instrument. Recent research has shown the resultant Motivation Thought Frequency scale (MTF) to have a stable factor structure (Intensity, Incentives Imagery, Self-Efficacy Imagery, Availability) when applied to physical activity, excessive snacking or alcohol use in the general population. The current study aimed to confirm the four-factor structure of the MTF for glucose testing, physical activity and healthy eating in people with type 2 diabetes. Associations with self-reports of concurrent diabetic self-care behaviours were also examined. METHOD: Confirmatory factor analyses tested the internal structure, and multiple regressions assessed the scale's relationship with concurrent self-care behaviours. The MTF was completed by 340 adults with type 2 diabetes, and 237 from that sample also reported self-care behaviours. Separate MTFs assessed motivation for glucose testing, physical activity and healthy eating. Self-care was assessed using questions from the Summary of Diabetes Self-Care Activities. RESULTS: The MTF for each goal achieved an acceptable fit on all indices after selected errors within factors were allowed to intercorrelate. Intensity and Self-Efficacy Imagery provided the strongest and most consistent correlations with relevant self-care behaviours. CONCLUSION: Results provide preliminary support for the MTF in a diabetes sample. Testing of its sensitivity to change and its predictive utility over time is needed.

Implementing a patient-initiated review system in rheumatoid arthritis: a qualitative evaluation.

BACKGROUND: The management of Rheumatoid Arthritis (RA), a chronic relapsing condition primarily affecting joints usually entails regular hospital reviews with a specialist. These reviews can occur when the patient is well. This study forms part of a service evaluation of a system wide implementation of a patient initiated review appointment system which we have called Direct Access (DA). The aim was to explore the experiences of patients and staff of a DA system in order to understand the process of the implementation and to identify potential improvements. METHODS: Twenty-three patients with RA that had completed one year of follow-up on the DA system and seven healthcare professionals (HCPs) involved in the implementation of the DA review system took part in semi-structured interviews. Thematic analysis was used to analyse the interview data and field notes. RESULTS: Four themes emerged in the data: (1) building patient confidence and empowerment, (2) right place right time, (3) safety, (4) the everyday challenges of managing change. These show that in order for implementation to be successful the patient needs to have confidence in using a new system of requesting a medical review, which, in turn, needs to be offered quickly and in a setting convenient to both patient and clinician. Embedded in the change process need to be systems for ensuring regular disease monitoring and general issues surrounding team working, communication and ownership of the change process also need to be considered from the outset. CONCLUSION: The clinics offer increased patient autonomy and the opportunity for greater self-management of chronic disease. This fits with new models of care where the patient is considered to be 'the expert'.

Block & replace regime versus titration regime of antithyroid drugs for the treatment of Graves' disease: a retrospective observational study.

CONTEXT: Two widely used antithyroid drug (ATD) regimes for Graves' disease (GD) include the 'block & replace' (B&R) regime (a fixed high-dose of ATD combined with levothyroxine) and the 'titration' regime (a titrating dose of ATD). Anecdotally, it is believed that B&R is less prone to fluctuating thyroid function. OBJECTIVE: To study whether, in routine clinical practice, the B&R regime, compared with the titration regime, is associated with more stable thyroid function. METHODS: We retrospectively analysed case-records for 450 patients treated with ATDs for GD at a secondary care hospital. Exclusion criteria included treatment with ATDs for <6 months, thyrotoxicosis due to other causes, treatment with radioiodine or thyroidectomy and pregnancy. RESULTS: Two hundred and twenty three patients were treated with the B&R regime ('B&R group'), 149 with the titration regime ('titration group') and 78 with both regimes. The number of thyroid function tests (TFTs) performed per year (mean(SD): 3·2(1·2) vs 3·4(1·5); adjusted mean difference = -0·4; 95% CI: -0·7 to -0·1; and P = 0·008) and the number of hospital clinic visits per year (mean (SD): 2·9 (1·0) vs 3·2 (1·3); adjusted mean difference = -0·4; 95% CI: -0·7 to -0·2; and P = 0·002) were lower in the B&R group than the titration group. The number of abnormal TFT results per year was similar in the two groups (mean(SD): 1·8(1·3) vs 1·8(1·4); adjusted mean difference = 0·05; 95%CI: -0·3 to 0·4; and P = 0·74). CONCLUSIONS: In this retrospective study, there was little evidence that patients under B&R have more stable thyroid function. Further data from prospective studies, however, are needed to confirm this finding.

Risks, dangers and competing clinical decisions on venous thromboembolism prophylaxis in hospital care.

Drawing on wider sociologies of risk, this article examines the complexity of clinical risks and their management, focusing on risk management systems, expert decision-making and safety standards in health care. At the time of this study preventing venous thromboembolism (VTE) among in-patients was one of the top priorities for hospital safety in the English National Health Service (NHS). An analysis of 50 interviews examining hospital professionals' perceptions about VTE risks and prophylaxis illuminates how National Institute for Health and Clinical Excellence (NICE) guidelines influenced clinical decision-making in four hospitals in one NHS region. We examine four themes: the identification of new risks, the institutionalisation and management of risk, the relationship between risk and danger and the tensions between risk management systems and expert decision-making. The implementation of NICE guidelines for VTE prevention extended managerial control over risk management but some irreducible clinical dangers remained that were beyond the scope of the new VTE risk management systems. Linking sociologies of risk with the realities of hospital risk management reveals the capacity of these theories to illuminate both the possibilities and the limits of managerialism in health care.

Scope of practice regulation in medicine: balancing patient safety, access to care and professional autonomy.

Scope of practice regulation in medicine is crucial for ensuring patient safety, access to care and professional autonomy. This paper explores the impact of scope of practice regulation on healthcare delivery, professional responsibilities and patient outcomes. It discusses the variability in standards for safe practice, the challenges in defining boundaries between medical specialties and the recent controversies in cosmetic surgery practice. The paper also examines the potential benefits and drawbacks of rigorous scope of practice regulations, including their impact on clinical innovation, flexibility and access to care. Furthermore, it delves into the implications of defensive medicine and the consequences of restrictive regulations on patient care. The author proposes implementing a proactive, national, artificial intelligence-powered, real-time outcome monitoring system to address these challenges. This system aims to cover every patient undergoing a surgical procedure and could be gradually extended to non-surgical conditions, benefiting all key stakeholders in the health system. The paper emphasises the need for a balanced approach to scope of practice regulation to avoid stifling clinical innovation and professional autonomy, while ensuring patient safety and professional accountability.

Telephone consultations in place of face to face out-patient consultations for patients discharged from hospital following surgery: a systematic review.

BACKGROUND: Routine follow-up following uncomplicated surgery is being delivered by telephone in some settings. Telephone consultations may be preferable to patients and improve outpatient resource use. We aimed to compare the effectiveness of telephone consultations with face to face follow-up consultations, in patients discharged from hospital following surgery. METHODS: Seven electronic databases (including Medline, Embase and PsycINFO) were searched from inception to July 2011. Comparative studies of any design in which routine follow-up via telephone was compared with face to face consultation in patients discharged from hospital after surgery were included. Study selection, data extraction and quality appraisal were performed independently by two reviewers with consensus reached by discussion and involvement of a third reviewer where necessary. RESULTS: Five papers (four studies; 865 adults) met the inclusion criteria. The studies were of low methodological quality and reported dissimilar outcomes precluding any formal synthesis. CONCLUSIONS: There has been very little comparative evaluation of different methods of routine follow-up care in patients discharged from hospital following surgery. Further work is needed to establish a role for telephone consultation in this patient group.

The implementation of NICE guidance on venous thromboembolism risk assessment and prophylaxis: a before-after observational study to assess the impact on patient safety across four hospitals in England.

BACKGROUND: Venous thromboembolism (VTE) is a major cause of morbidity and mortality in hospitalised patients. VTE prevention has been identified as a major health need internationally to improve patient safety. A National Institute for Health and Clinical Excellence (NICE) guideline was issued in February 2010. Its key priorities were to assess patients for risk of VTE on admission to hospital, assess patients for bleeding risk and evaluate the risks and benefits of prescribing VTE prophylaxis. The aim of this study was to evaluate the implementation of NICE guidance and its impact on patient safety. METHODS: A before-after observational design was used to investigate changes in VTE risk assessment documentation and inappropriate prescribing of prophylaxis between the year prior to (2009) and the year following (2010) the implementation of NICE guidance, using data from a 3-week period during each year. A total of 408 patients were sampled in each year across four hospitals in the NHS South region. RESULTS: Implementation strategies such as audit, education and training were used. The percentage of patients for whom a VTE risk assessment was documented increased from 51.5% (210/408) in 2009 to 79.2% (323/408) in 2010; difference 27.7% (95% CI: 21.4% to 33.9%; p < 0.001). There was little evidence of change in the percentage who were prescribed prophylaxis amongst patients without a risk assessment (71.7% (142/198) in 2009 and 68.2% (58/85) in 2010; difference -3.5% (95% CI: -15.2% to 8.2%; p =0.56) nor the percentage who were prescribed low molecular weight heparin amongst patients with a contraindication (14% (4/28) in 2009 and 15% (6/41) in 2010; RD = 0.3% (95% CI: -16.5% to 17.2%; p =0.97). CONCLUSIONS: The documentation of risk assessment improved following the implementation of NICE guidance; it is questionable, however, whether this led to improved patient safety with respect to prescribing appropriate prophylaxis.

Effectiveness and cost of atypical versus typical antipsychotic treatment in a nationwide cohort of patients with schizophrenia in Germany.

This study investigates the effectiveness and cost of typical versus atypical antipsychotics in a nationwide German cohort of patients with schizophrenia. The study sample consisted of patients insured with 4 sickness funds (n = 8,610) who were followed up for 12 months after hospital discharge with a diagnosis of schizophrenia in 2003. Multivariate regression models were fitted to assess the relationship between outcome variables (rehospitalization, bed-days, prescriptions against adverse effects, cost) and medication type, sex, age, and severity. Severity was assessed by prior bed-days due to schizophrenia during 2000 to 2002. Risk of rehospitalization did not differ between groups but within each group severity (P = 0.0003). Males (P = 0.0016) and patients younger than 35 years (P < 0.0001) had a higher risk of rehospitalization. Number of bed-days was lower for treatment with typicals compared with atypicals (P < 0.0001); furthermore, bed-days depended on severity of disease (P < 0.0001). Prescriptions of drugs against extrapyramidal symptoms, anxiety, and agitation were higher for patients treated with typicals (P < 0.0001 for each). Mean predicted treatment cost per year was € 6442 for atypicals versus € 4443 for typicals (P < 0.0001). This study does not support unconditional superiority of atypicals over typicals, neither in terms of effectiveness nor in terms of cost.

Emigration preferences and plans among medical students in Poland.

BACKGROUND: Migration and ethical recruitment of health care workers is receiving increased attention worldwide. Europe's aging population is creating new opportunities for medical doctors for finding employment in other countries, particularly those of a better standard of living. METHODS: We conducted a survey among 1214 medical students in five out of eleven universities in Poland with medical schools in October 2008. A series of statistical tests was applied to analyse the characteristics of potential migrants. Projections were obtained using statistical analyses: descriptive, multifactorial logistic regression and other statistical methods . RESULTS: We can forecast that 26-36% of Polish medical students will emigrate over the next few years; 62% of respondents estimated the likelihood of emigration at 50%. Students in their penultimate year of study declared a stronger desire to migrate than those in the final year. At the same time, many students were optimistic about career opportunities in Poland. Also noted among students were: the decline in interest in leaving among final year students, their moderate elaboration of departure plans, and their generally optimistic views about the opportunities for professional development in Poland. CONCLUSIONS: The majority of Polish students see the emigration as a serious alternative to the continuation of their professional training. This trend can pose a serious threat to the Polish health care system, however the observed decline of the interest in leaving among final year students, the moderate involvement in concrete departure plans and the optimistic views about the opportunities for professional development in Poland suggest that the actual scale of brain drain of young Polish doctors due to emigration will be more limited than previously feared.

Effectiveness of interventions to promote healthy weight in general populations of children and adults: a meta-analysis.

BACKGROUND: Responding to the obesity epidemic requires robust evidence to help prioritize the allocation of scarce resources to preventive interventions. The aim of this study was to evaluate interventions that promote healthy weight [defined as reduction in body mass index (BMI) or percentage body fat] in general populations (unselected by weight) using a comprehensive meta-analysis. Interventions with both single and multiple components were considered. METHODS: Studies were first identified through well-conducted systematic reviews complemented by a search for single studies in five large medical databases up to 6 November 2008. Sixty-eight controlled studies were included. For each intervention type and age group, all relevant studies were pooled in a random effects meta-analysis. RESULTS: In children, the highest reductions in mean BMI were achieved through promoting reduced television viewing [-0.27 kg/m(2) (95% CI -0.4 to -0.13 kg/m(2))]. Programmes combining physical activity, specifically themed or general health education and nutrition achieved a lower reduction [-0.1 kg/m(2) (95% CI -0.17 to -0.04 kg/m(2))]. Other interventions had high heterogeneity or showed no statistically significant reduction in outcomes. In adults, single component interventions were found to reduce both outcome measures. Their mean percentage body fat was reduced through education by -1.22% (95% CI -1.92 to -0.52). CONCLUSION: The evidence for the effectiveness of promoting healthy weight in general populations is limited, though multi-component interventions in schools and encouraging reduced children's television viewing are promising strategies. Improving the reporting of outcomes is vital, as imputation of inadequately reported measures may have contributed to the observed heterogeneity. Longer follow-up is essential for understanding policy relevance.

Evaluation of a patient-initiated review system in rheumatoid arthritis: an implementation trial protocol.

BACKGROUND: Rheumatoid arthritis is a chronic inflammatory condition that affects the joints causing unpredictable episodes of pain, stiffness and disability. People with rheumatoid arthritis usually require lifelong specialist follow-up but frequently have periods when their disease can be managed through self-care or that provided by their general practitioner. Compared to the traditional clinician-driven care in rheumatoid arthritis, patient-initiated care has proven to be more beneficial in terms of reducing unnecessary medical reviews, providing greater satisfaction to patients and staffs and maintaining the patient's physical and psychological status. We aim to evaluate the implementation of a patient-initiated review system in a routine secondary care rheumatology service in a public hospital in England, where patients get the opportunity to self-manage their disease by requesting specialist reviews at times of need instead of clinician-scheduled appointments. METHODS/DESIGN: Three hundred and eighty patients attending routine review at Plymouth Hospitals NHS Trust will be randomised to either enrol immediately into a patient-initiated review system (direct access group), or to be seen regularly by a clinician at the hospital (regular clinician-initiated group). Patients (or their general practitioner) in the direct access group can arrange a review by calling a rheumatology nurse-led advice line that enables telephone delivered clinical advice, or where appropriate, an appointment with a rheumatologist within 10 working days. Patients in the regular clinician-initiated group will attend their planned appointments at regular intervals during the intervening period of 12 months. The primary outcome of interest is patient satisfaction; secondary outcomes include service use, waiting times and clinical measures. Semi-structured, in-depth interviews will be conducted with a subset of patients and staff with the aim of identifying facilitators/barriers in implementing patient-initiated clinics. DISCUSSION: The implementation of a patient-initiated review system in routine care rheumatology will replace the fixed clinician-driven review system with a more flexible patient-driven system where patients usually self-manage their disease, but can request prompt help when required. We believe that this study will enable a comparison of the changes in local services and will be helpful in exploring the benefits/drawbacks of such implementation, thus providing lessons for implementation in other hospitals and for other chronic diseases.

Healthcare financing in Yemen.

Yemen is a low-middle-income country where more than half of the population live in rural areas and lack access to the most basic health care. At US$40 per capita, Yemen's annual total health expenditure (THE) is among the lowest worldwide. This study analyses the preconditions and options for implementing basic social health protection in Yemen. It reveals a four-tiered healthcare system characterised by high geographic and financial access barriers mainly for the poor. Out-of-pocket payments constitute 55% of THE, and cost-sharing exemption schemes are not well organised. Resource-allocation practices are inequitable because about 30% of THE gets spent on treatment abroad for a small number of patients, mainly from better-off families. Against the background of a lack of social health protection, a series of small-scale and often informal solidarity schemes have developed, and a number of public and private companies have set up health benefit schemes for their employees. Employment-based schemes usually provide reasonable health care at an average annual cost of YR44 000 (US$200) per employee. In contrast, civil servants contribute to a mandatory health-insurance scheme without receiving any additional health benefits in return. A number of options for initiating a pathway towards a universal health-insurance system are discussed.

Yulu Shequ - a unique rehabilitation program for illicit drug users in Kaiyuan in southwest China.

INTRODUCTION: In China, illicit drug use and addiction have been rapidly increasing over the last two decades. Traditional compulsory rehabilitation models in China are widely considered ineffective. Recently, a new model of drug user rehabilitation called the 'Yulu Shequ Program' has gained a national reputation for successful rehabilitation in the city of Kaiyuan in southwest China. The aim of this study was to describe this program to the international public and to assess the program's effectiveness in terms of relapse rates and costs to participants and public payers. CASE DESCRIPTION: The Yulu Shequ program provides up to one hundred participants at any point in time with the opportunity to live and work in a purpose-built, drug-free community after completing compulsory rehabilitation. The length of stay is not limited. Community members receive medical and psychological treatment and have the option to participate in social activities and highly valued job skills training. The program has very strict policies to prevent illicit drugs entering the community. EVALUATION: The evaluation was carried out through 1) a review of literature, official documents and websites in Chinese language describing the program and 2) an on-site visit and conduct of semi-structured interviews with key staff members of the Yulu Shequ program. The relapse rate in 2007 was 60% compared to 96% in the compulsory program. Annual costs to public payers of CNY4800 (US$700) were largely offset by income earned through on-site labour by participants totalling CNY4600 (US$670). CONCLUSIONS: The Yulu Shequ program is an interesting model for drug rehabilitation that could lead the way for a new Chinese national policy away from compulsory rehabilitation towards a more collaborative and effective approach. Caution is needed when interpreting relapse rates as Yulu Shequ participants need to have completed compulsory rehabilitation before entering the program. A more comprehensive evaluation of this program would be desirable before implementation in other parts of China or in other countries facing similar problems.

The effect of market reforms and new public management mechanisms on the Swiss health care system.

In 1996, the Federal Law on Health Insurance (LAMal) was adopted in order to contain costs in Swiss health care. At the same time, the reform aimed to maintain or even improve solidarity and encourage institutional reform through new public management (NPM) and market mechanisms. More freedom in contractual conditions between insurers and providers and a clearer distinction of responsibilities between federal and regional (cantonal) authorities were stipulated to achieve efficiency, effectiveness, and transparency. The focus of this paper is an analysis of the effects of market reforms and NPM mechanisms introduced with the LAMal on the cost-containment, quality of care and equity objectives in the Swiss health care system.

Effectiveness of a structured, framework-based approach to implementation: the Researching Effective Approaches to Cleaning in Hospitals (REACH) Trial.

BACKGROUND: Implementing sustainable practice change in hospital cleaning has proven to be an ongoing challenge in reducing healthcare associated infections. The purpose of this study was to develop a reliable framework-based approach to implement and quantitatively evaluate the implementation of evidence-based practice change in hospital cleaning. DESIGN/METHODS: The Researching Effective Approaches to Cleaning in Hospitals (REACH) trial was a pragmatic, stepped-wedge randomised trial of an environmental cleaning bundle implemented in 11 Australian hospitals from 2016 to 2017. Using a structured multi-step approach, we adapted the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to support rigorous and tailored implementation of the cleaning bundle intervention in eleven diverse and complex settings. To evaluate the effectiveness of this strategy we examined post-intervention cleaning bundle alignment calculated as a score (an implementation measure) and cleaning performance audit data collected using ultraviolet (UV) gel markers (an outcome measure). RESULTS: We successfully implemented the bundle and observed improvements in cleaning practice and performance, regardless of hospital size, intervention duration and contextual issues such as staff and organisational readiness at baseline. There was a positive association between bundle alignment scores and cleaning performance at baseline. This diminished over the duration of the intervention, as hospitals with lower baseline scores were able to implement practice change successfully. CONCLUSION: Using a structured framework-based approach allows for pragmatic and successful implementation of clinical trials across diverse settings, and assists with quantitative evaluation of practice change. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12615000325505, registered on 4 September 2015.