Integrated clinical pathway management for medical quality improvement-based on a semiotically inspired systems architecture

Clinical pathway is an approach to standardise care processes to support the implementations of clinical guidelines and protocols. It is designed to support the management of treatment processes including clinical and non-clinical activities, resources and also financial aspects. It provides detailed guidance for each stage in the management of a patient with the aim of improving the continuity and coordination of care across different disciplines and sectors. However, in the practical treatment process, the lack of knowledge sharing and information accuracy of paper-based clinical pathways burden health-care staff with a large amount of paper work. This will often result in medical errors, inefficient treatment process and thus poor quality medical services. This paper first presents a theoretical underpinning and a co-design research methodology for integrated pathway management by drawing input from organisational semiotics. An approach to integrated clinical pathway management is then proposed, which aims to embed pathway knowledge into treatment processes and existing hospital information systems. The capability of this approach has been demonstrated through the case study in one of the largest hospitals in China. The outcome reveals that medical quality can be improved significantly by the classified clinical pathway knowledge and seamless integration with hospital information systems.

Sample size considerations in active-control non-inferiority trials with binary data based on the odds ratio

This paper presents an approximate closed form sample size formula for determining non-inferiority in active-control trials with binary data. We use the odds-ratio as the measure of the relative treatment effect, derive the sample size formula based on the score test and compare it with a second, well-known formula based on the Wald test. Both closed form formulae are compared with simulations based on the likelihood ratio test. Within the range of parameter values investigated, the score test closed form formula is reasonably accurate when non-inferiority margins are based on odds-ratios of about 0.5 or above and when the magnitude of the odds ratio under the alternative hypothesis lies between about 1 and 2.5. The accuracy generally decreases as the odds ratio under the alternative hypothesis moves upwards from 1. As the non-inferiority margin odds ratio decreases from 0.5, the score test closed form formula increasingly overestimates the sample size irrespective of the magnitude of the odds ratio under the alternative hypothesis. The Wald test closed form formula is also reasonably accurate in the cases where the score test closed form formula works well. Outside these scenarios, the Wald test closed form formula can either underestimate or overestimate the sample size, depending on the magnitude of the non-inferiority margin odds ratio and the odds ratio under the alternative hypothesis. Although neither approximation is accurate for all cases, both approaches lead to satisfactory sample size calculation for non-inferiority trials with binary data where the odds ratio is the parameter of interest.

Targeting medication non-adherence behavior in selected autoimmune diseases: a systematic approach to digital health program development

Background 29 autoimmune diseases, including Rheumatoid Arthritis, gout, Crohn’s Disease, and Systematic Lupus Erythematosus affect 7.6-9.4% of the population. While effective therapy is available, many patients do not follow treatment or use medications as directed. Digital health and Web 2.0 interventions have demonstrated much promise in increasing medication and treatment adherence, but to date many Internet tools have proven disappointing. In fact, most digital interventions continue to suffer from high attrition in patient populations, are burdensome for healthcare professionals, and have relatively short life spans. Objective Digital health tools have traditionally centered on the transformation of existing interventions (such as diaries, trackers, stage-based or cognitive behavioral therapy programs, coupons, or symptom checklists) to electronic format. Advanced digital interventions have also incorporated attributes of Web 2.0 such as social networking, text messaging, and the use of video. Despite these efforts, there has not been little measurable impact in non-adherence for illnesses that require medical interventions, and research must look to other strategies or development methodologies. As a first step in investigating the feasibility of developing such a tool, the objective of the current study is to systematically rate factors of non-adherence that have been reported in past research studies. Methods Grounded Theory, recognized as a rigorous method that facilitates the emergence of new themes through systematic analysis, data collection and coding, was used to analyze quantitative, qualitative and mixed method studies addressing the following autoimmune diseases: Rheumatoid Arthritis, gout, Crohn’s Disease, Systematic Lupus Erythematosus, and inflammatory bowel disease. Studies were only included if they contained primary data addressing the relationship with non-adherence. Results Out of the 27 studies, four non-modifiable and 11 modifiable risk factors were discovered. Over one third of articles identified the following risk factors as common contributors to medication non-adherence (percent of studies reporting): patients not understanding treatment (44%), side effects (41%), age (37%), dose regimen (33%), and perceived medication ineffectiveness (33%). An unanticipated finding that emerged was the need for risk stratification tools (81%) with patient-centric approaches (67%). Conclusions This study systematically identifies and categorizes medication non-adherence risk factors in select autoimmune diseases. Findings indicate that patients understanding of their disease and the role of medication are paramount. An unexpected finding was that the majority of research articles called for the creation of tailored, patient-centric interventions that dispel personal misconceptions about disease, pharmacotherapy, and how the body responds to treatment. To our knowledge, these interventions do not yet exist in digital format. Rather than adopting a systems level approach, digital health programs should focus on cohorts with heterogeneous needs, and develop tailored interventions based on individual non-adherence patterns.

Efficacy of high intensity diode laser as an adjunct to non-surgical periodontal treatment: a randomized controlled trial

The high intensity diode laser has been studied in periodontics for the reduction of subgingival bacteria in non-surgical treatment. Our study evaluated the bacterial effect as well as changes in periodontal clinical parameters promoted by root scaling and planing associated with this wavelength. Twenty-seven patients randomly assigned in two groups underwent root scaling and planing on the tested sites, and only the experimental group received the diode laser irradiation. Among the clinical parameters studied, the clinical probing depth (CPD) and the clinical attachment level (CAL) resulted in significant enhancement in the control group when compared with the experimental group (P = 0.014 and P = 0.039, respectively). The results were similar for both groups regarding the plaque index (PI) and bleeding on probing (BP). No significant difference in the microbiological parameters was observed between the control and experimental groups. It was possible to conclude that the high power diode laser adjunct to the non-surgical periodontal treatment did not promote additional effects to the conventional periodontal treatment.

Evaluation of laccases and melanization in clinical and environmental Cryptococcus neoformans samples by non-denaturing PAGE

The increased incidence of infections caused by the opportunistic pathogen Cryptococcus neoformans, which mainly affects immunocompromised patients but can also infect immunocompetent individuals, has needed additional studies on this micro-organism`s pathogenicity and factors related to virulence, such as enzyme production, for a better understanding of the aetiology of cryptococcosis. The aim of this study was to verify the applicability of non-denaturing PAGE for analysis of laccases by quantification of the amount of melanin pigment produced by clinical and environmental strains of C. neoformans. After incubation of the gel with the substrate L-dopa, strains produced melanin spots of a bright brown to black colour. Quantification of these spots was performed by densitometry analysis and the amount of melanin produced was calculated and compared among the strains. All strains showed laccase activity. Serotype B strains showed a higher melanin intensity than serotype A strains. Over half of the clinical strains (56.2%) showed the lowest melanin intensities, suggesting that melanin production may not be the main virulence factor against host defence. The clinical strain ICB 88 revealed two melanin spots on the gel, indicating the presence of two laccase isoforms. The environmental strains showed the highest values of melanin intensity, which may be related to previous exposure to environmental stress conditions.

A non-parametric vessel detection method for complex vascular structures

Modern medical imaging techniques enable the acquisition of in vivo high resolution images of the vascular system. Most common methods for the detection of vessels in these images, such as multiscale Hessian-based operators and matched filters, rely on the assumption that at each voxel there is a single cylinder. Such an assumption is clearly violated at the multitude of branching points that are easily observed in all, but the Most focused vascular image studies. In this paper, we propose a novel method for detecting vessels in medical images that relaxes this single cylinder assumption. We directly exploit local neighborhood intensities and extract characteristics of the local intensity profile (in a spherical polar coordinate system) which we term as the polar neighborhood intensity profile. We present a new method to capture the common properties shared by polar neighborhood intensity profiles for all the types of vascular points belonging to the vascular system. The new method enables us to detect vessels even near complex extreme points, including branching points. Our method demonstrates improved performance over standard methods on both 2D synthetic images and 3D animal and clinical vascular images, particularly close to vessel branching regions. (C) 2008 Elsevier B.V. All rights reserved.

Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India : study protocol and intervention adaptation of a randomised control trial

The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion, among women as well as providers. It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic. Trial design The study is a randomised, controlled, non-superiority trial . Methods Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home, while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor. The primary objective of the study is to evaluate the effectiveness of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion. Providers or research assistants will not be blinded during outcome assessment. To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation. This was to optimise and tailor-make the intervention and the study procedures and resulted in the development of the pictorial instruction sheet for how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion. Discussion In this paper, we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment, 10-14 days after a medical abortion. Moreover, a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor. Trial registration: Clinicaltrials.gov NCT01827995. Registered 04 May 2013

An effective non-parametric method for globally clustering genes from expression profiles

Clustering is widely used in bioinformatics to find gene correlation patterns. Although many algorithms have been proposed, these are usually confronted with difficulties in meeting the requirements of both automation and high quality. In this paper, we propose a novel algorithm for clustering genes from their expression profiles. The unique features of the proposed algorithm are twofold: it takes into consideration global, rather than local, gene correlation information in clustering processes; and it incorporates clustering quality measurement into the clustering processes to implement non-parametric, automatic and global optimal gene clustering. The evaluation on simulated and real gene data sets demonstrates the effectiveness of the algorithm.

Injury profiles of Indigenous and non-Indigenous people in New South Wales

Objectives:
To compare the injury profiles of the Indigenous population in New South Wales with that of the non-Indigenous population.
Design and setting:
Descriptive analysis of NSW Health data obtained from the Health Outcomes Information and Statistical Toolkit (HOIST) database. Hospitalisation data were collected for the period 1 July 1999 to 30 June 2003. Mortality data were collected for the period 1 January 1999 to 31 December 2002.
Main outcome measures:
Hospitalisation and death rates due to injury by age, sex, injury mechanism and Indigenous status. Rate ratios for comparison between Indigenous and non-Indigenous populations.
Results:
Rates of death from injury were higher for all age groups in the Indigenous population, except people older than 65 years. Indigenous people aged 25–44 years were twice as likely to be hospitalised as their non-Indigenous counterparts (rate ratio [RR], 2.09; 95% CI, 2.03–2.14), and five times as likely to be hospitalised for interpersonal violence (RR, 5.19; 95% CI, 4.98–5.40).
Conclusion:
The higher rates of injury-related hospitalisation and death in the Indigenous population in NSW are consistent with data reported for other parts of Australia. Of particular concern is the number of Indigenous deaths and hospitalisations due to interpersonal violence.

Burden of disease and injury in Aboriginal and non-Aboriginal populations in the Northern Territory

Objective:
To quantify the burden of disease and injury for the Aboriginal and non-Aboriginal populations in the Northern Territory.

Design and setting:
Analysis of Northern Territory data for 1 January 1994 to 30 December 1998 from multiple sources.

Main outcome measures:
Disability-adjusted life-years (DALYs), by age, sex, cause and Aboriginality.

Results:
Cardiovascular disease was the leading contributor (14.9%) to the total burden of disease and injury in the NT, followed by mental disorders (14.5%) and malignant neoplasms (11.2%). There was also a substantial contribution from unintentional injury (10.4%) and intentional injury (4.9%). Overall, the NT Aboriginal population had a rate of burden of disease 2.5 times higher than the non-Aboriginal population; in the 35-54-year age group their DALY rate was 4.1 times higher. The leading causes of disease burden were cardiovascular disease for both Aboriginal men (19.1%) and women (15.7%) and mental disorders for both non-Aboriginal men (16.7%) and women (22.3%).

Conclusions:
A comprehensive assessment of fatal and non-fatal conditions is important in describing differentials in health status of the NT population. Our study provides comparative data to identify health priorities and facilitate a more equitable distribution of health funding.

Changing risk behaviours for non-communicable disease in New Zealand working men - is workplace intervention effective?

Aims. To evaluate the effectiveness of a health promotion
programme targeting dietary behaviours and physical
activity among male hourly-paid workers and to explore
demographic and attitudinal influences on dietary patterns
at baseline.
Methods. A controlled field trial compared workers at one
intervention and one control worksite. The intervention
comprised nutrition displays in the cafeteria and monthly
30-minute workshops for six months. Key outcome
measures at six and twelve-months were self-reported
dietary and lifestyle behaviours, nutrition knowledge, body
mass index (BMI), waist circumference and blood pressure.
Results. 132 men at the intervention site and 121 men at the
control site participated in the study and a high retention rate
(94% at 6-months and 89% at 12-months) was achieved. At
baseline, 40% of the total sample (253) were obese, 30% had
elevated blood pressure, 59% indicated an excessive fat intake
and 92% did not meet the recommended vegetable and fruit
intake. The intervention reduced fat intake, increased
vegetable intake and physical activity, improved nutrition
knowledge and reduced systolic blood pressure when
compared to the control site. There was no difference in
change in mean BMI or waist circumference. Reduction in
BMI was associated with reduction in fat intake.
Discussion. Low intensity workplace intervention can
significantly improve reported health behaviours and
nutrition knowledge although the impact on more
objective measures of risk was variable. A longer duration
or more intensive intervention may be required to achieve
further reduction in risk factors.

An urgent challenge: new training opportunities for junior medical officers

There will be a massive increase in the number of medical school graduates over the next 5–10 years — there were 1287 Australian resident graduates in 2004, and there will be more than 3000 by the middle of the next decade.

A workshop held during the 11th National Prevocational Medical Education Forum explored ways to provide the additional prevocational training posts that will be required.

Four possible sites for additional training posts were discussed:
         • expansion of public hospital training posts;
         • general practice;
         • private hospitals; and
         • other sites, including private rooms and community placements.

Current accreditation procedures will need to be amended to accommodate more interns.

There will be limited access to prevocational training posts for non-resident (full-fee-paying) graduates and international medical graduates.

There is an urgent need for postgraduate medical councils, state health departments, the federal government, and medical boards to work together to identify, develop and accredit new training posts.

Why do medical graduates choose rural careers?

Introduction: This study is based on the metaphor of the ‘rural pipeline’ into medical practice. The four stages of the rural
pipeline are: (1) contact between rural secondary schools and the medical profession; (2) selection of rural students into medical
programs; (3) rural exposure during medical training; and (4) measures to address retention of the rural medical workforce.
Methods: Using the rural pipeline template we conducted a literature review, analysed the selection methods of Australian
graduate entry medical schools and interviewed 17 interns about their medical career aspirations.
Results: Literature review: The literature was reviewed to assess the effectiveness of selection practices to predict successful
gradation and the impact of rural pipeline components on eventual rural practice. Undergraduate academic performance is the
strongest predictor of medical course academic performance. The predictive power of interviews is modest. There are limited data
on the predictive power of other measures of non-cognitive performance or the content of the undergraduate degree. Prior rural
residence is the strongest predictor of choice of a rural career but extended rural exposure during medical training also has a
significant impact. The most significant influencing factors are: professional support at national, state and local levels; career
pathway opportunities; contentedness of the practitioner’s spouse in rural communities; preparedness to adopt a rural lifestyle;
educational opportunities for children; and proximity to extended family and social circle. Analysis of selection methods: Staff
involved in student selection into 9 Australian graduate entry medical schools were interviewed. Four themes were identified:
(1) rurality as a factor in student selection; (2) rurality as a factor in student selection interviews; (3) rural representation on student
selection interview panels; (4) rural experience during the medical course. Interns’ career intentions: Three themes were identified:
(1) the efficacy of the rural pipeline; (2) community connectedness through the rural pipeline; (3) impediments to the effect of the
rural pipeline, the most significant being a partner who was not committed to rural life
Conclusion: Based on the literature review and interviews, 11 strategies are suggested to increase the number of graduates
choosing a career in rural medicine, and one strategy for maintaining practitioners in rural health settings after graduation.

Oxygen delivery to patients after cardiac surgery : a medical record audit

OBJECTIVE: To describe how intensive care nurses manage the administration of supplemental oxygen to patients during the first 24 hours after cardiac surgery.
METHODS: A retrospective audit was conducted of the medical records of 245 adult patients who underwent cardiac surgery between 1 January 2005 and 31 May 2008 in an Australian metropolitan hospital. Physiological data (oxygen saturation measured by pulse oximetry and respiratory rate) and intensive care unit management data (oxygen delivery device, oxygen flow rate and duration of mechanical ventilation) were collected at hourly intervals over the first 24 hours of ICU care.
RESULTS: Of the 245 patients whose records were audited, 185 were male; mean age was 70 years (SD, 10), and mean APACHE II score was 17.5 (SD, 5.14). Almost half the patients (122, 49.8%) were extubated within 8 hours of ICU admission. The most common oxygen delivery device used immediately after extubation was the simple face mask (214 patients, 87%). Following extubation, patients received supplemental oxygen via, on average, two different delivery devices (range, 1-3), and had the delivery device changed an average of 1.38 times (range, 0-6) during the 24 hours studied. Twenty-two patients (9%) received non-invasive ventilation or high-flow oxygen therapy, and 16 (7%) experienced one or more episode of hypoxaemia during mechanical ventilation. A total of 148 patients (60%) experienced one or more episodes of low oxygenation or abnormal respiratory rate during the first 24 hours of ICU care despite receiving supplemental oxygen.
CONCLUSION: These findings suggest that the ICU environment does not protect cardiac surgical patients from suboptimal oxygen delivery, and highlights the need for strategies to prompt the early initiation of interventions aimed at optimising blood oxygen levels in cardiac surgical patients in the ICU.

Clinical, ethical and legal considerations in the treatment of newborns with non-ketotic hyperglycinaemia

Non-ketotic hyperglycinaemia (NKH) is a devastating neurometabolic disorder leading, in its classical form, to early death or severe disability and poor quality of life in survivors. Affected neonates may need ventilatory support during a short period of respiratory depression. The transient dependence on ventilation dictates urgency in decision-making regarding withdrawal of therapy. The occurrence of patients with apparent transient forms of the disease, albeit rare, adds uncertainty to the prediction of clinical outcome and dictates that the current practice of withholding or withdrawing therapy in these neonates be reviewed. Both bioethics and law take the view that treatment decisions should be based on the best interests of the patient. The medical-ethics approach is based on the principles of non-maleficence, beneficence, autonomy and justice. The law relating to withholding or withdrawing life-sustaining treatment is complex and varies between jurisdictions. Physicians treating newborns with NKH need to provide families with accurate and complete information regarding the disease and the relative probability of possible outcomes of the neonatal presentation and to explore the extent to which family members are willing to take part in the decision making process. Cultural and religious attitudes, which may potentially clash with bioethical and juridical principles, need to be considered.