Self-assessment of the outcome of early medical abortion versus clinic follow-up in India : a randomised, controlled, non-inferiority trial

Background: The need for multiple clinical visits remains a barrier to women accessing safe legal medical abortion services. Alternatives to routine clinic follow-up visits have not been assessed in rural low-resource settings. We compared the effectiveness of standard clinic follow-up versus home assessment of outcome of medical abortion in a low-resource setting. Methods: This randomised, controlled, non-inferiority trial was done in six health centres (three rural, three urban) in Rajasthan, India. Women seeking early medical abortion up to 9 weeks of gestation were randomly assigned (1:1) to either routine clinic follow-up or self-assessment at home. Randomisation was done with a computer-generated randomisation sequence, with a block size of six. The study was not blinded. Women in the home-assessment group were advised to use a pictorial instruction sheet and take a low-sensitivity urine pregnancy test at home, 10-14 days after intake of mifepristone, and were contacted by a home visit or telephone call to record the outcome of the abortion. The primary (non-inferiority) outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone and misoprostol. The non-inferiority margin for the risk difference was 5%. All participants with a reported primary outcome and who followed the clinical protocol were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT01827995. Findings: Between April 23, 2013, and May 15, 2014, 731 women were recruited and assigned to clinic follow-up (n=366) or home assessment (n=365), of whom 700 were analysed for the main outcomes (n=336 and n=364, respectively). Complete abortion without continuing pregnancy, surgical intervention, or additional mifepristone and misoprostol was reported in 313 (93%) of 336 women in the clinic follow-up group and 347 (95%) of 364 women in the home-assessment group (difference -2.2%, 95% CI -5.9 to 1.6). One case of haemorrhage occurred in each group (rate of adverse events 0.3% in each group); no other adverse events were noted. Interpretation Home assessment of medical abortion outcome with a low-sensitivity urine pregnancy test is non-inferior to clinic follow-up, and could be introduced instead of a clinic follow-up visit in a low-resource setting.

Challenges of measuring and linking patient outcomes to nursing interventions in acute care settings

Measuring and linking patient outcomes to nursing intervention is an important task that has professional, financial and political ramifications. The importance and complexity of measuring patient outcomes accurately should not be overlooked, as there are a number of emergent factors that influence this process. These include the turbulent context of practise, variations in care due to the large number of health professionals, individual patient characteristics impacting on outcomes, determining appropriate nursing outcome measures, nursing's lack of autonomy within the system and difficulties experienced while trying to link patient outcomes to nursing interventions. So that the results reflect reality, it is important for researchers in the field to take note and consider these factors when measuring patient outcomes. The present article aimed to examine and discuss a number of these factors as they relate to the evaluation of patient care.

Development of a condition-specific measure of quality of life for children with cerebral palsy: empirical thematic data reported by parents and children

Background: Although there is increasing recognition that quality of life (QOL) and health-related quality of life (HRQOL) are important outcome variables in clinical trials for children with cerebral palsy, there are substantial limitations in existing measures of QOL. This study identify themes of QOL for children with cerebral palsy and their parents to guide the development of a new condition-specific QOL scale. Methods: A qualitative study of parent and child views on QOL composition was conducted, using a grounded theory framework. Families participated in semistructured interviews on QOL until thematic saturation was reached (n = 28 families). Results: Overall, 13 themes emerged from the interviews: physical health, body pain and discomfort, daily living tasks, participation in regular physical and social activities, emotional well-being and self-esteem, interaction with the community, communication, family health, supportive physical environment, future QOL, provision of, and access to services, financial stability, and social well-being. Conclusions: Research with parents and children with cerebral palsy, representative of severity across the disease spectrum and socio-economic status, reinforced and expanded on the traditional themes that have underpinned QOL measurement development. This has implications not only for the development of a new QOL scale for children with cerebral palsy, but also for clinical interventions and community care management.

Dying in hospital: medical failure or nature outcome?

The purpose of this study was to describe patterns of medical and nursing practice in the care of patients dying of oncological and hematological malignancies in the acute care setting in Australia. A tool validated in a similar American study was used to study the medical records of 100 consecutive patients who died of oncological or hematological malignancies before August 1999 at The Canberra Hospital in the Australian Capital Territory. The three major indicators of patterns of end-of-life care were documentation of Do Not Resuscitate (DNR) orders, evidence that the patient was considered dying, and the presence of a palliative care intention. Findings were that 88 patients were documented DNR, 63 patients' records suggested that the patient was dying, and 74 patients had evidence of a palliative care plan. Forty-six patients were documented DNR 2 days or less prior to death and, of these, 12 were documented the day of death. Similar patterns emerged for days between considered dying and death, and between palliative care goals and death. Sixty patients had active treatment in progress at the time of death. The late implementation of end-of-life management plans and the lack of consistency within these plans suggested that patients were subjected to medical interventions and investigations up to the time of death. Implications for palliative care teams include the need to educate health care staff and to plan and implement policy regarding the management of dying patients in the acute care setting. Although the health care system in Australia has cultural differences when compared to the American context, this research suggests that the treatment imperative to prolong life is similar to that found in American-based studies.

Patient engagement and coaching for health: the PEACH study- a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol.

Background
The PEACH study is based on an innovative 'telephone coaching' program that has been used effectively in a post cardiac event trial. This intervention will be tested in a General Practice setting in a pragmatic trial using existing Practice Nurses (PN) as coaches for people with type 2 diabetes (T2D). Actual clinical care often fails to achieve standards, that are based on evidence that self-management interventions (educational and psychological) and intensive pharmacotherapy improve diabetes control. Telephone coaching in our study focuses on both. This paper describes our study protocol, which aims to test whether goal focused telephone coaching in T2D can improve diabetes control and reduce the treatment gap between guideline based standards and actual clinical practice.
Methods/design
In a cluster randomised controlled trial, general practices employing Practice Nurses (PNs) are randomly allocated to an intervention or control group. We aim to recruit 546 patients with poorly controlled T2D (HbA1c >7.5%) from 42 General Practices that employ PNs in Melbourne, Australia. PNs from General Practices allocated to the intervention group will be trained in diabetes telephone coaching focusing on biochemical targets addressing both patient self-management and engaging patients to work with their General Practitioners (GPs) to intensify pharmacological treatment according to the study clinical protocol. Patients of intervention group practices will receive 8 telephone coaching sessions and one face-to-face coaching session from existing PNs over 18 months plus usual care and outcomes will be compared to the control group, who will only receive only usual care from their GPs. The primary outcome is HbA1c levels and secondary outcomes include cardiovascular disease risk factors, behavioral risk factors and process of care measures.
Discussion
Understanding how to achieve comprehensive treatment of T2D in a General Practice setting is the focus of the PEACH study. This study explores the potential role for PNs to help reduce the treatment and outcomes gap in people with T2D by using telephone coaching. The intervention, if found to be effective, has potential to be sustained and embedded within real world General Practice.

Effects of a walking program in the psychiatric in-patient treatment setting: a cohort study.

Issue addressed: To assess the effectiveness of a walking program in a psychiatric in-patient unit. Method: In-patients at a private psychiatric unit were offered the opportunity to participate in a daily morning 40 minute walk led by an activity supervisor. After discharge, outcomes for patients who had regularly participated in the walking group (n=35) and patients who had not participated (n=49) were compared for length of stay during their period of admission and Clinical Global Impression - Severity (CGI-S) and  Depression Anxiety Stress Scales (DASS) scores measured at admission and discharge. This was a retrospective analysis of data collected routinely. Results: There were no significant differences between the two cohorts on most primary outcome measures, including length of stay, DASS scores at admission and at discharge and CGI-S scores at admission. Patients who had not participated in the walking group had a significantly lower score on a single measure, the CGI-S, than patients who had participated (p=0.001). Conclusions: This study showed no evidence that in-patients benefited from participating in the physical activity program. However, this must be  interpreted within the confines of a number of study limitations and, as such, the findings can neither support nor refute the effectiveness of physical activities.

Extent of heart failure self-care as an endpoint to patient education: a literature review

Background: In western countries the number of chronic heart failure (CHF) management programs has escalated in recent times. One key component of them is to teach self-care behaviours that enable affected individuals to monitor themselves and engage in lifestyles that improve their health status.
Aim: The aim of this article is to describe CHF self-care management and to review the literature which examines the effectiveness of patient education on patients’ performance of self-care behaviours.
Design/method: bibliographical databases were searched for papers published in English between 1982 to 2006. The search used the key words: heart failure, education, self-care and measures. Only randomized controlled trials (RCTs) were selected.
Results: Ten randomized controlled trials were selected that used education as an intervention and, in total, 1064 patients with CHF participated in these studies. The studies were heterogenous as to the sample population, the health outcomes measured, the education interventions, the expertise of the educator, and the length of time that was spent on teaching patients. No consistent patterns of implementation and specific evaluation of its impact were found, although three respective groups of investigators reported signifi cant differences in recurrent hospitalisation rates and mortality rates which were relative to usual care.
Conclusions: Teaching patients appropriate CHF self-care behaviours can significantly improve their health outcomes. Improvements in self-care were demonstrated in seven studies but only three had used validated instruments to measure such changes. This suggests that no firm conclusions can be drawn about changes in self-care practices.

Rates of student-reported antisocial behavior, school suspensions, and arrests in Victoria, Australia and Washington State, United States

Background: Few methodologically rigorous international comparisons of student-reported antisocial behavior have been conducted. This paper examines whether there are differences in the frequency of both antisocial behavior and societal responses to antisocial behavior in Victoria, Australia and Washington State, United States. These 2 states were chosen due to their similarities on sociodemographic characteristics and their differences in policy frameworks around problem behavior including antisocial behavior and substance use.

Methods: State representative samples of students (N = 5769) in school grades 5, 7, and 9 in Victoria and Washington State completed a modified version of the Communities That Care self-report survey of behavior and societal responses to behavior. Chi-square analyses compared frequencies of antisocial behavior, school suspensions, and police arrests in the 2 states. Multivariate logistic regression analyses were conducted for each outcome measure to examine the effect of state, controlling for sample design, clustering of students within schools, age, socioeconomic status, and urbanicity.

Results: Few state differences in student-reported antisocial behavior were found, although frequencies varied across behavior type and grade level. Differences in societal responses were observed across grade levels with grade 5 Washington students reporting higher rates of school suspension. Older Washington students reported more arrests.

Conclusions: Rates of student antisocial behavior appear similar in these 2 states in Australia and the United States. However, youth in the United States relative to Australia may experience greater societal consequences for problem behavior. Further research is required to examine the impact of these consequences on subsequent behavior.

Alcohol and drug use in Australian male sex workers: its relationship to the safety outcome of the sex encounter

This paper describes the self-reporting patterns of alcohol and drug consumption among male sex workers (MSWs) in three Australian cities during commercial sex encounters, and examines to what extent alcohol and drugs are used and whether this is related to the safe/unsafe outcome of the commercial sex encounter. One hundred and eighty-six MSWs from Brisbane, Sydney and Melbourne completed a diary following each commercial sex encounter over a two-week period. MSWs reported 2,087 commercial sex encounters during the study period. Alcohol or drug consumption was reported in 50.5% of the encounters.

Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity

OBJECTIVES: To reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting.
DESIGN: Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey.
SETTING: Twenty nine general practices, Melbourne, Australia.
PARTICIPANTS: (1) BMI survey: 2112 children visiting their general practitioner (GP) April-December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score <3.0) children aged 5 years 0 months-9 years 11 months (82 intervention, 81 control).
INTERVENTION: Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials.
MAIN OUTCOME MEASURES: Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth.
RESULTS: Attrition was 10%. The adjusted mean difference (intervention-control) in BMI was -0.2 kg/m(2) (95% CI: -0.6 to 0.1; P=0.25) at 9 months and -0.0 kg/m(2) (95% CI: -0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms.
CONCLUSIONS: This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level.

Evaluation of outcome in child and adolescent mental health services: children with persistent conduct problems

This article focuses on the evaluation of outcome in child and adolescent mental health services. We examined the outcomes of 46 children with persistent conduct problems by gathering at baseline and six months information from multiple informants on multiple domains including the functioning of the child, risk factors, and parents’ and children’s perceptions of the treatment process. A statistically significant reduction in oppositional/conduct symptoms was reported six months after the initial clinical contact. However, the majority of the group still scored within the clinical range. The various outcome measures are correlated to only a mild to moderate degree. Teachers did not notice the same degree of change at school, despite the changes noticed by parents. Symptom improvement and satisfaction with a service are two separate issues. Parents’ satisfaction was related to their perception of the therapist and the therapy offered. Their satisfaction was high if they perceived that the therapist was able to communicate well, show care and concern, and if the therapy was perceived as organized. Much can be learned from a comprehensive outcome measurement system within a mental health service.

Patients' experiences of cardiology procedures using minimal conscous sedation

Aim: The study's purpose was to describe patients' experiences of minimal conscious sedation during diagnostic and interventional cardiology procedures.

Methods: Over a 6-week period, 119 consecutive patients (10% of annual throughput) from a major metropolitan hospital in Melbourne, Australia, were interviewed using a modified version of the American Pain Society Patient Outcome Questionnaire. Patients identified pain severity using a 10-point visual analogue scale and rated their overall comfort on a 6-point Likert scale ranging from very comfortable to very uncomfortable.

Results: Patients were aged 67.6 years (standard deviation 11.1), 70.8% were male, and the mean body mass index was 27.7 (standard deviation 4.8). Patients underwent diagnostic coronary angiography (67.5%), percutaneous coronary interventions (13.3%), or combined procedures (19.2%). Most patients (65%) were comfortable in the context of low-dose conscious sedation. Slight discomfort was reported by 26% of patients; 9% reported feeling uncomfortable primarily as a result of a combination of musculoskeletal pain, angina, and vasovagal symptoms experienced during the procedure. There was significant correlation (rho = .25, P = .01) between procedure length and patients' report of overall comfort, suggesting longer procedures were less comfortable for patients.

Conclusions: The minimal sedation protocol was effective for the majority of patients; however, 9% of patients experienced significant discomfort related to preexisting conditions, highlighting the need for individual patient assessment before, during, and after the procedure.

Measurement for improvement: a survey of current practice in Australian public hospitals

Objective:
To identify patient safety measurement tools in use in Australian public hospitals and to determine barriers to their use.

Design:
Structured survey, conducted between 4 March and 19 May 2005, designed to identify tools, and to assess current use of, levels of satisfaction with, and barriers to use of tools for measuring the domains and subdomains of: organisational capacity to provide safe health care; patient safety incidents; and clinical performance.

Participants and setting:
Hospital executives, managers and clinicians from a nationwide random sample of Australian public hospitals stratified by state and hospital peer grouping.

Main outcome measures:
Tools used by hospitals within the three domains and their subdomains; patient safety tools and processes identified by individuals at these hospitals; satisfaction with the tools; and barriers to their use.

Results:
Eighty-two of 167 invited hospitals (49%) responded. The survey ascertained a comprehensive list of patient safety measurement tools that are in current use for measuring all patient safety domains. Overall, there was a focus on use of processes rather than quantitative measurement tools. Approximately half the 182 individual respondents from participating hospitals reported satisfaction with existing tools. The main reported barriers were lack of integrated supportive systems, resource constraints and inadequate access to robust measurement tools validated in the Australian context. Measurement of organisational capacity was reported by 50 (61%), of patient safety incidents by 81 (99%) and of clinical performance by 81 (99%).

Conclusion:
Australian public hospitals are measuring the safety of their health care, with some variation in measurement of patient safety domains and their subdomains. Improved access to robust tools may support future standardisation of measurement for improvement.

Can a disease-specific education program augment self-management skills and improve Health-Related Quality of Life in people with hip or knee osteoarthritis?

Background: Patient education and self-management programs are offered in many countries to people with chronic conditions such as osteoarthritis (OA). The most well-known is the disease-specific Stanford Arthritis Self-Management Program (ASMP). While Australian and international clinical guidelines promote the concept of self-management for OA, there is currently little evidence to support the use of the ASMP. Several meta-analyses have reported that arthritis self-management programs had minimal or no effect on reducing pain and disability. However, previous studies have had methodological shortcomings including the use of outcome measures which do not accurately reflect program goals. Additionally, limited cost-effectiveness analyses have been undertaken and the cost-utility of the program has not been explored.

Methods/design: This study is a randomised controlled trial to determine the efficacy (in terms of Health-Related Quality of Life and self-management skills) and cost-utility of a 6-week group-based Stanford ASMP for people with hip or knee OA.

Six hundred participants referred to an orthopaedic surgeon or rheumatologist for hip or knee OA will be recruited from outpatient clinics at 2 public hospitals and community-based private practices within 2 private hospital settings in Victoria, Australia. Participants must be 18 years or over, fluent in English and able to attend ASMP sessions. Exclusion criteria include cognitive dysfunction, previous participation in self-management programs and placement on a waiting list for joint replacement surgery or scheduled joint replacement.

Eligible, consenting participants will be randomised to an intervention group (who receive the ASMP and an arthritis self-management book) or a control group (who receive the book only). Follow-up will be at 6 weeks, 3 months and 12 months using standardised self-report measures. The primary outcome is Health-Related Quality of Life at 12 months, measured using the Assessment of Quality of Life instrument. Secondary outcome measures include the Health Education Impact Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index (pain subscale and total scores), Kessler Psychological Distress Scale and the Hip and Knee Multi-Attribute Priority Tool. Cost-utility analyses will be undertaken using administrative records and self-report data. A subgroup of 100 participants will undergo qualitative interviews to explore the broader potential impacts of the ASMP.

Discussion: Using an innovative design combining both quantitative and qualitative components, this project will provide high quality data to facilitate evidence-based recommendations regarding the ASMP.

Enhancing patient engagement in chronic disease self-management support initiatives in Australia : the need for an integrated approach

♦ Although emphasis on the prevention of chronic disease is important, governments in Australia need to balance this with continued assistance to the 77% of Australians reported to have at least one long-term medical condition.

♦ Self-management support is provided by health care and community services to enhance patients’ ability to care for their chronic conditions in a cooperative framework.

♦ In Australia, there is a range of self-management support initiatives that have targeted patients (most notably, chronic disease self-management education programs) and health professionals (financial incentives, education and training).

♦ To date, there has been little coordination or integration of these self-management initiatives to enhance the patient–health professional clinical encounter.

♦ If self-management support is to work, there is a need to better understand the infrastructure, systems and training that are required to engage the key stakeholders — patients, carers, health professionals, and health care organisations.

♦ A coordinated approach is required in implementing these elements within existing and new health service models to enhance uptake and sustainability.