Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial

Background: Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA.

Methods/Design: Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics.

Discussion: Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA.

Trial registration: ACTR12605000503628; NCT00415259.

The campaigns

It is arguable that the 2007 election was decided on longer term issues, and longer term campaigning. This article focuses on the campaigning side. The campaigning commenced with the election of Labor's new leadership team of Kevin Rudd and Julia Gillard in December 2006. The Howard Coalition Government, after a minor cabinet reshuffle, pressed on with the promotion of its policies and programmes; but by May 2007 was forced to change tack, making concessions on the unpopular WorkChoices policy, and then introducing a controversial Aboriginal intervention programme. The election campaign was anti-climactic. The article includes a postscript on the election aftermath, comparing Kevin Rudd with Gough Whitlam in his rapid implementation of key campaign policies.

A new framework for interpreting the outcomes of imperfectly blinded controlled clinical trials

It is well known that the outcome of an intervention is affected both by the inherent effects of the intervention and the patient's expectations. For this reason in comparative clinical trials an effort is made to conceal the nature of the administered intervention from the participants in the trial i.e. to blind the trial. Yet, in practice perfect blinding is impossible to ensure or even verify post hoc. The current clinical standard is to follow up the trial with an auxiliary questionnaire, which allows trial participants to express in closed form their belief concerning the intervention, i.e. trial group assignment (treatment or control). Auxiliary questionnaire responses are then used to compute the extent of blinding in the trial in the form of a blinding index. If the estimated extent of blinding exceeds a particular threshold the trial is deemed sufficiently blinded; otherwise, the strength of evidence of the trial is brought into question. This may necessitate that the trial is repeated. In this paper we make several contributions. Firstly, we identify a series of problems of the aforesaid clinical practice and discuss them in context of the most commonly used blinding indexes. Secondly, we formulate a novel approach for handling imperfectly blinded trials. We adopt a feedback questionnaire of the same form as that which is currently in use, but interpret the collected data using a novel statistical method, significantly different from that proposed in the previous work. Unlike the previously proposed approaches, our method is void of any ad hoc free parameters and robust to small changes in the participants' feedback responses. Our method also does not discard any data and is not predicated on any strong assumptions used to interpret participants' feedback. The key idea behind the present method is that it is meaningful to compare only the corresponding treatment and control participant sub-groups, that is, sub-groups matched by their auxiliary responses. A series of experiments on simulated trials is used to demonstrate the effectiveness of the proposed approach and its superiority over those currently in use.

Assessing blinding in clinical trials

The interaction between the patient's expected outcome of an intervention and the inherent effects of that intervention can have extraordinary effects. Thus in clinical trials an effort is made to conceal the nature of the administered intervention from the participants in the trial i.e. to blind it. Yet, in practice perfect blinding is impossible to ensure or even verify. The current standard is follow up the trial with an auxiliary questionnaire, which allows trial participants to express their belief concerning the assigned intervention and which is used to compute a measure of the extent of blinding in the trial. If the estimated extent of blinding exceeds a threshold the trial is deemed sufficiently blinded; otherwise, the trial is deemed to have failed. In this paper we make several important contributions. Firstly, we identify a series of fundamental problems of the aforesaid practice and discuss them in context of the most commonly used blinding measures. Secondly, motivated by the highlighted problems, we formulate a novel method for handling imperfectly blinded trials. We too adopt a post-trial feedback questionnaire but interpret the collected data using an original approach, fundamentally different from those previously proposed. Unlike previous approaches, ours is void of any ad hoc free parameters, is robust to small changes in auxiliary data and is not predicated on any strong assumptions used to interpret participants' feedback.

Theorising about gender and computing interventions through an evaluation framework

Despite over 20 years of intervention programmes, the gender balance in the computing profession is not improving. It has been suggested that the problem with much of the research on gender and computing is that it is under-theorised. The contribution of this study is an evaluation framework, designed to evaluate gender and computing interventions, which will advance the theorisation of research through programme evaluation. This study was undertaken in three phases: The first involved theory building through an extensive review of the literature resulting in a conceptual framework for intervention programme evaluation. The second phase consisted of a multiple-case study of 14 major intervention programmes in Australia. Subsequent modifications to the conceptual framework resulted in the gender and computing intervention evaluation framework. The value of the framework was confirmed in phase three by intervention experts and showed that applying the framework will help programme champions to evaluate their programmes more thoroughly. The dissemination of sound evaluation results will then enable a deeper theorisation of the issues surrounding gender and computing interventions.

Outreach programmes to attract girls into computing: how the best laid plans can sometimes fail

This article presents a reflective analysis of an outreach programme called the Digital Divas Club. This curriculum-based programme was delivered in Australian schools with the aim of stimulating junior and middle school girls’ interest in computing courses and careers. We believed that we had developed a strong intervention programme based on previous literature and our collective knowledge and experiences. While it was coordinated by university academics, the programme content was jointly created and modified by practicing school teachers. After four years, when the final data were compiled, it showed that our programme produced significant change to student confidence in computing, but the ability to influence a desire to pursue a career path in computing did not fully eventuate. To gain a deeper insight in to why this may be the case, data collected from two of the schools are interrogated in more detail as described in this article. These schools were at the end of the expected programme outcomes. We found that despite designing a programme that delivered a multi-layered positive computing experience, factors beyond our control such as school culture and teacher technical self-efficacy help account for the unanticipated results. Despite our best laid plans, the expectations that this semester long programme would influence students’ longer term career outcomes may have been aspirational at best.

Intervention programmes to recruit female computing students : why do the programme champions do it?

This paper looks at intervention programmes to improve the representation of female students in computing education and the computer industry, A multiple case study methodology was used to look at major intervention programmes conducted in Australia. One aspect of the research focused on the programme champions; those women from the computing industry, those working within government organisations and those in academia who instigated the programmes. The success of these intervention programmes appears to have been highly dependent upon not only the design of the programme but on the involvement of these strong individuals who were passionate and worked tirelessly to ensure the programme's success. This paper provides an opportunity for the voices of these women to be heard. It describes the champions' own initial involvement with computing which frequently motivated and inspired them to conduct such programmes. The research found that when these types of intervention programmes were conducted by academic staff the work was undervalued compared to when the activities were conducted by staff in industry or in government. The academic environment was often not supportive of academics who conducted intervention programmes for female students.

Managing behavioural symptoms of dementia : Effectiveness of staff education and peer support

This study was designed to investigate the impact of staff education on the behaviour and quality of life of residents with dementia and on staff members' attitudes about working with people with dementia and level of burnout. Staff from three aged care facilities participated in the study (n = 52). These facilities were randomly assigned to one of two intervention groups or a control group. Staff assigned to the intervention groups received an eight-week behaviourally-based programme. Staff from one aged care facility also participated in a peer support group designed to reinforce educational material and facilitate positive changes among staff members. Behavioural symptoms displayed by residents (n = 76) in each of the facilities were also assessed. Assessments were conducted at pre-intervention, post-intervention, three- and six-month follow-up. The results of this study indicated that education or peer support was not associated with an improvement in resident behaviour or quality of life. Education or peer support also did not impact on staff members' level of burnout. There was, however, a change in staff members' attitudes about working with people with dementia. Possible explanations for these findings and implication for further research are considered.

Intervention for depression among palliative care patients and their families : a study protocol for evaluation of a training program for professional care staff

Background: Clinical depression is highly prevalent yet under-detected and under-treated in palliative care settings and is associated with a number of adverse medical and psychological outcomes for patients and their family members. This article presents a study protocol to evaluate a training intervention for non-physician palliative care staff to improve the recognition of depression and provide support for depressed patients and their family members. Details of the hypotheses and expected outcomes, study design, training program development and evaluation measures are described.
Methods and Design: A randomised controlled trial will be implemented across two palliative care services to evaluate the “Training program for professional carers to recognise and manage depression in palliative care settings”. Pre-, post- and three-month follow-up data will be collected to assess: the impact of the training on the knowledge, attitudes, self-efficacy and perceived barriers of palliative care staff when working with depression; referral rates for depression; and changes to staff practices. Quantitative and qualitative methods, in the form of self-report questionnaires and interviews with staff and family members, will be used to evaluate the effectiveness of the intervention.
Discussion: This study will determine the effectiveness of an intervention that aims to respond to the urgent need for innovative programs to target depression in the palliative care setting. The expected outcome of this study is the validation of an evidence-based training program to improve staff recognition and appropriate referrals for depression, as well as improve psychosocial support for depressed patients and their family members.

MAKINGtheLINK : a school-based health promotion programme to increase help-seeking for cannabis and mental health issues among adolescents

Aim: There is increasing concern regarding the use of cannabis among adolescents, especially given recent evidence highlighting its link with later mental disorders. Encouraging young people with mental health or drug issues to seek professional help is an important early intervention strategy; however, adolescents are typically reluctant to do so and instead turn to their peers for help. Peers may not have the skills or knowledge required to assist their friends to access professional help. This paper describes the development and evaluation of MAKINGtheLINK, a school-based health promotion programme that promotes help-seeking behaviour for mental health and cannabis use issues among young people.

Methods: The MAKINGtheLINK programme was piloted with 182 Year 10 students at a secondary school in Melbourne, Australia. Forty teachers received the MAKINGtheLINK staff professional development session.

Results: The delivery of the MAKINGtheLINK programme was found to be both acceptable and feasible within a school setting. Students and teachers described it as a fun, engaging, helpful and important programme. Students reported increased confidence and awareness of how to seek help for themselves or a friend, and teachers indicated increased confidence and awareness of how to assist students to seek help for cannabis use and/or mental health problems.

Conclusions: MAKINGtheLINK was successfully implemented within the school curriculum. We believe this is the first school-based programme that specifically focuses on facilitating professional help-seeking for cannabis use and mental health problems among young people, and demonstrates that utilizing peer models for help-seeking is a valuable resource for early intervention initiatives.

Mental Health First Aid: an international programme for early intervention.

AIM: To describe the development of the Mental Health First Aid (MHFA) programme in Australia, its roll-out in other countries and evaluation studies which have been carried out. METHODS: A description of the programme's development and evaluation, its cultural adaptations and its dissemination in seven countries. RESULTS: The programme was developed in Australia in 2001. By the end of 2007, there were 600 instructors and 55,000 people trained as mental health first aiders. A number of evaluations have been carried out, including two randomized controlled trials that showed changes in knowledge, attitudes and first aid behaviours. Special adaptations of the course have been rolled out for Aboriginal and Torres Strait Islander peoples and some non-English speaking immigrant groups. The course has spread to seven other countries with varying degrees of penetration. In all countries, the programme has been initially supported by government funding. Independent evaluations have been carried out in Scotland and Ireland. CONCLUSIONS: The concept of first aid by the public for physical health crises is familiar in many countries. This has made it relatively easy to extend this approach to early intervention by members of the public for mental disorders and crises. Through MHFA training, the whole of a community can assist formal mental health services in early intervention for mental disorders.

The population cost-effectiveness of a parenting intervention designed to prevent anxiety disorders in children

BACKGROUND: Prevention and early intervention for anxiety disorders has lagged behind many other forms of mental disorder. Recent research has demonstrated the efficacy of a parent-focussed psycho-educational programme. The programme is directed at parents of inhibited preschool children and has been shown to reduce anxiety disorders at 1 and 3 years following intervention. The current study assesses the cost-effectiveness of this intervention to determine whether it could provide value-for-money across a population. METHOD: A cost-utility economic framework, using Disability-Adjusted-Life-Years (DALYs) as the outcome, was adopted. Economic modelling techniques were used to assess the incremental cost-effectiveness ratio (ICER) of the intervention within the Australian population context, which was modelled as add-on to current practice. The perspective was the health sector. Uncertainty was measured using multivariate probabilistic testing and key assumptions were tested using univariate sensitivity analysis. RESULTS: The median ICER for the intervention was AUD$8,000 per DALY averted with 99.8% of the uncertainty iterations falling below the threshold value-for-money criterion of AUD$50,000 per DALY averted. The results were robust to sensitivity testing. CONCLUSIONS: Screening young children in a preschool setting for an inhibited temperament and providing a brief intervention to the parents of children with high levels of inhibition appears to provide very good value-for-money and worth considering in any package of preventive care. Further evaluation of this intervention under routine health service conditions will strengthen conclusions. Acceptability issues associated with this intervention, particularly to preschool staff and parents, need to be considered before wide-scale adoption is undertaken.

An exercise programme for smoking cessation: perceptions of the Fit2quit trial intervention

Introduction: Few trials of exercise interventions for smoking cessation have included a qualitative evaluation of the intervention from the participants' perspective. Aims: To determine the perceptions of participants who received a 6-month telephone counselling exercise intervention to aid smoking cessation. Methods: Participants in the Fit2Quit study intervention group were asked to take part in a semi-structured phone interview. All interviews were digitally recorded and transcribed verbatim, and a general inductive approach to data analysis was followed. Results/Findings: Twenty participants from the intervention group completed an interview. The following themes emerged from the analyses: (1) The support people were genuinely interested in what I was achieving, (2) new awareness, new attitude, new lifestyle: I could see the benefits, (3) lack of time, willpower and money stopped me from changing and (4) I would have preferred a more hands on approach: Recommendations for future programmes. Conclusions: A telephone counselling intervention to enhance exercise for smoking cessation was well received. Aspects of the intervention, particularly the provision of support and encouragement from the participant support person, were beneficial. Suggested improvements were greater tailoring of the call schedule, greater face-to-face contact and provision of a buddy system or support group. Such improvements may increase adherence and, therefore, effectiveness of exercise interventions for smoking cessation.

Rehabilitation staff perspectives on training for problem-solving therapy for primary care in a low vision service

Vision rehabilitation staff were trained to deliver problem-solving therapy for primary care (PSTPC) over the telephone to adults with depressive symptoms and low vision. Training was a 2-day workshop, completion of training cases, and assessment of treatment fidelity. Staff perspectives of training and challenges in PST-PC delivery were explored. Telephone-administered semistructured interviews were conducted pre- and post-workshop and following PST-PC competency. In all, 14 staff (mean age = 47.64 years, SD = 12.68 years, 93% females) achieved competency and 6 withdrew. Results showed an increased understanding of PST-PC from pre- to post-workshop (Z = −2.71, p = .007) and pre-workshop to post-competency (Z = −3.09, p = .002). A high level of satisfaction with training was reported. Staff challenges included the clients’ ability to define problems and brainstorm solutions. Training enabled staff to competently deliver PST-PC and may serve as a model for integrating depression care into vision rehabilitation services recommended by international guidelines.