Consent in forefoot surgery; What does it mean to the patient?

Aims: This study aimed to assess patient risk recall and find risk thresholds for patients undergoing elective forefoot procedures.

Methods: Patients were interviewed in the pre-assessment clinic (PAC) or on day of surgery (DOS); some in both settings. A standardised questionnaire was used for all interviews, regardless of setting.

Vulnerability in human research.

The conduct of prior ethics review of human research projects helps to protect vulnerable groups or populations from potential negative impacts of research. Contemporary considerations in human research considers the concept of vulnerability in terms of access to research opportunities, impacts on the consenting process, selection bias, and the generalisability of results. Recent work questions the validity of using enumerated lists as a check box approach to protect research participants from exploitation.

Long-Term Follow-up of Arthrodesis vs Total Joint Arthroplasty for Hallux Rigidus.

Background: The optimal operative management of hallux rigidus is still a matter for debate among surgeons. Despite arthrodesis widely considered to be the gold standard treatment, many surgeons advocate arthroplasty as a suitable alternative. There are, however, few long-term or high-quality studies evaluating these modalities.

Beneficence as a principle in human research.

Beneficence is one of the four principles that form the basis of the Australian National Statement. The aim of this paper is to explore the philosophical development of this principle and to clarify the role that beneficence plays in contemporary discussions about human research ethics. By examining the way that guidance documents, particularly the National Statement, treats beneficence we offer guidance to researchers and human research ethics committee members on the practical application of what can be a conceptually difficult principle.

Cost-effectiveness of steroid (methylprednisolone) injections versus anaesthetic alone for the treatment of Morton's neuroma: economic evaluation alongside a randomised controlled trial (MortISE trial).

Background: Morton's neuroma is a common foot condition affecting health-related quality of life. Though its management frequently includes steroid injections, evidence of cost-effectiveness is sparse. So, we aimed to evaluate whether steroid injection is cost-effective in treating Morton's neuroma compared with anaesthetic injection alone.

Soft tissue swellings in the foot: rheumatoid nodulosis.

Background rheumatoid nodulosis is a rare disease characterised by multiple subcutaneous nodules, a high titre of rheumatoid factor, radiologically detectable cystic bone lesions, but with none or few of the systemic manifestations or joint activity of rheumatoid disease. Histopathologically, nodulosis is the same as the nodules found in rheumatoid arthritis. It is considered to be a benign variant of rheumatoid arthritis.

Justice in human research ethics. A conceptual and practical guide.

One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy.

Methylprednisolone injections for the treatment of Morton neuroma: a patient-blinded randomized trial.

Background: Morton neuroma is a common cause of neuralgia affecting the web spaces of the toes. Corticosteroid injections are commonly administered as a first-line therapy, but the evidence for their effectiveness is weak. Our primary research aim was to determine whether corticosteroid injection is an effective treatment for Morton neuroma compared with an anesthetic injection as a placebo control.

Contextualising merit and integrity within human research.

The first consideration of any Australian Human Research Ethics Committee should be to satisfy itself that the project before them is worth undertaking. If the project does not add to the body of knowledge, if it does not improve social welfare or individual wellbeing then the use of human participants, their tissue or their data must be questioned. Sometimes, however, committees are criticised for appearing to adopt the role of scientific review committees.

Hemiarthroplasty augmented with bone graft for the failed hallux metatarsophalangeal Silastic® implant.

Symptomatic failure of Silastic® implants at the hallux metatarsophalangeal joint can result in the challenging problem of instability which may be painful. There is often marked bone loss making reconstruction difficult. Arthrodesis sacrifices joint movement while excision arthroplasty shortens the ray and is less acceptable to active patients.

WITHDRAWN. Interventions for treating plantar heel pain.

Background: Ten percent of people may experience pain under the heel (plantar heel pain) at some time. Injections, insoles, heel pads, strapping and surgery have been common forms of treatment offered. The absolute and relative effectiveness of these interventions are poorly understood.

No need to go! Workplace studies and the resources of the revised National Statement.

In their article 'Unintended consequences of human research ethics committees: au revoir workplace studies?', Greg Bamber and Jennifer Sappey set out some real obstacles in the practices and attitudes of some Human Research Ethics Committees (HRECs), to research in the social sciences and particulalry in industrial sociology. They sheet home these attitudes and practices to the way in which various statements in the NHMRC's National Statement [1999] are implemented, which they say is often in 'conflict with an important stream of industrial sociological research' in Australia. They do not discuss the recently completed revision of the NS.

Analysis of the reactions used for the preparation of drug candidate molecules.

The purpose of this perspective is to indicate the range of chemistries used in the manufacture of drug candidate molecules and to highlight certain gaps in current technologies. To do this a survey was carried out of chemical syntheses within the Process Chemistry R&D departments of GlaxoSmithKline, AstraZeneca and Pfizer.

Protecting health information privacy in research: what's an ethics committee like yours doing in a job like this?

The Commonwealth and State legislation designed to protect the privacy of personal health information has attracted the criticism that the constraints imposed on the use of the information in research obstructs that research. A central and common feature of the legislation is the reliance upon the review by human research ethics committees of research that proposes to use personal health information for research without prior consent from those whose information it is. The origins of this reliance are explored and explained and it is suggested that this has proved to be an inappropriate policy choice.

Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial.

Background: Arthrodesis is the current treatment for end-stage hallux rigidus, although there are many reports advocating total joint replacement arthroplasty. The aim of this randomized controlled trial was to evaluate clinical outcomes after first metatarsophalangeal joint (MTPJ) arthrodesis and replacement arthroplasty.

Methods: Between November, 1998, and January 2001, 63 patients between the ages of 34 and 77 years, with unilateral or bilateral MTPJ arthritis were recruited and randomly selected to have either MTPJ arthrodesis or arthroplasty.

Protecting health information privacy in research: how much law do Australians need?

Privacy regulation in Australia, whether by federal or state legislation or other means, has provoked complaints from researchers. Its scope depends on defining the information it covers, the organisations it governs and the principles it applies. Regulation is inconsistent, and compliance can be complex (as illustrated by a hypothetical research example).

The effectiveness of extra corporeal shock wave therapy for plantar heel pain: a systematic review and meta-analysis.

Background: There is considerable controversy regarding the effectiveness of extracorporeal shock wave therapy in the management of plantar heel pain. Our aim was to conduct a systematic review of randomised controlled trials to investigate the effectiveness of extracorporeal shock wave therapy and to produce a precise estimate of the likely benefits of this therapy.

Methods: We conducted a systematic review of all randomised controlled trials (RCTs) identified from the Cochrane Controlled trials register, MEDLINE, EMBASE and CINAHL from 1966 until September 2004.