Assessing research capacity in Victoria's south-west health service providers.

OBJECTIVE: To investigate the research interest, capacity and culture in individuals, teams and health organisations across south-western Victoria. DESIGN: Cross-sectional survey. SETTING: Eight public health services in the south-western region of Victoria. PARTICIPANTS: All staff were invited to participate. INTERVENTION: Hospital staff survey. MAIN OUTCOME MEASURE: The Research Capacity and Culture tool. RESULTS: The survey was completed by 776 staff including nurses, allied health staff and doctors. Half of the respondents were currently involved in research, while most wanted to be more involved. Respondents reported having moderate research skills and success at individual, team and organisation levels. Women and nurses reported having lower skills than comparable groups. Motivators for undertaking research were skill development (increased job satisfaction and brain stimulation) while the most commonly selected barriers were lack of time, other work taking priority and lack of funding. CONCLUSION: Health organisations in regional and rural Victoria could harness opportunities to enable staff participation in research by supporting identified strengths, addressing barriers and providing "permission" for staff to get involved in research. Efforts to improve research capacity among women and nurses could lead to the greatest overall improvement in organisations' research capacity and output-and translation of evidence into practice.

Accepting risk in the acceleration of drug development for rare cancers.

Rare cancers collectively contribute a disproportionate fraction of the total burden of cancer. The oncology community is increasingly facing small numbers of patients with each cancer subtype, requiring cooperation and collaboration to complete multicentre trials that advance knowledge and patient care. At the same time, new insights into the biology of rare cancers have led to an explosion in knowledge and development of targeted agents. These insights and techniques are set to revolutionise the care of patients with cancer. However, drug development strategies and the availability of new agents for rare cancers are at risk of stalling owing to the ever-increasing complexity and costs of clinical trials. Finding solutions to these problems is imperative to the future of cancer care. We propose that a greater degree of risk sharing is needed than is currently accepted to enable the use of new methods with confidence, and to keep pace with scientific advancement.

General medical practitioners' knowledge and beliefs about osteoporosis and its investigation and management.

UNLABELLED: This qualitative study explored beliefs and attitudes regarding osteoporosis and its management. General medical practitioners (GPs) were ambivalent about osteoporosis due to concern about financial barriers for patients and their own beliefs about the salience of osteoporosis. GPs considered investigation and treatment in the context of patients' whole lives. PURPOSE: We aimed to investigate barriers, enablers, and other factors influencing the investigation and management of osteoporosis using a qualitative approach. This paper analyses data from discussions with general medical practitioners (GPs) about their beliefs and attitudes regarding osteoporosis and its management. METHODS: Fourteen GPs and two practice nurses aged 27-89 years participated in four focus groups, from June 2010 to March 2011. Each group comprised 3-5 participants, and discussions were semi-structured, according to the protocol developed for the main study. Discussion points ranged from the circumstances under which GPs would initiate investigation for osteoporosis and their subsequent actions to their views about treatment efficacy and patient adherence to prescribed treatment. Audio recordings were transcribed and coded for analysis using analytic comparison to identify the major themes. RESULTS: The GPs were not particularly concerned about osteoporosis in their patients or the general population, ranking diabetes, osteoarthritis, cardiovascular disease, and hypertension higher than concern about osteoporosis. They expressed confidence in the efficacy of anti-fracture medications but were concerned about the potential financial burden on patients with limited incomes. The GPs were unsure about guidelines for investigation and management of osteoporosis in men and the appropriate duration of treatment, particularly for the bisphosphonates in all patients. CONCLUSIONS: The GPs' ambivalence about osteoporosis appeared to stem from structural factors such as financial barriers for patients and their own beliefs about the salience of osteoporosis. GPs considered the impact of investigating and prescribing treatment in the context of patients' whole lives.

Methodological reflections on using pilot data from fracture patients to develop a qualitative study.

BACKGROUND: Qualitative studies are particularly valued for their exploratory nature but, like other research methods, they do require careful planning to ensure rigorous study design. Our objective was to undertake a pilot study to inform the development of a larger qualitative study. RESULTS: We conducted a series of brief interviews with out-patients in a hospital setting. The interviews were designed to elicit superficial information about whether (and how) post-fracture osteoporosis investigation and/or treatment were being initiated among patients receiving treatment or follow-up for a current or recent fracture. We used thematic analysis to identify key themes in the data that related to the broader research questions.We analysed data obtained from 11 out of a total of 12 interviews conducted. Participants were male and female, aged 19-83 years of age (median age 57 years). Participants attended 2-8 medical appointments to seek treatment and follow up for a current or recent fracture. The following four overarching themes emerged from thematic analysis of the data: fracture event, referral pathway, osteoporosis investigation and/or treatment, and communication by health practitioners and staff. CONCLUSIONS: This pilot study was necessarily tentative and exploratory in nature, but provided a helpful snapshot of some typical experiences in the public health system following fracture. Several themes emerged for consideration in the design of the main study.Despite its critics, theoretical sampling and saturation continue to provide sustainable methods for ensuring that relevant themes and categories are covered in sufficient depth and breadth, appropriate to the needs of the study.

Qualitative methods in early-phase drug trials: broadening the scope of data and methods from an RCT of N-acetylcysteine in schizophrenia.

OBJECTIVE: The pharmacokinetic profile of a drug often gives little indication of its potential therapeutic application, with many therapeutic uses of drugs being discovered serendipitously while being studied for different indications. As hypothesis-driven, quantitative research methodology is exclusively used in early-phase trials, unexpected but important phenomena may escape detection. In this context, this study aimed to examine the potential for integrating qualitative research methods with quantitative methods in early-phase drug trials. To our knowledge, this mixed methodology has not previously been applied to blinded psychopharmacologic trials. METHOD: We undertook qualitative data analysis of clinical observations on the dataset of a randomized, double-blind, placebo-controlled trial of N-acetylcysteine (NAC) in patients with DSM-IV-TR-diagnosed schizophrenia (N = 140). Textual data on all participants, deliberately collected for this purpose, were coded using NVivo 2, and emergent themes were analyzed in a blinded manner in the NAC and placebo groups. The trial was conducted from November 2002 to July 2005. RESULTS: The principal findings of the published trial could be replicated using a qualitative methodology. In addition, significant differences between NAC- and placebo-treated participants emerged for positive and affective symptoms, which had not been captured by the rating scales utilized in the quantitative trial. Qualitative data in this study subsequently led to a positive trial of NAC in bipolar disorder. CONCLUSIONS: The use of qualitative methods may yield broader data and has the potential to complement traditional quantitative methods and detect unexpected efficacy and safety signals, thereby maximizing the findings of early-phase clinical trial research. TRIAL REGISTRATION: www.anzctr.org.au Identifier: ACTRN12605000363684.