Difficult Decisions: A Critical Analysis Of Consent To High-risk Medical Procedures
Funder
National Health and Medical Research Council
Funding Amount
$320,918.00
Summary
Consent is the cornerstone of ethics as applied to healthcare and is central to the relationship between healthcare and the law. Whilst no-one would deny the importance of seeking consent to high-risk medical procedures, much depends on the practical manner in which this is done. By studying consent for high-risk procedures with the participation of patients and their health care providers, we will both test the limits of consent and find practical ways to address those limits. In doing so, the ....Consent is the cornerstone of ethics as applied to healthcare and is central to the relationship between healthcare and the law. Whilst no-one would deny the importance of seeking consent to high-risk medical procedures, much depends on the practical manner in which this is done. By studying consent for high-risk procedures with the participation of patients and their health care providers, we will both test the limits of consent and find practical ways to address those limits. In doing so, the project will re-cast consent processes in a way that better accommodates the contingencies of clinical practice in high-risk settings in which patient autonomy is often compromised. Because this reformulation of consent will be grounded in the realities of high-risk clinical practice, our findings will reflect the needs and values of relevant stakeholders (patient and health professionals) and more likely to make a significant contribution to patient care and health policy. This project also addresses what the High Court of Australia has acknowledged as widespread weaknesses in the common formulation of consent in medicine. Finally this project, which operates in an important area of overlap between the law and medicine, will show how these disciplines can work jointly to serve the interests of all Australians, and Australian society.Read moreRead less
An Ethical Analysis Of The Disclosure Of Surgeons' Performance Data To Patients Within The Informed Consent Process
Funder
National Health and Medical Research Council
Funding Amount
$148,937.00
Summary
For over a decade, hospitals in the American state of New York have been collecting information about the mortality rates of surgeons conducting Coronary Artery Bypass Grafts, and making this information available to patients. The United Kingdom is set to make these and other performance indicators on the ability of surgeons ('report cards') available from 2004. There are good reasons to think a similar system may be introduced in Australia in the near future. Patients can use the information co ....For over a decade, hospitals in the American state of New York have been collecting information about the mortality rates of surgeons conducting Coronary Artery Bypass Grafts, and making this information available to patients. The United Kingdom is set to make these and other performance indicators on the ability of surgeons ('report cards') available from 2004. There are good reasons to think a similar system may be introduced in Australia in the near future. Patients can use the information contained in report cards when deciding whether or not to consent to have a particular surgeon conduct an operation on them. Contemporary bioethicists stress the importance of a proper informed consent process in medicine. This is a process in which a doctor advises a patient of relevant information and ensures that the patient comprehends that information, before the patient consents to an operation. Currently report cards in America are publicly disseminated on the internet, however there is no systematic attempt to incorporate the information contained in report cards into the informed consent process. We do not know if patients understand the information they are given, or if they incorporate it into their decision making procedures appropriately. In our study we will consider how information that is contained in report cards could best be used in the informed consent process. We will keep in mind the importance of helping patients to make their own informed decisions to consent to operations, the importance of respecting the professional integrity of surgeons and the importance of providing the best possible standard of care for patients. The result of our study will be a revised model of the informed consent process that incorporates report cards in an ethically acceptable way.Read moreRead less
Consumer Information Materials And A Communication Aid For Diagnostic Tests For Breast Disease
Funder
National Health and Medical Research Council
Funding Amount
$105,863.00
Summary
Many studies have now shown that the majority of patients want to participate in clinical decisions about medical treatments they might receive. As a result, information materials are being developed to help consumers and doctors work together to reach satisfying treatment decisions which are based on the best available evidence and also reflect the individual patient's needs and preferences about the treatment options. Very little is known, however, about whether consumers also want to particip ....Many studies have now shown that the majority of patients want to participate in clinical decisions about medical treatments they might receive. As a result, information materials are being developed to help consumers and doctors work together to reach satisfying treatment decisions which are based on the best available evidence and also reflect the individual patient's needs and preferences about the treatment options. Very little is known, however, about whether consumers also want to participate in decisions about whether to have a medical test. Tests can be trivial, such as a blood or urine test, or quite major and invasive, such as a biopsy or a colonoscopy. People considering a medical test might want to know the answers to the following questions: What is my chance of having the disease being tested for? If the test result is positive what is the chance I have the disease? If the test result is negative what is the chance I have the disease anyway? How will the test result influence treatment of my condition? What are possible side-effects of the test? Generally information materials about medical tests only describe the test itself, and do not contain the information people need to answer these questions. Even doctors may not have to hand the data needed to answer these questions. Yet without this information, consumers cannot make truly informed and rational choices about whether to have the test. This project aims to find out whether consumers want to participate in decisions about medical tests, what information they would want to do this, and to develop and trial information materials and a communication aid for a small number of breast cancer tests. We will use tests for diagnosing breast cancer as our model but we anticipate the work will be applicable across a wide range of medical tests.Read moreRead less
Development And Evaluation Of A Decision Aid For Women With A Breech-presenting Baby.
Funder
National Health and Medical Research Council
Funding Amount
$156,890.00
Summary
Many studies have shown that women want to participate in clinical decisions about the treatments they receive during pregnancy and that involvement in decision making increases satisfaction with maternity care. Decision aids are interventions to help people make specific and deliberative decisions by providing information on the options and outcomes relevant to the person's health. This project aims to develop and evaluate the world's first decision aid for women with a breech presenting baby ( ....Many studies have shown that women want to participate in clinical decisions about the treatments they receive during pregnancy and that involvement in decision making increases satisfaction with maternity care. Decision aids are interventions to help people make specific and deliberative decisions by providing information on the options and outcomes relevant to the person's health. This project aims to develop and evaluate the world's first decision aid for women with a breech presenting baby (bottom rather than head first) in late pregnancy. A decision aid for breech presentation is timely because recent results of an international trial have dramatically altered women's options in the management of breech presentation. The trial of vaginal breech birth versus planned caesarean section (CS) found overwhelming evidence of reduced infant death and disability for women with a planned CS. Planned CS is now considered best practice for delivery of a breech presentation at birth. However, another treatment option for women with a breech presentation is turning the breech to head first before birth (called external cephalic version, ECV). Each of these options (ECV or planned CS) has benefits and risks, and the relative importance of these benefits and risks varies for individual women, a scenario where a decision aid produces the greatest benefit. The breech decision aid developed in this project will be based on the best and most recently available evidence and outcomes. It will incorporate a workbook, audiotape-CD and worksheet that will guide (but not direct) women to a treatment option that best suits them, taking ~20 minutes to complete. The decision aid will be evaluated to assess the impact on women's satisfaction with decision making, knowledge, anxiety and pregnancy outcomes. If successful, the results could be applied to improve consumer information and participation in clinical decisions across a wide spectrum of pregnancy care issues.Read moreRead less
Predicting And Promoting Improved Long Term Adjustment For Men With Localised Prostate Cancer: ProsCan
Funder
National Health and Medical Research Council
Funding Amount
$307,407.00
Summary
In the western world prostate cancer is the most common male cancer and the second most common cause of cancer death. Currently, the most contentious public health issue regarding prostate cancer is uncertainty about the benefits of diagnosing and treating prostate cancer at a localised stage. Prostate cancer is heterogeneous and the risk of morbidity and mortality from localised disease is difficult to quantify owing to the cancer's relatively slow growth rate. Thus, after the diagnosis of loca ....In the western world prostate cancer is the most common male cancer and the second most common cause of cancer death. Currently, the most contentious public health issue regarding prostate cancer is uncertainty about the benefits of diagnosing and treating prostate cancer at a localised stage. Prostate cancer is heterogeneous and the risk of morbidity and mortality from localised disease is difficult to quantify owing to the cancer's relatively slow growth rate. Thus, after the diagnosis of localised prostate cancer it is recommended that all men be advised of three possible treatment options at a minimum: watchful waiting, radiation therapy, or radical prostatectomy. Most men prefer active involvement in the treatment decision, however many find this difficult due to uncertainty about the likely survival gain; significant treatment side effects and ambiguous risk probabilities for these effects. While prostate cancer is common, mortality is low with most men surviving 10 years. This means quality of life after prostate cancer is a critical issue. Survivorship concerns for this patient group include fears about cancer recurrence; managing physical effects of treatments; and social effects such as disruption to daily living. Men seek help less for psychological difficulties than do women. Accessible and well targeted support services for men are critical. This project aims to identify men who after the diagnosis of localised prostate cancer are at risk of poorer psychosocial adjustment over the long term and to assess the effectiveness of a psychosocial and decision support intervention in improving their long term outcomes. Identification of predictors of men's adjustment over time and of effective ways to promote optimal long term outcomes are important research questions that are as yet unanswered. The present research will be the first of its kind internationally to address these questions.Read moreRead less
A Randomised Controlled Trial Of A Decision Aid For Prenatal Screening And Diagnosis
Funder
National Health and Medical Research Council
Funding Amount
$269,625.00
Summary
Prenatal screening is becoming increasingly available to pregnant women in many countries, including Australia, to test for Down syndrome and other chromosomal disorders as well as neural tube defects. Almost half the pregnant women in Victoria are now undergoing prenatal screening. Inherent in all screening tests is the possibility of false positive or false negative results. More than 5% of all women undergoing prenatal screening are likely to receive false positive results and must decide whe ....Prenatal screening is becoming increasingly available to pregnant women in many countries, including Australia, to test for Down syndrome and other chromosomal disorders as well as neural tube defects. Almost half the pregnant women in Victoria are now undergoing prenatal screening. Inherent in all screening tests is the possibility of false positive or false negative results. More than 5% of all women undergoing prenatal screening are likely to receive false positive results and must decide whether to put the pregnancy at risk of miscarriage, or a possible pregnancy termination, as a result of the necessary follow-up invasive diagnostic test. Many women do not realise they may have to face this decision. Others are not aware that their baby may be born with undiagnosed problems even if they have the screening test. One aspect of care that is likely to have a crucial influence on women's experience of screening is how much they are informed about a test prior to undergoing it. Most women visit a GP early in the first trimester of pregnancy. This visit provides an opportunity for information provision about prenatal screening. Decision aids have been developed as adjuncts to practitioners' counselling to prepare patients for decision-making. In this project we will be developing a decision aid for women considering their prenatal screening options. A randomised controlled trial will compare the efficacy of a general educational pamphlet to that of a tailored decision aid in preparing women for decision-making about prenatal screening. A total of 500 women who are less than 11 weeks pregnant and are attending one of 50 GPs will be included. Self-report questionnaires will be used to assess women immediately after use of the educational materials and then again at 24 weeks of pregnancy. The impact of the educational materials on informed choice, decisional conflict, anxiety, depression and uptake of prenatal screening tests will be compared.Read moreRead less
PSA Testing: A Population-based Longitudinal Study Of Decision Making, Psychological Effects And Patterns Of Care
Funder
National Health and Medical Research Council
Funding Amount
$576,977.00
Summary
Prostate cancer is the most commonly diagnosed cancer in Australian men and the second most common cancer- related cause of death. Since being introduced into Australia in 1988 the Prostate Specific Antigen (PSA) blood test has been widely adopted as a method for detecting early-stage asymptomatic prostate cancer. However there is controversy about the potential benefits and harms of testing for prostate cancer. Little has been documented in Australia about the information men receive when consi ....Prostate cancer is the most commonly diagnosed cancer in Australian men and the second most common cancer- related cause of death. Since being introduced into Australia in 1988 the Prostate Specific Antigen (PSA) blood test has been widely adopted as a method for detecting early-stage asymptomatic prostate cancer. However there is controversy about the potential benefits and harms of testing for prostate cancer. Little has been documented in Australia about the information men receive when considering a PSA test, what happens to men after having an abnormal PSA test and the consequences of PSA testing (including physical and psychological effects). The aim of this study is to interview a representative community sample of men aged 50 to 84 years and resident in NSW to describe: (1) the decision-making process regarding PSA testing; (2) the psychological consequences of men's PSA testing experiences; and (3) patterns of care for men who have had an abnormal PSA test. The main outcomes from this study will include substantial information on the experiences of men regarding patterns of PSA participation (frequency of, and reasons for, testing), the clinical management of men who have had an abnormal PSA test, the psychological effects of PSA testing (both positive and negative) and how decisions about testing are being made. This will provide important information to assist GPs, urologists and Australian men make decisions about PSA testing. It will highlight areas of need regarding the information required by men for informed decision-making and the support they require when undergoing PSA testing to ensure positive psychological outcomes.Read moreRead less
A Randomised Controlled Trial Of A Decision Aid For The Management Of Pain In Labour And Childbirth
Funder
National Health and Medical Research Council
Funding Amount
$267,375.00
Summary
Many studies have shown that women want to participate in clinical decisions about the treatments they receive during pregnancy and that involvement in decision making increases satisfaction with maternity care. Decision aids are interventions to help people make specific and deliberative decisions by providing information on the options and outcomes relevant to the person's health. This project aims to develop and evaluate the world's first decision aid for women regarding the management of pai ....Many studies have shown that women want to participate in clinical decisions about the treatments they receive during pregnancy and that involvement in decision making increases satisfaction with maternity care. Decision aids are interventions to help people make specific and deliberative decisions by providing information on the options and outcomes relevant to the person's health. This project aims to develop and evaluate the world's first decision aid for women regarding the management of pain in labour and childbirth. A decision aid for managing the pain of childbirth is both practical and timely because there is a strong evidence base on labour analgesia but a lack of evidence-based information for women. For example, brochures on epidural analgesia outline the advantages of epidurals such as complete amelioration of pain, but do not present any information on adverse obstetric outcomes such as the doubling of risk for an instrumental birth. Most women are willing to experience pain in childbirth but do not want pain to overwhelm them. The decision aid will include a range of available drug and non-drug options for pain relief in labour and childbirth. Each of the options has benefits and risks, and the relative importance of these benefits and risks varies for individual women, a scenario where a decision aid produces the greatest benefit. The pain management decision aid developed in this project will be based on the best most recently available evidence and outcomes. It will incorporate a workbook, audiotape-CD and worksheet that will guide (but not direct) women with their pain management options that best suit them, taking ~30 minutes to complete. The decision aid will be evaluated to assess the impact on women's satisfaction with decision making, knowledge, anxiety and pregnancy outcomes. If successful, the results could be applied to improve consumer information and participation in clinical decisions across a wide spectrum of pregnancy care issues.Read moreRead less
A Randomised Controlled Trial Of A Bowel Cancer Screening Decision Aid For Adults With Low Education And Literacy
Funder
National Health and Medical Research Council
Funding Amount
$237,277.00
Summary
The Commonwealth has committed funds for a national bowel cancer screening program. This will involve mailing bowel testing kits direct to eligible consumers at their homes. To minimise inequalities in accessing screening and to ensure effectiveness of the program, information and instructions for testing will have to be accessible to participants from low as well as high educational backgrounds. This project will evaluate communication strategies to achieve this. Reliance on written information ....The Commonwealth has committed funds for a national bowel cancer screening program. This will involve mailing bowel testing kits direct to eligible consumers at their homes. To minimise inequalities in accessing screening and to ensure effectiveness of the program, information and instructions for testing will have to be accessible to participants from low as well as high educational backgrounds. This project will evaluate communication strategies to achieve this. Reliance on written information has rapidly increased within healthcare. In particular, the use of patient decision aids to support and inform health decisions is rapidly increasing. The need to improve information in screening programs has been particularly highlighted and decision aids provide an evidence based approach to achieve this. However, whilst there is level 1 evidence that decision aids improve the decision making process for consumers, research has been carried out almost exclusively among educated participants with high literacy. There is concern that the needs of adults with low education and limited literacy have been ignored. The proposed study is 2 phased. Phase I will test optimal quantitative risk communication formats for adults with low education and literacy. Phase 2 will evaluate a tailored low literacy decision aid for FOBT screening. The trial will test whether the decision aid can increase knowledge of screening, increase involvement in decisions and improve the quality of decision making among adults with low education, and will examine its impact on screening intentions and behaviour. This is a highly significant study. Screening providers need better ways to inform consumers of screening programs that are accessible to a diverse audience and equitable across the target population. This study will have direct implications for use in the national bowel cancer screening program.Read moreRead less
Cancer Trials Australia-OnLine: A Tool For Cancer Patients To Find Open Clinical Trials And Consider Trial Participation
Funder
National Health and Medical Research Council
Funding Amount
$525,604.00
Summary
We will develop and evaluate a website for consumers which will interface with the ACTR to provide up to date information on currently recruiting cancer trials. Aims are: a) to increase awareness of cancer trials, and facilitate discussion between doctors and patients about participation in a clinical trial, and b) to support cancer consumers to make an informed decision about enrolling in a trial. A randomized trial will assess the effectiveness of the site in achieving these aims.