A national epidemiological study of Myasthenia Gravis in Australia.

BACKGROUND AND PURPOSE: Existing epidemiological studies of Myasthenia Gravis have generally examined small populations. Few national studies have been conducted, and published incidence and prevalence rates vary widely. We report one of the largest national studies of Myasthenia Gravis, and the first incidence and prevalence rates for Australia. METHODS: Prescriptions for Pyridostigmine Bromide in 2009 were utilized from a national prescribing database to estimate incidence and the prevalence of symptomatic and treated disease. Crude rates were age-standardized to the WHO world population. We compared standardized rates to recent national studies from Norway and Taiwan. RESULTS: In 2009, there were 2574 prevalent cases of symptomatic and treated Myasthenia Gravis, corresponding to an annual crude prevalence rate of 117.1 per 1 million residents. There were 545 incident cases, yielding a crude incidence rate of 24.9 per 1 million residents. The crude incidence in women and men was estimated to be 27.9 and 21.9 per 1 million, respectively. Prevalence and incidence rates were higher in women than men between the ages of 15 and 64 years, and were higher in men than women in those older than 65 years. Rates peaked between the ages of 74 and 84 years, declining thereafter. Standardized incidence was higher in Australia than Norway, but similar to Taiwan (P-values = 0.007 and 1.00, respectively). CONCLUSIONS: This first Australian epidemiological study of symptomatic Myasthenia Gravis is one of the largest population-based studies ever reported and supports higher incidence rates for Myasthenia Gravis. Myasthenia Gravis disproportionately affected younger females and older males.

Local opinion leaders: effects on professional practice and health care outcomes.

BACKGROUND: Clinical practice is not always evidence-based and, therefore, may not optimise patient outcomes. Opinion leaders disseminating and implementing 'best evidence' is one innovative method that holds promise as a strategy to bridge evidence-practice gaps. OBJECTIVES: To assess the effectiveness of the use of local opinion leaders in improving the behaviour of health care professionals and patient outcomes. SEARCH STRATEGY: We searched MEDLINE, Health Star, SIGLE and the Cochrane Effective Practice and Organisation of Care Group Trials Register. We did not apply date restrictions to our search strategy. Searches were last updated in February 2005. In addition, we searched reference lists of all potential studies that were identified. SELECTION CRITERIA: Studies eligible for inclusion were randomized controlled trials that used objective measures of performance/provider behaviour and/or patient health outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data from each study and assessed its methodological quality. We calculated the absolute difference in the risk of 'non-compliance' with desired practice, adjusting for baseline levels of non-compliance where these data were available. MAIN RESULTS: Twelve studies met our eligibility criteria. The adjusted absolute risk difference of non-compliance with desired practice varied from -6% (favouring control) to +25% (favouring opinion leader intervention). Overall, the median adjusted risk difference (ARD) was 0.10 representing a 10% absolute decrease in non-compliance in the intervention group. AUTHORS' CONCLUSIONS: The use of local opinion leaders can successfully promote evidence-based practice. However the feasibility of its widespread use remains uncertain.

Does a deadline improve men's participation in self-administered health surveys? A randomized controlled trial in general practice.

BACKGROUND: Self-administered questionnaires are commonly used in experimental studies to elicit quality of life or other outcomes. Hence, achieving an acceptable level of follow-up from patients is critical to minimizing bias. Many methods for maximizing follow-up remain untested. It is also unclear what level of follow-up is required to prevent bias being introduced. METHODS: We recruited 246 men from general practice surgeries in Sydney, Australia. These 246 men were randomized to receive a covering letter with their follow-up questionnaire either advising of a deadline to reply (Deadline, n = 126) or a standard letter without a deadline (No Deadline, n = 120). Four standardized reminder prompts subsequently were administered. We calculated interim response rates and the final proportion of follow-up questionnaires received according to group. We also compared scores on two main outcomes, namely, knowledge and decisional conflict at each time when reminder prompts were administered. RESULTS: One hundred and twelve (88.9%) men in the Deadline group returned their follow-up questionnaires compared with 102 (85.0%) men in the No Deadline group. This difference was not statistically significant [odds ratio = 1.41, 95% confidence interval (CI) = 0.67-2.99; p = 0.36]. Time to response also was not significantly affected by cover letter received (hazard ratio = 0.96; 95% CI = 0.73-1.25; p = 0.76). Results of the original RCT were similar in terms of direction and effect size at all times irrespective of when reminder prompts were administered. CONCLUSION: The addition of a deadline adds no further impact in improving response rates from male patients compared with an unspecified letter. Despite the accepted wisdom that higher response protects against bias, differences in outcomes were consistent throughout the post-test data collection period.

Impact of national guidelines about the management of colorectal cancer on Australian surgeons' awareness of evidence: a pre/post survey.

OBJECTIVE: To evaluate the immediate impact of national evidence-based guidelines about colorectal cancer on Australian surgeons' self-reported practice and their deficits in awareness of scientific evidence underpinning clinical management practices. DESIGN: Pre/post evaluation, comprising preguidelines survey (November 1998) and postguidelines survey (February 2001). METHODS: One hundred and fourteen Australian surgeons returned postguidelines surveys, of whom 103 (90%) agreed to matching of their pre- and postguidelines responses. National distribution of the CRC guidelines occurred in November 1999. Over the ensuing year, dissemination strategies included seminars, presentations at conferences and journal articles. The main outcome measures used were changes in awareness of evidence for each of 23 clinical recommendations, changes in overall awareness score (maximum possible 23), changes in subscore for nine items for which evidence was compelling and predictors of change. RESULTS: Of those surgeons followed up, 95% were aware of the guidelines and 32% had read them in detail. Only 47% recalled the consumer version. The three most highly rated topics in the guidelines were: high-risk familial syndromes (45%); screening based on family history of colorectal cancer (40%); population screening for colorectal cancer (25%). Compared with baseline, there was a modest improvement in the mean overall awareness score (P = 0.02). Paired analyses of awareness of the evidence for each of 23 individual topics revealed significant improvement only in five. For two, awareness significantly decreased. CONCLUSIONS: Our pre/post findings are not inconsistent with the expectation that dissemination of the CRC guidelines has had some short-term impact. However, definitive evidence acquired through more rigorously designed controlled trials will be needed to determine first, whether surgical practice has changed and, second, whether implementation of the CRC guidelines or some other secular event caused such change.

Antitumour antibiotic containing regimens for metastatic breast cancer.

BACKGROUND: Antitumour antibiotics are used in the management of metastatic breast cancer. Some of these agents have demonstrated higher tumour response rates than non-antitumour antibiotic regimens, however a survival benefit has not been established in this setting. OBJECTIVES: To identify and review the randomised evidence comparing anti-tumour antibiotic containing chemotherapy regimens with regimens not containing an anti-tumour antibiotic in the management of women with metastatic breast cancer. SEARCH STRATEGY: The specialised register maintained by the Editorial Base of the Cochrane Breast Cancer Group was searched on 2nd May, 2003 using the codes for "advanced breast cancer" and "chemotherapy". Details of the search strategy and coding applied by the Group to create the register are described in the Group's module on The Cochrane Library. SELECTION CRITERIA: Randomised trials comparing anti-tumour antibiotic containing regimens with regimens not containing anti-tumour antibiotics in women with metastatic breast cancer. DATA COLLECTION AND ANALYSIS: Data were collected from published trials. Studies were assessed for eligibility and quality, and data were extracted by two independent reviewers. Hazard ratios (HRs) were derived from time-to-event outcomes where possible, and a fixed effect model was used for meta-analysis. Response rates were analysed as dichotomous variables. Quality of life and toxicity data were extracted where present. A primary analysis was conducted for all trials and by class of antitumour antibiotic. MAIN RESULTS: Thirty-three trials reporting on 45 treatment comparisons were identified. All trials published results for tumour response and 26 trials published time-to-event data for overall survival. The observed 4084 deaths in 5284 randomised women did not demonstrate a statistically significant difference in survival between regimens that contained antitumour antibiotics and those that did not (HR 0.97, 95% CI 0.91 to 1.03, P = 0.35) and no significant heterogeneity. Antitumour antibiotic regimens were favourably associated with time-to-progression (HR 0.84, 95% CI 0.77 to 0.91) and tumour response rates (odds ratio (OR) 1.34, 95% CI 1.21 to 1.48) although statistically significant heterogeneity was observed for these outcomes. These associations were consistent when the analysis was restricted to the 29 trials that reported on anthracyclines. Patients receiving anthracycline-containing regimens were also more likely to experience toxic events compared to patients receiving non-antitumour antibiotic regimens. No statistically significant difference was observed in any outcome between mitoxantrone-containing and non-antitumour antibiotic-containing regimens. REVIEWERS' CONCLUSIONS: Compared to regimens without antitumour antibiotics, regimens that contained these agents showed a statistically significant advantage for tumour response and time to progression in women with metastatic breast cancer but were not associated with an improvement in overall survival. The favourable effect on tumour response and time to progression observed in anthracycline-containing regimens was also associated with greater toxicity.

Does evidence-based information about screening for prostate cancer enhance consumer decision-making? A randomised controlled trial.

OBJECTIVES: Efforts to educate men about the controversy surrounding prostate cancer screening are well intended but rarely evaluated rigorously. We evaluated an evidence-based (EB) booklet for men designed to promote informed decision-making. We also determined whether men's preference for involvement in decision-making ("passive", "collaborative" or "active") modified its impact. SETTING AND METHODS: Men aged 40-70 years were recruited from the practices of 13 local general practitioners (GPs) in Sydney, Australia. They completed a self-administered questionnaire before seeing their GP, who, according to pre-randomised codes, distributed either our EB booklet or conventional information. Post-test questionnaires were mailed to men three days later. Of the 248 eligible men recruited, 214 (86% response rate) returned post-test questionnaires. Knowledge of evidence and of risk of developing and dying from prostate cancer, attitudes, interest in screening for prostate-specific antigen (PSA), worry and decisional conflict were the main outcome measures. RESULTS: Compared with those receiving conventional information, men receiving the EB booklet had significantly improved knowledge (50% of items correct, 95% CI 46-53%; vs 45% correct, 95% CI 42-48%) (p = 0.048) and lower levels of decisional conflict (mean 21.6, 95% CI 20.7-22.5; vs mean 24.3, 95% CI 23.4-25.2) (p < 0.001). Interest in PSA screening was significantly reduced in both groups at post-test (p < 0.001). Men preferring a "passive" approach to decision-making gained as much from our EB booklet as those with "active" or "collaborative" preferences. CONCLUSIONS: Our findings show the benefits of providing evidence-based information to men about PSA screening. Our EB booklet facilitated informed choice, even among "passive" decision-makers.

Randomized, controlled trials in surgery: perceived barriers and attitudes of Australian colorectal surgeons.

PURPOSE: Although the randomized, controlled trial has gained preeminence as the criterion standard for evaluating pharmaceutical treatments, randomized controlled trials in surgery have been perceived as difficult to surmount. Furthermore, attitudes of surgeons toward randomized, controlled trials are not well understood. We determined the views of Australian surgeons about feasibility of and barriers to surgical randomized trials. METHODS: All members of the Section of Colon and Rectal Surgery of the Royal Australasian College of Surgeons (n = 147) and all Australian colorectal subspecialist surgeons (n = 72) were mailed a questionnaire that included questions about surgical randomized, controlled trials. RESULTS: A total of 195 surgeons responded (89 percent). Two-thirds (66.7 percent; 95 percent confidence interval 59.5-73.1) of respondents agreed that "Randomized controlled trials should be the study design of choice" to evaluate new surgical procedures. Only 19 percent (95 percent confidence interval 13.9-25.3) endorsed the statement that "too much emphasis is placed on results of randomized controlled trials." Barriers to conducting surgical randomized, controlled trials identified by the majority included insufficient funding (74.4 percent; 95 percent confidence interval 67.5-80.2), a lack of support from the wider surgical community (55.9 percent; 95 percent confidence interval 48.6-62.9), and difficulties in convincing patients to accept random allocation to treatment (62.6 percent; 95 percent confidence interval 55.3-69.3). CONCLUSION: These results reveal positive attitudes among Australian surgeons toward randomized, controlled trials, although concerns about the feasibility of randomized, controlled trials have been reinforced.

Sharing decisions in cancer care.

Previous studies have demonstrated that the majority of cancer patients fail to achieve their desired level of participation during treatment decision making. However, it is unclear whether this failure affects patient well-being and satisfaction. Furthermore, whilst shared decision making is currently espoused as the preferred model for doctor patient relations, little empirical evidence exists showing it has beneficial effects for patients. We aimed to evaluate the impact of shared decision making and the achievement of preferred role on patient anxiety, recall of information, and satisfaction. Patients with cancer indicated their preferred level of participation in decision making and preferences for information and emotional support prior to their initial consultation with an oncologist. Anxiety was assessed prior to and immediately after the consultation and recall seven days after the consultation. Anxiety was reassessed at two-weeks post-consultation at which time patients also reported their satisfaction with the consultation and perceived role of participation in treatment decision making. Satisfaction with the information and emotional support received was also evaluated. Of the 233 patients available for analysis, a match between preferred and perceived roles was found for over one-third of patients (34%), with 29% more active and 37% less involved in decision making than preferred. Multivariate analyses demonstrated that role mismatch significantly predicted changes in anxiety levels from pre to immediate postconsultation (p = 0.03). However, irrespective of preferred role in decision making, perceived role, but not role mismatch, significantly and independently predicted satisfaction with both the consultation (p = 0.0005) and the amount of information and emotional support received from the doctor (p = 0.004). Patients who reported a shared role in decision making were most satisfied with the consultation and with the information about treatment and emotional support received. Those who reported that either themselves or the doctor exclusively made the decision were least satisfied. These findings underscore the pre-eminence of the shared decision making model and suggest that encouraging participation may be the safest standard approach. Doctor - as well as patient - based interventions are required to promote patient participation.

Will donations to their learned college increase surgeons' participation in surveys? A randomized trial.

Effective strategies to maximize response rates to self-administered surveys of clinicians are crucial to minimize response bias. Offers of charitable donations have been assessed for their potential to promote participation of community samples but not in the context of medical specialist samples. We randomized all Australian colorectal surgeons (n = 219) to whom we mailed a survey about clinical practice guidelines to receive either a standard covering letter or one promising a donation to their peak professional organization upon our receipt of their completed survey. Contrary to expectations, surgeons advised that their participation would secure a donation to their college were significantly less likely to return their questionnaire (84.3%, 95% CI 76.0-90.5%) than those receiving a standard letter (93.7%, 95% CI 87.4-97.4%). They also were more tardy in their response (Hazard Ratio = 0.75, 95% CI 0.57-1.00) (P = 0.047). In this context, offering donations to surgeons was counterproductive in enhancing response rates.

Discussing adjuvant cancer therapy.

PURPOSE: To document the adequacy of patient information in oncology consultations concerning adjuvant therapy and explore predictors of physician communication patterns, treatment decisions, patient information recall, and satisfaction. PATIENTS AND METHODS: Retrospective analysis of audiotapes and verbatim transcripts of 101 initial adjuvant therapy consultations with medical and radiation oncologists was undertaken. Content analysis, data on communication patterns, treatment decisions, patient anxiety, satisfaction, and information recall were collected. Predictors of physician communication, treatment decisions, recall, and satisfaction with the consultation were identified. RESULTS: The majority of patients were well informed of their prognosis, benefits and risks of therapy, and alternative management options. Only half were asked about preferences for information or decision-making involvement. Predictors of information detail given include patient sex, age, occupation, and education. Radiation and medical oncologists express prognosis and treatment benefit using similar phrases. When offered the chance to delay decision-making, most patients do so (P <.01). Final treatment decisions appear to be influenced by the presentation of choice in treatment options by the oncologist and whether the treatment decision was made during the initial consultation (P <.01). Information recall was not influenced by communication factors. Patients receiving less detailed information had slightly higher satisfaction with the consultation (P =.03). More anxious patients tended to be less satisfied (P =.07). CONCLUSION: The optimal way to discuss adjuvant therapy is undefined. More emphasis can be placed on soliciting patient preferences for information and decision-making involvement and tailoring both to the needs of the individual patient. Providing choice in treatment and delaying decision-making may affect the patient's treatment decision.

Implementing guidelines about colorectal cancer: a national survey of target groups.

BACKGROUND: An Australia-wide postal survey was undertaken to determine surgeons' attitudes towards guidelines and their preferred strategies for dissemination and implementation of guidelines for the management of colorectal cancer, developed by the Australian Cancer Network (ACN) and the Clinical Oncological Society of Australia (COSA). This survey was conducted as a baseline before the release of the definitive guidelines. METHODS: All members of the Royal Australasian College of Surgeons (RACS) with a self-nominated special interest in colorectal surgery and members of the Colorectal Surgical Society of Australia (CSSA) were surveyed. RESULTS: A total of 195 of the 219 surgeons eligible for the study returned questionnaires (89% response rate). Most (86%) were aware that these guidelines were being developed. More than one-half had read at least one draft version. Almost half (44.6%; 95%CI: 37.6-51.9%) agreed that guidelines represented 'cookbook medicine' and one-third (33.3%; 95%CI: 26.9-40.5%) agreed that guidelines might increase the number of malpractice suits. Local adaptation of guidelines and 'academic detailing' were most favourably ranked to assure implementation. Further, 54.9% (95%CI: 47.6-61.9%) of respondents believed that a successful legal defence of a surgeon whose practice had been within the guidelines would encourage uptake. Surgeons operating outside teaching hospitals were more likely to endorse this view than others. CONCLUSIONS: These results demonstrate that an important target group for colorectal cancer guidelines, namely surgeons, appears receptive to clinical practice guidelines. These results could also permit interventions that target attitudinal barriers to implementing guidelines and subgroups of surgeons who have particular concerns. Expensive strategies for implementation ought to be subject to rigorous evaluation for their impact in modifying clinical practice.

Does type of surgeon matter in rectal cancer surgery? Evidence, guideline consensus and surgeons' views.

One of the most obvious but controversial trends in contemporary surgical practice is that of subspecialization. There is a lack of definitive evidence that subspecialization improves cancer outcomes largely because previous research is compromised by confounding variables of referral practice, lack of standardized definitions of surgical skills and selection bias. Randomized controlled trials of generalized versus subspecialist surgical care are unlikely ever to be performed. The present study of surgeons' views about the role of subspecialization in the care of colorectal cancer patients demonstrates partisan reactions among surgeons themselves (89% response rate). Results of national audits will contribute to wider debate about surgical subspecialization in colorectal cancer.

Misunderstanding in cancer patients: why shoot the messenger?

AIM: We aimed to document the prevalence of misunderstanding in cancer patients and investigate whether patient denial is related to misunderstanding. PATIENTS AND METHODS: Two hundred forty-four adult cancer outpatients receiving treatment completed a survey assessing levels of understanding and denial. Doctors provided the facts against which patient responses were compared. Multiple logistic regression analyses determined the predictors of misunderstanding. RESULTS: Most patients understood the extent of their disease (71%, 95% CI: 65%-77%) and goal of treatment (60%, 95% CI: 54%-67%). Few correctly estimated the likelihood of treatment achieving cure (18%, 95% CI: 13%-23%), prolongation of life (13%, 95% CI: 8%-17%) and palliation (18%, 95% CI: 10%-27%). Patient denial predicted misunderstanding of the probability that treatment would cure disease when controlling for other patient and disease variables (OR = 2.20, 95% CI: 0.99-4.88, P = 0.05). Patient ratings of the clarity of information received were also predictive of patient understanding. CONCLUSIONS: Patient denial appears to produce misunderstanding, however, doctors' ability to communicate effectively is also implicated. The challenge that oncologists face is how to communicate information in a manner which is both responsive to patients' emotional status and sufficiently informative to allow informed decision-making to take place.

The use of unproven methods of treatment by cancer patients. Frequency, expectations and cost.

The use of unproven therapies is of concern for a number of reasons, including the lack of scientific evidence of support them, their potential financial costs and the possibility of interference with conventional treatment. This study explored the prevalence, predictors and experiences of unproven therapy use by cancer patients attending an oncology clinic at an Australian teaching hospital. A questionnaire was administered to patients whilst they were waiting for a consultation with their oncologist. A total of 173 patients were invited to participate, and 156 consented to complete the survey (90%). Over half the patients (81, 52%) had used at least one unproven therapy since their diagnosis, and 28% had used three or more. Patients most commonly practised mediation/relaxation, changed their diet and used multi-vitamins. Most expected that the therapies would aid their conventional treatments and make them feel more in control of their situation. Benefits reported were largely psychological, such as an increased sense of control or a reduction in anxiety. Younger patients, those with early stage or advanced metastatic disease and those who had used unproven therapies prior to developing cancer were more likely to use unproven therapies. Health professionals involved in the care of cancer patients should be prepared to discuss the use of unproven therapies and try to identify and deal with unmet needs to help patients to cope with their illness.

Restrained and unrestrained females' positive and negative associations with specific foods and body parts.

OBJECTIVE: This study was concerned with the positive and negative affective associations of categories of "forbidden" and "allowed" foods, and "threatening" and "nonthreatening" body parts, among dieters and nondieters. METHOD: Forty-one females, categorized according to their cognitive restraint scores, completed a rating task that involved indicating the extent to which each food and body part was associated with three positive and three negative emotions or experiences, as well as with health and illness. RESULTS: Judgements of forbidden foods were more positive. There was also a significant restraint group by food type interaction for negative judgements of forbidden foods. A significant interaction was also produced for subjects' negative ratings of body parts; subjects high in restraint were more likely to rate threatening parts higher on guilt and on anxiety. Forbidden foods were rated lower on health and higher on illness, and high restraint subjects rated both food types more healthy compared with subjects low in restraint. DISCUSSION: Taken together, the results emphasize the subtlety in the affective associations with foods and body parts, which depend on their categorization or specific meanings. Fewer differences emerged when we compared subjects from the high and low restraint groups. Emotionality could underly the "attentional biases" reported in studies using the modified Stroop.