Consumer choice and the National Bowel Cancer Screening Program.
The opportunity for informed choice in screening is limited.
Australia↗
Biomedical subjects
Jane M Young
Publications and source records attributed to Jane M Young.
Clinical trials in head and neck oncology: an evaluation of clinicians' willingness to participate.
BACKGROUND: This study investigated the individual and collective ("community") equipoise of surgeons and oncologists and their willingness to take part in each of six hypothetical randomized controlled trials in head and neck oncology. METHODS: A survey was mailed to Australasian head and neck specialists. RESULTS: Among 109 respondents (74% response), the scenario with the highest level of individual equipoise pertained to the use of adjuvant interferon for patients with high-risk malignant melanoma, with 45% indicating complete uncertainty between treatment approaches. Significant differences in levels of community equipoise were demonstrated between surgeons and oncologists for three of the scenarios. Willingness to participate in randomized controlled trials ranged from 39% to 72%. Increasing strength of treatment preference was associated with unwillingness to participate in randomized controlled trials for two of six scenarios. CONCLUSION: High levels of equipoise and willingness to participate in clinical research augur well for future randomized controlled trials in head and neck oncology.
Adult↗
How does an historic control study of a surgical procedure compare with the "gold standard"?
PURPOSE: It has been suggested that nonrandomized studies of interventions can neither discriminate between the effect of an intervention and that of bias nor accurately estimate the magnitude of measured effects. This study was designed to compare the results of an historic control study of a surgical procedure with those of a subsequent randomized control trial conducted under similar circumstances. METHODS: The results of an historic control study and a randomized, controlled trial of the safety and efficacy of laparoscopic rectopexy for rectal prolapse that were conducted 17 months apart by the same group of surgeons at the same institution were compared in terms of direction and magnitude of measured effects. RESULTS: The historic control study was reliable in determining the direction of measured effects in six of six (100 percent) outcomes common between the two studies, and there was agreement on the statistical significance (or lack of it) in five (83 percent); however, the magnitude of measured effects for all but one outcome assessed was 33 to 107 percent larger than in the randomized, controlled trial. There was no agreement in the medical literature on the effect of the historic control design on the direction and magnitude of measured effects. CONCLUSIONS: The results of a surgical historic control trial compared favorably with those of a randomized, controlled trial conducted under similar circumstances in determining the direction of measured effects but tended to yield larger estimates of effect magnitudes. The medical literature is divided on the effect of the historic control study design on study outcomes and more research is required to further define its role in evidence-based surgery.
Colorectal Surgery↗
A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials.
BACKGROUND: The low recruitment rates into surgical randomized controlled trials (RCTs) threaten the validity of their findings. We reviewed the reasons for nonentry of eligible patients into surgical RCTs that would form the basis for future prospective research. METHODS: A systematic review of the English language literature for studies reporting reasons for nonentry of eligible patients into surgical RCTs and of recommendations made to improve the low recruitment rates. RESULTS: We reviewed 401 articles, including 94 articles presenting the results of 62 studies: 23 reports of recruitment into real surgical RCTs, 11 surveys of patients regarding hypothetical surgical RCTs, 10 surveys of clinicians and 18 literature reviews. The most frequently reported patient-related reasons for nonentry into surgical RCTs were preference for one form of treatment, dislike of the idea of randomization, and the potential for increased demands. Distrust of clinicians caused by a struggle to understand, explicit refusal of a no-treatment (placebo) arm, and the mere inability to make a decision were frequently reported in studies of real RCTs and patient surveys, but were not emphasized in surveys of clinicians and review articles. Difficulties with informed consent, the complexity of study protocols, and the clinicians' loss of motivation attributable to lack of recognition were the most commonly reported clinician-related reasons. CONCLUSIONS: There seems to be a discrepancy between real reasons for nonentry of eligible patients into surgical RCTS and those perceived by the clinicians, which require further prospective research. A summary and discussion of main recommendations sighted in the literature is presented.
Health Status↗
Publication bias in papers presented to the Australian Orthopaedic Association Annual Scientific Meeting.
BACKGROUND: The selective publication of articles based on factors, such as positive outcome, statistical significance and study size is known as publication bias. If publication bias is present, any clinical decision based on a review of the published work will also be biased. Publication bias has been shown in various specialties, based on review of publication rates for abstracts presented at major scientific meetings. This study was conducted to investigate publication bias in orthopaedics. METHODS: Abstracts presented at the 1998 Australian Orthopaedic Association Annual Scientific Meeting were reviewed independently by two reviewers. Details of sample size, study setting, country of origin, outcome and study type were recorded for each abstract. Publication within 5 years was ascertained by electronic searching of Medline and Embase databases and direct author contact. Logistic regression analysis was used to identify predictors of publication. RESULTS: The overall publication rate was 31%. Publication was more likely if the study was a laboratory study, rather than a clinical study (odds ratio (OR), 3.45; 95% confidence interval (CI) 1.69-7.01, P < 0.001). Sample size, country of origin, study type, statistical significance and positive outcome were not significantly associated with publication. CONCLUSION: According to this study, laboratory studies were significantly more likely to be published than clinical studies. In contrast to previous studies, publication bias due to the selective publication of papers with a positive outcome or those reporting statistical significance was not found.
Abstracting and Indexing↗
Non-entry of eligible patients into the Australasian Laparoscopic Colon Cancer Study.
BACKGROUND: There is currently a need to assess the reasons for non-entry of eligible patients into surgical randomized controlled trials to determine measures to improve the low recruitment rates in such trials. METHODS: Reasons for non-entry of all eligible patients not recruited into the Australasian Laparoscopic Colon Cancer Study were prospectively recorded using a survey completed by the participating surgeons for a period of 6 months. RESULTS: In the 6-month period of the study, 51 (45%) out of 113 eligible patients examined by the 18 actively participating surgeons were recruited into the trial. Eighty-nine reasons were recorded for the non-entry of the 62 eligible patients. The most commonly recorded reason was preference for one form of surgery (42%) or the surgeon (31%) by the patient (45 patients (73%) in total). This was followed by lack of time (10 patients (16%)), hospital accreditation (7 patients (11%)) or staffing/equipment (6 patients (10%)). Concern about the doctor-patient relationship or causing the patient anxiety was recorded for three (5%) and two (3%) patients, respectively. Recruitment was positively associated with the availability of a data manager (chi2 = 19.91; P < 0.001, odds ratio (95% confidence interval) = 9.50 (3.53-25.53)) and negatively associated with an increased caseload (more than five eligible patients seen by the surgeon in the study period) (continuity adjusted chi2 = 16.052; P < 0.001, odds ratio (95% confidence interval) = 0.11(0.04-0.30)). CONCLUSION: Having a preference for one form of surgery by the patient or the surgeon was the most common reason for non-entry of eligible patients in the Australasian Laparoscopic Colon Cancer Study. Concern about the doctor-patient relationship played a minimal role in determining the outcome of recruitment. Patient and surgeon preferences, caseload and the distribution of supportive staff such as data managers according to patient population density should be considered in the planning of future trials.
Aged↗
Does telling people what they have been doing change what they do? A systematic review of the effects of audit and feedback.
BACKGROUND: Many people advocate audit and feedback as a strategy for improving professional practice. The main results of an update of a Cochrane review on the effects of audit and feedback are reported. DATA SOURCES: The Cochrane Effective Practice and Organisation of Care Group's register up to January 2004 was searched. Randomised trials of audit and feedback that reported objectively measured professional practice in a healthcare setting or healthcare outcomes were included. REVIEW METHODS: Data were independently extracted and the quality of studies were assessed by two reviewers. Quantitative, visual and qualitative analyses were undertaken. MAIN RESULTS: 118 trials are included in the review. In the primary analysis, 88 comparisons from 72 studies were included that compared any intervention in which audit and feedback was a component to no intervention. For dichotomous outcomes, the median-adjusted risk difference of compliance with desired practice was 5% (interquartile range 3-11). For continuous outcomes, the median-adjusted percentage change relative to control was 16% (interquartile range 5-37). Low baseline compliance with recommended practice and higher intensity of audit and feedback appeared to predict the effectiveness of audit and feedback. CONCLUSIONS: Audit and feedback can be effective in improving professional practice. The effects are generally small to moderate. The absolute effects of audit and feedback are likely to be larger when baseline adherence to recommended practice is low and intensity of audit and feedback is high.
Education, Medical, Continuing↗
Telephone vs. face-to-face biofeedback for fecal incontinence: comparison of two techniques in 239 patients.
PURPOSE: Biofeedback is an effective treatment for patients with fecal incontinence, yet little is known about how it works or the minimum regime necessary to provide clinical benefit. This study compares the effectiveness of a novel protocol of telephone-assisted biofeedback treatment for patients living in rural and remote areas with the standard face-to-face protocol for patients with fecal incontinence. METHODS: A new treatment program comprising an initial face-to-face assessment and treatment with transanal manometry and ultrasound biofeedback, followed by three treatments conducted via telephone and a final face-to-face assessment, was developed. Standard treatment involved five face-to-face treatment sessions with manometry and ultrasound. Patients from rural areas were offered the telephone-assisted treatment protocol. Data gathered prospectively included incontinence scores, a quality of life index, anal manometry, and external sphincter isometric and isotonic fatigue times. RESULTS: A total of 239 consecutive patients treated between July 2001 and July 2004 were enrolled. There were no significant differences in demographic details, past history, or pretreatment measures of the two groups. Forty-six of 55 patients (84 percent) treated with the telephone protocol and 129 of 184 (70 percent) treated by the standard technique completed treatment. There were substantial, significant improvements after treatment, including 54 percent mean improvement in patient's own rating of their incontinence in both groups; a mean decrease of 3.1 and 3.2 on the St. Mark's incontinence score (from 7.9 to 4.7 and 7.4 to 4.2 of 13) and relative improvements of 128 and 130 percent in the quality of life index (from 0.29 to 0.65 and 0.3 to 0.69 of 1) for the telephone-assisted and standard groups respectively. Importantly, there were no significant differences between the telephone-assisted or standard groups in any outcome. Of patients who completed treatment, 78 percent were better or much better. CONCLUSIONS: A less intensive regime of biofeedback seems to be equally effective as the standard intensive protocol. This finding adds weight to the evolving concept that the physical aspects of biofeedback treatment, such as manometry or ultrasound, may not be necessary in the treatment of most patients with fecal incontinence. This needs to be further tested in a randomized, controlled trial.
Adult↗
Is it worth the risk? A systematic review of instruments that measure risk propensity for use in the health setting.
In this era of shared doctor-patient decision-making, eliciting and incorporating patients' treatment choices is essential to ensure all patients receive the treatment that is right for them. Clinicians and researchers should fully understand the many factors that influence and guide patients in their preferences for treatment. One of these influences is an individual's general risk propensity or willingness to take risks, yet there is little in the literature about methods for measuring risk propensity. A systematic review was undertaken to identify instruments that measure risk propensity and to appraise their validity and relevance for a clinical setting. Of 3546 articles, 139 were potentially relevant. From these, 14 instruments were identified. Eight measured risk propensity, whereas six measured personality traits associated with risk propensity. Most instruments demonstrated good internal reliability but their appropriateness for patients, particularly older adults, remains unclear. While no instrument was specific to or tested in a clinical setting, instruments that directly measured risk propensity were considered to be the most useful for clinical populations. The further adaptation and validation of these instruments among older adults are important avenues for future research.
Choice Behavior↗
Role for opinion leaders in promoting evidence-based surgery.
HYPOTHESIS: "Opinion leaders" can be identified by surgeons from among their peers, and opinion leaders have a role in promoting best surgical practice. DESIGN: Postal survey. SETTING AND PARTICIPANTS: Four hundred eighteen (77% response fraction) randomly selected fellows of the Royal Australasian College of Surgeons. MAIN OUTCOME MEASURES: Number of opinion leaders identified locally, statewide, and nationally; ratings of 22 possible attributes in conferring status as an opinion leader; and views about and ratings of the role of opinion leaders. RESULTS: Most respondents were unable to identify a local colleague whom they considered to be an opinion leader in their own specialty (mode, 0; and median, 1) or in surgery in general (mode, 0; and median, 0). Estimated numbers of opinion leaders were significantly higher at the state and national levels for the respondents' own specialty and for surgery in general (P<.001 for all). Surgical expertise and teaching skills were rated most highly as conferring status as an opinion leader. Academic and professional contributions received the lowest ratings. Most surgeons (88%; 95% confidence interval, 84%-91%) agreed that opinion leaders could influence them to change their practice. Opinion leaders were rated as "very influential" by significantly more surgeons than clinical audit (38% vs 27%, chi21 = 13.6, P<.001) and clinical practice guidelines (38% vs 24%, chi21 = 21.4, P<.001) (McNemar test for both). CONCLUSIONS: Australian surgeons support the concept of opinion leaders. Although few local colleagues whom they consider as fulfilling such a role can be identified, opinion leaders are evident at a national level. Once opinion leaders are identified using attributes ranked in our survey, interventional studies will further delineate their influence in improving evidence-based surgical practice.
Adult↗
Improving the evidence base in surgery: sources of bias in surgical studies.
Clinical epidemiology, which is concerned with the application of epidemiological principles to patient care, provides the scientific basis for evidence-based medicine. The present paper reviews the epidemiological concepts of selection bias, measurement bias and confounding in surgical research and discusses ways in which these sources of bias can be minimized in surgical studies.
Bias↗
Improving the evidence-base in surgery: evaluating surgical effectiveness.
This second of two articles about clinical epidemiology reviews the generation and synthesis of evidence for the effectiveness of surgical procedures. While well-designed randomized controlled trials of surgical procedures are considered the 'gold standard' of evaluation design, they may achieve high internal validity at the expense of external validity (generalizability). Improving the -evidence-base in surgery likely will require a comprehensive approach to surgical outcomes assessment, involving both improvements in the quality and quantity of randomized controlled trials as well as recognition of the complementary role of alternate study designs.
Algorithms↗
Patient entry into randomized controlled trials of colorectal cancer treatment: factors influencing participation.
BACKGROUND: The objective of this study was to investigate willingness to participate in hypothetical surgical randomized controlled trials (RCTs) among patients and clinicians, who answered as if they themselves were patients. METHODS: We interviewed consecutive patients with colorectal cancer admitted for surgery at a tertiary center in Sydney, Australia. We mailed a questionnaire to all colorectal surgeons and medical oncologists in Australia. RESULTS: Overall, 42% (95% CI, 32% to 52%) of patients, 44% (95% CI, 29% to 60%) of surgeons, and 63% (95% CI, 53% to 72%) of oncologists were willing to enter a randomized clinical trial. Oncologists were significantly more likely to participate than either surgeons (P <.001) or patients (P =.001). No significant associations were seen between willingness to participate and patient characteristics. "Risk of cancer recurrence" was rated by the most patients and doctors as an important reason for refusal of trial entry, although patients additionally identified dislike of randomization and quality of life concerns as important barriers. CONCLUSION: More than 40% of patients were willing to enter into a hypothetical RCT involving surgery. Aversion to randomization and perceptions of differential impact of treatment on cancer recurrence and quality of life are likely to be major barriers to patient accrual in trials of colorectal cancer treatment.
Aged↗
GP and patient predictors of PSA screening in Australian general practice.
OBJECTIVE: We determined GP and patient variables associated first with men's prior uptake of prostate-specific antigen (PSA) screening and, subsequently, its initiation during an 'index consultation' in Australian general practice. METHODS: From the practices of 60 GPs, we recruited a sample of 423 male patients aged 40-70 years. In a waiting room questionnaire completed before their 'index consultation' (retrospective component), men reported their previous PSA screening status. We obtained demographic and clinical data, including the presence of lower urinary tract symptoms (LUTS). Men also were mailed a questionnaire 2 days after their 'index consultation' to ascertain whether the GP had discussed PSA screening (prospective component) for prostate cancer and other behaviours. GPs themselves completed questionnaires eliciting demographic and practice characteristics as well as their propensity to screen and understanding of the evidence about PSA testing. GP and patient study variables were modelled simultaneously in analyses. RESULTS: Of those 348 men consulting with their regular GP, 80 (23.0%) reported previously having had a PSA screening test. Men were significantly and independently more likely ever to have had PSA screening if their regular GP reported a propensity to initiate screening [adjusted odds ratio (AOR) = 2.27, 95% confidence interval (CI) 1.23-4.20; P = 0.009]. GP age also was independently associated with men's PSA screening status [chi-squared (3) P < 0.0001] as was men's age and severity of LUTS (AOR = 2.38, 95% CI 1.58-3.57, P < 0.0001 and AOR = 1.79, 95% CI 1.00-3.19, P = 0.004, respectively). Current smokers were less likely ever to have had a PSA screening test (AOR = 0.34, 95% CI 0.16-0.69; P = 0.003). Discussion of PSA screening in their 'index consultation' was recalled independently more often by older men (AOR = 1.46, 95% CI 1.00-2.13; P = 0.04), those with moderate/severe LUTS (AOR = 1.94, 1.07-3.49; P = 0.04), those whose GP had performed or discussed a cholesterol test (AOR = 2.26, 95% CI 1.03-4.92; P = 0.04) and those whose GP had postgraduate training in family medicine (AOR = 3.13, 95% CI 1.23-8.00; P = 0.02). CONCLUSION: In the absence as yet of compelling evidence that PSA screening will prolong life or enhance its quality, our findings identify GP and patient factors that could be targeted to modify PSA screening.
Adolescent↗
Randomised trial of intensive academic detailing to promote opportunistic recruitment of women to cervical screening by general practitioners.
OBJECTIVE: To evaluate a multifaceted intervention involving intensive academic detailing for general practitioners (GPs) to improve recruitment of women for cervical screening. METHODS: We conducted a cluster randomisation trial involving 39 general practices in inner-metropolitan Sydney. GPs' knowledge, propensity to an opportunistic approach, competence and confidence were assessed by self-report before and after the intervention. To measure GP behaviour, recall of an opportunistic discussion about cervical screening was determined in cross-sectional samples of female patients at baseline (n = 1,090) and post-test (n = 1,062). RESULTS: Knowledge improved marginally in both groups but there were no changes in other GP self-reported measures. At post-test, women attending GPs in the intervention group were no more likely than those in the control group to recall an opportunistic inquiry about their cervical screening status (OR 0.65, 95% CI 0.40-1.08). Women in the intervention group who were overdue for cervical screening were no more likely than their control group counterparts at post-test to recall advice about cervical screening (OR 2.16, 95% CI 0.75-6.14) or written information (OR 0.34, 95% CI 0.04-26.5). CONCLUSIONS: Intensive academic detailing does not improve an opportunistic approach to cervical screening in general practice. IMPLICATIONS FOR PUBLIC HEALTH PRACTICE: In an evidence-based climate, implementation of academic detailing as a strategy to improve cervical screening rates in general practice would be premature.
Adult↗
Influence of 'framing effect' on women's support for government funding of breast cancer screening.
OBJECTIVES: To explore whether Australian women's support for government funding of mammographic screening is influenced by 'framing effect'. METHOD: Self-administered survey of 701 women in general practice to elicit their support for government funding of each of four mammographic screening programs where benefits were expressed as a relative risk reduction (RRR); absolute risk reduction (ARR); number needed to screen (NNS) and number of cases detected for additional death avoided. RESULTS: The proportion of respondents indicating they 'definitely would support funding' was significantly greater when benefits were expressed as RRR than ARR (chi 2(1) = 148.4, p < 0.0001), NNS (chi 2(1) = 126.4, p < 0.0001) or number of cases detected for additional deaths avoided (chi 2(1) = 29.0, p < 0.0001). 55.8% of women were not influenced by 'framing effect'. Younger women and those with higher educational levels were more likely to be susceptible to 'framing effect'. CONCLUSION: Having demonstrated its influence among these women, 'framing effect' should be acknowledged in future research.
Adult↗
GPs' views of which professions should conduct academic visits in general practice to promote preventive care.
Explore the source record for details and available documents.
Attitude of Health Personnel↗
General practitioners' self ratings of skills in evidence based medicine: validation study.
Explore the source record for details and available documents.
Clinical Competence↗