TL;DR: Breast-conserving surgery was recommended by surgeons and attempted in the majority of patients evaluated, with surgeon recommendation, patient decision, and failure of BCS all contributing to the mastectomy rate.
Abstract: Context There is concern that mastectomy is overused in the United States. Objectives To evaluate the association of patient-reported initial recommendations by surgeons and those given when a second opinion was sought with receipt of initial mastectomy; and to assess the use of mastectomy after attempted breast-conserving surgery (BCS). Design, Setting, and Patients A survey of women aged 20 to 79 years with intraductal or stage I and II breast cancer diagnosed between June 2005 and February 2007 and reported to the National Cancer Institute's Surveillance, Epidemiology, and End Results registries for the metropolitan areas of Los Angeles, California, and Detroit, Michigan. Patients were identified using rapid case ascertainment, and Latinas and blacks were oversampled. Of 3133 patients sent surveys, 2290 responded (73.1%). A mailed survey was completed by 96.5% of respondents and 3.5% completed a telephone survey. The final sample included 1984 female patients (502 Latinas, 529 blacks, and 953 non-Hispanic white or other). Main Outcome Measures The rate of initial mastectomy and the perceived reason for its use (surgeon recommendation, patient driven, medical contraindication) and the rate of mastectomy after attempted BCS. Results Of the 1984 patients, 1468 had BCS as an initial surgical therapy (75.4%) and 460 had initial mastectomy, including 13.4% following surgeon recommendation and 8.8% based on patient preference. Approximately 20% of patients (n = 378) sought a second opinion; this was more common for those patients advised by their initial surgeon to undergo mastectomy (33.4%) than for those advised to have BCS (15.6%) or for those not receiving a recommendation for one procedure over another (21.2%) (P Conclusion Breast-conserving surgery was recommended by surgeons and attempted in the majority of patients evaluated, with surgeon recommendation, patient decision, and failure of BCS all contributing to the mastectomy rate.
TL;DR: Implementation of guidelines with mandatory second opinion can lead to a small reduction in caesarean section rates, predominately in intrapartum sections, and there is insufficient evidence that prenatal education and support programmes, computer patient decision- aids, decision-aid booklets and intensive group therapy are effective.
Abstract: Background
Caesarean section rates are steadily increasing globally. The factors contributing to these observed increases are complex. Non-clinical interventions, those applied independent of patient care in a clinical encounter, may have a role in reducing unnecessary caesarean sections.
Objectives
To evaluate the effectiveness and safety of non-clinical interventions for reducing unnecessary caesarean sections.
Search methods
We searched the following electronic databases: the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (29 March 2010), the Cochrane Pregnancy and Childbirth Group Specialised Register (29 March 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 2); MEDLINE (1950 to March 2010); EMBASE (1947 to March 2010) and CINAHL (1982 to March 2010).
Selection criteria
We included randomised controlled trials (RCTs), quasi-experimental studies, controlled clinical trials (CCTs), controlled before and after studies (CBAs) with at least two intervention and control sites, and interrupted time series analyses (ITS) where the intervention time was clearly defined and there were at least three data points before and three after the intervention. Studies evaluated non-clinical interventions to reduce unnecessary caesarean section rates. Participants included pregnant women and their families, healthcare providers who work with expectant mothers, communities and advocacy groups.
Data collection and analysis
Three review authors independently assessed the quality and abstracted data of all eligible studies using a standardised data extraction form, modified from the Cochrane EPOC checklists. We contacted study authors for additional information.
Main results
We included 16 studies in this review.
Six studies specifically targeted pregnant women. Two RCTs were shown to be effective in reducing caesarean section rates: a nurse-led relaxation training programme for women with a fear or anxiety of childbirth and birth preparation sessions. However, both RCTs were small in size and targeted younger mothers with their first pregnancies. There is insufficient evidence that prenatal education and support programmes, computer patient decision-aids, decision-aid booklets and intensive group therapy are effective.
Ten studies targeted health professionals. Three of these studies were effective in reducing caesarean section rates. A cluster-RCT of guideline implementation with mandatory second opinion resulted in a small, statistically significant reduction in total caesarean section rates (adjusted risk difference (RD) -1.9; 95% confidence interval (CI) -3.8 to -0.1); this reduction was predominately in intrapartum sections. An ITS study of mandatory second opinion and peer review feedback at department meetings found statistically significant results at 48 months for reducing repeat caesarean section rates (change in level was -6.4%; 95% CI -9.7% to -3.1% and change in slope -1.14%; 95% CI -1.9% to -0.3%) but not for total caesarean section rates. A cluster-RCT of guideline implementation with support from local opinion leaders increased the proportion of women with a previous caesarean section being offered a trial of labour (absolute difference 16.8%) and the number who had a vaginal birth (VBAC rates) (absolute difference 13.5%). The P values are, however, not reported due to unit of analysis errors. There was insufficient evidence that audit and feedback, training of public health nurses, insurance reform, external peer review and legislative changes are effective.
Authors' conclusions
Implementation of guidelines with mandatory second opinion can lead to a small reduction in caesarean section rates, predominately in intrapartum sections. Peer review, including pre-caesarean consultation, mandatory secondary opinion and postcaesarean surveillance can lead to a reduction in repeat caesarean section rates. Guidelines disseminated with endorsement and support from local opinion leaders may increase the proportion of women with previous caesarean sections being offered a trial of labour in certain settings. Nurse-led relaxation classes and birth preparation classes may reduce caesarean section rates in low-risk pregnancies.
TL;DR: When patients are referred to one's own institution for therapy based on a histopathologic diagnosis rendered at another institution, many hospitals require a second opinion of the surgical pathology material.
TL;DR: In hospitals applying this policy of second opinion, 22 intrapartum caesarean sections could be prevented per 1000 deliveries, without affecting maternal or perinatal morbidity, and without affecting mothers' satisfaction with the care process.
TL;DR: Radiology involves decision-making under conditions of uncertainty2, and therefore cannot always produce infallible interpretations or reports, and the use of the term “error” is often unsuitable; it is more appropriate to concentrate on "discrepancies" between a report and a retrospective review of a film or outcome.
Abstract: “All men are liable to error; and most men are, in many points, by passion or interest, under temptation to it”. Locke, John, An Essay concerning Human Understanding (1690), bk. 4, ch. 20, sect. 17.
In all branches of medicine, there is an inevitable element of patient exposure to problems arising from human error, and this is increasingly the subject of bad publicity, often skewed towards an assumption that perfection is achievable, and that any error or discrepancy represents a wrong that must be punished1. Radiology involves decision-making under conditions of uncertainty2, and therefore cannot always produce infallible interpretations or reports. The interpretation of a radiologic study is not a binary process; the “answer” is not always normal or abnormal, cancer or not. The final report issued by a radiologist is influenced by many variables, not least among them the information available at the time of reporting. In some circumstances, radiologists are asked specific questions (in requests for studies) which they endeavour to answer; in many cases, no obvious specific question arises from the provided clinical details (e.g. “chest pain”, “abdominal pain”), and the reporting radiologist must strive to interpret what may be the concerns of the referring doctor. (A friend of one of the authors, while a resident in a North American radiology department, observed a staff radiologist dictate a chest x-ray reporting stating “No evidence of leprosy”. When subsequently confronted by an irate respiratory physician asking for an explanation of the seemingly-perverse report, he explained that he had no idea what the clinical concerns were, as the clinical details section of the request form had been left blank).
Notwithstanding these complexities, the public frequently expects that a medical investigation will produce “the correct answer”, all the time. This unfortunate over-simplification of a multi-factorial process is often informed by representations on TV dramas, media reports describing every discrepancy or dispute over interpretation as a scandal, and the political imperative to divert anger over perceived failings on to others, preferably easy targets, often portrayed and perceived as privileged.
Amid many possibilities of error, it would be strange indeed to be always in the right. Peter Mere Latham (1789-1875), General remarks on the Practice of Medicine, The Heart and its Affections Ch. IV
With respect to radiological investigations, the use of the term “error” is often unsuitable; it is more appropriate to concentrate on “discrepancies” between a report and a retrospective review of a film or outcome1. Professional body guidelines recommend that all imaging procedures should include an expert opinion from a radiologist, given by means of a written report or comment3. “Opinion” may be defined as “a conclusion arrived at after some weighing of evidence, but open to debate or suggestion”, and thus an expert’s opinion should not be expected to be incontrovertible4. Error implies a mistake (an incorrect interpretation of an imaging study, in this context). In order for a report to be erroneous, it follows that a correct report must also be possible. Because of the subjectivity of image interpretation, the definition of error depends on “expert opinion”. An observer makes an error if he or she fails to reach the same conclusion that would be reached by a group of expert observers. Errors can only arise in cases where the correct interpretation is not in dispute. Somewhere between the clear-cut error and the inevitable difference of opinion in interpretation is an arbitrary division defining the limit of professional acceptability4.
Errors in judgement must occur in the practice of an art which consists largely in balancing probabilities. Sir William Osler (1849-1919), Aequanimitas, with Other Addresses, Teacher and Student.
Unlike physical examination of patients, or findings at surgery or endoscopy, evidence of a radiologic examination remains available for subsequent scrutiny, and can be used for study of observer variation. A 20-year literature review in 2001 suggested the level of error for clinically significant or major error in radiology is in the range 2-20% and varies depending on the radiological investigation5.
The issue of error in radiology has been recognised for many years. Studies in the 1940s found that CXRs of patients with suspected tuberculosis were read differently by different observers in 10-20% of cases. In the 1970s, it was found that 71% of lung cancers detected on screening radiographs were visible in retrospect on previous films4,6. The “average” observer has been found to miss 30% of visible lesions on barium enemas4. A 1999 study found that 19% of lung cancers presenting as a nodular lesion on chest x-rays were missed7. Another study identified major disagreement between 2 observers in interpreting x-rays of patients in an emergency department in 5-9% of cases, with an estimated incidence of errors per observer of 3-6%8. A 1997 study using experienced radiologists reporting a collection of normal and abnormal x-rays found an overall 23% error rate when no clinical information was supplied, falling to 20% when clinical details were available9. A recent report suggests a significant major discrepancy rate (13%) between specialist neuroradiology second opinion and primary general radiology opinion10.
A recent review found a “real-time” error rate among radiologists in their day-to-day practices averages 3-5%, but also quoted previous research showing that in patients subsequently diagnosed with lung or breast cancer with previous “normal” relevant radiologic studies, retrospective review of the chest radiographs (in the case of lung cancer) or mammogram (in breast cancer cases) identified the lung cancer in as many as 90% and the breast cancer in as many as 75% of cases11. Prolonged attention to a specific area on a radiograph (“visual dwell”) increases both false negative and false positive errors. Reducing the viewing time for CXRs to less than 4 seconds also increases the miss rate4.
Comparative studies of other medical non-radiologic fields have found a similar prevalence of inaccuracy in clinical assessment and examination. A Mayo Clinic study of autopsies published in 2000, which compared clinical diagnoses with post-mortem diagnoses, found that in 26% of cases, a major diagnosis was missed clinically11.
Common experience in radiology suggests that many errors are of little or no significance to the patient, and some significant errors remain undiscovered. Errors are inevitable, and the concept of necessary fallibility must be accepted. Equally a threshold of competency is required of all professionals involved in the delivery of radiology services.