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PubMed2005

Adjusting for partially missing baseline measurements in randomized trials.

Adjustment for baseline variables in a randomized trial can increase power to detect a treatment effect. However, when baseline data are partly missing, analysis of complete cases is inefficient. We consider various possible improvements in the case of normally distributed baseline and outcome variables. Joint modelling of baseline and outcome is the most efficient method. Mean imputation is an excellent alternative, subject to three conditions. Firstly, if baseline and outcome are correlated more than about 0.6 then weighting should be used to allow for the greater information from complete cases. Secondly, imputation should be carried out in a deterministic way, using other baseline variables if possible, but not using randomized arm or outcome. Thirdly, if baselines are not missing completely at random, then a dummy variable for missingness should be included as a covariate (the missing indicator method). The methods are illustrated in a randomized trial in community psychiatry.

Data Interpretation, Statistical↗
PubMed2001

Short-term outcome after laparoscopic and open 360 degrees fundoplication. A prospective randomized trial.

BACKGROUND: Despite the lack of randomized trials supporting the laparoscopic approach, laparoscopic antireflux surgery has gained widespread acceptance during the last decade. The aim of this study was to compare the short-term symptomatic and objective outcome after laparoscopic and open 360 degrees fundoplication in a prospective randomized clinical trial. METHODS: Sixty patients with GERD were randomized to undergo either laparoscopic (LF) or open 360 degrees fundoplication (OF). Endoscopy, esophageal manometry, 24-h pH monitoring, clinical symptom evaluation, and symptom scoring according to a validated questionnaire (the Gastrointestinal Symptom Rating Scale [GSRS]) was performed preoperatively and 6 months after surgery. RESULTS: Five patients randomized to the laparoscopic group were converted to open surgery. Esophageal acid exposure was restored to normal in all patients. Lower esophageal sphincter length and resting pressure were significantly increased after both laparoscopic and open fundoplication (p < 0.001); there were no differences between the groups. No significant differences were seen in symptomatic outcome, although there was a trend toward a higher rate of mild dysphagia (p = 0.051) after laparoscopic surgery. GSRS revealed a decrease in reflux score (p < 0.001) and abdominal pain score (p < 0.001) postoperatively. There were no significant differences in GSRS scores between the two groups. CONCLUSION: Laparoscopic 360 degrees fundoplication is as effective in treating reflux disease as open fundoplication. Six months postoperatively, no significant differences were seen in symptomatic or objective outcome. Long-term evaluation is needed.

Adult↗
PubMed1989

An overview of randomized trials of rehabilitation with exercise after myocardial infarction.

Of 22 randomized trials of rehabilitation with exercise after myocardial infarction (MI), one trial had results that achieved conventional statistical significance. To determine whether or not these studies, in the aggregate, show a significant benefit of rehabilitation after myocardial infarction, we performed an overview of all randomized trials, involving 4,554 patients; we evaluated total and cardiovascular mortality, sudden death, and fatal and nonfatal reinfarction. For each endpoint, we calculated an odds ratio (OR) and 95% confidence interval (95% CI) for the trials combined. After an average of 3 years of follow-up, the ORs were significantly lower in the rehabilitation than in the comparison group: specifically, total mortality (OR = 0.80 [0.66, 0.96]), cardiovascular mortality (OR = 0.78 [0.63, 0.96]), and fatal reinfarction (OR = 0.75 [0.59, 0.95]). The OR for sudden death was significantly lower in the rehabilitation than in the comparison group at 1 year (OR = 0.63 [0.41, 0.97]). The data were compatible with a benefit at 2 (OR = 0.76 [0.54, 1.06]) and 3 years (OR = 0.92 [0.69, 1.23]), but these findings were not statistically significant. For nonfatal reinfarction, there were no significant differences between the two groups after 1 (OR = 1.09 [0.76, 1.57]), 2 (OR = 1.10 [0.82, 1.47]), or 3 years (OR = 1.09 [0.88, 1.34]) of follow-up. The observed 20% reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfarction throughout at least 3 years and a reduction in sudden death during the 1st year after infarction and possibly for 2-3 years. With respect to the independent effects of the physical exercise component of cardiac rehabilitation, the relatively small number of "exercise only" trials, combined with the possibility that they may have had a formal or informal nonexercise component precludes the possibility of reaching any definitive conclusion. To do so would require a randomized trial of sufficient size to distinguish between no effect and the most plausible effect based on the results of this overview.

Clinical Trials as Topic↗
PubMed2003

Baseline adjustments for binary data in repeated cross-sectional cluster randomized trials.

Analysis of covariance models, which adjust for a baseline covariate, are often used to compare treatment groups in a controlled trial in which individuals are randomized. Such analysis adjusts for any baseline imbalance and usually increases the precision of the treatment effect estimate. We assess the value of such adjustments in the context of a cluster randomized trial with repeated cross-sectional design and a binary outcome. In such a design, a new sample of individuals is taken from the clusters at each measurement occasion, so that baseline adjustment has to be at the cluster level. Logistic regression models are used to analyse the data, with cluster level random effects to allow for different outcome probabilities in each cluster. We compare the estimated treatment effect and its precision in models that incorporate a covariate measuring the cluster level probabilities at baseline and those that do not. In two data sets, taken from a cluster randomized trial in the treatment of menorrhagia, the value of baseline adjustment is only evident when the number of subjects per cluster is large. We assess the generalizability of these findings by undertaking a simulation study, and find that increased precision of the treatment effect requires both large cluster sizes and substantial heterogeneity between clusters at baseline, but baseline imbalance arising by chance in a randomized study can always be effectively adjusted for.

Cluster Analysis↗
PubMed1992

Modifying myocardial management in cardiac surgery: a randomized trial.

Among the 160 patients randomly assigned to one of eight protocols of myocardial management, all of which included controlled aortic root reperfusion, no important differences were found between protocols as to the prevalence of death (0 instances), use of an intra-aortic balloon pump (no instances), use of catecholamines, elaboration of CK-MB isoenzymes, new Q-waves, abnormal wall motion scores, or postoperative atrial fibrillation. Ventricular defibrillation was required more often in patients in the protocol with noncardioplegic blood reperfusate. Cardiac index was highest in the operating room in the group receiving hyperkalemic cold cardioplegia and initial hyperkalemic reperfusion. The reperfusion flow at the controlled pressures had initially a low flow rate (pressure 30 mmHg for 2 min; thereafter 50 mmHg), which increased to reach a peak flow rate at about 3 min after the start of reperfusion, followed by a declining flow rate reflecting changes in coronary resistance. Comparison of the overall randomly assigned group with a historical control group of 100 patients operated upon prior to the randomized trial showed no differences except for a higher rate of postoperative atrial fibrillation (25%) in the historical control group than in the randomized protocols with initial cardioplegic reperfusion (14%). The controlled reperfusion technique was found to be easy to use and is now used routinely.

Aged↗
PubMed1988

Prenatal diagnosis and the Canadian collaborative randomized trial of chorionic villi sampling: the physician's view.

Women eligible for the Canadian randomized trial of chorionic villi sampling (CVS) often cite physician influence as a reason for refusing to participate. To measure directly physicians' attitudes to and knowledge of prenatal diagnosis (PND), amniocentesis, CVS, randomized trials, and the Canadian trial, a 3-page questionnaire was mailed to all registered obstetricians in British Columbia (BC) and in Montreal (Mtl). The overall response rate was 70%. Most physicians thought PND was important and that it was their role to discuss and advise PND to their patients. Physicians were split in their preferences for amniocentesis or CVS (32% vs. 34%); reasons for their preferences paralleled those given by women studied previously by us. Physicians who thought CVS was too experimental, who were hesitant about the trial or who were less likely to discuss the study with patients were older, less likely to have participated in a randomized trial previously and less comfortable with randomization and discussing uncertain risks with patients. Mtl physicians were less aware and more hesitant about the Canadian trial than those in BC. Moreover, Mtl physicians were more likely to consider the ongoing trial inappropriate and too experimental than BC physicians. Because physicians act as "gatekeepers," educating them about new technologies and about randomized studies is essential for ensuring both participant's access to a new procedure and success of the randomized trial.

Attitude of Health Personnel↗
PubMed2000

Meclizine for prevention of nausea associated with use of emergency contraceptive pills: a randomized trial.

OBJECTIVE: We conducted a randomized trial to determine whether pretreatment with meclizine reduces the incidence of nausea and vomiting associated with the Yuzpe regimen of emergency contraception. METHODS: We randomly assigned 343 women aged 18-45 years who were not at risk for pregnancy to pretreatment with 50 mg of meclizine, placebo, or no drug 1 hour before the first of two doses of emergency contraceptive pills. We asked participants to complete three questionnaires over the following 48 hours. RESULTS: The incidence of nausea was 47% in the group pretreated with meclizine and 64% in the other two groups (relative risk adjusted for center 0.7, 95% confidence intervals 0.6, 0.9 for comparisons of meclizine with both placebo and no drug). The severity of nausea and the incidence of vomiting were also significantly lower in the meclizine pretreatment group than in the other two groups. Drowsiness was reported by about twice as many women in the meclizine pretreatment group (31%) than in the other two groups (13% in the placebo group, 16% in the no-pretreatment group; P < .01 for both comparisons). CONCLUSION: Meclizine is effective for preventing nausea and vomiting associated with the Yuzpe regimen of emergency contraceptive pills. Women using this drug should be cautioned to anticipate drowsiness.

Adolescent↗
PubMed2004

Comparison of a high-intensity and a low-intensity lumbar extensor training program as minimal intervention treatment in low back pain: a randomized trial.

In a randomized, observer-blinded trial, the effectiveness of 3-month high-intensity training (HIT) of the isolated lumbar extensors was compared to low-intensity training (LIT). Eighty-one workers with nonspecific low back pain longer than 12 weeks were randomly assigned to either of the two training programs. Training sessions were performed on a modified training device that isolated the lower back extensors. Total intervention time was limited to 5-10 min (one or two training sessions) per week. Training effects were assessed in terms of changes in self-rated degree of back complaints, functional disability, and general, physical and mental health. Secondary outcomes in this study were muscle strength and fear of moving the back (kinesiophobia). Outcomes were evaluated at 1,2, 3, 6, and 9 months after randomization. The results showed that the two treatment programs led to comparable improvements in all outcome measures, except for mean isometric strength at 1, 2, 3, 6, and 9 months and kinesiophobia score at 2 and 9 months of follow-up. The high-intensity training group showed a higher strength gain (24 to 48 Nm) but a smaller decline in kinesiophobia (2.5 and 3.4 points, respectively), compared to the low-intensity training group. It can be concluded that high-intensity training of the isolated back extensors was not superior to a non-progressive, low-intensity variant in restoring back function in nonspecific (chronic) low back pain. In further research, emphasis should be put on identifying subgroups of patients that will have the highest success rate with either of these training approaches.

Adult↗
PubMed1985

Mammographic breast cancer screening--a randomized trial in Malmö, Sweden.

A randomized trial is presented on the effect of repeated invitation to breast cancer screening with mammography on mortality from breast cancer. The invited group and the control group each consisted of approximately 21,000 women aged 45-69 yr at the start of the screening. The attendance rate was 74% at the first screening and 70% at the two subsequent screening rounds. The cancer detection rate was 7.5 per 1000 women examined in the first screening round and 2.2 and 2.0 per 1000 woman-years in the second and third screenings with an incidence of 0.9 in the intervals. The incidence in the control group was 2.7 per 1000 woman-years. The proportion of positive biopsies was 61% in the first screening round, 33% in the second, and 58% in the third. After the prevalence screening, the stage distribution was more favourable in the invited group (including non-attenders) than in the control group. In the two most recent periods of the programme, 62 out of 160 women with cancer (39%) in the invited group were in stage II-IV compared with 91 out of 159 (57%) in the control group. More than 60% of cancers detected at screening were either non-invasive or invasive with a diameter of 1 cm. The corresponding percentage in the control group was 27%. The importance of sampling bias is discussed. Although data on mortality still have to be awaited, the results so far clearly indicate a positive effect of screening.

Adenocarcinoma↗
PubMed2005

Reducing selection bias in a cluster randomized trial in West African villages.

Selection bias in cluster randomized trials may threaten the validity of the results. This bias may occur either at the level of the cluster or of the individual. We describe measures for maintaining comparability of intervention groups in a cluster randomized trial of a health education package to reduce dietary salt. The setting was 12 villages of the Ashanti region of Ghana. In total, 1896 villagers between 40 and 75 years of age were selected to take part in the trial using stratified random sampling, based on age and sex. Following individuals' consent and baseline measurements in a pair of villages, villages were randomized to intervention or control arms, stratified for locality (semi-urban or rural). Primary outcomes of the trial were reduction in 24-hour urinary sodium and blood pressure. Of the villagers, 1013 individuals agreed to take part, with a response rate of 53%. The groups were comparable with respect to mean (SD) systolic and diastolic blood pressure (125/74 (27/14) mmHg versus 126/75 (25/14) mmHg) and other outcomes. In conclusion, in this study blind recruitment, aided by randomization in small blocks, and stratified random sampling of the subjects within the clusters helped to ensure comparability of intervention groups, which is vital for the validity of the trial results.

Cluster Analysis↗
PubMedDate not supplied

Telephone care as an adjunct to routine medical follow-up. A negative randomized trial.

CONTEXT: In 1992, a randomized trial at one outpatient clinic demonstrated that making telephone appointments part of routine medical follow-up could save money and reduce hospitalization. OBJECTIVE: To ascertain the effects of telephone care in other clinics. DESIGN: Consenting patients of 20 physicians were randomly assigned to receive telephone care or usual care. SETTING: Veterans Affairs General Medical Clinics in Denver, Colorado, and Sioux Falls, South Dakota. PATIENTS: 512 predominately male elderly veterans (mean age, 68 years) who had a broad range of chronic medical conditions. INTERVENTION: At the intake clinic visit, the recommended revisit interval (e.g., return in 3 months) for telephone care patients was doubled (e.g., return in 6 months) and three intervening telephone appointments were scheduled. Three telephone appointments were also scheduled at all subsequent clinic visits. MAIN OUTCOME MEASURES: Utilization of services and self-reported health status. RESULTS: More than 2000 calls were made during the 2-year study period. Although the revisit interval was longer for telephone care patients after the intake visit (as was expected), it was the same for both telephone care and usual care patients after all subsequent visits, despite the scheduling of three telephone appointments for telephone care patients. The intervention had no effect on self-reported health status, hospital admission, or number of deaths. The intervention also had no effect on the total number of clinic visits, outpatient laboratory tests, or radiologic tests. Telephone care patients had fewer unscheduled visits than did usual care patients (2.0 vs. 2.8 visits/patient; P = 0.01). CONCLUSION: Telephone care had little effect in this study. Instead of providing a way to maintain contact with patients without requiring them to appear in clinic frequently, telephone appointments became simply an additional service.

Aged↗
PubMed2000

[Postoperative radiotherapy in lung cancer: comments on several randomized trials or the contribution of well-conducted radiotherapy].

Postoperative radiotherapy is classically proposed after surgical resection in case of a high risk of local recurrence (incomplete resection and nodal invasion especially mediastinal). Its interest was shown by non-randomized trials. Nevertheless, several randomized trials and one meta-analysis of them have recently questioned the contribution of radiotherapy. We analyze here these trials then the meta-analysis, emphasizing certain methodology problems such as the noninclusion of certain therapeutic trials and differences in radiotherapy dosages and techniques. In our opinion, excessive toxicity observed in certain trials can be attributed to technical errors; if well conducted, postoperative radiotherapy improves survival in operated patients when there is a high risk of local reccurence. This affirmation is based on a comparison of long term results of 347 non randomized cases with Port Meta-Analysis randomized cases and GETCB trial randomized cases.

Clinical Trials as Topic↗
PubMed1993

Should vancomycin be used empirically in febrile patients with prolonged and profound neutropenia? Results of a randomized trial.

OBJECTIVES: We conducted a randomized trial with ceftazidine alone or associated with amikacin or vancomycin to investigate the efficacy of the daily 3 g dosage of ceftazidime and the efficacy of monotherapy with ceftazidime and to determine if vancomycin should be added empirically. METHODS: Patient inclusion criteria were: age over 10 years, therapeutically-induced neutropenia and fever for at least three hours above 38.5 degrees C in absence of a clear non-infectious aetiology. Patients were randomized into three groups: group C, ceftazidime alone 3 g/day; group CA, ceftazidime 3 g/day plus amikacin 15 mg/kg/day; or group C, ceftazidime 3 g/day plus vancomycin 1.5 g/day. RESULTS: Results from one hundred and two episodes of fever were analyzed. The underlying diseases were haematological malignancies (89 patients) and solid tumours (13 patients). The median duration of neutropenia (< 0.5 x 10(9) PMN/L) was 18 days and the minimum duration of 7 days. The main criterion for the analysis of efficacy was the onset of a major infectious event, i.e. death related to documented or suspected infection and any infectious event considered life-threatening or hindering future treatment of the underlying disease. Eight (22%) patients in group C developed major infectious events compared with four (13%) in group CA and none in group CV (p < 0.01). Major infectious events were mainly due to Gram-positive organisms, particularly Streptococcus species. CONCLUSION: We conclude that: 1) ceftazidime alone and in association with amikacin is effective in preventing Gram-negative major infectious events; and 2) vancomycin should not be added only when a Gram-positive infection is documented, but used empirically.

Adolescent↗
PubMed2005

Feasibility of a randomized trial of extended lymphadenectomy for pancreatic cancer.

HYPOTHESIS: The required sample size of a prospective randomized trial comparing standard pancreaticoduodenectomy with pancreaticoduodenectomy plus extended lymphadenectomy for pancreatic adenocarcinoma is prohibitively large, making such a trial infeasible. DESIGN: Retrospective cohort study. SETTING: Comprehensive cancer center. PATIENTS: We identified 158 patients who underwent pancreaticoduodenectomy for pancreatic adenocarcinoma with separate pathologic analysis of second-echelon lymph nodes, defined as lymph nodes along the proximal hepatic artery and/or the great vessels. MAIN OUTCOME MEASURES: To estimate the sample size required for a randomized trial, we devised a biostatistical model with the following assumptions: extended lymphadenectomy can benefit only patients who (1) actually have disease removed from second-echelon nodes, (2) have microscopically negative (R0) primary tumor resection margins, and (3) do not have visceral metastatic (M0) disease. RESULTS: Seventy-six patients (48.1%) had negative first- and second-echelon lymph nodes, 65 (41.1%) had positive first-echelon and negative second-echelon lymph nodes, and 17 (10.8%) had positive first- and second-echelon lymph nodes. Patients with positive second-echelon lymph nodes had an R0 resection rate of 47.1%. At a median follow-up of 65.1 months, 4 patients with positive second-echelon lymph nodes were alive, but 3 had recurrent disease. This implies that only 1 patient (5.9%) with positive second-echelon lymph nodes may have had true M0 disease. Therefore, only 0.3% of patients (10.8% with positive second-echelon lymph nodes x 47.1% with R0 resection x 5.9% with M0 disease) may achieve a survival benefit from extended lymphadenectomy. A randomized trial of standard pancreaticoduodenectomy vs pancreaticoduodenectomy with extended lymphadenectomy would require 202 000 patients in each study arm to detect such a small difference. CONCLUSIONS: Definitive evaluation of the potential benefits of extended lymphadenectomy would require a prohibitively large sample size. Adequately powered randomized trials to address the potential benefit of extended lymphadenectomy are infeasible.

Adenocarcinoma↗
PubMed2003

Radiofrequency lesioning using two different time modalities for the treatment of lumbar discogenic pain: a randomized trial.

STUDY DESIGN: A prospective randomized trial. OBJECTIVE: To evaluate the efficacy of percutaneous intradiscal radiofrequency thermocoagulation by modifying the duration of heating, using two different time methods, for relieving pain and improving functional disability. SUMMARY OF BACKGROUND DATA: Lumbar discogenic pain is the major problem in lumbar degenerative disc disease that percutaneous intradiscal radiofrequency thermocoagulation has been suggested for as a nonsurgical invasive treatment technique for lumbar discogenic pain. In a previous controlled study, this method was found to be ineffective with 8 weeks of follow-up. MATERIALS AND METHODS: Sixty patients with chronic low back pain were selected for provocative discography to diagnose the discogenic pain and to locate the discs to be treated. From this group, 39 patients were randomly selected and divided into two groups. In the first group, treatment was performed for 120 seconds, and in the second group for 360 seconds, both at 80C. Patients were assessed with a visual analogue scale for pain relief and functional improvement. Evaluations were performed before, immediately after treatment, at 1 and 2 weeks, and at 1, 3, and 6 months after the procedure. RESULTS: A total of 39 patients with positive provocative discographies were found to eligible for the study. There were no statistical differences in pain relief and functional improvement between two groups (P > 0.05). The immediate, 1-week and 2-week, and 1-month visual analogue scale (VAS) scores were decreased significantly in both groups when comparing them with the pretreatment scores (P < 0.05). However, the final values after 6 months were similar to those measured at the beginning of the study (P > 0.05). CONCLUSION: Percutaneous intradiscal radiofrequency thermocoagulation has been suggested and performed to relieve discogenic pain. In the previous controlled study, no effective pain relief has been obtained. In this study, the authors increased the duration of radiofrequency thermocoagulation to improve the effectiveness of this method. Yet, the authors have not found any significant differences between the application of lesioning at two different times in percutaneous intradiscal radiofrequency thermocoagulation.

Adult↗
PubMed2004

Adjunctive transmyocardial revascularization: five-year follow-up of a prospective, randomized trial.

BACKGROUND: In a prospective, randomized trial involving 263 patients who would be incompletely revascularized by coronary artery bypass grafting (CABG) alone, CABG plus transmyocardial revascularization (CABG/TMR) provided an early mortality benefit with similar angina relief compared with CABG alone at 1 year. We evaluated the long-term outcome of patients randomized to CABG/TMR or CABG alone. METHODS: Thirteen centers that enrolled 83% (218/263) of the patients in the original trial participated in this longitudinal study. Between 1996 and 1998, these centers randomized 218 patients who would be incompletely revascularized by CABG alone because of diffusely diseased target vessels to either holmium:yttrium-aluminum-garnet (holmium:YAG) CABG/TMR (n = 110) or CABG alone (n = 108). Baseline demographics and operative characteristics were similar between groups. Follow-up (mean 5.0 +/- 1.7 years) included survival and blinded angina class assessment. RESULTS: At this 5-year follow-up both groups experienced significant angina improvement from baseline, however, the CABG/TMR group had a lower mean angina score (0.4 +/- 0.7 vs 0.7 +/- 1.1, p = 0.05), a significantly lower proportion of patients with severe angina (class III/IV: 0% [0/68] vs 10% [6/60], p = 0.009), and a trend towards greater number of angina-free patients (78% [53/68] vs 63% [38/60], p = 0.08), compared with CABG alone patients. Kaplan-Meier survival at 6 years was similar between CABG/TMR and CABG alone patients (76% vs 80%, p = 0.90). CONCLUSIONS: Five-year follow-up of prospectively randomized patients who would be incompletely revascularized because of diffuse coronary artery disease indicates that the addition of TMR to conventional CABG provides superior angina relief compared to CABG alone.

Aged↗
PubMed2004

Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial.

CONTEXT: The long-term results of randomized trials have demonstrated equivalent survival rates for mastectomy and breast-conserving therapy for the treatment of early stage breast cancer. Consequently, the choice of treatment should be based on a patient's preferences. OBJECTIVE: To evaluate the impact of a decision aid regarding the different surgical treatment options on patient decision making. DESIGN AND SETTING: A cluster randomized trial for which general surgeons in the communities of central-west, and eastern Ontario, Canada, were randomly assigned to use the decision aid or not in the surgical consultation. Patients received the decision aid or not based on the surgeon seen. PARTICIPANTS: Twenty surgeons participated in the study. Of the 208 eligible women with newly diagnosed clinical stage I or II breast cancer seen by study surgeons, 201 agreed to be evaluated: 94 were assigned to the decision board and 107 to usual practice. Patients were recruited from November 1999 to April 2002. INTERVENTION: The decision board is a decision aid designed to help physicians inform their patients about different treatment options and to enable patients to express a preference for treatment. MAIN OUTCOME MEASURES: Patient knowledge about the surgical treatment of breast cancer; decisional conflict; satisfaction with decision making; and the treatment decision following the consultation. RESULTS: Patients in the decision board group had higher knowledge scores about their treatment options (66.9 vs 58.7; P<.001), had less decisional conflict (1.40 vs 1.62, P =.02), and were more satisfied with decision making (4.50 vs 4.32, P =.05) following the consultation. Patients who used the decision board were more likely to choose BCT (94% vs 76%, P =.03). CONCLUSIONS: The decision board was helpful in improving communication and enabling women to make a choice regarding treatment. Such instruments should be considered by surgeons when communicating the different surgical options to women with breast cancer.

Breast Neoplasms↗