Multicenter randomized trial of centralized nurse-led telephone-based care coordination to improve outcomes after surgical resection for colorectal cancer: the CONNECT intervention.

PURPOSE: To investigate the effectiveness of a centralized, nurse-delivered telephone-based service to improve care coordination and patient-reported outcomes after surgery for colorectal cancer. PATIENTS AND METHODS: Patients with a newly diagnosed colorectal cancer were randomly assigned to the CONNECT intervention or usual care. Intervention-group patients received standardized calls from the centrally based nurse 3 and 10 days and 1, 3, and 6 months after discharge from hospital. Unmet supportive care needs, experience of care coordination, unplanned readmissions, emergency department presentations, distress, and quality of life (QOL) were assessed by questionnaire at 1, 3, and 6 months. RESULTS: Of 775 patients treated at 23 public and private hospitals in Australia, 387 were randomly assigned to the intervention group and 369 to the control group. There were no significant differences between groups in unmet supportive care needs, but these were consistently low in both groups at both follow-up time points. There were no differences between the groups in emergency department presentations (10.8% v 13.8%; P = .2) or unplanned hospital readmissions (8.6% v 10.5%; P = .4) at 1 month. By 6 months, 25.6% of intervention-group patients had reported an unplanned readmission compared with 27.9% of controls (P = .5). There were no significant differences in experience of care coordination, distress, or QOL between groups at any follow-up time point. CONCLUSION: This trial failed to demonstrate substantial benefit of a centralized system to provide standardized, telephone follow-up for postoperative patients with colorectal cancer. Future interventions could investigate a more tailored approach.

Meta-analysis of well-designed nonrandomized comparative studies of surgical procedures is as good as randomized controlled trials.

OBJECTIVE: To compare the results of meta-analysis of nonrandomized comparative studies (NRCSs) of a surgical procedure with that of randomized controlled trials (RCTs), and to assess the effect of design and conduct issues in NRCSs on measured outcomes. STUDY DESIGN AND SETTING: Two meta-analyses of RCTs and NRCSs (2,512 and 6,438 procedures, respectively) of laparoscopic resection for colorectal cancer were performed according to accepted protocols, and 13 outcomes common between them were compared. Odds ratios (ORs) and 95% confidence intervals (CI) for dichotomous outcomes were assessed for the degree of overlap. Continuous outcomes were compared using cumulative weighted ratios (CWRs) and percentages for which a mean and standard deviation (SD) were calculated. The effects of design and conduct issues in the meta-analysis of NRCSs on measured morbidity rates were assessed using subgroup analysis. RESULTS: The ORs of the three dichotomous outcomes overlapped widely. For the 10 continuous variables, the mean difference (SD) in the results of the two meta-analyses was only 5.6% (4.9%). Fulfillment of certain quality and conduct issues in the NRCSs determined the statistical homogeneity of the results of meta-analysis and their comparability with the "gold standard." CONCLUSION: Meta-analysis of well-designed NRCSs of surgical procedures is probably as accurate as that of RCTs.

Meta-analysis of non-randomized comparative studies of the short-term outcomes of laparoscopic resection for colorectal cancer.

Laparoscopic resection remains to be established as the procedure of first choice for operable colorectal cancer. The aim of the study was to conduct a systematic review of non-randomized comparative studies of laparoscopic resection for colorectal cancer. Published work in English was searched for relevant articles published by the end of 2003. The MOOSE statement was used to conduct the meta-analysis. Study quality was assessed by two investigators using the MINORS tool and the analysis was conducted using Comprehensive Meta-analysis software (Biostat, Englewood, NJ, USA) and Microsoft Excel (Microsoft, Redmond, WA, USA). One thousand two hundred and twenty abstracts were reviewed and 398 articles examined in detail. Out of 108 articles reporting the results of relevant studies, 75 were reports of 64 non-randomized comparative studies. Fifteen studies were excluded. Analysis of the outcomes of 6438 resections showed that the conversion rate was 13.3% with a statistically significant difference between studies with more than 50 versus those with 50 or less attempted resections (11.7 vs 16.5%; P<0.001). Laparoscopic resection took 27.6% (41 min) longer to carry out than open resection. There was no significant difference between the two groups in early mortality rates (1.2 vs 1.1%; P=0.787) or likelihood of re-operation (2.3 vs 1.5%; P=0.319). Laparoscopic resection was associated with a lower morbidity rate (24.05 vs 30.80%, odds ratio (95% confidence interval)=0.77 (0.63-0.95); P=0.014, n=4111, random-effects model). Time until passage of first flatus, passage of a bowel motion, tolerating oral fluids and a solid diet was 1.2-1.6 days (26 to 37%) shorter, measurements of pain and narcotic analgesic requirements were 16-35% lower and hospital stay was 3.5 days (18.8%) shorter following laparoscopic resection compared with open resection. The two approaches were 99% similar in terms of adequacy of oncological clearance. Meta-analysis of non-randomized comparative studies favours laparoscopic over open resection for colorectal cancer. The results were remarkably similar to those of a contemporaneous meta-analysis of randomized controlled trials published by the end of 2002.

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.

Will the dilemma of evidence-based surgery ever be resolved?

Exponents of evidence-based medicine do not undermine the importance of clinical expertise and skills, but they emphasize that decision-making in medicine should be based on the best available evidence derived from the systematic analysis of observations made in an objective, unbiased and a reproducible fashion. The randomized controlled trial (RCT) is the most scientifically rigorous means of hypothesis testing in epidemiology. Discrepancies between established surgical and other interventions and best available evidence are common. These can be in the form of significant delay in adopting a new intervention despite strong supportive evidence, adopting an intervention before supportive evidence becomes available for reasons of novelty or pear pressure and the lack of supportive evidence for many established common practices. This is compounded further by the paucity of good quality evidence for most surgical procedures. This is arguably because of the inherent difficulties in conducting surgical RCT. The practical, ethical and financial ramifications are complex and the nature of surgical disease often compromise the chances of success or completion of RCT. Carrying out surgical RCT may have more implications on the clinician's authority, autonomy and income and their results are more likely to be influenced by his/her expertise and competence than medical RCT. Furthermore, the success of surgical RCT is often jeopardized by very low recruitment rates. The aim of this study is to discuss the dilemma of producing evidence in surgery.

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.

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.