Vern Farewell

Enduring impact of communication skills training: results of a 12-month follow-up

The efficacy of a communication skills training programme was shown through a randomised trial. Oncologists (N=160) from 34 cancer centres were allocated to written feedback plus course; course alone; written feedback alone or control. Each clinician had 6 – 10 interviews with patients videotaped at baseline and 3 months postintervention. Analysis of videotapes revealed improvements in the communication skills of clinicians randomised to training (n=80) compared with others (n=80). A 12-month follow-up assessment is reported here. Robust Poisson conditional analyses of counts of changes in communication behaviours revealed no demonstrable attrition in those who had shown improvement previously, including fewer leading questions, appropriate use of focused and open-ended questions and responses to patient cues. Additional skills, not apparent at 3 months, were now evident; the estimated effect sizes corresponded to 81% fewer interruptions (P=0.001) and increased summarising of information to 38% (P=0.038). However, expressions of empathy (54%, P=0.001) declined. The overall results show that 12 – 15 months postintervention, clinicians had integrated key communication skills into clinical practice and were applying others. This is the first RCT to show an enduring effect of communication skills training with transfer into the clinic.

Multiplicity considerations in the design and analysis of clinical trials

The need for efficient use of available resources in medical research has led to the increased appeal of clinical trial designs based on multiple responses, multiple treatment arms and repeated tests of significance. In recent years there has been considerable methodological work pertaining to these types of multiple comparison, with the common objective typically being the control of the experimental type I error rate. Here we reconsider the appropriateness of these objectives in a variety of contexts and suggest that multiple‐comparison procedures are frequently adopted unnecessarily. In particular we argue that, provided that a select number of important well‐defined clinical questions are specified at the design, there are situations in which multiple tests of significance can be performed without control of the experimental type I error rate. The primary restriction for this to be reasonable is that test results are interpreted marginally.

Pathogenesis of hypotension in septic shock: correlation of circulating phospholipase A2 levels with circulatory collapse.

Circulating phospholipase A2 (PLA2) has been recognized as a mediator of circulatory collapse in experimental endotoxic shock. To assess the role of serum PLA2 in septic shock in man, we determined serum PLA2 profiles in a prospective study in 12 patients with septic shock. During the hypotensive phase of sepsis, serum PLA2 levels were consistently elevated as high as 33,428 U/ml (normal range 115 +/- 12 [SE]; n = 101). In all 12 patients, PLA2 levels correlated directly with the magnitude and duration of circulatory collapse (p less than .001), with a progressive fall of serum PLA2 levels during convalescence. In contrast, serum PLA2 levels in patients with cardiogenic shock secondary to myocardial infarction remained low. In pancreatitis, PLA2 levels paralleled fluctuations of serum amylase and lipase, whereas in septic shock without pancreatic involvement, PLA2 changes were discordant with changes in pancreatic enzymes. As well, septic shock serum PLA2 failed to crossreact by radioimmunoassay with antiserum against human pancreatic PLA2. These data are consistent with an extrapancreatic source of intravascular PLA2 release during sepsis. Since endogenous serum PLA2 levels correlate directly with the magnitude of hypotension in both experimental endotoxic shock and clinical septic shock, and since parenteral administration of purified exogenous PLA2 reproduces hypotension in experimental models, we conclude that high levels of intravascular PLA2 may contribute similarly to the circulatory collapse in septic shock in man.

Randomized trials versus observational studies in adolescent pregnancy prevention

The objective of this study is to compare the results of randomized trials and observational studies of interventions to prevent adolescent pregnancy. We identified published and unpublished reports through computerized searches of CATLINE, CINAHL, CONFERENCE PAPERS INDEX, DISSERTATION ABSTRACTS ONLINE, EMBASE, ERIC, MEDLINE, NTIS, POPLINE, PsycINFO, and SOCIOLOGICAL ABSTRACTS; manual searches of eight relevant journals; reference lists from primary articles; and contact with content experts. We included randomized trials and observational studies that evaluated the impact of primary prevention interventions including sex education classes, school-based clinics, free-standing clinics, physician/nurse practitioner practice-based service, improved access, and community-based programs on four outcomes: sexual intercourse, birth control use, responsible sexual behavior, or pregnancy in adolescents. One investigator abstracted the data and a second conducted a detailed review of the abstraction. We identified 13 randomized trials and 17 observational studies. We generated estimates of the impact of the interventions separately for males and females for all four outcomes for both observational studies and randomized trials. For six of the eight outcomes the summary odds ratios for the observational studies showed a significant intervention benefit (P<0.05) while the randomized trials did not show a benefit for any outcome in either females or males. The difference between the results of the observational studies and randomized trials was statistically significant in two of the eight outcomes (P<0.05 for initiation of intercourse and pregnancy in females). Observational studies yield systematically greater estimates of treatment effects than randomized trials of adolescent pregnancy prevention interventions. Public policy or individual patient treatment decisions should be based on observational studies only when randomized trials are unavailable and only with careful consideration of possible biases.

Risk-Adjusted Monitoring of Binary Surgical Outcomes

A graphical procedure suitable for prospectively monitoring surgical performance is proposed. The approach is based on accumulating evidence from the outcomes of all previous surgical patients in a series using a new type of cumulative sum chart. Cumulative sum procedures are designed to “signal” if sufficient evidence has accumulated that the surgical failure rate has changed substantially. In this way, the chart rapidly detects deterioration (or improvement) in surgical performance while not overreacting to the expected fluctuations due to chance. Through the use of a likelihood-based scoring method, the cumulative sum procedure is adapted so that it adjusts for the surgical risk of each patient estimated preoperatively. The procedure is therefore applicable in situations where it is desirable to adjust for a mix of patients. Signals of the chart lead to investigations of the cause and to the timely introduction of remedial measures designed to avoid unnecessary future failures.

The attitudes of 1066 patients with cancer towards participation in randomised clinical trials

Background:Barriers to randomised clinical trial (RCT) recruitment include failure to identify eligible patients, reluctance of staff to approach them and attitudes of some health-care professionals and patients. As part of a larger UK prospective study examining the communication and involvement in RCTs of 22 multidisciplinary teams in Wales, we also assessed the attitudes of patients they treat towards trials.Methods:Out of 1146 patients attending outpatient departments who were approached, 1146 (93%) completed the seven-item Attitudes to Randomised Trials Questionnaire (ARTQ), probing their general attitudes towards medical research and likely participation in a hypothetical two-arm RCT.Results:Randomisation initially deterred many patients from endorsing a willingness to participate. However, if information about the trial logic, voluntary nature and rights to withdraw were provided, together with further treatment details, 83% (886 out of 1066) would potentially participate. Other variables associated with a positive inclination towards participation included previous trial experience (P<0.01), male gender (P<0.01) and younger age, with patients ⩾70 years less likely to consider trial entry (P<0.01).Conclusion:The majority of patients were receptive to RCT participation. Many of those initially disinclined because of randomisation would consider joining if given further details that form part of standard GCP consent guidelines. These data show the importance and need for clear communication and information to encourage RCT participation. Evidence-based training courses are available to assist with this.

Monitoring the Evolutionary Process of Quality: Risk-Adjusted Charting to Track Outcomes in Intensive Care

OBJECTIVE To present graphical procedures for prospectively monitoring outcomes in the intensive care unit. DESIGN Observational study: risk-adjusted control chart analysis of a case series. SETTING Tertiary referral adult intensive care unit: Princess Alexandra Hospital, Brisbane, Australia. PATIENTS A total of 3398 intensive care unit admissions from January 1, 1995, to January 1, 1998. CONCLUSIONS Risk-adjusted process control charting procedures for continuous monitoring of intensive care unit outcomes are proposed as quality management tools. A modified Shewhart p chart and cumulative sum process control chart, using the Acute Physiology and Chronic Health Evaluation III model mortality prediction for risk adjustment, are presented. The risk-adjusted p chart summarizes performance at arbitrary intervals and plots observed against predicted mortality rate to detect large changes in risk-adjusted mortality. The risk-adjusted cumulative sum procedure is a likelihood-based scoring method that adjusts for estimated risk of death, accumulating evidence from outcomes of all previous patients. It formally tests the hypothesis of a change in the odds of death. In this application, we detected a decrease from above to predicted risk-adjusted mortality. This was temporally related to increased senior staffing levels and enhanced ongoing multidisciplinary review of practice, quality improvement, and educational activities. Formulas and analyses are provided as appendices.

Guidelines for Monitoring Efficacy and Toxicity Responses in Clinical Trials

There is currently a need for clinical trial methodology that allows formal consideration of toxicity responses. Since a complete evaluation of an experimental therapy addresses both relative efficacy and relative toxicity, general methods for handling bivariate response data are of interest. A procedure for sequentially analysing both efficacy and toxicity data is presented. The procedure is designed to allow early termination due to efficacy results, toxicity results, or both. The method is based on modified marginal sequential analyses, accounting for bivariate correlated responses and multiple analyses over time. The theory is presented in the context of normally distributed responses. Extensions to bivariate failure time data are indicated and an example from a kidney transplant study demonstrates the procedure.

Monitoring paired binary surgical outcomes using cumulative sum charts

Correlated binary data are encountered in many areas of medical research, system reliability and quality control. For monitoring failures rates in such situations, simultaneous bivariate cumulative sum (CUSUM) charts with the addition of secondary control limits are proposed. Using an approach based on a Markov chain model, the run length properties of such a monitoring scheme can be determined for sudden, or gradual, changes in the failure rates. The proposed control charts are easy to implement, and are shown to be very effective at detecting small changes in the rate of undesirable outcomes, especially when the changes are gradual. This procedure is illustrated using bivariate outcome data arising from a series of paediatric surgeries. The methodology is sufficiently general that it may be adapted for multivariate normal, binomial or Poisson responses.

Pulmonary metastasectomy in colorectal cancer: Time for a trial

Pulmonary metastasectomy is undertaken for a range of cancers. The questions we raise here are specifically related to colorectal cancer, the commonest tumour for which pulmonary metastasectomy is undertaken. The primary objective of metastasectomy is to increase survival. There are no randomised trials in support of this practice nor are there any other forms of controlled studies. We present a critical look at the assumption of efficacy for this surgery and propose that a trial is needed and suggest a trial design.