Daphne Russell

Introducing Critical Care Outreach: a ward-randomised trial of phased introduction in a general hospital

ObjectiveThe purpose of the study was to investigate the effects of introducing a critical care outreach service on in-hospital mortality and length of stay in a general acute hospital.DesignA pragmatic ward-randomised trial design was used, with intervention introduced to all wards in sequence. No blinding was possible.SettingSixteen adult wards in an 800-bed general hospital in the north of England.Patients and participantsAll admissions to the 16 surgical, medical and elderly care wards during 32-week study period were included (7450 patients in total, of whom 2903 were eligible for the primary comparison).InterventionsEssential elements of the Critical Care Outreach service introduced during the study were a nurse-led team of nurses and doctors experienced in critical care, a 24-h service, emphasis on education, support and practical help for ward staff.Measurements and resultsThe main outcome measures were in-hospital mortality and length of stay. Outreach intervention reduced in-hospital mortality compared with control (two-level odds ratio: 0.52 (95% CI 0.32–0.85). A possible increased length of stay associated with outreach was not fully supported by confirmatory and sensitivity analyses.ConclusionsThe study suggests outreach reduces mortality in general hospital wards. It may also increase length of stay, but our findings on this are equivocal.

Mindfulness-Based Cognitive Therapy for Preventing Relapse in Recurrent Depression: A Randomized Dismantling Trial.

Objective: We compared mindfulness-based cognitive therapy (MBCT) with both cognitive psychological education (CPE) and treatment as usual (TAU) in preventing relapse to major depressive disorder (MDD) in people currently in remission following at least 3 previous episodes. Method: A randomized controlled trial in which 274 participants were allocated in the ratio 2:2:1 to MBCT plus TAU, CPE plus TAU, and TAU alone, and data were analyzed for the 255 (93%; MBCT = 99, CPE = 103, TAU = 53) retained to follow-up. MBCT was delivered in accordance with its published manual, modified to address suicidal cognitions; CPE was modeled on MBCT, but without training in meditation. Both treatments were delivered through 8 weekly classes. Results: Allocated treatment had no significant effect on risk of relapse to MDD over 12 months follow-up, hazard ratio for MBCT vs. CPE = 0.88, 95% CI [0.58, 1.35]; for MBCT vs. TAU = 0.69, 95% CI [0.42, 1.12]. However, severity of childhood trauma affected relapse, hazard ratio for increase of 1 standard deviation = 1.26 (95% CI [1.05, 1.50]), and significantly interacted with allocated treatment. Among participants above median severity, the hazard ratio was 0.61, 95% CI [0.34, 1.09], for MBCT vs. CPE, and 0.43, 95% CI [0.22, 0.87], for MBCT vs. TAU. For those below median severity, there were no such differences between treatment groups. Conclusion: MBCT provided significant protection against relapse for participants with increased vulnerability due to history of childhood trauma, but showed no significant advantage in comparison to an active control treatment and usual care over the whole group of patients with recurrent depression.

The effectiveness of one-to-one risk-communication interventions in health care: a systematic review

Objectives. To assess whether risk-communication interventions are associated with changes in patient knowledge, attitudes, and behaviors, and to identify aspects of these interventions that modify these effects. Design. Systematic review. Data sources. 96 studies from the period 1985-1996 retrieved by electronic searching of eight databases, hand searching of four journals, contacting key authors, and reference list searching. Main outcome measures. The effect size of the principal outcome was identified from each study. Outcomes measuring behavioral change were preferred; if these were not available, knowledge, anxiety, or risk perceptions were used, according to the focus of the study. Data were available to calculate the principal effect sizes for 82 of the studies. Analysis. Meta-regression. Results. The methodologic qualities of the studies varied. Nevertheless, risk-communication interventions generally had positive (beneficial) effects. Interventions addressing treatment choices were associated with larger effects than were those in other contexts, such as prevention or screening. Interventions using individual risk estimates were associated with larger effects than were those using more general risk information. Two design variables were identified as effect modifiers: randomized controlled trials were associated with smaller effects than other designs, and dichotomous outcomes were associated with larger effects than continuous outcomes. Conclusions. Risk communication interventions may be most productive if they include individual risk estimates in the discussion between professional and patient. Patient decisions about treatment appear more amenable to change by these interventions than attendance for screening or modification of risky behavior. Key words: risk communication; prevention interventions; patient behavioral changes; systematic review. (Med Decis Making 2000;20:290-297)

Mindfulness Groups for Distressing Voices and Paranoia: A Replication and Randomized Feasibility Trial

BACKGROUND The clinical literature cautions against use of meditation by people with psychosis. There is, however, evidence for acceptance-based therapy reducing relapse, and some evidence for clinical benefits of mindfulness groups for people with distressing psychosis, though no data on whether participants became more mindful. AIMS To assess feasibility of randomized evaluation of group mindfulness therapy for psychosis, to replicate clinical gains observed in one small uncontrolled study, and to assess for changes in mindfulness. METHOD Twenty-two participants with current distressing psychotic experiences were allocated at random between group-based mindfulness training and a waiting list for this therapy. Mindfulness training comprised twice-weekly sessions for 5 weeks, plus home practice (meditation CDs were supplied), followed by 5 weeks of home practice. RESULTS There were no significant differences between intervention and waiting-list participants. Secondary analyses combining both groups and comparing scores before and after mindfulness training revealed significant improvement in clinical functioning (p = .013) and mindfulness of distressing thoughts and images (p = .037). CONCLUSIONS Findings on feasibility are encouraging and secondary analyses replicated earlier clinical benefits and showed improved mindfulness of thoughts and images, but not voices.

Nurse-led vs. conventional physician-led follow-up for patients with cancer: systematic review

AIM This paper is a report of a systematic review of the effectiveness and cost-effectiveness of nurse-led follow-up for patients with cancer. BACKGROUND As cancer survivorship increases, conventional follow-up puts a major burden on outpatient services. Nurse-led follow-up is a promising alternative. Data sources. Searches were conducted covering a period from inception to February 2007 of 19 electronic databases, seven online trial registries, five conference proceedings reference lists of previous reviews and included studies. REVIEW METHODS Standard systematic review methodology was used. Comparative studies and economic evaluations of nurse-led vs. physician-led follow-up were eligible. Studies comparing different types of nurse-led follow-up were excluded. Any cancer was considered; any outcome measure included. RESULTS Four randomised controlled trials were identified, two including cost analyses. There were no statistically significant differences in survival, recurrence or psychological morbidity. One study showed better HRQL measures for nurse-led follow-up, but one showed no difference, two showed a statistically significant difference for patient satisfaction, but two did not. Patients with lung cancer were more satisfied with nurse-led telephone follow-up and more were able to die at home. Patients with breast cancer thought patient-initiated follow-up convenient, but found conventional follow-up more reassuring. One study showed the cost of nurse-led follow-up to be less than that of physician-led follow-up, but no statistical comparison was made. CONCLUSION Patients appeared satisfied with nurse-led follow-up. Patient-initiated or telephone follow-up could be practical alternatives to conventional care. However, well-conducted research is needed before equivalence to physician-led follow-up can be assured in terms of survival, recurrence, patient well-being and cost-effectiveness.

Follow-up of cancer in primary care versus secondary care: systematic review

BACKGROUND Cancer follow-up has traditionally been undertaken in secondary care, but there are increasing calls to deliver it in primary care. AIM To compare the effectiveness and cost-effectiveness of primary versus secondary care follow-up of cancer patients, determine the effectiveness of the integration of primary care in routine hospital follow-up, and evaluate the impact of patient-initiated follow-up on primary care. DESIGN OF STUDY Systematic review. SETTING Primary and secondary care settings. METHOD A search was carried out of 19 electronic databases, online trial registries, conference proceedings, and bibliographies of included studies. The review included comparative studies or economic evaluations of primary versus secondary care follow-up, hospital follow-up with formal primary care involvement versus conventional hospital follow-up, and hospital follow-up versus patient-initiated or minimal follow-up if the study reported the impact on primary care. RESULTS There was no statistically significant difference for patient wellbeing, recurrence rate, survival, recurrence-related serious clinical events, diagnostic delay, or patient satisfaction. GP-led breast cancer follow-up was cheaper than hospital follow-up. Intensified primary health care resulted in increased home-care nurse contact, and improved discharge summary led to increased GP contact. Evaluation of patient-initiated or minimal follow-up found no statistically significant impact on the number of GP consultations or cancer-related referrals. CONCLUSION Weak evidence suggests that breast cancer follow-up in primary care is effective. Interventions improving communication between primary and secondary care could lead to greater GP involvement. Discontinuation of formal follow-up may not increase GP workload. However, the quality of the data in general was poor, and no firm conclusions can be reached.

Mindfulness-based cognitive therapy: further issues in current evidence and future research.

The authors respond to the article by H. F. Coelho, P. H. Canter, and E. Ernst (2007)A. T. Beck, C. H. Ward, M. Mendelson, J. Mock, & J. Erbaugh, 1961) after treatment.

Generalized method for adaptive randomization in clinical trials

A flexible, generalized method of treatment allocation is proposed. The method uses a set of controlling parameters that enables the generic algorithm to produce a family of possible outcomes ranging from simple randomization to deterministic allocation. The method controls balance at stratum level, stratification level and overall without detriment to the predictability of the method. The paper lists the desirable characteristics of allocation methods and shows that the proposed method fulfils the majority and is easy to use in the clinical context, once the coding has been established. An explanation of the method for 2, 3 and 4 treatment group allocations is given. Simulations demonstrate the flexibility of the method.

Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14 618 Patients

Background The incidence of incisional hernias (IHs) following midline abdominal incisions is difficult to estimate. Furthermore recent analyses have reported inconsistent findings on the superiority of absorbable versus non-absorbable sutures. Objective To estimate the mean IH rate following midline laparotomy from the published literature, to identify variables that predict IH rates and to analyse whether the type of suture (absorbable versus non-absorbable) affects IH rates. Methods We undertook a systematic review according to PRISMA guidelines. We sought randomised trials and observational studies including patients undergoing midline incisions with standard suture closure. Papers describing two or more arms suitable for inclusion had data abstracted independently for each arm. Results Fifty-six papers, describing 83 separate groups comprising 14 618 patients, met the inclusion criteria. The prevalence of IHs after midline incision was 12.8% (range: 0 to 35.6%) at a weighted mean of 23.7 months. The estimated risk of undergoing IH repair after midline laparotomy was 5.2%. Two meta-regression analyses (A and B) each identified seven characteristics associated with increased IH rate: one patient variable (higher age), two surgical variables (surgery for AAA and either surgery for obesity surgery (model A) or using an upper midline incision (model B)), two inclusion criteria (including patients with previous laparotomies and those with previous IHs), and two circumstantial variables (later year of publication and specifying an exact significance level). There was no significant difference in IH rate between absorbable and non-absorbable sutures either alone or in conjunction with either regression analysis. Conclusions The IH rate estimated by pooling the published literature is 12.8% after about two years. Seven factors account for the large variation in IH rates across groups. However there is no evidence that suture type has an intrinsic effect on IH rates.

Multifaceted implementation of stroke prevention guidelines in primary care: cluster-randomised evaluation of clinical and cost effectiveness

Objective: To evaluate clinical and cost effectiveness of implementing evidence-based guidelines for the prevention of stroke. Design: Cluster-randomised trial Setting: Three primary care organisations in the North of England covering a population of 400 000. Participants: Seventy six primary care teams in four clusters: North, South & West, City I and City II. Intervention: Guidelines for the management of patients with atrial fibrillation and transient ischaemic attack (TIA) were developed and implemented using a multifaceted approach including evidence-based recommendations, audit and feedback, interactive educational sessions, patient prompts and outreach visits. Outcomes: Identification and appropriate treatment of patients with atrial fibrillation or TIA, and cost effectiveness. Results: Implementation led to 36% increase (95% CI 4% to 78%) in diagnosis of atrial fibrillation, and improved treatment of TIA (odds ratio of complying with guidelines 1.8; 95% CI 1.1 to 2.8). Combined analysis of atrial fibrillation and TIA estimates that compliance was significantly greater (OR 1.46 95% CI 1.10 to 1.94) in the condition for which practices had received the implementation programme. The development and implementation of guidelines cost less than £1500 per practice. The estimated costs per quality-adjusted life year gained by patients with atrial fibrillation or TIA were both less than £2000, very much less than the usual criterion for cost effectiveness. Conclusions: Implementation of evidence-based guidelines improved the quality of primary care for atrial fibrillation and TIA. The intervention was feasible and very cost effective. Key components of the model include contextual analysis, strong professional support, clear recommendations based on robust evidence, simplicity of adoption, good communication and use of established networks and opinion leaders.