Jean A. Mackay

Clinician-patient communication: a systematic review

Goal of WorkThe goal of this work was to identify methods of clinician–patient cancer-related communication that may impact patient outcomes associated with distress at critical points in the course of cancer care.Materials and methodsA systematic review of practice guidelines, systematic reviews, or randomized trials on this topic was conducted. Guidelines for quality was evaluated using the Appraisal of Guidelines for Research and Evaluation Instrument, and the contributive value for recommendations was assessed. Systematic reviews and randomized trials were also evaluated for methodological rigor.ResultsFour existing guidelines, eight systematic reviews and nine randomized trials were identified. Two of the guidelines were of high quality, and all systematic reviews reported clear search criteria and support for their conclusions; the randomized trials were of modest or low quality. For all situations and disease stages, guidelines consistently identified open, honest, and timely communication as important; specifically, there was evidence for a reduction in anxiety when discussions of life expectancy and prognosis were included in consultations. Techniques to increase patient participation in decision-making were associated with greater satisfaction but did not necessarily decrease distress. Few studies took cultural and religious diversity into account.ConclusionsThere is little definitive evidence supporting the superiority of one specific method for communicating information compared to another. Evidence regarding the benefit of decision aids or other strategies to facilitate better communication is inconsistent. Since patients vary in their communication preferences and desire for active participation in decision making, there is a need to individualize communication style.

Computerized clinical decision support systems for primary preventive care: a decision-maker-researcher partnership systematic review of effects on process of care and patient outcomes.

BackgroundComputerized clinical decision support systems (CCDSSs) are claimed to improve processes and outcomes of primary preventive care (PPC), but their effects, safety, and acceptance must be confirmed. We updated our previous systematic reviews of CCDSSs and integrated a knowledge translation approach in the process. The objective was to review randomized controlled trials (RCTs) assessing the effects of CCDSSs for PPC on process of care, patient outcomes, harms, and costs.MethodsWe conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovids EBM Reviews Database, Inspec, and other databases, as well as reference lists through January 2010. We contacted authors to confirm data or provide additional information. We included RCTs that assessed the effect of a CCDSS for PPC on process of care and patient outcomes compared to care provided without a CCDSS. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.ResultsWe added 17 new RCTs to our 2005 review for a total of 41 studies. RCT quality improved over time. CCDSSs improved process of care in 25 of 40 (63%) RCTs. Cumulative scientifically strong evidence supports the effectiveness of CCDSSs for screening and management of dyslipidaemia in primary care. There is mixed evidence for effectiveness in screening for cancer and mental health conditions, multiple preventive care activities, vaccination, and other preventive care interventions. Fourteen (34%) trials assessed patient outcomes, and four (29%) reported improvements with the CCDSS. Most trials were not powered to evaluate patient-important outcomes. CCDSS costs and adverse events were reported in only six (15%) and two (5%) trials, respectively. Information on study duration was often missing, limiting our ability to assess sustainability of CCDSS effects.ConclusionsEvidence supports the effectiveness of CCDSSs for screening and treatment of dyslipidaemia in primary care with less consistent evidence for CCDSSs used in screening for cancer and mental health-related conditions, vaccinations, and other preventive care. CCDSS effects on patient outcomes, safety, costs of care, and provider satisfaction remain poorly supported.

Computerized clinical decision support systems for drug prescribing and management: A decision-maker-researcher partnership systematic review

BackgroundComputerized clinical decision support systems (CCDSSs) for drug therapy management are designed to promote safe and effective medication use. Evidence documenting the effectiveness of CCDSSs for improving drug therapy is necessary for informed adoption decisions. The objective of this review was to systematically review randomized controlled trials assessing the effects of CCDSSs for drug therapy management on process of care and patient outcomes. We also sought to identify system and study characteristics that predicted benefit.MethodsWe conducted a decision-maker-researcher partnership systematic review. We updated our earlier reviews (1998, 2005) by searching MEDLINE, EMBASE, EBM Reviews, Inspec, and other databases, and consulting reference lists through January 2010. Authors of 82% of included studies confirmed or supplemented extracted data. We included only randomized controlled trials that evaluated the effect on process of care or patient outcomes of a CCDSS for drug therapy management compared to care provided without a CCDSS. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.ResultsSixty-five studies met our inclusion criteria, including 41 new studies since our previous review. Methodological quality was generally high and unchanged with time. CCDSSs improved process of care performance in 37 of the 59 studies assessing this type of outcome (64%, 57% of all studies). Twenty-nine trials assessed patient outcomes, of which six trials (21%, 9% of all trials) reported improvements.ConclusionsCCDSSs inconsistently improved process of care measures and seldomly improved patient outcomes. Lack of clear patient benefit and lack of data on harms and costs preclude a recommendation to adopt CCDSSs for drug therapy management.

Computerized clinical decision support systems for acute care management: A decision-maker- researcher partnership systematic review of effects on process of care and patient outcomes

BackgroundAcute medical care often demands timely, accurate decisions in complex situations. Computerized clinical decision support systems (CCDSSs) have many features that could help. However, as for any medical intervention, claims that CCDSSs improve care processes and patient outcomes need to be rigorously assessed. The objective of this review was to systematically review the effects of CCDSSs on process of care and patient outcomes for acute medical care.MethodsWe conducted a decision-maker-researcher partnership systematic review. MEDLINE, EMBASE, Evidence-Based Medicine Reviews databases (Cochrane Database of Systematic Reviews, DARE, ACP Journal Club, and others), and the Inspec bibliographic database were searched to January 2010, in all languages, for randomized controlled trials (RCTs) of CCDSSs in all clinical areas. We included RCTs that evaluated the effect on process of care or patient outcomes of a CCDSS used for acute medical care compared with care provided without a CCDSS. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.ResultsThirty-six studies met our inclusion criteria for acute medical care. The CCDSS improved process of care in 63% (22/35) of studies, including 64% (9/14) of medication dosing assistants, 82% (9/11) of management assistants using alerts/reminders, 38% (3/8) of management assistants using guidelines/algorithms, and 67% (2/3) of diagnostic assistants. Twenty studies evaluated patient outcomes, of which three (15%) reported improvements, all of which were medication dosing assistants.ConclusionThe majority of CCDSSs demonstrated improvements in process of care, but patient outcomes were less likely to be evaluated and far less likely to show positive results.

Computerized clinical decision support systems for therapeutic drug monitoring and dosing: A decision-maker-researcher partnership systematic review

BackgroundSome drugs have a narrow therapeutic range and require monitoring and dose adjustments to optimize their efficacy and safety. Computerized clinical decision support systems (CCDSSs) may improve the net benefit of these drugs. The objective of this review was to determine if CCDSSs improve processes of care or patient outcomes for therapeutic drug monitoring and dosing.MethodsWe conducted a decision-maker-researcher partnership systematic review. Studies from our previous review were included, and new studies were sought until January 2010 in MEDLINE, EMBASE, Evidence-Based Medicine Reviews, and Inspec databases. Randomized controlled trials assessing the effect of a CCDSS on process of care or patient outcomes were selected by pairs of independent reviewers. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.ResultsThirty-three randomized controlled trials were identified, assessing the effect of a CCDSS on management of vitamin K antagonists (14), insulin (6), theophylline/aminophylline (4), aminoglycosides (3), digoxin (2), lidocaine (1), or as part of a multifaceted approach (3). Cluster randomization was rarely used (18%) and CCDSSs were usually stand-alone systems (76%) primarily used by physicians (85%). Overall, 18 of 30 studies (60%) showed an improvement in the process of care and 4 of 19 (21%) an improvement in patient outcomes. All evaluable studies assessing insulin dosing for glycaemic control showed an improvement. In meta-analysis, CCDSSs for vitamin K antagonist dosing significantly improved time in therapeutic range.ConclusionsCCDSSs have potential for improving process of care for therapeutic drug monitoring and dosing, specifically insulin and vitamin K antagonist dosing. However, studies were small and generally of modest quality, and effects on patient outcomes were uncertain, with no convincing benefit in the largest studies. At present, no firm recommendation for specific systems can be given. More potent CCDSSs need to be developed and should be evaluated by independent researchers using cluster randomization and primarily assess patient outcomes related to drug efficacy and safety.

Management of Unresected Stage III Non-small Cell Lung Cancer: A Systematic Review

Purpose: To conduct a systematic review to determine the most effective therapy for patients with unresected stage III non-small cell lung cancer. Methods: Relevant randomized trials and meta-analyses were identified through a systematic search of the literature. Results: Forty-seven trials and six meta-analyses were included. No statistically significant survival differences were detected for immediate versus delayed administration of radiotherapy or different doses of hyperfractionated radiotherapy. Three of 12 trials comparing various doses and schedules of radiotherapy detected a statistically significant survival advantage with higher radiation doses. All meta-analyses found a statistically significant survival advantage for chemoradiation, particularly platinum-based, compared with radiation alone. One meta-analysis and three trials comparing concurrent with sequential chemoradiation detected a statistically significant survival advantage with concurrent administration. Increased toxicities, especially esophagitis and hematologic events, were generally associated with concurrent chemoradiation. The survival advantage for concurrent platinum-based chemoradiation corresponds to a 4% absolute survival benefit at 2 years. With respect to trials comparing different chemotherapy regimens or schedules, there is insufficient evidence to determine which particular regimen or schedule is most effective. Conclusion: Palliative radiotherapy can provide symptom relief for symptomatic patients with poor performance status. For patients with good performance status, chemoradiation improves survival compared with radiotherapy alone, particularly when the two modalities are administered concurrently. Sequential chemoradiation is a treatment option for borderline-status patients. Adequate assessment of performance status is important when evaluating treatment options for patients with unresected non-small cell lung cancer. Patients and physicians should have a full discussion of the benefits, limitations, and toxicities of therapy.

Use of the Epidermal Growth Factor Receptor Inhibitors Gefitinib and Erlotinib in the Treatment of Non-small Cell Lung Cancer: A Systematic Review

Introduction: Inhibition of the epidermal growth factor receptor is a promising therapy in the treatment of non-small cell lung cancer (NSCLC). In this systematic review, we evaluated the role of the epidermal growth factor receptor inhibitors gefitinib and erlotinib in the treatment of patients with advanced NSCLC. Methods: Relevant randomized trials published as articles or abstracts were identified through a systematic search of the literature from 1975 to November 2005 by two independent reviewers. Results: Twelve randomized trials met the predefined eligibility criteria for this systematic review. Four large placebo-controlled trials demonstrated that the addition of gefitinib or erlotinib to platinum-based first-line chemotherapy did not significantly improve overall survival or time-to-disease progression. A large placebo-controlled trial revealed a clinically and statistically significant survival benefit for erlotinib therapy as second- or third-line systemic therapy. The results of a single placebo-controlled trial and two phase II trials suggest that modest tumor response rates and symptom control can be achieved with gefitinib as second-line or subsequent therapy; however, a statistically significant survival benefit was not found for gefitinib compared with placebo. Conclusion: There is strong evidence to recommend against the use of gefitinib or erlotinib in combination with chemotherapy or as maintenance therapy after chemotherapy and radiation as a first-line treatment for advanced NSCLC. Erlotinib monotherapy is an effective treatment that can prolong survival for patients with advanced NSCLC whose disease has relapsed or recurred after prior chemotherapy. Although a significant survival benefit has not been demonstrated for gefitinib in a placebo-controlled study, the two randomized phase II trials suggest that gefitinib may provide clinically important symptomatic benefits.

Weekly doxorubicin and continuous infusional 5-fluorouracil for advanced breast cancer.

Drug scheduling alterations can improve the therapeutic index of both 5-fluorouracil and anthracyclines. We investigated a regimen of weekly doxorubicin and continuous infusional 5-fluorouracil (AcF) in loco-regionally recurrent and metastatic breast cancer. The aims of this phase II study were to use low-dose weekly anthracyclines in a patient group where liver metastases are a frequent problem, to optimise scheduling of 5-fluorouracil using continuous infusion and to conserve alkylating agent use for late intensification in responding patients. Fifty-six patients received 5-fluorouracil 200 mg m-2 day-1 and doxorubicin 20-30 mg m-2 week-1 for at least 6 weeks. Sixty-two percent were chemonaive. Patients were evaluated for dose intensity, response, toxicity and survival. Of the assessable patients, 76% achieved UICC response criteria (20% complete response, 56% partial response). WHO grade 3+ toxicities were: alopecia, 98%; mucositis, 62%; neutropenia, 22%; and grade 3 palmar-plantar syndrome, 24%. Median survival was 13 months, with visceral metastasis conferring a significantly worse outcome (P = 0.03). Grade 3+ mucositis was more frequent with planned doxorubicin dose intensity > or = 25 mg m-2 week-1 (P = 0.04). AcF is highly active in breast cancer with acceptable toxicities and can be used before alkylating agent-based high-dose therapy.

Practitioner Feedback on Lung Cancer Practice Guidelines in Ontario

Purpose: Practitioner feedback (PF) surveys are sent to practitioners who care for lung cancer patients as each new practice guideline is completed. In this study, the PF was reviewed to assess the frequency of response to the surveys, the respondents’ characteristics, the nature of the feedback, and the intention to adopt the guideline in practice. Methods: Fourteen practice guidelines (PGs) were sent to Ontario practitioners treating lung cancer, and feedback on the PGs was obtained through either an eight- or 21-item survey. Results: Between 1995 and 2002, 1198 surveys were sent to 223 practitioners. The overall response rate was 58.9% but varied by specialty (radiation and medical oncologists, 67%; thoracic surgeons, 46%; respirologists, 38%), by location of practice (cancer center, 65%; community-based practice, 55%), by geographic region of the province (highest, 72%; lowest, 42%), and by PG topic (chemotherapy, 60%; radiotherapy, 63%; combined modality therapy, 52%). The response rate to the PF surveys did not decline over time. Eighty-six percent of respondents agreed with the lung cancer guidelines and indicated that they were likely or very likely to use the PGs in their practice. Conclusion: The results suggest that practitioners view the guideline development process as credible and useful to guide practice. Whether the stated intention to use the guidelines will actually translate into practice requires further study.