Development and Validation of an Instrument for Measuring Attitudes and Beliefs about Complementary and Alternative Medicine (CAM) Use among Cancer Patients.

Despite cancer patients' extensive use of complementary and alternative medicine (CAM), validated instruments to measure attitudes, and beliefs predictive of CAM use are lacking. We aimed at developing and validating an instrument, attitudes and beliefs about CAM (ABCAM). The 15-item instrument was developed using the theory of planned behavior (TPB) as a framework. The literature review, qualitative interviews, expert content review, and cognitive interviews were used to develop the instrument, which was then administered to 317 outpatient oncology patients. The ABCAM was best represented as a 3-factor structure: expected benefits, perceived barriers, and subjective norms related to CAM use by cancer patients. These domains had Eigenvalues of 4.79, 2.37, and 1.43, and together explained over 57.2% of the variance. The 4-item expected benefits, 7-item perceived barriers, and 4-item subjective norms domain scores, each had an acceptable internal consistency (Cronbach's alpha) of 0.91, 0.76, and 0.75, respectively. As expected, CAM users had higher expected benefits, lower perceived barriers, and more positive subjective norms (all P < 0.001) than those who did not use CAM. Our study provides the initial evidence that the ABCAM instrument produced reliable and valid scores that measured attitudes and beliefs related to CAM use among cancer patients.

Coverage with evidence development, only in research, risk sharing, or patient access scheme? A framework for coverage decisions.

BACKGROUND: Until recently, purchasers' options regarding whether to pay for the use of medical technologies have been binary in nature: a treatment is either covered or not. Policies, however, have emerged that expand the decision options, for example, linking coverage to evidence development, an option increasingly used for treatments with limited/uncertain evidence. There has been little effort to reconcile the features of technologies with the available decision options. METHODS: We described a framework within which different decision options can be evaluated. We distinguished two sources of value in terms of health: the value of the technology per se and the value of reducing decision uncertainty. The costs of reversing decisions were also considered. FINDINGS: Purchasers should weigh the expected benefits of coverage against the possibility that the decision may need to be reversed and the chance that adoption will hinder evidence generation. Based on the purchaser's range of authority over access, research, and price and on the characteristics of the technology with regard to reversibility and evidence, different decisions may be appropriate. The framework clarified the assessments needed to establish the appropriateness of different decisions. A taxonomy of coverage decisions was suggested. CONCLUSIONS: A range of decision options may facilitate paying for the use of promising medical technologies despite their uncertain evidence. It is important that the option be chosen on the basis of not only the expected value of a technology but also the value of further research, the anticipated effect of coverage on further research, and the costs associated with reversing the decision.

Costs of dispersal.

Dispersal costs can be classified into energetic, time, risk and opportunity costs and may be levied directly or deferred during departure, transfer and settlement. They may equally be incurred during life stages before the actual dispersal event through investments in special morphologies. Because costs will eventually determine the performance of dispersing individuals and the evolution of dispersal, we here provide an extensive review on the different cost types that occur during dispersal in a wide array of organisms, ranging from micro-organisms to plants, invertebrates and vertebrates. In general, costs of transfer have been more widely documented in actively dispersing organisms, in contrast to a greater focus on costs during departure and settlement in plants and animals with a passive transfer phase. Costs related to the development of specific dispersal attributes appear to be much more prominent than previously accepted. Because costs induce trade-offs, they give rise to covariation between dispersal and other life-history traits at different scales of organismal organisation. The consequences of (i) the presence and magnitude of different costs during different phases of the dispersal process, and (ii) their internal organisation through covariation with other life-history traits, are synthesised with respect to potential consequences for species conservation and the need for development of a new generation of spatial simulation models.

How valuable are multiple treatment comparison methods in evidence-based health-care evaluation?

OBJECTIVES: To compare the use of pair-wise meta-analysis methods to multiple treatment comparison (MTC) methods for evidence-based health-care evaluation to estimate the effectiveness and cost-effectiveness of alternative health-care interventions based on the available evidence. METHODS: Pair-wise meta-analysis and more complex evidence syntheses, incorporating an MTC component, are applied to three examples: 1) clinical effectiveness of interventions for preventing strokes in people with atrial fibrillation; 2) clinical and cost-effectiveness of using drug-eluting stents in percutaneous coronary intervention in patients with coronary artery disease; and 3) clinical and cost-effectiveness of using neuraminidase inhibitors in the treatment of influenza. We compare the two synthesis approaches with respect to the assumptions made, empirical estimates produced, and conclusions drawn. RESULTS: The difference between point estimates of effectiveness produced by the pair-wise and MTC approaches was generally unpredictable-sometimes agreeing closely whereas in other instances differing considerably. In all three examples, the MTC approach allowed the inclusion of randomized controlled trial evidence ignored in the pair-wise meta-analysis approach. This generally increased the precision of the effectiveness estimates from the MTC model. CONCLUSIONS: The MTC approach to synthesis allows the evidence base on clinical effectiveness to be treated as a coherent whole, include more data, and sometimes relax the assumptions made in the pair-wise approaches. However, MTC models are necessarily more complex than those developed for pair-wise meta-analysis and thus could be seen as less transparent. Therefore, it is important that model details and the assumptions made are carefully reported alongside the results.

Value of information and value of implementation: application of an analytic framework to inform resource allocation decisions in metastatic hormone-refractory prostate cancer.

OBJECTIVE: In a budget-constrained health-care system, decisions about investing in strategies to promote implementation have to be made alongside decisions about health-care provision and research funding. Using a Bayesian decision-theoretic approach, an analytic framework has been developed to inform these separate but related decisions, establishing the expected value of both perfect information (EVPI) and perfect implementation (EVPIM). We applied this framework to inform decision-making about resource allocation to metastatic hormone-refractory prostate cancer (mHRPC) in the UK. METHODS: Based on available evidence on the cost-effectiveness of all plausible treatments for mHRPC, we determined which treatment option(s) were cost-effective and explored the uncertainty surrounding this decision. Given the decision uncertainty and the variation in care provided by health-care professionals, we then determined the EVPI and EVPIM. Finally, we performed sensitivity analyses to explore the influence of alternative assumptions regarding various decision parameters on the efficiency of resource allocation. RESULTS: Depending on the cost-effectiveness threshold (lambda), we identified mitoxantrone plus prednisone/prednisolone and docetaxel plus prednisone/prednisolone (3 weekly) as the optimal treatments for mHRPC. Given current clinical practice, there appears to be considerable scope for improving the efficiency of health-care provision: the EVPI (estimated to be over pound13 million) indicates that acquiring further information could be cost-effective; and the EVPIM (estimated to be over pound4 million) suggests that investing in strategies to implement the treatments regimens being identified as optimal is potentially worthwhile. Through sensitivity analyses, we found that the EVPI and EVPIM are mainly driven by lambda, the number of treatment options being considered, the current level of implementation, and the size of the eligible patient population. CONCLUSION: The application demonstrates that the framework provides a simple and useful analytic tool for decision-makers to address resource allocation problems between health-care provision, further research, and implementation efforts.

Cancer survivors with unmet needs were more likely to use complementary and alternative medicine.

PURPOSE: Despite advancements in cancer care, cancer survivors continue to experience a substantial level of physical and emotional unmet needs (UMN). This study aims to determine the relationship between patients' perceived UMN and their use of complementary and alternative medicine (CAM) to help with cancer problems during and after treatment. METHODS: A mailed, cross-sectional survey was completed by 614 cancer survivors identified through the Pennsylvania Cancer Registry 3.5 to 4 years from initial diagnosis. Relationships among UMN and CAM use along with clinical and socio-demographic factors were examined. RESULTS: Respondents who identified any UMN were 63% more likely to report CAM use than those without UMN (58% vs. 36%), p < 0.001. UMN remained the only independent predictor (adjusted odds ratio = 2.30, 95% confidence interval = 1.57-3.36, p < 0.001) of CAM use in a multivariate logistic regression model that included age, sex, marital status, education, previous chemotherapy and radiotherapy. Adjusted for covariates, UMN in domains of emotional, physical, nutritional, financial, informational, treatment-related, employment-related, and daily living activities were all related to CAM use, whereas UMN in transportation, home care, medical staff, family and spirituality were not related to CAM use. Patients who experienced multiple types of unmet needs were also more likely to use multiple types of CAM (p < 0.001 for model). CONCLUSIONS: Cancer survivors who experienced unmet needs within the existing cancer treatment and support system were more likely to use CAM to help with cancer problems. Research is needed to determine if appropriate CAM use decreases unmet needs among cancer survivors.

The relationship between somatisation and outcome in patients with severe irritable bowel syndrome.

OBJECTIVE: This study aimed to assess the relationship between somatisation and outcome in patients with severe irritable bowel syndrome (IBS). METHOD: Two hundred fifty-seven patients with severe IBS included in a randomised controlled trial were assessed at baseline and divided into four quartiles on the basis of their somatisation score. The patients were randomised to receive the following over 3 months: brief interpersonal psychotherapy, 20 mg daily of the SSRI antidepressant paroxetine, or treatment as usual. Outcome 1 year after treatment was assessed using the Short Form-36 physical component summary (PCS) score and total costs for posttreatment year. RESULTS: The patients in the quartile with the highest baseline somatisation score had the most severe IBS, the most concurrent psychiatric disorders, and the highest total costs for the year prior to baseline. At 1 year after the end of treatment, however, the patients with marked somatisation, who received psychotherapy or antidepressant, had improved health status compared to those who received usual care: mean (S.E.) PCS scores at 15 months were 36.6 (2.2), 35.5 (1.9), and 26.4 (2.7) for psychotherapy, antidepressant, and treatment-as-usual groups, respectively (adjusted P=.014). Corresponding data for total costs over the year following the trial, adjusted for baseline costs, were pound 1092 (487), pound 1394 (443), and pound 2949 (593) (adjusted P=.050). CONCLUSIONS: Patients with severe IBS who have marked somatisation improve with treatment like other IBS patients and show a greater reduction of costs. Antidepressants and psychotherapy are cost-effective treatments in severe IBS accompanied by marked somatisation.

An iterative Bayesian approach to health technology assessment: application to a policy of preoperative optimization for patients undergoing major elective surgery.

PURPOSE: This article presents an iterative framework for managing the dynamic process of health technology assessment. The framework uses Bayesian statistical decision theory and value of information (VOI) analysis to inform decision making regarding appropriate patient management and to direct future research effort over the lifetime of a technology. Within the article, the framework is applied to a policy decision regarding preoperative patient management before major elective surgery, for which trial data are available. METHOD: The evidence available prior to the trial is used to determine the appropriate method of patient management and to ascertain whether, at the time of commissioning, the trial was potentially worthwhile. The prior information is then updated with the trial data via a Bayesian analysis using informative priors. This post trial information set is then used to reassess the appropriate method for patient management and to determine whether there is a requirement for any further research. RESULTS: Prior to the trial, preoperative optimization with dopexamine is identified as the appropriate method of patient management. The results of the VOI analysis suggest that a short-term trial was potentially worthwhile (population expected value of perfect information [EVPI] = 48 million pounds sterling). Following the trial, the uncertainty surrounding the choice of appropriate patient management and the potential worth of further research had increased (population EVPI = 67 million pounds sterling). CONCLUSIONS: The article demonstrates the value and practicality of applying the iterative framework to the dynamic process of health technology assessment. It is only by formally incorporating all of the information available to decision makers, through informed priors, that the appropriate decisions can be made.

Cognitive-behavioural therapy in first-episode and early schizophrenia. 18-month follow-up of a randomised controlled trial.

BACKGROUND: The initial phase of a trial of cognitive-behavioural therapy (CBT) for acutely ill patients with schizophrenia of recent onset showed that it speeded recovery. AIMS: To test the hypothesis that CBT in addition to treatment as usual (TAU) during the first or second acute episode of schizophrenia will confer clinical benefit over a follow-up period. METHOD: This was an 18-month follow-up of a multicentre prospective trial of CBT or supportive counselling administered as an adjunct to TAU, compared with TAU alone, for patients hospitalised for an acute episode of schizophrenia of recent onset. Primary outcomes were total and positive symptom scales, time to relapse and re-hospitalisation. RESULTS: There were significant advantages for CBT and supportive counselling over TAU alone on symptom measures at 18 months but no group difference was seen for relapse or re-hospitalisation. There was a significant centre-treatment interaction, reflecting centre differences in the effect of introducing either treatment, but not in the comparison of CBT and supportive counselling. Medication dosage and compliance did not explain group differences. CONCLUSIONS: Adjunctive psychological treatments can have a beneficial long-term effect on symptom reduction.