PracticeCALM: Coaching Anxiety Lessening Methods for Radiation Therapists: A Pilot Study of a Skills-Based Training Program in Radiation Oncology.

PracticeCALM is an 8-week on-the-job training program to teach radiation therapists (RTs) techniques for assisting patients who are experiencing treatment-related anxiety. Twelve clinical RTs in a regional oncology program were recruited on a volunteer basis to participate in the training. A mixed-method approach was undertaken to evaluate perceived benefits to clinical practice. The quantitative findings from the Perceived Stress Scale (PSS) showed there were no changes before and after training. Qualitative findings showed significant benefits to RTs, including (1) ability to empathically attune more effectively and earlier to signs of anxiety in patients; (2) improved confidence and self-efficacy for effectively intervening in difficult treatment situations; and (3) enhanced creative problem solving in partnership with patients to assist the acutely anxious patient. The PSS results suggest that intrinsic and extrinsic stressors are a variable but consistent part of the everyday reality of RT practice. A training program focusing on the therapeutic presence dimension of RT practice has a direct impact on effectiveness in assisting anxious patients undergoing RT. When embedded in the clinical life of a radiation therapy department, such a training program has the potential to capture the lived practice wisdom and creative skills of RTs, and effectively mediate these skills across a team through group discussions and documentation on patient charts.

Pharmacotherapy for Depression Posttraumatic Brain Injury: A Meta-analysis.

OBJECTIVE: To examine the effectiveness of pharmacotherapy for the treatment of depression following traumatic brain injury (TBI). DESIGN: Systematic review and meta-analysis. Multiple electronic databases were searched to identify relevant studies examining effectiveness of pharmacotherapy for depression post-TBI. Clinical trials evaluating the use of pharmacotherapy in individuals with depression at baseline and using standardized assessments of depression were included. Data abstracted included sample size, antidepressant used, treatment timing/duration, method of assessment, and results pertaining to impact of treatment. Study quality was assessed using a modified Jadad scale. RESULTS: Nine studies met criteria for inclusion. Pooled analyses based on reported means (standard deviations) from repeated assessments of depression showed that, over time, antidepressant treatment was associated with a significant effect in favor of treatment (Hedges g = 1.169; 95% confidence interval, 0.849-1.489; P < .001). Similarly, when limited to placebo-controlled trials, treatment was associated with a significant reduction in symptoms (standardized mean difference = 0.84; 95% confidence interval, 0.314-1.366; P = .002). CONCLUSION: Pharmacotherapy after TBI may be associated with a reduction in depressive symptomatology. Given limitations within the available literature, further well-powered, placebo-controlled trials should be conducted to confirm the effectiveness of antidepressant therapy in this population.

Using realist evaluation to open the black box of knowledge translation: a state-of-the-art review.

BACKGROUND: In knowledge translation, complex interventions may be implemented in the attempt to improve uptake of research-based knowledge in practice. Traditional evaluation efforts that focus on aggregate effectiveness represent an oversimplification of both the environment and the interventions themselves. However, theory-based approaches to evaluation, such as realist evaluation (RE), may be better-suited to examination of complex knowledge translation interventions with a view to understanding what works, for whom, and under what conditions. It is the aim of the present state-of-the-art review to examine current literature with regard to the use of RE in the assessment of knowledge translation interventions implemented within healthcare environments. METHODS: Multiple online databases were searched from 1997 through June 2013. Primary studies examining the application or implementation of knowledge translation interventions within healthcare settings and using RE were selected for inclusion. Varying applications of RE across studies were examined in terms of a) reporting of core elements of RE, and b) potential feasibility of this evaluation method. RESULTS: A total of 14 studies (6 study protocols), published between 2007 and 2013, were identified for inclusion. Projects were initiated in a variety of healthcare settings and represented a range of interventions. While a majority of authors mentioned context (C), mechanism (M) and outcome (O), a minority reported the development of C-M-O configurations or testable hypotheses based on these configurations. Four completed studies reported results that included refinement of proposed C-M-O configurations and offered explanations within the RE framework. In the few studies offering insight regarding challenges associated with the use of RE, difficulties were expressed regarding the definition of both mechanisms and contextual factors. Overall, RE was perceived as time-consuming and resource intensive. CONCLUSIONS: The use of RE in knowledge translation is relatively new; however, theory-building approaches to the examination of complex interventions in this area may be increasing as researchers attempt to identify what works, for whom and under what circumstances. Completion of the RE cycle may be challenging, particularly in the development of C-M-O configurations; however, as researchers approach challenges and explore innovations in its application, rich and detailed accounts may improve feasibility.

Prevention of poststroke depression: does prophylactic pharmacotherapy work?

BACKGROUND: Given the negative influence of poststroke depression (PSD) on functional recovery, cognition, social participation, quality of life, and risk for mortality, the early initiation of antidepressant therapy to prevent its development has been investigated; however, individual studies have offered conflicting evidence. The present systematic review and meta-analysis examined available evidence from published randomized controlled trials (RCTs) evaluating the effectiveness of pharmacotherapy for the prevention of PSD to provide updated pooled analyses. METHODS: Literature searches of 6 databases were performed for the years 1990 to 2011. RCTs meeting study inclusion criteria were evaluated for methodologic quality. Data extracted included the antidepressant therapy used, treatment timing and duration, method(s) of assessment, and study results pertaining to the onset of PSD. Pooled analyses were conducted. RESULTS: Eight RCTs were identified for inclusion. Pooled analyses demonstrated reduced odds for the development of PSD associated with pharmacologic treatment (odds ratio [OR] 0.34; 95% confidence interval [CI] 0.22-0.53; P<.001), a treatment duration of 1 year (OR 0.31; 95% CI 0.18-0.56; P<.001), and the use of a selective serotonin reuptake inhibitor (OR 0.37; 95% CI 0.22-0.61; P<.001). CONCLUSIONS: The early initiation of antidepressant therapy, in nondepressed stroke patients, may reduce the odds for development of PSD. Optimum timing and duration for treatment and the identification of the most appropriate recipients for a program of indicated prevention require additional examination.

A scale for distinguishing efficacy from effectiveness was adapted and applied to stroke rehabilitation studies.

OBJECTIVES: To apply a tool that purports to differentiate between efficacy and effectiveness studies to stroke rehabilitation trials and to evaluate its applicability and reliability. STUDY DESIGN AND SETTING: Three raters developed item operational definitions before independently applying the seven-item scale to 151 randomized controlled trials (RCT), published during or after 1997, that evaluated either a pharmacologic (P, n=78) or a nonpharmacologic (NP, n=73) intervention. Inter-rater reliability was assessed for both individual items and total scores, separately for P and NP trials. RESULTS: Item inter-rater reliability (multiple-rater kappa) ranged from 0.00 (95% CI [confidence interval]: -0.13, 0.13) to 0.85 (95% CI: 0.73, 0.98) and from 0.21 (95% CI: 0.08, 0.34) to 0.79 (95% CI: 0.66, 0.92) for P and NP RCTs, respectively. For the total score (dichotomized), kappa values were 0.43 (95% CI: 0.31, 0.56) and 0.51 (95% CI: 0.37, 0.64) for P and NP trials, respectively. CONCLUSIONS: The tool provides a solid foundation on which to base further discussion of the differential criteria of efficacy-effectiveness trial design. Scale items should be properly operationalized depending on the research question of interest and evaluated for reliability before the scale is used for definitively judging a given study's design or the external validity of its results.

A review of the relationship between dysphagia and malnutrition following stroke.

OBJECTIVE: To clarify the relationship between malnutrition and dysphagia following stroke. DESIGN: Systematic review. METHODS: All published trials that had examined both the swallowing ability and nutritional status of subjects following stroke were identified. Pooled analyses were performed to establish whether the odds of being malnourished were increased given the presence of dysphagia. RESULTS: Eight studies were identified. The presence of malnutrition and dysphagia ranged from 8.2% to 49.0% and 24.3% to 52.6%, respectively. Five of the included trials were conducted within the first 7 days following stroke, while 3 were conducted during the rehabilitation phase. The overall odds of being malnourished were higher among subjects who were dysphagic compared with subjects with intact swallowing (odds ratio: 2.425; 95% confidence interval: 1.264-4.649, p < 0.008). In subgroup analysis, the odds of malnutrition were significantly increased during the rehabilitation stage (odds ratio: 2.445; 95% confidence interval: 1.009-5.925, p < 0.048), but not during the first 7 days of hospital admission (odds ratio: 2.401; 95% confidence interval: 0.918-6.277, p < 0.074). CONCLUSION: In a systematic review including the results from 8 studies, the odds of being malnourished were increased given the presence of dysphagia following stroke.

Which reported estimate of the prevalence of malnutrition after stroke is valid?

BACKGROUND AND PURPOSE: The reported prevalence of malnutrition after stroke varies widely, whereas it remains unclear which of the estimates is most accurate. The aim of this review was to explore possible sources of this heterogeneity among studies and to evaluate whether the nutritional assessment techniques used were valid. METHODS: A literature search was conducted to identify all studies in which the nutritional state of patients was assessed after inpatient admission for stroke. The percentages of patients identified as malnourished in each study and method of nutritional assessment are reported. For the purposes of this study, an assessment technique was considered valid if at least one form of validity had been demonstrated previously through psychometric evaluation. RESULTS: Eighteen studies meeting inclusion criteria were identified. The reported frequency of malnutrition ranged from 6.1% to 62%. Seventeen different methods of nutritional assessment were used. Four trials used previously validated assessment methods: Subjective Global Assessment, "an informal assessment," and Mini Nutritional Assessment. The nutritional assessment methods used in the remaining studies used had not been validated previously. CONCLUSIONS: The use of a wide assortment of nutritional assessment tools, many of which have not been validated, may have contributed to the wide range of estimates of malnutrition. If so, this underscores the need for valid and reliable assessment tools to further our understanding of the relationship between stroke and nutritional status.

In a review of stroke rehabilitation studies, concealed allocation was under reported.

OBJECTIVE: The objective of this two-phase study was to assess the adequacy of the reporting of concealed allocation (CA) in randomized controlled trials (RCTs) evaluating interventions associated with stroke rehabilitation. STUDY DESIGN AND SETTING: In phase I of the study, 50 RCTs included in a systematic review were selected to establish agreement between two raters. Two investigators determined if the method described to conceal the randomization schedule was adequate, inadequate, or not reported. In phase II, using a larger sample size (n=165), the differences in the proportion of studies with and without adequate CA are reported for two comparisons: (1) pharmacological vs. nonpharmacological trials and (2) multicentered vs. single-site studies. RESULTS: In both phases I and II, CA was described adequately in one-third of all studies sampled. The agreement between raters was 88% (small ka, Cyrillic=0.79; 95% confidence interval: 0.65, 0.94). No significant differences in the adequacy of reporting for CA were found with respect to study type (pharmacological vs. nonpharmacological), whereas multicentered trials reported adequacy of CA more frequently. CONCLUSION: Although concealment of group allocation is an important feature of trial design, it was frequently not reported in many RCTs associated with stroke rehabilitation.

Health-related quality of life after stroke: what are we measuring?

As there is no single, accepted definition of health-related quality of life (HRQOL), it is assumed to be a broad, multidimensional construct referring to those aspects of people's lives that reasonably relate to their health. Although many scales are used to assess HRQOL, the operationalization of this construct within each tool is unclear. To clarify what each tool is measuring, this study reviewed eight scales commonly used to evaluate HRQOL after stroke. Two reviewers classified scale items from five generic and three stroke-specific scales within an established framework with nine dimensions; physical functioning, symptoms, global judgments of health, psychological well-being, social well-being, cognitive functioning, role activities, personal constructs, and satisfaction with care. All scales reviewed provide multidimensional assessment, but vary in number and combination of dimensions. All include assessment of physical functioning and most incorporate concepts, such as psychological well-being, social well-being, and role activities. One generic (Sickness Impact Profile) and two stroke-specific scales (Stroke Impact Scale and Stroke-Specific Quality of Life Scale) seemed most comprehensive. Evaluated against a common framework of dimensions, scales commonly used in the assessment of HRQOL after stroke provide varying multidimensional assessments of aspects of life function related to health. Whether any of these assessments are sufficient to describe HRQOL in its entirety is unclear.

A blueprint for transforming stroke rehabilitation care in Canada: the case for change.

Stroke is a major source of disability in Canada and other developed countries, which carries with it a high toll in terms of personal suffering for the stroke survivor and their family in addition to the associated economic costs. Despite the impressive body of evidence describing effective and feasible stroke rehabilitation practices, stroke survivors, their families, and health professionals currently do not benefit from a rehabilitation system that is well organized and evidence based. Using the principles of best evidence, we make the case for needed changes to the current system based on 5 processes of care known to be important in the pursuit of optimal outcomes: (1) admission to specialized stroke rehabilitation units, (2) early admission to stroke rehabilitation units, (3) intensive stroke rehabilitation therapies, (4) task-specific rehabilitation therapies, and (5) well-resourced outpatient programs. Implementation of these strategies will be expected to result in improved functional gain, fewer complications, decreased mortality, and reduced need for institutionalization. In addition to providing improved care for both the stroke survivor and their family, evidence-based stroke rehabilitation care is more efficient and may reduce costs. Our experience in Canada suggests that instituting these 5 measures alone will result in significant improvements to the health care system.

Assessment of participation outcomes in randomized controlled trials of stroke rehabilitation interventions.

In recent years, the importance of understanding the impact of interventions on an individual's ability to participate in social roles after a stroke event has gained much attention. Comprehensive assessment of treatment effectiveness should include a broader range of outcomes, including social participation. This study attempted to determine the degree to which the assessment of social participation has been included in randomized controlled trials of stroke rehabilitation. An extensive literature search was used to identify all randomized controlled trials from 1968 to 2005. Assessment scales used to evaluate study outcomes were recorded and classified based on the International Classification of Functioning Disability and Health (ICF) framework. Studies citing assessment of more than one ICF component were identified. In total, 1447 outcomes were assessed using 489 measurement scales and were cited in 491 identified trials. Both number of studies and assessment of participation outcomes increased over time. Participation assessments accounted for less than 6% of all measurement citations. Around 56.8% of studies reported multicomponent assessment. Of these, 25% included assessment at the level of ICF Participation. In conclusion, the vast body of work within the areas of impairment and function is a cornerstone for rehabilitation. This is certainly reflected in the recorded measurement citations. Despite increasing awareness and a significant increase in participation assessment, relatively few studies include assessment at this level, thereby limiting our understanding with regard to the impact of rehabilitation interventions on more complex areas of social participation.

Outcome assessment in randomized controlled trials of stroke rehabilitation.

The lack of a unified approach to outcome assessment in stroke rehabilitation limits our ability to interpret evidence provided by randomized controlled trials (RCTs). The purpose of this review was to identify outcomes and assessment tools reported in RCTs of stroke rehabilitation interventions as a first step toward consistent assessment of outcomes. Given that the validity of research is linked to reliability and validity of measurement, the relationship between the use of previously developed outcome measures and the methodological quality of RCTs was explored. Electronic literature searches identified RCTs examining stroke rehabilitation therapies from 1968 to 2005. The Physiotherapy Evidence Database (PEDro) scale was used to assess methodological quality. Cited outcomes were recorded and assessment tools identified as previously published or study specific. Four hundred ninety-one RCTs cited the assessment of 1447 outcomes using 489 measurement tools. Two hundred fifty-four of these were previously published, and 235 were study specific. A core of 30 frequently cited tools was identified. The use of previously published assessment tools to evaluate primary study outcomes was associated with higher PEDro scores. Significant heterogeneity in outcome assessment was demonstrated, although a core of 30 frequently cited tools could be identified. Appropriate evaluation and selection of outcome measures would enhance the methodological quality of randomized controlled trials.