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Incorporating results of a provider attitudes survey in development of an outcomes assessment program.

The objective of this study was to obtain information from providers of a behavioral health service and from decision makers for organizations interacting with that service (external contacts) on their attitudes regarding outcomes assessment in their clinical practice. The goal of obtaining the information was to use it in development of a formal Outcomes Assessment Program for the service. The design was a semi-structured interview format, with entry into a computer database and qualitative analysis of responses obtained. Participants included all providers (n = 26) and a purposive sample of external contacts (n = 10) of an academic Department of Psychiatry. Results indicated differences among categories of external contacts regarding priorities of types of outcomes (general health, general mental health, disorder specific, or patient satisfaction) to be shared and absence of concordance within the service about these priorities. No guidelines were available about preferred instruments, though the Global Assessment of Functioning, the Beck Depression Inventory, and the Abnormal Involuntary Movements Scale emerged as instruments to be prioritized in the service's program. Physicians and nonphysicians differed in their perceptions as to important barriers and advantages of a clinical outcomes assessment program. In conclusion, the survey raised providers' awareness of outcomes assessment and provided information that was used in developing the service's Outcomes Assessment Program. Components of the Program that were influenced by survey input were priorities of outcomes instruments to be included and their potential audiences, time sequence of Program development, time to be allotted to outcomes assessment in clinical encounters, and content of educational experiences for providers.

Academic Medical Centers↗

Cost-effectiveness as an outcome in randomized clinical trials.

BACKGROUND: Economic outcomes are now included in many contemporary randomized trials and provide an additional dimension to the assessment of interventions. Economic data collection and analysis pose several methodologic challenges, however. PURPOSE: This paper reviews methods of incorporating economic outcomes in clinical trials. RESULTS: Data on medical resource utilization and cost can readily be collected along with data on clinical outcomes. The cost of planned interventions can be measured with reasonable accuracy, but costs due to unplanned clinical events are more difficult to measure reliably. The total cost depends critically on these relatively infrequent, yet costly, adverse outcomes, which may partially, or even completely, offset any difference between the planned costs of the randomized therapies. Newer therapies are typically more expensive than older therapies, so the most important question is whether patient outcomes are improved sufficiently to justify the added expense. Cost-effectiveness analysis helps gauge the value provided by a new therapy. The cost-effectiveness of an intervention compared with an alternative is defined as the ratio of the incremental costs and the incremental clinical benefits, measured as dollars per quality-adjusted life-year added. The follow-up period in most clinical trials is generally long enough to measure the added cost of therapy, but may not capture the full benefits of treatment. The limited time horizon of clinical trials makes it necessary to use a model to extrapolate the observed effect of treatment and project the increase in life expectancy. The resulting cost-effectiveness ratio is sensitive to assumptions about the long-term efficacy of treatment, particularly whether the treatment effect will continue or dissipate over time. CONCLUSION: Economic outcomes can be measured alongside clinical outcomes in randomized trial. While the use of cost-effectiveness models falls outside the strictly empirical, within-trial analysis framework that is embraced by most clinical trialists, it provides an explicit approach to assessing whether the intervention under study provides a clinically meaningful improvement in outcome that is worthwhile.

Clinical Protocols↗

Randomized trials, generalizability, and meta-analysis: graphical insights for binary outcomes.

BACKGROUND: Randomized trials stochastically answer the question. "What would be the effect of treatment on outcome if one turned back the clock and switched treatments in the given population?" Generalizations to other subjects are reliable only if the particular trial is performed on a random sample of the target population. By considering an unobserved binary variable, we graphically investigate how randomized trials can also stochastically answer the question, "What would be the effect of treatment on outcome in a population with a possibly different distribution of an unobserved binary baseline variable that does not interact with treatment in its effect on outcome?" METHOD: For three different outcome measures, absolute difference (DIF), relative risk (RR), and odds ratio (OR), we constructed a modified BK-Plot under the assumption that treatment has the same effect on outcome if either all or no subjects had a given level of the unobserved binary variable. (A BK-Plot shows the effect of an unobserved binary covariate on a binary outcome in two treatment groups; it was originally developed to explain Simpsons's paradox.) RESULTS: For DIF and RR, but not OR, the BK-Plot shows that the estimated treatment effect is invariant to the fraction of subjects with an unobserved binary variable at a given level. CONCLUSION: The BK-Plot provides a simple method to understand generalizability in randomized trials. Meta-analyses of randomized trials with a binary outcome that are based on DIF or RR, but not OR, will avoid bias from an unobserved covariate that does not interact with treatment in its effect on outcome.

Data Interpretation, Statistical↗

A systematic review of outcomes assessed in randomized controlled trials of surgical interventions for carpal tunnel syndrome using the International Classification of Functioning, Disability and Health (ICF) as a reference tool.

BACKGROUND: A wide range of outcomes have been assessed in trials of interventions for carpal tunnel syndrome (CTS), however there appears to be little consensus on what constitutes the most relevant outcomes. The purpose of this systematic review was to identify the outcomes assessed in randomized clinical trials of surgical interventions for CTS and to compare these to the concepts contained in the International Classification of Functioning, Disability and Health (ICF). METHODS: The bibliographic databases Medline, AMED and CINAHL were searched for randomized controlled trials of surgical treatment for CTS. The outcomes assessed in these trials were identified, classified and linked to the different domains of the ICF. RESULTS: Twenty-eight studies were retrieved which met the inclusion criteria. The most frequently assessed outcomes were self-reported symptom resolution, grip or pinch strength and return to work. The majority of outcome measures employed assessed impairment of body function and body structure and a small number of studies used measures of activity and participation. CONCLUSION: The ICF provides a useful framework for identifying the concepts contained in outcome measures employed to date in trials of surgical intervention for CTS and may help in the selection of the most appropriate domains to be assessed, especially where studies are designed to capture the impact of the intervention at individual and societal level. Comparison of results from different studies and meta-analysis would be facilitated through the use of a core set of standardised outcome measures which cross all domains of the ICF. Further work on developing consensus on such a core set is needed.

Activities of Daily Living↗

A review of the psychometric properties of the Health of the Nation Outcome Scales (HoNOS) family of measures.

BACKGROUND: The Health of the Nation Outcome Scales was developed to routinely measure outcomes for adults with mental illness. Comparable instruments were also developed for children and adolescents (the Health of the Nation Outcome Scales for Children and Adolescents) and older people (the Health of the Nation Outcome Scales 65+). All three are being widely used as outcome measures in the United Kingdom, Australia and New Zealand. There is, however, no comprehensive review of these instruments. This paper fills this gap by reviewing the psychometric properties of each. METHOD: Articles and reports relating to the instruments were retrieved, and their findings synthesised to assess the instruments' validity (content, construct, concurrent, predictive), reliability (test-retest, inter-rater), sensitivity to change, and feasibility/utility. RESULTS: Mostly, the instruments perform adequately or better on most dimensions, although some of their psychometric properties warrant closer examination. CONCLUSION: Collectively, the Health of the Nation Outcome Scales family of measures can assess outcomes for different groups on a range of mental health-related constructs, and can be regarded as appropriate for routinely monitoring outcomes.

Adolescent↗

Serum neuron-specific enolase as early predictor of outcome after in-hospital cardiac arrest: a cohort study.

INTRODUCTION: Outcome after cardiac arrest is mostly determined by the degree of hypoxic brain damage. Patients recovering from cardiopulmonary resuscitation are at great risk of subsequent death or severe neurological damage, including persistent vegetative state. The early definition of prognosis for these patients has ethical and economic implications. The main purpose of this study was to investigate the prognostic value of serum neuron-specific enolase (NSE) in predicting outcomes in patients early after in-hospital cardiac arrest. METHODS: Forty-five patients resuscitated from in-hospital cardiac arrest were prospectively studied from June 2003 to January 2005. Blood samples were collected, at any time between 12 and 36 hours after the arrest, for NSE measurement. Outcome was evaluated 6 months later with the Glasgow outcome scale (GOS). Patients were divided into two groups: group 1 (unfavorable outcome) included GOS 1 and 2 patients; group 2 (favorable outcome) included GOS 3, 4 and 5 patients. The Mann-Whitney U test, Student's t test and Fisher's exact test were used to compare the groups. RESULTS: The Glasgow coma scale scores were 6.1 +/- 3 in group 1 and 12.1 +/- 3 in group 2 (means +/- SD; p < 0.001). The mean time to NSE sampling was 20.2 +/- 8.3 hours in group 1 and 28.4 +/- 8.7 hours in group 2 (p = 0.013). Two patients were excluded from the analysis because of sample hemolysis. At 6 months, favorable outcome was observed in nine patients (19.6%). Thirty patients (69.8%) died and four (9.3%) remained in a persistent vegetative state. The 34 patients (81.4%) in group 1 had significantly higher NSE levels (median 44.24 ng/ml, range 8.1 to 370) than those in group 2 (25.26 ng/ml, range 9.28 to 55.41; p = 0.034). CONCLUSION: Early determination of serum NSE levels is a valuable ancillary method for assessing outcome after in-hospital cardiac arrest.

Aged↗

Severe brain injury ICU outcomes are associated with Cranial-Arterial Pressure Index and noninvasive Bispectral Index and transcranial oxygen saturation: a prospective, preliminary study.

INTRODUCTION: The purpose of this study was to determine if noninvasive transcranial oxygen saturation (StcO2) and Bispectral Index (BIS) correlate with severe traumatic brain injury intensive care unit (ICU) outcomes. METHODS: This is a prospective observational study. Values of intracranial pressure (ICP), mean arterial pressure (MAP), BIS, and StcO2 were recorded hourly for the first six, post-injury days in 18 patients with severe brain injury. Included in the analyses was the Cranial-Arterial Pressure (CAP) Index, which is ICP/(MAP-ICP). RESULTS: After 1,883 hours of data were analyzed, we found that StcO2 and BIS are associated with survival, good neurological outcome, ICP </=20, cerebral perfusion pressure (CPP) > or =60, and CAP index < or =0.30 (p < or = 0.001). Survival and good outcome are independently associated with BIS > or =60, StcO2 > or =70, and ICP < or =20 (p < 0.0001). BIS > or =60 or StcO2 > or =70 is associated with survival, good outcome, CPP > or =60, ICP < or =20, CAP index < or =0.30, and fewer ICP interventions (p < 0.0001). With BIS > or =60 or StcO2 > or =70, the rate of CPP > or =60 is 97.2% and the rate of ICP< or = 25 is 97.1%. An increased CAP index is associated with death, poor neurological outcome, and increased ICP interventions (p < 0.0001). With CAP index >0.25, MAP is not related to ICP (p = 0.16). CONCLUSION: Numerous significant associations with ICU outcomes indicate that BIS and StcO2 are clinically relevant. The independent associations of BIS, StcO2, and ICP with outcomes suggest that noninvasive multi-modal monitoring may be beneficial. Future studies of patients with BIS > or =60 or StcO2 > or =70 will determine if select patients can be managed without ICP monitoring and whether marginal ICP can be observed. An increased CAP index is associated with poor outcome.

Adult↗

What is the association between the different components of stroke rehabilitation and health outcomes?

OBJECTIVES: To describe the rehabilitation input stroke patients received from health professionals during the early post stroke period and to explore possible associations between health outcomes and these rehabilitation inputs. DESIGN: Community-based study with prospective identification of stroke patients from a random sample of 24 general practices stratified by geographical area and practice size. SETTING: Ayrshire and Arran Health Board area, West of Scotland. INTERVENTIONS: All physiotherapy, occupational therapy, dietetics, podiatry, speech and language therapy and community nursing inputs given to stroke patients in the course of normal treatment were recorded. OUTCOME MEASURES: Barthel Index and Medical Outcomes Study Short Form-36 (SF-36). Both recorded at one, three and six months post stroke. RESULTS: Of the 152 people providing data, more had received physiotherapy than any other rehabilitation input at all three follow-ups (81%, 47%, 39%), with occupational therapy being the next most common service (65%, 44%, 25%). Amount of rehabilitation input was significantly negatively correlated with health outcomes measured at each discrete time point: those patients with the poorest outcomes received greatest input. However, regression analysis of change in outcome scores showed that increasing amounts of rehabilitation input were significantly associated with a reduction in disability, particularly between one and three months post stroke. CONCLUSIONS: Not only have we shown that those stroke patients with poorest outcomes received most rehabilitation input, but, from analysis of the individual rehabilitation inputs, we have identified some rehabilitation inputs that significantly predict improved outcomes. This suggests that there would be merit in further investigation of these associations.

Activities of Daily Living↗

Cerebral white matter lesions in bipolar affective disorder: relationship to outcome.

BACKGROUND: Twenty per cent of patients with bipolar affective disorder suffer an illness that responds inadequately to treatment and has a poor outcome. Many patients, but not all, with bipolar disorder show white matter abnormalities on T(2)-weighted magnetic resonance imaging (MRI). AIMS: To explore the hypothesis that white matter abnormalities on MRI are seen more frequently in subjects whose illness has a poor outcome compared with those with a good outcome or controls. METHOD: Two groups of age- and gender-matched patients with bipolar disorder (14 with a good outcome and 15 with a poor outcome) and 15 controls, aged 20-65 years, were studied. Axial T(2)-weighted MRI scans were examined for the presence and severity of white matter abnormalities. RESULTS: Significantly more poor outcome group members had deep subcortical punctate, but not periventricular, white matter hyperintensities than the good outcome group (P:=0.035) or controls (P:=0.003) and these abnormalities were of greater severity (P:=0.030 and P:<0.014, respectively). CONCLUSIONS: Subcortical white matter lesions are associated with poor outcome bipolar disorder.

Adult↗

Heterogeneity of outcomes in schizophrenia. 3-year follow-up of treated prevalent cases.

BACKGROUND: Care for people with schizophrenia should address a wide range of outcomes, including professional and consumer perspectives. AIMS: To measure changes in psychopathology, functioning, needs for care and quality of life; to develop predictive models for each outcome domain; and to assess the frequency of 'good'and'poor' outcomes, as defined in a series of different definitions that use combinations of the four domains measured. METHOD: Three-year follow-up of a 1-year-treated prevalence cohort of 107 patients with an ICD-10 diagnosis of schizophrenia attending the South Verona community-based mental health service. RESULTS: Mean symptom severity and some types of needs for care worsen, but quality of life shows no change. Functioning shows a non-significant trend to deteriorate. Between 32% and 42% of the variance in the four key outcomes was explained by our model. Different definitions of 'good'and 'poor' outcome included 0-31% of patients, depending on the definition used. CONCLUSIONS: The 3-year outcome for schizophrenia depends on the domain of outcome used, whether staff or patient ratings are used and the stringency of the definitions used for good and poor outcome.

Adult↗

Choosing outcome assessment instruments for trauma registries.

While trauma registries have the potential to collect detailed information about patient outcomes, the most commonly reported outcome, mortality, only represents the outcome from a small proportion of the total trauma population. If trauma registries are to progress to routine monitoring of outcomes in trauma survivors, instruments that measure relevant outcomes in the remainder of the trauma population must be identified and implemented. This report provides an overview of the specific needs of trauma registries with respect to assessing patient outcomes other than mortality. The use of previously recommended outcome assessment instruments is discussed, with a focus on the utility of these instruments for use in routine monitoring of trauma outcomes other than mortality through trauma registries.

Abbreviated Injury Scale↗

Predictors of outcome in pediatric epilepsy surgery.

OBJECTIVE: To determine the correlation between pre- and perioperative variables on the outcome of children undergoing focal resections for medically intractable partial epilepsy. METHODS: Retrospective analysis of pre- and perioperative variables in a cohort of 75 patients younger than 12 years of age who underwent excisional surgery and had at least 1 year of follow-up. Outcome, measured by postoperative seizure frequency, was analyzed as a function of age at seizure onset, duration of epilepsy, presence of cognitive impairment, lobe of seizure origin, presence of a lesion, histopathology, and completeness of resection. Completeness of resection was defined on the basis of excising both the entire structural lesion if present and the region revealing prominent interictal and ictal abnormalities on intracranial EEG. RESULTS: Seventy-seven percent of patients had good outcomes (class 1 or 2), and 59% were seizure-free. Lesional status, site of resection, and pathologic diagnoses were not significant predictors of outcome except for in multilobar resection, for which overall outcome was relatively poor (44% class 3 or 4; 22% seizure-free). Completeness of resection was the only significant predictor of good outcome (p < 0.001), with 92% of patients who underwent complete resection of the epileptogenic zone achieving good outcome compared with 50% of patients who had incomplete resections. CONCLUSION: In this series of pediatric patients, complete resection of the lesion and the electrographically abnormal region was the main determinant of outcome after focal resections. Except for multilobar resections, other factors examined in this study did not significantly influence postoperative seizure prognosis and should not influence candidate selection for the surgical process.

Child↗

Relationship of flumazenil and glucose PET abnormalities to neocortical epilepsy surgery outcome.

BACKGROUND: Cortical areas showing abnormal glucose metabolism and [(11)C]flumazenil (FMZ) binding are commonly seen on PET scans of patients with intractable partial epilepsy, but it is unclear whether these must be totally resected to achieve seizure control. OBJECTIVE: To analyze whether the extent of cortex showing 2-deoxy-2-[(18)F]fluoro-D-glucose (FDG) or FMZ PET abnormalities correlates with the outcome of resective epilepsy surgery. METHODS: Cortical FDG and FMZ PET abnormalities in 15 young patients (mean age, 12.2 +/- 7.0 years) with intractable partial epilepsy of neocortical origin were marked as regions with abnormal asymmetry using an objective semiautomated software package. These marked regions were then projected and measured on the brain surface reconstructed from the coregistered high-resolution MRI. Following cortical resection, the size of nonresected cortex with preoperative PET abnormalities was also measured (calculated separately for marked areas in the lobe of seizure onset as defined by long-term video EEG monitoring, and in remote cortical areas). Extent of preoperative PET abnormalities and postoperative nonresected cortex abnormalities on PET were correlated with outcome scores. RESULTS: Large preoperative FMZ PET abnormalities were associated with poor outcome (r = 0.57; p = 0.025). Larger areas of nonresected cortex with preoperative FMZ PET abnormalities in the lobe of seizure onset were also associated with worse outcome in the whole group (r = 0.66; p = 0.007) as well as in patients with extratemporal resection (r = 0.73; p = 0.007), and in those with no lesion on MRI (r = 0.60; p = 0.049). Patients with seizure-free outcome had significantly smaller nonresected cortex with preoperative FMZ PET abnormalities than those who continued to have seizures (p = 0.022). No significant correlations between nonresected FDG PET abnormalities and surgical outcome were found. CONCLUSIONS: Extensive cortical abnormalities on FMZ PET predict poor outcome in neocortical epilepsy surgery. Resection of FMZ abnormalities in the lobe of seizure onset is associated with excellent outcome even in the absence of a structural lesion. In contrast, although FDG PET abnormalities regionalized the epileptogenic area, their size was not related to the extent of epileptogenic tissue to be removed.

Adolescent↗

Effect of clipping, craniotomy, or intravascular coiling on cerebral vasospasm and patient outcome after aneurysmal subarachnoid hemorrhage.

OBJECTIVE: Although several recent studies have suggested that the incidence of vasospasm after aneurysmal subarachnoid hemorrhage is lower in patients undergoing aneurysmal coiling as compared with clipping, other studies have had conflicting results. We reviewed our experience over 8 years and assessed whether clipping, craniotomy, or coiling affects patient outcomes or the risk for vasospasm. METHODS: We included 515 patients with aneurysmal subarachnoid hemorrhage, identified prospectively from November 2000 to February 2003 (243 patients) and retrospectively from November 1995 to October 2000 (272 patients), by using International Classification of Diseases, 9th Revision, codes for subarachnoid hemorrhage. We classified patients as follows: clipping (413 patients), coiling (79 patients), and craniotomy (436 patients, including all 413 patients who underwent clipping plus 23 who underwent coiling as well as craniotomy for various reasons). We studied four outcome measures: total vasospasm, symptomatic vasospasm, poor outcome (modified Rankin score 3-6), and in-hospital mortality. To assess the risk of total vasospasm and symptomatic vasospasm, we performed multivariate regression analyses adjusting for age, Fisher grade, Hunt and Hess grade, aneurysm location (anterior versus posterior circulation), and aneurysm treatment modality. To assess the risk for poor outcome and in-hospital mortality, we adjusted for all the above variables as well as for total and symptomatic vasospasm. RESULTS: In the clipping group there was 63% total vasospasm and 28% symptomatic vasospasm; in the coiling group there was 54% total vasospasm and 33% symptomatic vasospasm; and in the craniotomy group there was 64% total vasospasm and 28% symptomatic vasospasm. In the multivariate analysis, age <50 years (P = 0.0099) and Fisher Grade 3 (P < 0.00001) predicted total vasospasm, and Fisher Grade 3 (P < 0.000001) and Hunt and Hess Grade IV or V (P = 0.018) predicted symptomatic vasospasm. Predictors of poor outcome were age >or=50 years (P < 0.0001), Fisher Grade 3 (P = 0.0072), Hunt and Hess Grade IV or V (P < 0.00001), symptomatic vasospasm (P < 0.0001), and coiling (P = 0.0314 versus clipping and P = 0.045 versus craniotomy). Predictors of in-hospital mortality were age >or= 50 years (P = 0.0030), Hunt and Hess Grade IV or V (P = 0.0001), symptomatic vasospasm (P < 0.00001), and coiling (P = 0.008 versus clipping and P = 0.0013 versus craniotomy). There was no significant difference in total vasospasm or symptomatic vasospasm when patients who underwent clipping or craniotomy were compared with patients who underwent coiling. In patients with Hunt and Hess Grade I to III ("good grade"), clipping and craniotomy were associated with better outcome and less in-hospital mortality, but there was no difference in total vasospasm or symptomatic vasospasm versus coiling. In patients with Hunt and Hess Grade IV or V ("poor grade"), there was no difference in any outcome measure among the treatment groups. CONCLUSION: In a single-center, retrospective, nonrandomized study, performance of clipping and/or craniotomy had significantly better outcome and lower mortality at discharge than coiling in good-grade patients but had no effect on total vasospasm or symptomatic vasospasm in good- or poor-grade patients.

Craniotomy↗

Functional outcome after central corpectomy in poor-grade patients with cervical spondylotic myelopathy or ossified posterior longitudinal ligament.

OBJECTIVE: We studied the long-term functional outcome in poor-grade patients (Nurick Grades 4 and 5) with cervical spondylotic myelopathy (CSM) or ossified posterior longitudinal ligament after central corpectomy (CC). We sought to determine whether there were any prognostic factors that could predict functional outcome in these patients. METHODS: Functional outcome data were collected for 72 patients (68 men and 4 women; mean age, 49.7 yr; range, 30-67 yr) with CSM (60 patients) or OPLL (12 patients) of Nurick Grades 4 (55 patients) and 5 (17 patients). Uninstrumented CC was performed at 1 level in 12 patients, at 1 level combined with a discoidectomy at another level in 4 patients, at 2 levels in 50 patients, and at 2 levels plus a discoidectomy in 5 patients. The age at presentation (< or =50 yr or >50 yr), grade before surgery (4 or 5), the number of levels operated (1 or >1), diagnosis (CSM or ossified posterior longitudinal ligament), and duration of myelopathic symptoms (< or =12 mo or >12 mo) were studied for their effect on the functional outcome noted at the last follow-up. Functional outcome was graded as poor (no change in Nurick grade), fair (improvement of one Nurick grade), good (improvement of two Nurick grades), and cure (follow-up Nurick grade of 0 or 1). RESULTS: The follow-up ranged from 9 to 104 months (mean, 36.3 mo). One patient died 3 weeks after CC after surgery for a perforated duodenal ulcer. There was transient operative morbidity in 12 patients (16.9%). The mean Nurick score improved from 4.24 to 2.47 (P < 0.001). Of the 54 patients (76%) who improved in their Nurick grade, the functional outcome was graded as fair in 13 patients (18.3%), good in 24 patients (33.8%), and cure in 17 patients (23.9%). The functional outcome was poor in 17 patients (23.9%). Functional improvement after CC was uniformly correlated with myelopathic symptoms of 12 months' duration or shorter. The other favorable prognostic indicators for improvement after CC were a diagnosis of CSM and preoperative Nurick Grade 5; however, patients with a preoperative Nurick grade of 4 were more likely to experience a cure. CONCLUSION: More than three-fourths of patients with poor-grade CSM improve in their functional status after CC, with nearly 24% of patients obtaining a cure. Because patients with a duration of myelopathic symptoms of 12 months or less had the best functional outcome, early decompressive surgery should be offered to patients with poor-grade CSM.

Adult↗

Effect on health-related outcomes of interventions to alter the interaction between patients and practitioners: a systematic review of trials.

PURPOSE: We wanted to identify published randomized trials of interventions to alter the interaction between patients and practitioners, develop taxonomies of the interventions and outcomes, and assess the evidence that such interventions improve patients' health and well-being. METHODS: Undertaking a systematic review of randomized trials, we sought trials in primary and secondary care with health-related outcomes, which we found by searching MEDLINE, HealthSTAR, and PsycINFO bibliographic databases through 1999. We also completed one round of manual citation searching. RESULTS: Thirty-five trials were included. Most were set in primary care in North America. Trials were heterogeneous in populations, settings, interventions, and measures. Interventions frequently combined several poorly described elements. Explicit theoretical underpinning was rare, and only one study linked intervention through process to outcome measures. Health outcomes were rarely measured objectively (6 of 35), and only 4 trials with health outcomes met predefined quality criteria. Interventions frequently altered the process of interactions (significantly in 73%, 22 of 30 trials). Principal outcomes favored the intervention group in 74% of trials (26 of 35), reaching statistical significance in 14 (40%). Positive effects on health outcomes achieved statistical significance in 44% of trials (11 of 25); negative effects were uncommon (5 of 25, 20%). Simple approaches to increasing the participation of patients in the clinical encounter, such as providing practitioners with a note from patients about their concerns beforehand, showed promise, as did more complex programs providing specific information about disease and attention to emotion. Apparently similar interventions varied in effectiveness across studies. CONCLUSIONS: Successful interactions between patients and their practitioners lie at the heart of medicine, yet there are few rigorous trials of well-specified interventions to inform best practice. Trial evidence suggests that a range of approaches can achieve changes in this interaction, and some show promise in improving patients' health. To advance knowledge further, we need to replicate promising studies using rigorous methods. These should include explicit theoretical frameworks designed to link effects on key communication and interaction characteristics through to effects on health outcomes.

Delivery of Health Care↗

Clinical outcome estimates based on treatment target limits of laboratory tests: proposal for a plot visualizing effects and differences of medical target setting exemplified by glycemic control in diabetes.

BACKGROUND: In modern medicine many laboratory measurements are used as a surrogate for clinical outcome. There is therefore a need for models to quantify this approach. The target plot presented here is based on the difference plot. The difference between two measurements is plotted against the initial measurement, of which the first measurement is the index measurement (Mindex) and the second the outcome measurement (Moutcome). A vertical line separates normal vs. increased Mindex concentrations according to a selected target concentration, and a horizontal line describes the situation of no change. A target line (Mtarget) with a slope equal to -1 and indicating the selected target concentration is drawn through the crossing point. The six outcome areas thus refer to the combined effect of Mindex and Moutcome. A target plot taking the biological and analytical variation in consideration is considered. MATERIALS AND MODEL: The target plot addresses sources of outcome categories, and calculates the percentage in each of these categories according to a defined target value. Hemoglobin A1c (HbA1c) in diabetes in patients from Vejle County, Denmark was taken as an example. RESULTS: Different strategies for target setting for HbA1c were investigated: the Danish Diabetes Association (DDA) target of 5.84% HbA1c, the target from the American Diabetes Association (ADA) of 7.0% HbA1c, and 6.62% HbA1c, which is the 99.9 centile of the Danish national reference interval. All three strategies can be validated from the target plot for differences in surrogate clinical outcome in spite of identical patient material. Use of the ADA target (the highest nominal value) reveals the lowest percentage of index values above the target, and of those the highest percentage outcome values of the surrogate measure reached the target. CONCLUSION: The target plot allows detailed stratification of outcome based on surrogate parameters and assessment of risk of disease based on the selected target. The need to standardize outcome targets in diabetes to allow comparison of quality of treatment is obvious.

Blood Glucose↗

Using DSM axis II information to predict outcome in short-term individual psychotherapy.

The present study considered three methods of using DSM Axis II information to examine the effect of personality disorder on outcome in two forms of short-term, individual psychotherapy (interpretive and supportive). The first method involved examining whether the presence of any personality disorder influenced treatment outcome. The second method involved examining the effect of the number of personality disorders on outcome. The third involved examining outcome for specific personality disorders. The study found that a diagnosis of any personality disorder did not influence the outcome of therapy. In contrast, the number of personality disorders was significantly related to outcome at post-therapy and at 12-month follow-up. The findings indicated that a greater number of personality disorders was associated with less favorable outcome across both forms of therapy. This supports the notion that personality pathology is more severe when it involves a greater number of personality disorders. In an exploratory set of analyses, the study also found some evidence of differences in outcome for specific personality disorders.

Adolescent↗