Research Setting Versus Clinic Setting: Which Produces Better Outcomes in Cognitive Therapy for Depression?

To compare the outcomes of cognitive therapy for depression under controlled and clinically representative conditions, while holding several therapist and clinical assessment factors constant. Treatment outcomes for a sample of 23 adults with a primary diagnosis of Major Depressive Disorder who received cognitive therapy in an outpatient clinic were compared with outcomes of 18 clients who were treated in the cognitive therapy condition of a large, multi-site randomized clinical trial of treatments for depression. All participants had been treated by one of two therapists who served as clinicians in both settings. Individuals in the two samples were diagnostically and demographically similar (approximately 50 % Female, 83 % White). A variety of client characteristics, assessed prior to treatment, as well as the outcomes of treatment, were examined. Significantly superior treatment outcomes were observed in the individuals treated in the research study, relative to clients in the outpatient clinic, and the difference was not accounted for by intake characteristics. Individuals treated by the therapists in the RCT experienced almost three times as much improvement in depressive symptoms as clients seen in the outpatient setting. If replicated, the findings suggest that differences exist between treatment outcomes in research and outpatient settings and that these differences may not simply be due to therapist experience and training, or differences in patient populations. Future research should further examine the impact of fidelity monitoring, treatment expectation and motivation, and the duration and timing of treatment protocols on clinical outcomes.     

Migraine and Autonomic Dysfunction: Which Is the Horse and Which Is the Jockey?

Purpose of Review

Symptoms of autonomic dysfunction are common in patients with migraine, both during and between migraine attacks. Studies evaluating objective autonomic testing in patients have found significant, though somewhat conflicting results. The purposes of this review are to summarize and interpret the key findings of these studies, including those evaluating heart rate variability, autonomic reflex testing, and functional imaging in patients with migraine. The neuroanatomy of the central autonomic network as it relates to migraine is also reviewed.

Recent Findings

Several studies have evaluated autonomic balance in migraineurs, with conflicting results on the magnitude of sympathetic versus parasympathetic dysfunction. Most studies demonstrate sympathetic impairment, with a lesser degree of parasympathetic impairment.

Summary

Three trends have emerged: (1) migraine with aura tends to produce more significant autonomic dysfunction than migraine without aura, (2) sympathetic impairment is more common than parasympathetic impairment, and (3) sympathetic impairment is common in the interictal period, with increased sympathetic responsiveness during the ictal period, suggesting adrenoreceptor hypersensitivity.

     

Blood Pressure Measurement in Peritoneal Dialysis: Which Method Is Best?

♦ Background: The optimal approach to monitoring blood pressure (BP) in the peritoneal dialysis (PD) population is unclear. Ambulatory BP monitoring reliably predicts prognosis, but can be inconvenient. The accuracy of home BP monitoring in this population is unproven. The automated BpTRU device (BpTRU Medical Devices, Coquitlam, BC, Canada), which provides an average of up to 6 successive in-office BP measurements, has not been studied in this patient group.♦ Methods: We studied 17 patients (average age: 54 ± 12 years; 12 men, 5 women; 94% on automated PD) attending a single center. All patients underwent office, home, BpTRU, and ambulatory BP measurement. The reference standard for analysis was daytime ambulatory BP. Correlation between the referent method and each comparator method was determined (Pearson correlation coefficient), and Bland-Altman scatter plots depicting the differences in the BP measurements were constructed.♦ Results: Mean office BP (126.4 ± 16.9/78.8 ± 11.6 mmHg) and BpTRU BP (123.8 ± 13.7/80.7 ± 11.1 mmHg) closely approximated mean daytime ambulatory BP (129.3 ± 14.8/78.2 ± 7.9 mmHg). Mean home BP (143.8 ± 15.0/89.9 ± 28.1 mmHg) significantly overestimated mean daytime systolic BP by 14.2 mmHg (95% confidence interval: 4.3 mmHg to 24.1 mmHg; p = 0.008). Bland-Altman plots demonstrated poorest agreement between home BP and daytime ambulatory BP. No patient had “white-coat hypertension,” and only 1 patient had false-resistant hypertension. Most patients showed abnormal nocturnal dipping patterns (non-dipping: n = 11; reverse-dipping: n = 5; normal dipping: n = 1).♦ Conclusions: We report a novel finding that BP measurement using the BpTRU device is more accurate than home BP measurement in a PD population. Potential explanations for this observation include poor home BP measurement technique, use of poorly validated home BP measurement devices, or a reduced prevalence of white-coat effect among PD patients. Our study also confirms that, in the PD population, BP measurements vary considerably with patient location, time of day, and measurement technique.     

Insulin-Based Versus Triple Oral Therapy for Newly Diagnosed Type 2 Diabetes: Which is better?

OBJECTIVE

Early use of insulin after diagnosis of type 2 diabetes is met with resistance because of associated weight gain, hypoglycemia, and fear of decreased compliance and quality of life (QoL).

RESEARCH DESIGN AND METHODS

In treatment-naive patients with newly diagnosed type 2 diabetes, insulin and metformin were initiated for a 3-month lead-in period, then patients were randomly assigned to insulin and metformin (insulin group) or metformin, pioglitazone, and glyburide (oral group) for 36 months. Hypoglycemic events, compliance, A1C, weight, QoL, and treatment satisfaction were assessed.

RESULTS

Of 29 patients randomly assigned into each group, 83% (insulin group) and 72% (oral group) completed this 3-year study. At study completion, A1C was 6.1 ± 0.6% (insulin group) versus 6.0 ± 0.8% (oral group). Weight increased similarly in both groups (P = 0.09) by 4.47 kg (95% CI 0.89–8.04 kg) (insulin group) and 7.15 kg (95% CI 4.18–10.13 kg) (orals group). Hypoglycemic events did not differ between groups (mild 0.51 event/person-month in the insulin group vs. 0.68 event/person-month in the orals group, P = 0.18 and severe 0.04 event/person-year in the insulin group vs. 0.09 event/person-year in the orals group, P = 0.53). Compliance, QoL, and treatment satisfaction were similar between groups, with 100% of patients randomly assigned to insulin willing to continue such treatment.

CONCLUSIONS

When compared with a clinically equivalent treatment regimen, insulin-based therapy is effective and did not cause greater weight gain or hypoglycemia nor decrease compliance, treatment satisfaction, or QoL. Insulin is safe, well-accepted, and effective for ongoing treatment of patients with newly diagnosed type 2 diabetes.Type 2 diabetes is characterized by a progressive loss of β-cell function that results in deterioration of glucose control, which increases the incidence of diabetes-related complications. There are substantial data associating chronic hyperglycemia with long-term micro- and macrovascular complications (1–4), supporting the need for stringent glycemic control. Chronic hyperglycemia is thought to contribute to pancreatic β-cell dysfunction and loss of insulin secretory capacity by exerting a glucotoxic effect (5) and possibly exhaustion from the increased demand (6). This self-perpetuating cycle leads to progressive and often profound insulin deficiency, and such patients ultimately require insulin to maintain their A1C level at goal. In the UK Prospective Diabetes Study, only 9% of patients randomized to therapy with diet alone had A1C level of <7.0% at 9 years follow-up (7). In that same cohort, 53% of patients receiving sulfonylurea therapy required insulin therapy within 6 years (8).Insulin is the most effective hypoglycemic agent in our treatment armamentarium and is now recommended by the American Diabetes Association (ADA) guidelines (9) as the second agent added after metformin. Insulin is also thought to protect β-cell function decline (10), therefore exerting a “disease-modifying” effect. Yet there is resistance to insulin initiation among physicians and patients alike, not only as an early treatment option but also when oral hypoglycemic agents fail to control glucose levels (11). Some commonly cited barriers to insulin initiation are patient fear of disease progression and needle anxiety, as well as patient and provider fears of weight gain and hypoglycemic episodes (12). For these reasons, insulin has traditionally been viewed as a last resort for patients who fail to maintain glycemic control with diet and oral hypoglycemic drugs.However, previous studies have shown comparable weight gain, edema, and lipid changes in a comparison of insulin glargine or rosiglitazone added to a combination of sulfonylurea and metformin therapy. Insulin therapy was more cost-effective and produced greater reductions in A1C, when the baseline A1C was >9.5% (13). When an insulin and metformin treatment regimen was compared with addition of a third oral hypoglycemic agent after failure of two oral agents, patients with triple oral therapy were less likely to complete the regimen due to lack of efficacy or intolerable side effects (14). Studies suggest that short-term treatment with insulin after diagnosis (15) or at time of “secondary drug failure” (16) improves β-cell function and metabolic control. To evaluate the feasibility of an insulin-based regimen as first-line treatment for type 2 diabetes we compared compliance, satisfaction, quality of life (QoL), effectiveness, and safety in patients with newly diagnosed type 2 diabetes randomly assigned to triple oral hypoglycemic therapy or an insulin-based regimen.     

Obesity: Which drug and when?

BACKGROUND: Obesity, with all its consequences, is audaciously confronting medical professionals and health service providers worldwide. Diet and exercise intervention is an essential part of any weight management strategy, but may not succeed in isolation. Effective approaches for routine practice are more likely to involve affordable, efficacious and well-tolerated drug therapy than the more expensive, case selective approach of bariatric surgery. OBJECTIVES AND CONCLUSIONS: Advancement of pharmacotherapy is expanding the battery of available drugs; the clinician is faced with an increasingly complex therapeutic decision. Which drug to use, and when, is influenced by a range of factors, discussed here. There is a large body of high quality evidence in the literature to support the presently available drugs; however, many questions remain unanswered including duration of therapy and whether longer-term goals of improved morbidity and mortality are achievable. Clinician and patient awareness of these issues will provide a more informed therapeutic decision and ultimately improve the potential for reaching the weight management targets.     

Is Sleep Disordered Breathing Confounding Rehabilitation Outcomes in Spinal Cord Injury Research?

The purpose of this article is to highlight the importance of considering sleep-disordered breathing (SDB) as a potential confounder to rehabilitation research interventions in spinal cord injury (SCI). SDB is highly prevalent in SCI, with increased prevalence in individuals with higher and more severe lesions, and the criterion standard treatment with continuous positive airway pressure remains problematic. Despite its high prevalence, SDB is often untested and untreated in individuals with SCI. In individuals without SCI, SDB is known to negatively affect physical function and many of the physiological systems that negatively affect physical rehabilitation in SCI. Thus, owing to the high prevalence, under testing, low treatment adherence, and known negative effect on the physical function, it is contended that underdiagnosed SDB in SCI may be confounding physical rehabilitation research studies in individuals with SCI. Studies investigating the effect of treating SDB and its effect on physical rehabilitation in SCI were unable to be located. Thus, studies investigating the likely integrated relationship among physical rehabilitation, SDB, and proper treatment of SDB in SCI are needed. Owing to rapid growth in both sleep medicine and physical rehabilitation intervention research in SCI, the authors contend it is the appropriate time to begin the conversations and collaborations between these fields. We discuss a general overview of SDB and physical training modalities, as well as how SDB could be affecting these studies.     

Automobile Versus Pedestrian Injuries: Does Gender Matter?

Background: Automobile vs. pedestrian (AVP) injuries cause substantial morbidity and mortality. Gender may be an important factor in determining the anatomic distribution and severity of these injuries. The objective of this study was to examine the effect of gender on the nature and severity of automobile vs. pedestrian injuries and the outcome. Methods: Trauma registry study that included all AVP pedestrian injuries admitted during a 14-year period to a Level I trauma center. The following variables were included in an Excel (Microsoft Corporation, Redmond, WA) file for the purpose of this study: age, gender, body area Abbreviated Injury Score, Injury Severity Score, specific fractures (pelvic, spine, femur, tibia), survival, and intensive care unit (ICU) and hospital length of stay. Results: The study population included 6965 patients, 67.3% of whom were male. Overall, 20.7% were in the age group < 15 years, 60.5% in the age group 15–55 years, 7.6% in the age group 56–65 years, and 11.1% in the age group > 65 years. Pelvic fractures were significantly more common in females than males (20.7% vs. 11.4%, respectively, p < 0.0001). This difference was present in all age groups, but especially in the groups 56–65 years (28.5% vs. 12.3%, respectively, p < 0.0001) and > 65 years (32.5% vs. 15.7%, respectively, p < 0.0001). Males in the age group 15–55 years were significantly more likely to suffer tibia fractures (31.8% vs. 25.7%, respectively, p < 0.001). Multivariate analysis showed no difference in survival or ICU stay between the two genders, but there was a significantly longer hospital stay in males 15–65 years. Conclusions: Gender plays a significant role in the incidence of pelvic and tibial fractures but has no effect on survival or ICU stay, but male patients in the age group 15–65 years had a significantly longer hospital stay.     

Which dimensions of disability does the HIV Disability Questionnaire (HDQ) measure? A factor analysis

Abstract

Purpose: To assess the dimensions of disability measured by the HIV Disability Questionnaire (HDQ), a newly developed 72-item self-administered questionnaire that describes the presence, severity and episodic nature of disability experienced by people living with HIV. Methods: We recruited adults living with HIV from hospital clinics, AIDS service organizations and a specialty hospital and administered the HDQ followed by a demographic questionnaire. We conducted an exploratory factor analysis using disability severity scores to determine the domains of disability in the HDQ. We used the following steps: (a) ensured correlations between items were >0.30 and <0.80; (b) conducted a principal components analysis to extract factors; (c) used the Scree Test and eigenvalue threshold >1.5 to determine the number of factors to retain; and d) used oblique rotation to simplify the factor loading matrix. We assigned items to factors based on factor loadings of >0.30. Results: Of the 361 participants, 80% were men and 77% reported living with at least two concurrent health conditions in addition to HIV. The exploratory factor analysis suggested retaining six factors. Items related to symptoms and impairments loaded on three factors (physical [20 items], cognitive [3 items], and mental and emotional health [11 items]) and items related to worrying about the future, daily activities, and personal relationships loaded on three additional factors (uncertainty [14 items], difficulties with day-to-day activities [9 items], social inclusion [12 items]). Conclusions: The HDQ has six domains: physical symptoms and impairments; cognitive symptoms and impairments; mental and emotional health symptoms and impairments; uncertainty; difficulties with day-to-day activities and challenges to social inclusion. These domains establish the scoring structure for the dimensions of disability measured by the HDQ.

• Implications for Rehabilitation

• As individuals live longer and age with HIV, they may be living with the health-related consequences of HIV and concurrent health conditions, a concept that may be termed disability. Measuring disability is important to understand the impact of HIV and its comorbidities.

• The HIV Disability Questionnaire (HDQ) is a self-administered questionnaire developed to describe the presence, severity and episodic nature of disability experienced by people living with HIV. The HDQ is comprised of six domains of disability including: physical symptoms and impairments (20 items); cognitive symptoms and impairments (3 items); mental and emotional health symptoms and impairments (11 items); uncertainty (14 items); difficulties with day-to-day activities (9 items) and challenges to social inclusion (12 items). These domains represent the dimensions of disability measured by the HDQ.

• The HDQ is the first known HIV-specific disability measure for adults living with HIV. The HDQ may be used by clinicians and researchers to assess disability experienced by adults living with HIV.

     

Transvaginal Multifetal Pregnancy Reduction: Which? When? How Many?

This report contains the experience of our centre, using the transvaginally guided puncture procedure, to reduce the number of fetuses in a multifetal pregnancy to a lower number. The aim of the procedure was to improve perinatal outcome and/or to meet the personal desires of patients and their families. We surveyed 148 multifetal pregnancy reductions. The fetus or fetuses overlying the internal os was most commonly reduced. The total uncorrected loss of the entire pregnancy was 13.4%. The corrected pregnancy loss was 11%. Of the 63 twins left after the reduction, 33 delivered preterm. Of the 36 singletons, two delivered preterm. Our conclusion was that multifetal pregnancy reduction is a safe procedure for the mother and has an acceptable loss rate of the entire pregnancy. The reduction of a fetus overlying the internal os by the transvaginal puncture procedure seems to yield results at least as good as the transabdominally performed puncture procedures for multifetal pregnancy reduction.     

How Good Is the Neurophysiology of Pain Questionnaire? A Rasch Analysis of Psychometric Properties

The Neurophysiology of Pain Questionnaire (NPQ) was devised to assess how an individual conceptualizes the biological mechanisms that underpin his or her pain. Despite its widespread use, its psychometric properties have not been comprehensively interrogated. Rasch analysis was undertaken on NPQ data from a convenience sample of 300 spinal pain patients, and test-retest reliability was assessed in a sample of 45 low back pain patients. The NPQ effectively targeted the ability of the sample and had acceptable internal consistency and test-retest reliability. However, some items functioned erratically for persons of differing abilities or were psychometrically redundant. The NPQ was reanalyzed with 7 questionable items excluded, and superior psychometric properties were observed. These findings suggest that the NPQ could be improved, but future prospective studies including qualitative measures are needed. In summary, the NPQ is a useful tool for assessing a patient's conceptualization of the biological mechanisms that underpin his or her pain and for evaluating the effects of cognitive interventions in clinical practice and research. These findings suggest that it has adequate psychometric properties for use with chronic spinal pain patients.PerspectiveRasch analysis was used to analyze the NPQ. Despite several limitations, these results suggest that it is a useful tool with which to assess a patient's conceptualization of the biological mechanisms that underpin his or her pain and to evaluate the effects of cognitive interventions in clinical practice and research.