Charles H. Goldsmith

Multiattribute and single-attribute utility functions for the Health Utilities index mark 3 system

Background. The Health Utilities Index Mark 3 (HUI3) is a generic multiattribute preference‐based measure of health status and health‐related quality of life that is widely used as an outcome measure in clinical studies, in population health surveys, in the estimation of quality‐adjusted life years, and in economic evaluations. HUI3 consists of eight attributes (or dimensions) of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain with 5 or 6 levels per attribute, varying from highly impaired to normal. Objectives. The objectives are to present a multiattribute utility function and eight single‐attribute utility functions for the HUI3 system based on community preferences. Study Design. Two preference surveys were conducted. One, the modeling survey, collected preference scores for the estimation of the utility functions. The other, the direct survey, provided independent scores to assess the predictive validity of the utility functions. Measures. Preference measures included value scores obtained on the Feeling Thermometer and standard gamble utility scores obtained using the Chance Board. Respondents. A random sample of the general population (≥16 years of age) in Hamilton, Ontario, Canada. Results. Estimates were obtained for eight single‐attribute utility functions and an overall multiattribute utility function. The intraclass correlation coefficient between directly measured utility scores and scores generated by the multiattribute function for 73 health states was 0.88. Conclusions. The HUI3 scoring function has strong theoretical and empirical foundations. It performs well in predicting directly measured scores. The HUI3 system provides a practical way to obtain utility scores based on community preferences.

Determining asthma treatment by monitoring sputum cell counts: effect on exacerbations

One important goal of asthma treatment is to reduce exacerbations. The current authors investigated if the use of sputum cell counts to guide treatment would achieve this goal. A total of 117 adults with asthma were entered into a multicentre, randomised, parallel group-effectiveness study for two treatment strategies over a 2-yr period. In one strategy (the clinical strategy: CS) treatment was based on symptoms and spirometry. In the other (the sputum strategy: SS) sputum cell counts were used to guide corticosteroid therapy to keep eosinophils ≤2%; symptoms and spirometry were used to identify clinical control, exacerbations and other treatments. Patients were blind to sputum cell counts in both strategies and physicians were blind in the CS, thus removing bias. First, the minimum treatment to maintain control was identified in 107 patients (Phase 1) and then this treatment was continued (Phase 2) for the remaining of the 2 yrs. The primary outcomes were the relative risk reduction for the occurrence of the first exacerbation in Phase 2 and the length of time without exacerbation. The current authors also examined the type and severity of exacerbations and the cumulative dose of inhaled steroid needed. The duration and number of exacerbations in Phase 1 were similar in both groups. In Phase 2 there were a 126 exacerbations of which 79 occurred in the CS (62.7%) and 47 (37.3%) in the SS groups. The majority of the 126 exacerbations (101; 80.1%) were mild. The majority of the 102 exacerbations, where sputum examination was performed before any treatment (n = 70), were noneosinophilic. In the SS patients, the time to the first exacerbation was longer (by 213 days) especially in those considered to need treatment with a long acting β2-agonist (by 490 days), the relative risk ratio was lower (by 49%), and the number of exacerbations needing prednisone was reduced (5 versus 15). This benefit was seen mainly in patients needing treatment with inhaled steroid in a daily dose equivalent to fluticasone >250 μg, and was due to fewer eosinophilic exacerbations. The cumulative dose of corticosteroid during the trial was similar in both groups. Monitoring sputum cell counts was found to benefit patients with moderate-to-severe asthma by reducing the number of eosinophilic exacerbations and by reducing the severity of both eosinophilic and noneosinophilic exacerbations without increasing the total corticosteroid dose. It had no influence on the frequency of noneosinophilic exacerbations, which were the most common exacerbations.

Muscle weakness and falls in older adults: a systematic review and meta-analysis.

Objectives: To evaluate and summarize the evidence of muscle weakness as a risk factor for falls in older adults.

A Randomized Clinical Trial of Exercise and Spinal Manipulation for Patients With Chronic Neck Pain

Study Design. A randomized, parallel-group, single-blinded clinical trial was performed. After a 1-week baseline period, patients were randomized to 11 weeks of therapy, with posttreatment follow-up assessment 3, 6, and 12 months later. Objectives. To compare the relative efficacy of rehabilitative neck exercise and spinal manipulation for the management of patients with chronic neck pain. Summary of Background Data. Mechanical neck pain is a common condition associated with substantial morbidity and cost. Relatively little is known about the efficacy of spinal manipulation and exercise for chronic neck pain. Also, the combination of both therapies has yet to be explored. Methods. Altogether, 191 patients with chronic mechanical neck pain were randomized to receive 20 sessions of spinal manipulation combined with rehabilitative neck exercise (spinal manipulation with exercise), MedX rehabilitative neck exercise, or spinal manipulation alone. The main outcome measures were patient-rated neck pain, neck disability, functional health status (as measured by Short Form-36 [SF-36]), global improvement, satisfaction with care, and medication use. Range of motion, muscle strength, and muscle endurance were assessed by examiners blinded to patients’ treatment assignment. Results. Clinical and demographic characteristics were similar among groups at baseline. A total of 93% of the patients completed the intervention phase. The response rate for the 12-month follow-up period was 84%. Except for patient satisfaction, where spinal manipulative therapy and exercise were superior to spinal manipulation with (P = 0.03), the group differences in patient-rated outcomes after 11 weeks of treatment were not statistically significant (P = 0.13). However, the spinal manipulative therapy and exercise group showed greater gains in all measures of strength, endurance, and range of motion than the spinal manipulation group (P < 0.05). The spinal manipulation with exercise group also demonstrated more improvement in flexion endurance and in flexion and rotation strength than the MedX group (P < 0.03). The MedX exercise group had larger gains in extension strength and flexion–extension range of motion than the spinal manipulation group (P < 0.05). During the follow-up year, a greater improvement in patient-rated outcomes were observed for spinal manipulation with exercise and for MedX exercise than for spinal manipulation alone (P = 0.01). Both exercise groups showed very similar levels of improvement in patient-rated outcomes, although the spinal manipulation and exercise group reported greater satisfaction with care (P < 0.01). Conclusions. For chronic neck pain, the use of strengthening exercise, whether in combination with spinal manipulation or in the form of a high-technology MedX program, appears to be more beneficial to patients with chronic neck pain than the use of spinal manipulation alone. The effect of low-technology exercise or spinal manipulative therapy alone, as compared with no treatment or placebo, and the optimal dose and relative cost effectiveness of these therapies, need to be evaluated in future studies.

Measurement Properties of the Neck Disability Index: A Systematic Review

STUDY DESIGN Systematic review of clinical measurement. OBJECTIVE To find and synthesize evidence on the psychometric properties and usefulness of the neck disability index (NDI). BACKGROUND The NDI is the most commonly used outcome measure for neck pain, and a synthesis of knowledge should provide a deeper understanding of its use and limitations. METHODS AND MEASURES Using a standard search strategy (1966 to September 2008) and 4 databases (Medline, CINAHL, Embase, and PsychInfo), a structured search was conducted and supplemented by web and hand searching. In total, 37 published primary studies, 3 reviews, and 1 in-press paper were analyzed. Pairs of raters conducted data extraction and critical appraisal using structured tools. Ranking of quality and descriptive synthesis were performed. RESULTS Horizon estimation suggested the potential for 1 missed paper. The agreement between raters on quality assessments was high(kappa = 0.82). Half of the studies reached a quality level greater than 70%. Failures to report clear psychometric objectives/hypotheses or to rationalize the sample size were the most common design flaws. Studies often focused on less clinically applicable properties, like construct validity or group reliability, than transferable data, like known group differences or absolute reliability (standard error of measurement [SEM] or minimum detectable change [MDC]). Most studies suggest that the NDI has acceptable reliability, although intraclass correlation coefficients (ICCs) range from 0.50 to 0.98. Longer test intervals and the definition of stable can influence reliability estimates. A number of high-quality published (Korean, Dutch, Spanish, French, Brazilian Portuguese) and commercially supported translations are available. The NDI is considered a 1-dimensional measure that can be interpreted as an interval scale. Some studies question these assumptions. The MDC is around 5/50 for uncomplicated neck pain and up to 10/50 for cervical radiculopathy. The reported clinically important difference (CID) is inconsistent across different studies ranging from 5/50 to 19/50. The NDI is strongly correlated (>0.70) to a number of similar indices and moderately related to both physical and mental aspects of general health. CONCLUSION The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain. More studies of CID in different clinical populations and the relationship to subjective/work/function categories are required.

Conservative management of mechanical neck pain: systematic overview and meta-analysis

Abstract Objective: To review the efficacy of conservative management of mechanical neck disorders. Methods: Published and unpublished reports were identified through computerised and manual searches of bibliographical databases, reference lists from primary articles, and letters to authors, agencies, foundations, and content experts. Selection criteria were applied to blinded articles, and selected articles were scored for methodological quality. Effect sizes were calculated from raw pain scores and combined by using meta-analytic techniques when appropriate. Results: Twenty four randomised clinical trials met the selection criteria and were categorised by type of intervention: nine used manual treatments; 12 physical medicine methods; four drug treatment; and three education of patients (four trials investigated more than one form of intervention). The intervention strategies were summarised separately. Pooling of studies was considered only within each category. Five of the nine trials that used manual treatment in combination with other treatments were combined. One to four weeks after treatment the pooled effect size was −0.6 (95% confidence interval −0.9 to −0.4), equivalent to an improvement of 16 (6.9 to 23.1) points on a 100 point scale. Sensitivity analyses on study quality, chronicity, and data imputation did not alter this estimate. For other interventions, studies could not be combined to arrive at pooled estimates of effect. Conclusions: There is little information available from clinical trials to support many of the treatments for mechanical neck pain. In general, conservative interventions have not been studied in enough detail to assess efficacy or effectiveness adequately. Key messages Many treatments are available and accepted as standard forms of practice Systematic literature searching finds a limited number of clinical trials There is early evidence to support the use of manual treatments in combination with other treatments for short term pain relief, but in general, conservative interventions have not been studied in enough detail to assess efficacy or effec- tiveness adequately Further clinical trials are needed to determine optimal treatment approaches

A cochrane review of manipulation and mobilization for mechanical neck disorders

Study Design and Objectives. Our systematic review of randomized trials assessed whether manipulation and mobilization relieve pain or improve function/disability, patient satisfaction, and global perceived effect in adults with mechanical neck disorders. Summary of Background Data. Neck disorders are common, disabling, and costly. Methods. Computerized bibliographic databases were searched up to March 2002. Two independent reviewers conducted study selection, data abstraction, and methodologic quality assessment. Relative risk and standardized mean differences were calculated. In the absence of heterogeneity, pooled effect measures were calculated using a random effects model. Results. Of the 33 selected trials, 42% were high quality trials. Single or multiple (3–11) sessions of manipulation or mobilization showed no benefit in pain relief when assessed against placebo, control groups, or other treatments for acute/subacute/chronic mechanical neck disorders with or without headache. There was strong evidence of benefit favoring multimodal care (mobilization and/or manipulation plus exercise) over a waiting list control for pain reduction [pooled standardized mean differences −0.85 (95% CI: −1.20 to −0.50)], improvement in function [pooled SMD −0.57 (95% CI: −0.94 to −0.21)] and global perceived effect [standardized mean differences −2.73 (95% CI: −3.30 to −2.16)] for subacute/chronic mechanical neck disorders with or without headache. Conclusions. Mobilization and/or manipulation when used with exercise are beneficial for persistent mechanical neck disorders with or without headache. Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior. There was insufficient evidence available to draw conclusions for neck disorder with radicular findings. Factorial design would help determine the active agent(s) within a treatment mix.

Agreement among reviewers of review articles.

OBJECTIVE To assess the consistency of an index of the scientific quality of research overviews. DESIGN Agreement was measured among nine judges, each of whom assessed the scientific quality of 36 published review articles. ITEM SELECTION: An iterative process was used to select ten criteria relative to five key tasks entailed in conducting a research overview. SAMPLE The review articles were drawn from three sampling frames: articles highly rated by criteria external to the study; meta-analyses; and a broad spectrum of medical journals. JUDGES: Three categories of judges were used: research assistants; clinicians with research training; and experts in research methodology; with three judges in each category. RESULTS The level of agreement within the three groups of judges was similar for their overall assessment of scientific quality and for six of the nine other items. With four exceptions, agreement among judges within each group and across groups, as measured by the intraclass correlation coefficient (ICC), was greater than 0.5, and 60% (24/40) of the ICCs were greater than 0.7. CONCLUSIONS It was possible to achieve reasonable to excellent agreement for all of the items in the index, including the overall assessment of scientific quality. The implications of these results for practising clinicians and the peer review system are discussed.

A Systematic Review and Meta-Analysis of Hypoglycemia and Cardiovascular Events: A comparison of glyburide with other secretagogues and with insulin

OBJECTIVE—Glyburide is the most widely used sulfonylurea but has unique pharmacodynamic properties that may increase harm. We hypothesized that glyburide causes more hypoglycemia and cardiovascular events than other secretagogues or insulin. RESEARCH DESIGN AND METHODS—Data sources were Medline, Embase, Cochrane, and three other web-based clinical trial registers (1966–2005). Parallel, randomized, controlled trials in people with type 2 diabetes comparing glyburide monotherapy with monotherapy using secretagogues or insulin were selected. Outcomes were hypoglycemia, glycemic control, cardiovascular events, body weight, and death. Titles and abstracts of 1,806 publications were reviewed in duplicate and 21 relevant articles identified. Data on patient characteristics, interventions, outcomes, and validity were extracted in duplicate using predefined criteria. RESULTS—Glyburide was associated with a 52% greater risk of experiencing at least one episode of hypoglycemia compared with other secretagogues (relative risk 1.52 [95% CI 1.21–1.92]) and with 83% greater risk compared with other sulfonylureas (1.83 [1.35–2.49]). Glyburide was not associated with an increased risk of cardiovascular events (0.84 [0.56–1.26]), death (0.87 [0.70–1.07]), or end-of-trial weight (weighted mean difference 1.69 kg [95% CI −0.41 to 3.80]) compared with other secretagogues. Limitations included suboptimal reporting of original trials. Loss to follow-up exceeded 20% in some studies, and major hypoglycemia was infrequently reported. CONCLUSIONS—Glyburide caused more hypoglycemia than other secretagogues and other sulfonylureas. Glyburide was not associated with an increased risk of cardiovascular events, death, or weight gain.

THE RELATIONSHIP OF HAND PREFERENCE TO ANATOMY OF THE CORPUS CALLOSUM IN MEN

Area of the midsagittal section of the corpus callosum, particularly in the region of the isthmus, was found previously to be greater in non-consistent-right-handed than consistent-right-handed men in a sample of 15 postmortem cases. Seven cases were obtained subsequent to this analysis. The new cases showed the same association previously observed between hand preference and area of the corpus callosum and its isthmus. In addition, a high negative correlation was found between isthmal area and a quantitative score of the direction and magnitude of hand preference. In the new cases, handedness was predicted better than chance using statistical functions of callosal anatomy derived from the previous group of 15 cases. These results support a relationship between variation in callosal anatomy and handedness in men and the hypothesis of a relationship between callosal morphology and functional asymmetry. The lack of such a relationship among women suggests that the developmental mechanisms leading to callosal anatomical variation in relation to lateralization are influenced by sex hormones. Methodological issues in the use of magnetic resonance imaging for the quantitative study of callosal anatomy are discussed.