Assessing observational studies of medical treatments

BACKGROUND: Previous studies have assessed the validity of the observational study design by comparing results of studies using this design to results from randomized controlled trials. The present study examined design features of observational studies that could have influenced these comparisons. METHODS: To find at least 4 observational studies that evaluated the same treatment, we reviewed meta-analyses comparing observational studies and randomized controlled trials for the assessment of medical treatments. Details critical for interpretation of these studies were abstracted and analyzed qualitatively. RESULTS: Individual articles reviewed included 61 observational studies that assessed 10 treatment comparisons evaluated in two studies comparing randomized controlled trials and observational studies. The majority of studies did not report the following information: details of primary and ancillary treatments, outcome definitions, length of follow-up, inclusion/exclusion criteria, patient characteristics relevant to prognosis or treatment response, or assessment of possible confounding. When information was reported, variations in treatment specifics, outcome definition or confounding were identified as possible causes of differences between observational studies and randomized controlled trials, and of heterogeneity in observational studies. CONCLUSION: Reporting of observational studies of medical treatments was often inadequate to compare study designs or allow other meaningful interpretation of results. All observational studies should report details of treatment, outcome assessment, patient characteristics, and confounding assessment

A longitudinal study of chiropractic use among older adults in the United States

<p>Abstract</p> <p>Background</p> <p>Longitudinal patterns of chiropractic use in the United States, particularly among Medicare beneficiaries, are not well documented. Using a nationally representative sample of older Medicare beneficiaries we describe the use of chiropractic over fifteen years, and classify chiropractic users by annual visit volume. We assess the characteristics that are associated with chiropractic use versus nonuse, as well as between different levels of use.</p> <p>Methods</p> <p>We analyzed data from two linked sources: the baseline (1993-1994) interview responses of 5,510 self-respondents in the Survey on Assets and Health Dynamics Among the Oldest Old (AHEAD), and their Medicare claims from 1993 to 2007. Binomial logistic regression was used to identify factors associated with chiropractic use versus nonuse, and conditional upon use, to identify factors associated with high volume relative to lower volume use.</p> <p>Results</p> <p>There were 806 users of chiropractic in the AHEAD sample yielding a full period prevalence for 1993-2007 of 14.6%. Average annual prevalence between 1993 and 2007 was 4.8% with a range from 4.1% to 5.4%. Approximately 42% of the users consumed chiropractic services only in a single calendar year while 38% used chiropractic in three or more calendar years. Chiropractic users were more likely to be women, white, overweight, have pain, have multiple comorbid conditions, better self-rated health, access to transportation, higher physician utilization levels, live in the Midwest, and live in an area with fewer physicians per capita. Among chiropractic users, 16% had at least one year in which they exceeded Medicare's "soft cap" of 12 visits per calendar year. These over-the-cap users were more likely to have arthritis and mobility limitations, but were less likely to have a high school education. Additionally, these over-the-cap individuals accounted for 58% of total chiropractic claim volume. High volume users saw chiropractors the most among all types of providers, even more than family practice and internal medicine combined.</p> <p>Conclusion</p> <p>There is substantial heterogeneity in the patterns of use of chiropractic services among older adults. In spite of the variability of use patterns, however, there are not many characteristics that distinguish high volume users from lower volume users. While high volume users accounted for a significant portion of claims, the enforcement of a hard cap on annual visits by Medicare would not significantly decrease overall claim volume. Further research to understand the factors causing high volume chiropractic utilization among older Americans is warranted to discern between patterns of "need" and patterns of "health maintenance".</p

Long-term declines in ADLs, IADLs, and mobility among older Medicare beneficiaries

<p>Abstract</p> <p>Background</p> <p>Most prior studies have focused on short-term (≤ 2 years) functional declines. But those studies cannot address aging effects inasmuch as all participants have aged the same amount. Therefore, the authors studied the extent of long-term functional decline in older Medicare beneficiaries who were followed for varying time lengths, and the authors also identified the risk factors associated with those declines.</p> <p>Methods</p> <p>The analytic sample included 5,871 self- or proxy-respondents who had complete baseline and follow-up survey data that could be linked to their Medicare claims for 1993-2007. Functional status was assessed using activities of daily living (ADLs), instrumental ADLs (IADLs), and mobility limitations, with declines defined as the development of two of more new difficulties. Multiple logistic regression analysis was used to focus on the associations involving respondent status, health lifestyle, continuity of care, managed care status, health shocks, and terminal drop.</p> <p>Results</p> <p>The average amount of time between the first and final interviews was 8.0 years. Declines were observed for 36.6% on ADL abilities, 32.3% on IADL abilities, and 30.9% on mobility abilities. Functional decline was more likely to occur when proxy-reports were used, and the effects of baseline function on decline were reduced when proxy-reports were used. Engaging in vigorous physical activity consistently and substantially protected against functional decline, whereas obesity, cigarette smoking, and alcohol consumption were only associated with mobility declines. Post-baseline hospitalizations were the most robust predictors of functional decline, exhibiting a dose-response effect such that the greater the average annual number of hospital episodes, the greater the likelihood of functional status decline. Participants whose final interview preceded their death by one year or less had substantially greater odds of functional status decline.</p> <p>Conclusions</p> <p>Both the additive and interactive (with functional status) effects of respondent status should be taken into consideration whenever proxy-reports are used. Encouraging exercise could broadly reduce the risk of functional decline across all three outcomes, although interventions encouraging weight reduction and smoking cessation would only affect mobility declines. Reducing hospitalization and re-hospitalization rates could also broadly reduce the risk of functional decline across all three outcomes.</p

A prospective cohort study of long-term cognitive changes in older Medicare beneficiaries

<p>Abstract</p> <p>Background</p> <p>Promoting cognitive health and preventing its decline are longstanding public health goals, but long-term changes in cognitive function are not well-documented. Therefore, we first examined long-term changes in cognitive function among older Medicare beneficiaries in the Survey on Assets and Health Dynamics among the Oldest Old (AHEAD), and then we identified the risk factors associated with those changes in cognitive function.</p> <p>Methods</p> <p>We conducted a secondary analysis of a prospective, population-based cohort using baseline (1993-1994) interview data linked to 1993-2007 Medicare claims to examine cognitive function at the final follow-up interview which occurred between 1995-1996 and 2006-2007. Besides traditional risk factors (i.e., aging, age, race, and education) and adjustment for baseline cognitive function, we considered the reason for censoring (entrance into managed care or death), and post-baseline continuity of care and major health shocks (hospital episodes). Residual change score multiple linear regression analysis was used to predict cognitive function at the final follow-up using data from telephone interviews among 3,021 to 4,251 (sample size varied by cognitive outcome) baseline community-dwelling self-respondents that were ≥ 70 years old, not in managed Medicare, and had at least one follow-up interview as self-respondents. Cognitive function was assessed using the 7-item Telephone Interview for Cognitive Status (TICS-7; general mental status), and the 10-item immediate and delayed (episodic memory) word recall tests.</p> <p>Results</p> <p>Mean changes in the number of correct responses on the TICS-7, and 10-item immediate and delayed word recall tests were -0.33, -0.75, and -0.78, with 43.6%, 54.9%, and 52.3% declining and 25.4%, 20.8%, and 22.9% unchanged. The main and most consistent risks for declining cognitive function were the baseline values of cognitive function (reflecting substantial regression to the mean), aging (a strong linear pattern of increased decline associated with greater aging, but with diminishing marginal returns), older age at baseline, dying before the end of the study period, lower education, and minority status.</p> <p>Conclusions</p> <p>In addition to aging, age, minority status, and low education, substantial and differential risks for cognitive change were associated with sooner vs. later subsequent death that help to clarify the terminal drop hypothesis. No readily modifiable protective factors were identified.</p

Validation of the Body Concealment Scale for Scleroderma (BCSS): Replication in the Scleroderma Patient-centered Intervention Network (SPIN) Cohort

© 2016 Elsevier Ltd Body concealment is an important component of appearance distress for individuals with disfiguring conditions, including scleroderma. The objective was to replicate the validation study of the Body Concealment Scale for Scleroderma (BCSS) among 897 scleroderma patients. The factor structure of the BCSS was evaluated using confirmatory factor analysis and the Multiple-Indicator Multiple-Cause model examined differential item functioning of SWAP items for sex and age. Internal consistency reliability was assessed via Cronbach's alpha. Construct validity was assessed by comparing the BCSS with a measure of body image distress and measures of mental health and pain intensity. Results replicated the original validation study, where a bifactor model provided the best fit. The BCSS demonstrated strong internal consistency reliability and construct validity. Findings further support the BCSS as a valid measure of body concealment in scleroderma and provide new evidence that scores can be compared and combined across sexes and ages