Excess weight gain in American Indian/Alaskan native (AI/AN) children is a public health concern. This study tested 1) the feasibility of delivering community-wide interventions, alone or in combination with family-based interventions, to promote breastfeeding and reduce the consumption of sugar-sweetened beverages; and 2) whether these interventions decrease Body Mass Index (BMI)-Z scores in children 18–24 months of age.
Three AI/AN tribes were randomly assigned to two active interventions; a community-wide intervention alone (tribe A; n=63 families) or community-wide intervention containing a family component (tribes B and C; n=142 families). Tribal staff and the research team designed community-tailored interventions and trained community health workers to deliver the family intervention through home visits. Feasibility and acceptability of the intervention and BMI-Z scores at 18–24 months were compared between tribe A and tribes B&C combined using a separate sample pretest, posttest design.
Eighty-six percent of enrolled families completed the study. Breastfeeding initiation and 6-month duration increased 14 and 15%, respectively, in all tribes compared to national rates for American Indians. Breastfeeding at 12 months was comparable to national data. Parents expressed confidence in their ability to curtail family consumption of sugar-sweetened beverages. Compared to a pretest sample of children of a similar age two years before the study begun, BMI-Z scores increased in all tribes. However, the increase was less in tribes B &C compared to tribe A (−0.75, p=0.016).
Family, plus community-wide interventions to increase breastfeeding and curtail sugar-sweetened beverages attenuate BMI rise in AI/AN toddlers more than community-wide interventions alone.
Obesity prevention; infants; toddlers; breastfeeding; sugar-sweetened beverages
The Toddler Overweight and Tooth decay prevention Study (TOTS) was an overweight and early childhood caries (ECC) project in the Pacific Northwest USA. It targeted American Indian (AI) toddlers from birth, to effect changes in breastfeeding and sweetened beverage consumption.
The intervention cohort was children born in three communities during 12 months; expectant mothers were identified through prenatal visits, and recruited by tribal coordinators. The local comparison cohorts were children in those communities who were 18–30 months at study start. A control longitudinal cohort consisted of annual samples of children aged 18–30 months in a fourth community, supplying secular trends.
d1–2mfs was used to identify incident caries in intervention, comparison, and control cohorts after 18-to-30 months of follow-up in 2006.
No missing or filled teeth were found. For d1t, all three intervention cohorts showed statistically significant downward intervention effects, decreases of between 0.300 and 0.631 in terms of the fraction of affected mouths. The results for d2t were similar but of smaller magnitudes, decreases of between 0.342 and 0.449; these results met the 0.05 level for significance in two of three cases. In light of an estimated secular increase in dental caries in the control site, all three intervention cohorts showed improvements in both d1t and d2t.
Simple interventions targeting sweetened beverage availability (in combination with related measures) reduced high tooth decay trends, and were both feasible and acceptable to the AI communities we studied.
Caries; American Indian; child; community intervention; soft drinks; sugared beverages
There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making.
The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document.
Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.
The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.
Comparative effectiveness research; Effectiveness guidance document; Chinese medicine research
Childhood obesity is a growing epidemic in family medicine with few clinical treatment options. We implemented and evaluated a group office-visit intervention by family physicians emphasizing nutrition and physical activity within a resiliency psychosocial model, for overweight children and their parents.
The intervention lasted for 3 months, with half of the children crossing over to intervention after 6 months on study. Participants included 35 children who met eligibility criteria of being in third through fifth grades and having a body mass index above the 85th percentile. The 3-month twelve-session intervention, “Choices”, included topics on nutrition, physical activity, and resiliency. The sessions were developed for delivery by a family physician, and a nutritionist, who all received training in positive psychology and resilience skills. Main outcome measures were body mass index (BMI) z-scores for age-and-gender, and weight-for-age-and-gender z-scores, as well as qualitative interviews to understand individual and family processes.
The intervention resulted in a significant effect on one primary outcome, BMI z-score (-0.138 per 9 months (p =0.017) and a trend toward significance on the other, weight for age z-score (-0.87 per 9 months (p=0.09). The net shift of activity from the low METS to the high METS had an intervention effect of 2.84 METS (p = 0.037). Families reported lasting changes in behaviors and attitudes.
The innovative approach used in this study demonstrated modest efficacy in reducing BMI z-score, changing physical activity levels, and possibly shifting family dynamics.
intervention for overweight children; sedentary behavior in children; resiliency
This dual-site study sought to identify the appropriate role for TCM (acupuncture and herbs) in conjunction with a validated psychosocial self-care intervention (SC) for treating chronic TMD-associated pain. Participants with RDC-TMD-confirmed TMD (n=168) entered a stepped-care protocol that began with a basic TMD class. At weeks 2 and 10, patients receiving SC whose worst facial pain was above predetermined levels were reallocated by minimization to SC or TCM with experienced practitioners. Characteristic facial pain (CFP: mean of worst pain, average pain when having pain, current pain; each VAS 0-10) was the primary outcome. Social activity interference (VAS 0-10) was a secondary outcome. Patients were monitored for safety.
TCM provided significantly greater short-term (8-week) relief than SC (CFP reduction difference, −0.60 [SDE 0.26], p=0.020), and greater reduction in interference with social activities (−0.81 [SDE 0.33], p=0.016). In two of five treatment trajectory groups, more than 2/3 of participants demonstrated clinically meaningful responses (> 30% improvement) in pain interference over 16 weeks. This study provides evidence that TMD patients referred for TCM in a community-based model will receive safe treatment that is likely to provide some short-term pain relief and improved quality of life. Similar designs may also apply to evaluations of other kinds of chronic pain. (ClinicalTrials.gov number NCT00856167)
This short-term comparative effectiveness study of chronic facial pain suggests that Traditional Chinese Medicine is safe and frequently efficacious alone or subsequent to standard psychosocial interventions. TCM is widely available throughout North America and may provide clinicians and patients with a reasonable addition or alternative to other forms of therapy.
Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that American Indian (AI) children have higher rates of overweight and obesity than children of other races/ethnicities. The Prevention of Toddler Obesity and Teeth Health Study (PTOTS) is a community-partnered randomized controlled trial designed to prevent obesity beginning at birth in AI children. PTOTS was developed to test the effectiveness of a multi-component intervention designed to: promote breastfeeding, reduce sugar-sweetened beverage consumption, appropriately time the introduction of healthy solid foods, and counsel parents to reduce sedentary lifestyles in their children. A birth cohort of 577 children from five AI tribes is randomized by tribe to either the intervention (three tribes) or the comparison condition (two tribes). The strengths and weaknesses of PTOTS include a focus on a critical growth phase, placement in the community, and intervention at many levels, using a variety of approaches.
Primary Obesity Prevention; Infants; Toddlers; American Indians
Investigators of homeopathy have proposed that nonlinear dynamical systems (NDS) and complex systems science offer conceptual and analytic tools for evaluating homeopathic remedy effects. Previous animal studies demonstrate that homeopathic medicines alter delta electroencephalographic (EEG) slow wave sleep. The present study extended findings of remedy-related sleep stage alterations in human subjects by testing the feasibility of using two different NDS analytic approaches to assess remedy effects on human slow wave sleep EEG.
Subjects (N=54) were young adult male and female college students with a history of coffee-related insomnia who participated in a larger 4-week study of the polysomnographic effects of homeopathic medicines on home-based all-night sleep recordings. Subjects took one bedtime dose of a homeopathic remedy (Coffea cruda or Nux vomica 30c). We computed multiscale entropy (MSE) and the correlation dimension (Mekler-D2) for stage 3 and 4 slow wave sleep EEG sampled in artifact-free 2-minute segments during the first two rapid-eye-movement (REM) cycles for remedy and post-remedy nights, controlling for placebo and post-placebo night effects.
MSE results indicate significant, remedy-specific directional effects, especially later in the night (REM cycle 2) (CC: remedy night increases and post-remedy night decreases in MSE at multiple sites for both stages 3 and 4 in both REM cycles; NV: remedy night decreases and post-remedy night increases, mainly in stage 3 REM cycle 2 MSE). D2 analyses yielded more sporadic and inconsistent findings.
Homeopathic medicines Coffea cruda and Nux vomica in 30c potencies alter short-term nonlinear dynamic parameters of slow wave sleep EEG in healthy young adults. MSE may provide a more sensitive NDS analytic method than D2 for evaluating homeopathic remedy effects on human sleep EEG patterns.
homeopathy; polysomnography; electroencephalography; Coffea cruda; Nux vomica; nonlinear dynamics, multiscale entropy; correlation dimension; slow wave sleep; complex systems; time-dependent sensitization
Although many researchers agree that applying conventional drug-trial quality criteria to CAM studies lacks plausibility, few take on the burden of devising alternative criteria in a specific area of CAM. This commentary points out strengths and weaknesses in the approach taken in the work of Mathie and colleagues to do this for homeopathy.
Medical records contain an abundance of information, very little of which is extracted and put to clinical use. Increasing the flow of information from medical records to clinical practice requires methods of analysis that are appropriate for large nonintervention studies. The purpose of this article is to explain in nontechnical language what these methods are, how they differ from conventional statistical analyses, and why the latter are generally inappropriate. This is important because of the current volume of nonintervention study analyses that either use incorrect methods or misuse correct methods. A set of guidelines is suggested for use in nonintervention clinical research.
Methods for analyzing data in nonintervention clinical studies are substantially different from those that are appropriate for randomized clinical trials. Although the latter methods are well known, the former are not. A systematic approach for dealing with statistical confounding in nonintervention research has been developed over the past 30 to 40 years, and the essence of this theory constitutes the contents of this article. An accompanying, less technical article explains the implications of these results for clinical research.
There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making.
Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved.
Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.
The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.
Comparative effectiveness research; Effectiveness guidance document; Acupuncture
There are many commercially available instruments for measuring electrical conductance, but there is little information about their reliability. The aim of this study was to quantify measurement variability and assess reliability of the AcuGraph system—a commonly used electrodermal screening device.
Four experiments were conducted to measure variability in electrical conductance readings obtained by the AcuGraph system. The fi rst involved measuring known resistors. The second measured non-human organic matter. The third was a test–retest assessment of the Yuan-Source and Jing-Well points in 30 healthy volunteers who were measured by a single operator. The fourth was an interoperator reliability evaluation of seven acupuncturists at the Yuan-Source and Jing-Well acupoints on four individuals at two time points.
Against known resistors, the AcuGraph had an average coeffi cient of variability (CV) of 1.8% between operators and test–retests. On non-human organic material the AcuGraph had an average CV of 0.9% and 2.8%. When a single operator tested 30 participants, the average reliability for the Yuan-Source points was 0.86 and 0.76 for Jing-Well points with a CV of 23.2% and 25.9% respectively. The average CV for the seven acupuncturists was 24.5% on Yuan-Source points and 23.7% on Jing-Well points.
The AcuGraph measures known resistors and organic matter accurately and reliably. Skin conductance at acupoints recorded by one operator was also reliable. There was less consistency in electrodermal recordings obtained by seven different operators. Operator training and technical improvements to the AcuGraph may improve consistency among operators.
Context: Participants in a randomized trial of traditional Chinese medicine (TCM) for temporomandibular joint dysfunction (TMD) had a linear decline in pain over 16 TCM visits.
Objective: To investigate whether reductions in pain among participants receiving TCM can be explained by increased use of pain medications, or whether use of pain medications also declined in this group.
Design: One hundred sixty-eight participants with TMD were treated with TCM or enhanced self-care according to a stepped-care design. Those for whom self-care failed were sequentially randomized to further self-care or TCM. This report includes 111 participants during their first 16 TCM visits. The initial 8 visits occurred more than once a week; participants and practitioners determined the frequency of subsequent visits.
Outcome measures: Average pain (visual analog scale, range 0–10) and morphine and aspirin dose equivalents.
Results: The sample was 87% women and the average age was 44 ± 13 years. Average pain of narcotics users (n = 21) improved by 2.73 units over 16 visits (p < 0.001). Overall narcotics use trended downward until visit 11 (−3.27 doses/week, p = 0.156), and then trended upward until week 16 (+4.29 doses/week, p = 0.264). Among those using narcotics, use of nonsteroidal anti-inflammatory drugs (NSAIDs) declined linearly over visits 1–16 (−1.94 doses/week, p = 0.002).
Among the top quartile of NSAID-only users (n = 22), average pain decreased linearly over 16 visits (−1.52 units, p = 0.036). Overall NSAID doses/week declined between visits 1 and 7 (−9.95 doses/week, p < 0.001) and then remained stable through 16 visits. NSAID use also declined among the third quartile (n = 23) and remained low and stable among the lower half (sorted by total intake) of NSAID users.
Conclusions: Among the heaviest NSAID users, we observed a short-term reduction in NSAID use that was sustained as TCM visits became less frequent. There was no indication that pain reduction during TCM treatment was influenced by drug use.
Homeopathy, a common form of alternative medicine worldwide, relies on subjective patient reports for diagnosis and treatment. Polysomnography offers a modern methodology for evaluating the objective effects of taking homeopathic remedies that clinicians claim exert effects on sleep quality in susceptible individuals. Animal studies have previously shown changes in non rapid eye movement sleep with certain homeopathic remedies.
Young adults of both sexes (ages 18–31) with above-average scores on standardized personality scales for either cynical hostility or anxiety sensitivity (but not both), and a history of coffee-induced insomnia, participated in the month-long study. At-home polysomnographic recordings were obtained on successive pairs of nights once per week for a total of eight recordings (nights 1, 2, 8, 9, 15, 16, 22, 23). Subjects (N=54) received placebo pellets on night 8 (single-blind) and verum pellets on night 22 (double-blind) in 30c doses of one of two homeopathic remedies, Nux Vomica or Coffea Cruda. Subjects completed daily morning sleep diaries and weekly Pittsburgh Sleep Quality Index scales, as well as Profile of Mood States Scales at bedtime on polysomnography nights.
Verum remedies significantly increased PSG total sleep time and NREM, as well as awakenings and stage changes. Changes in actigraphic and self-rated scale effects were not significant.
The study demonstrated the feasibility of using in-home all-night sleep recordings to study homeopathic remedy effects. Findings are similar though not identical to those reported in animals with the same remedies. Possible mechanisms include initial disruption of the nonlinear dynamics of sleep patterns by the verum remedies.
Complementary and alternative medicine; Homeopathy; Polysomnography; Coffee; Insomnia; Young Adults; Coffea Cruda; Nux Vomica
There are widespread assumptions that a large proportion of American adults use a variety of complementary and alternative medicine (CAM) therapies. The goal of this study is to explore the clustering or linkages among CAM categories in the general population. Linkset analysis and data from the 2002 National Health Interview Survey (NHIS) were used to address two specific aims. First, the dominant linkages of CAM categories used by the same individual were delineated, and population estimates were generated of the percentage of American adults using different linksets of CAM categories. Second, it was determined whether dominant linkages of CAM modalities differ by age, gender, ethnicity, and education.
Linkset analysis, a method of estimating co-occurrence beyond chance, was used on data from the 2002 NHIS (N = 29,862) to identify possible sets of CAM use.
Most adults use CAM therapies from a single category. Approximately 20% of adults combined two CAM categories, with the combination of mind–body therapies and biologically based therapies estimated to be most common. Only 5% of adults use therapies representing three or more CAM categories. Combining therapies across multiple CAM categories was more common among those 46–64, women, whites, and those with a college education.
The results of this study allow researchers to refine descriptions of CAM use in the adult population. Most adults do not use a wide assortment of CAM; most use therapies within a single CAM category. Sets of CAM use were found to differ by age, gender, ethnicity, and education in ways consistent with previous research.
The purpose of this study was to prospectively examine the relationship between anemia and incident fractures of the hip, spine and all skeletal sites in women from diverse racial and ethnic backgrounds enrolled in the Women's Health Initiative (WHI) Observational Study and Clinical Trials.
Prospective cohort study.
40 WHI clinical centers across the US.
Postmenopausal women (n = 160,080), mean age 63.2 (SD: 7.2) years, were recruited and followed for an average of 7.8 years.
Anemia was defined as hemoglobin levels at baseline less than 12 g/dL. All fractures were self-reported. Hip fractures were further confirmed by trained physicians using medical records.
Among the participants 8,739 women (5.5%) were anemic. The age-adjusted incidence rate of hip fractures per 10,000 person years were 21.4 in women with anemia and 15.0 in women without anemia; a higher incidence rate for spine or all fractures in anemic women was also observed. After multiple covariates were included in the Cox proportional hazards models, significant increased fracture risk associated with anemia still existed as demonstrated by the hazards ratios (95% confidence interval) of fractures associated with anemia being 1.38 (1.13–1.68), 1.30 (1.09–1.55) and 1.07 (1.01–1.14) for hip, spine and all-types respectively. No significant racial/ethnic difference was found in these relationships.
A significantly increased fracture risk was observed in multi-ethnic postmenopausal women with anemia. Given the high prevalence of anemia in the elderly population, it is important to better understand the relationship and mechanisms linking anemia to fracture risk.
fracture risk; anemia; hemoglobin; prospective studies
Substantial recent research examines the efficacy of many types of complementary and alternative (CAM) therapies. However, outcomes associated with the "real-world" use of CAM has been largely overlooked, despite calls for CAM therapies to be studied in the manner in which they are practiced. Americans seek CAM treatments far more often for chronic musculoskeletal pain (CMP) than for any other condition. Among CAM treatments for CMP, acupuncture and chiropractic (A/C) care are among those with the highest acceptance by physician groups and the best evidence to support their use. Further, recent alarming increases in delivery of opioid treatment and surgical interventions for chronic pain--despite their high costs, potential adverse effects, and modest efficacy--suggests the need to evaluate real world outcomes associated with promising non-pharmacological/non-surgical CAM treatments for CMP, which are often well accepted by patients and increasingly used in the community.
This multi-phase, mixed methods study will: (1) conduct a retrospective study using information from electronic medical records (EMRs) of a large HMO to identify unique clusters of patients with CMP (e.g., those with differing demographics, histories of pain condition, use of allopathic and CAM health services, and comorbidity profiles) that may be associated with different propensities for A/C utilization and/or differential outcomes associated with such care; (2) use qualitative interviews to explore allopathic providers' recommendations for A/C and patients' decisions to pursue and retain CAM care; and (3) prospectively evaluate health services/costs and broader clinical and functional outcomes associated with the receipt of A/C relative to carefully matched comparison participants receiving traditional CMP services. Sensitivity analyses will compare methods relying solely on EMR-derived data versus analyses supplementing EMR data with conventionally collected patient and clinician data.
Successful completion of these aggregate aims will provide an evaluation of outcomes associated with the real-world use of A/C services. The trio of retrospective, qualitative, and prospective study will also provide a clearer understanding of the decision-making processes behind the use of A/C for CMP and a transportable methodology that can be applied to other health care settings, CAM treatments, and clinical populations.
The purpose of this paper is to present a preliminary model to identify the effects of expectancy of treatment success and the patient-provider encounter (PPE) on outcomes in an open-label randomized trial.
80 participants with chronic cervicogenic headache (CGH) were randomized to 4 groups: 2 levels of treatment dose (8 or 16) and 2 levels of therapy from a chiropractor (spinal manipulation or light massage). Providers were instructed to have equal enthusiasm for all care. Structural equation modeling with standardized path coefficients (β) was used in a path analysis to identify the effects of patient expectancy and the PPE on CGH pain. The model included monthly pain from baseline to 12 weeks. Expectancy and PPE were evaluated on Likert scales. The PPE was measured as patient perception of chiropractor enthusiasm, confidence, and comfort with care.
Baseline patient expectancy was balanced across groups. PPE measures were balanced across groups and consistent over the 8-week treatment period. Treatment and baseline pain had the strongest effects on pain outcomes (|β| =.46 to .59). Expectations had little effect on pain (|β| < .15). The PPE had a weak effect on pain (|β| = .03 to .27) and on subsequent confidence in treatment success (|β| = .09 and .12).
Encouraging equipoise in the provider-patient encounter and balancing expectancy across treatment groups may protect against some confounding related to the absence of blinding in a randomized controlled trial of pain. In this trial, their effects were found to be small relative to the effects of treatment and baseline values.
The present study describes the development of a comprehensive quality of reporting assessment tool and its application to acupuncture RCTs from 1997–2007. This Oregon CONSORT STRICTA Instrument (OCSI) is based on the revised CONSORT guidelines as modified by the STRICTA recommendations for acupuncture trials. Each of the resulting 27 OCSI items were applied to English language prospective RCTs that compared acupuncture, using manual and/or electro-stimulation, to no treatment, a sham procedure, or usual biomedical care. The 333 RCTs that met inclusion criteria were dispersed among 27 countries and 141 journals. Mean quality of reporting score for all articles was 63.0% (SD 16.5). Mean OCSI scores revealed a 30.9% improvement over the ten-year period (P < .001). Our findings suggest that to enhance quality of reporting, authors should better attend to seven specific OCSI items in three categories: practitioner training, adverse events, and aspects of randomization and blinding (n = 5). The broad diversity in geographical origin, publication site and quality of reporting, viewed in light of the considerable room for improvement in mean OCSI scores, emphasizes the importance of making STRICTA as well as CONSORT more widely known to journals and to the acupuncture research community.