Psychosocial predictors of weight regain in the weight loss maintenance trial.

This study's purpose was to identify psychosocial predictors of weight loss maintenance in a multi-site clinical trial, following a group-based weight loss program. Participants (N = 1025) were predominately women (63%) and 38% were Black (mean age = 55.6 years; SD = 8.7). At 12 months, higher SF-36 mental health composite scores were associated with less weight regain (p < .01). For Black participants, an interaction existed between race and friends' encouragement for exercise, where higher exercise encouragement was related to more weight regain (p < .05). At 30 months, friends' encouragement for healthy eating was associated with more weight regain (p < .05), whereas higher SF-36 mental health composite scores were related to less weight regain (p < .0001). Perceived stress and select health-related quality of life indices were associated with weight regain; this relationship varied across gender, race, and treatment conditions. Temporal changes in these variables should be investigated for their impact on weight maintenance.

Weight loss history as a predictor of weight loss: results from Phase I of the weight loss maintenance trial.

Past studies have suggested that weight loss history is associated with subsequent weight loss. However, questions remain whether method and amount of weight lost in previous attempts impacts current weight loss efforts. This study utilized data from the Weight Loss Maintenance Trial to examine the association between weight loss history and weight loss outcomes in a diverse sample of high-risk individuals. Multivariate regression analysis was conducted to determine which specific aspects of weight loss history predict change in weight during a 6-month weight loss intervention. Greater weight loss was predicted by fewer previous weight loss attempts with assistance (p = 0.03), absence of previous dietary/herbal weight loss supplement use (p = 0.01), and greater maximum weight loss in previous attempts (p < 0.001). Future interventions may benefit from assessment of weight loss history and tailoring of interventions based on past weight loss behaviors and outcomes.

Comparison of characteristics and outcomes by initial study contact (website versus staff) for participants enrolled in a weight management study.

BACKGROUND: Traditional recruitment methods for clinical trials, such as telephone, mail, and print media, are often inefficient, costly, and use large amounts of staff time and resources. PURPOSE: This analysis was conducted to determine whether retention, demographics, and outcomes differed between enrolled participants who responded to recruitment outreach using an Internet-based information and registration system and enrollees whose first contact was with study staff via telephone. METHODS: We identified potentially eligible participants from Kaiser Permanente Northwest (KPNW) databases and mailed brochures inviting them to participate in the Life weight loss maintenance study. We also used employee newsletters, a member-directed website, and messages to employee email distribution lists to publicize the study. All outreach methods contained both a website address and a telephone number through which respondents could register for an information session. The website contained the same information as was provided by staff over the telephone. RESULTS: Out of 2122 potential participants who expressed interest in the study, 70% did so through the website. There was no difference in retention rates between enrollees who initiated contact through the website (WEB = 308) and enrollees who contacted the study by telephone (staff = 161). The WEB group was younger (p = 0.01), had higher income (p = 0.01) and education (p < 0.01) levels, and lower body mass index (BMI; p < 0.01). There was a trend toward greater weight loss in the WEB group (p = 0.06). LIMITATIONS: We did not conduct a formal cost analysis of the two methods. Also, the population for this analysis was mostly Caucasian and middle income; thus, we cannot draw conclusions about the generalizability of our findings to more racially and economically diverse populations. CONCLUSION: Enrolled participants who used a website to register for an initial study information session had similar study retention and outcome performance as enrollees who used a more traditional telephone method. For larger clinical trials, a website may help researchers more efficiently and cost-effectively achieve recruitment, eligibility, and randomization goals. More research is needed to determine whether similar recruitment and retention patterns are observed among racially and economically diverse populations when these and similar methods are compared.

Randomized trial of Tapas Acupressure Technique for weight loss maintenance.

BACKGROUND: Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance. METHODS: Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®), or a control intervention comprised of social-support group meetings (SS) led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation. RESULTS: Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd) = 11), mean BMI at randomization was 34 (sd = 5), and mean initial weight loss was 9.8 kg (sd = 5). In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85) weight regain for TAT and 2.96 kg (se 0.96) weight regain for SS, p < 0.097) Tests of between- arm differences for secondary outcomes were also not significant. A secondary analysis showed a significant interaction between treatment and initial weight loss (p < .036), with exploratory post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT. CONCLUSIONS: The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research.

Examiner training and reliability in two randomized clinical trials of adult dental caries.

OBJECTIVES: This report describes the training of dental examiners participating in two dental caries clinical trials and reports the inter- and intra-examiner reliability scores from the initial standardization sessions. METHODS: Study examiners were trained to use a modified International Caries Detection and Assessment System II system to detect the visual signs of non-cavitated and cavitated dental caries in adult subjects. Dental caries was classified as no caries (S), non-cavitated caries (D1), enamel caries (D2), and dentine caries (D3). Three standardization sessions involving 60 subjects and 3,604 tooth surface calls were used to calculate several measures of examiner reliability. RESULTS: The prevalence of dental caries observed in the standardization sessions ranged from 1.4 percent to 13.5 percent of the coronal tooth surfaces examined. Overall agreement between pairs of examiners ranged from 0.88 to 0.99. An intra-class coefficient threshold of 0.60 was surpassed for all but one examiner. Inter-examiner unweighted kappa values were low (0.23-0.35), but weighted kappas and the ratio of observed to maximum kappas were more encouraging (0.42-0.83). The highest kappa values occurred for the S/D1 versus D2/D3 two-level classification of dental caries, for which seven of the eight examiners achieved observed to maximum kappa values over 0.90. Intra-examiner reliability was notably higher than inter-examiner reliability for all measures and dental caries classifications employed. CONCLUSION: The methods and results for the initial examiner training and standardization sessions for two large clinical trials are reported. Recommendations for others planning examiner training and standardization sessions are offered.

Design of the xylitol for adult caries trial (X-ACT).

BACKGROUND: Dental caries incidence in adults is similar to that in children and adolescents, but few caries preventive agents have been evaluated for effectiveness in adults populations. In addition, dentists direct fewer preventive services to their adult patients. Xylitol, an over-the-counter sweetener, has shown some potential as a caries preventive agent, but the evidence for its effectiveness is not yet conclusive and is based largely on studies in child populations. METHODS/DESIGN: X-ACT is a three-year, multi-center, placebo controlled, double-blind, randomized clinical trial that tests the effects of daily use of xylitol lozenges versus placebo lozenges on the prevention of adult caries. The trial has randomized 691 participants (ages 21-80) to the two arms. The primary outcome is the increment of cavitated lesions. DISCUSSION: This trial should help resolve the overall issue of the effectiveness of xylitol in preventing caries by contributing evidence with a low risk of bias. Just as importantly, the trial will provide much-needed information about the effectiveness of a promising caries prevention agent in adults. An effective xylitol-based caries prevention intervention would represent an easily disseminated method to extend caries prevention to individuals not receiving caries preventive treatment in the dental office. TRIAL REGISTRATION: ClinicalTrials.Gov NCT00393055.

Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries.

BACKGROUND: Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. METHODS/DESIGN: The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. DISCUSSION: This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. TRIAL REGISTRATION NUMBER: NCT00357877.

Weight loss during the intensive intervention phase of the weight-loss maintenance trial.

BACKGROUND: To improve methods for long-term weight management, the Weight Loss Maintenance (WLM) trial, a four-center randomized trial, was conducted to compare alternative strategies for maintaining weight loss over a 30-month period. This paper describes methods and results for the initial 6-month weight-loss program (Phase I). METHODS: Eligible adults were aged > or =25, overweight or obese (BMI=25-45 kg/m2), and on medications for hypertension and/or dyslipidemia. Anthropomorphic, demographic, and psychosocial measures were collected at baseline and 6 months. Participants (n=1685) attended 20 weekly group sessions to encourage calorie restriction, moderate-intensity physical activity, and the DASH (dietary approaches to stop hypertension) dietary pattern. Weight-loss predictors with missing data were replaced by multiple imputation. RESULTS: Participants were 44% African American and 67% women; 79% were obese (BMI> or =30), 87% were taking anti-hypertensive medications, and 38% were taking antidyslipidemia medications. Participants attended an average of 72% of 20 group sessions. They self-reported 117 minutes of moderate-intensity physical activity per week, kept 3.7 daily food records per week, and consumed 2.9 servings of fruits and vegetables per day. The Phase-I follow-up rate was 92%. Mean (SD) weight change was -5.8 kg (4.4), and 69% lost at least 4 kg. All race-gender subgroups lost substantial weight: African-American men (-5.4 kg +/- 7.7); African-American women (-4.1 kg +/- 2.9); non-African-American men (-8.5 kg +/- 12.9); and non-African-American women (-5.8 kg +/- 6.1). Behavioral measures (e.g., diet records and physical activity) accounted for most of the weight-loss variation, although the association between behavioral measures and weight loss differed by race and gender groups. CONCLUSIONS: The WLM behavioral intervention successfully achieved clinically significant short-term weight loss in a diverse population of high-risk patients.

Comparison of strategies for sustaining weight loss: the weight loss maintenance randomized controlled trial.

CONTEXT: Behavioral weight loss interventions achieve short-term success, but re-gain is common. OBJECTIVE: To compare 2 weight loss maintenance interventions with a self-directed control group. DESIGN, SETTING, AND PARTICIPANTS: Two-phase trial in which 1032 overweight or obese adults (38% African American, 63% women) with hypertension, dyslipidemia, or both who had lost at least 4 kg during a 6-month weight loss program (phase 1) were randomized to a weight-loss maintenance intervention (phase 2). Enrollment at 4 academic centers occurred August 2003-July 2004 and randomization, February-December 2004. Data collection was completed in June 2007. INTERVENTIONS: After the phase 1 weight-loss program, participants were randomized to one of the following groups for 30 months: monthly personal contact, unlimited access to an interactive technology-based intervention, or self-directed control. Main Outcome Changes in weight from randomization. RESULTS: Mean entry weight was 96.7 kg. During the initial 6-month program, mean weight loss was 8.5 kg. After randomization, weight regain occurred. Participants in the personal-contact group regained less weight (4.0 kg) than those in the self-directed group (5.5 kg; mean difference at 30 months, -1.5 kg; 95% confidence interval [CI], -2.4 to -0.6 kg; P = .001). At 30 months, weight regain did not differ between the interactive technology-based (5.2 kg) and self-directed groups (5.5 kg; mean difference -0.3 kg; 95% CI, -1.2 to 0.6 kg; P = .51); however, weight regain was lower in the interactive technology-based than in the self-directed group at 18 months (mean difference, -1.1 kg; 95% CI, -1.9 to -0.4 kg; P = .003) and at 24 months (mean difference, -0.9 kg; 95% CI, -1.7 to -0.02 kg; P = .04). At 30 months, the difference between the personal-contact and interactive technology-based group was -1.2 kg (95% CI -2.1 to -0.3; P = .008). Effects did not differ significantly by sex, race, age, and body mass index subgroups. Overall, 71% of study participants remained below entry weight. CONCLUSIONS: The majority of individuals who successfully completed an initial behavioral weight loss program maintained a weight below their initial level. Monthly brief personal contact provided modest benefit in sustaining weight loss, whereas an interactive technology-based intervention provided early but transient benefit. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00054925.

Feasibility and short-term outcomes of a shamanic treatment for temporomandibular joint disorders.

CONTEXT: Temporomandibular joint disorders (TMDs) are chronic, recurrent, non-progressive pain conditions affecting the jaw and face. Patients least likely to respond to allopathic treatment are those with the most marked biological responsiveness to external stressors and concomitant emotional and psychosocial difficulties. These characteristics describe individuals who are "dispirited" and may benefit from shamanic healing, an ancient form of spiritual healing. OBJECTIVE: This phase 1 study tested feasibility and safety of shamanic healing for TMDs. DESIGN: Participants were randomized to 1 of 4 shamanic practitioners and attended 5 shamanic healing sessions. Self-reported pain and disability were recorded at baseline and each treatment visit and at 1, 3, 6, and 9-month follow-ups. Participants also were clinically evaluated at baseline and end of treatment. In-depth interviews, part of our mixed methods design, were conducted at baseline and end of treatment to evaluate acceptability and nonclinical changes associated with treatment. SETTING: Portland, Oregon. PATIENTS OR OTHER PARTICIPANTS: Twenty-three women with diagnosed TMDs. INTERVENTION: Shamanic treatment carried out during 5 treatment visits. MAIN OUTCOME MEASURES: Change from baseline to posttreatment in diagnosis of TMDs by Research Diagnostic Criteria (RDC) exam and participant self-ratings on the "usual" pain, "worst" pain, and functional impact of TMDs subscales of the RDC Axis II Pain Related Disability and Psychological Status Scale. This paper reports on outcomes at end of treatment. RESULTS: This study demonstrated the feasibility and acceptability of clinical trials of shamanic healing. The mean of usual pain went from 4.96 to 2.70, P<.0001; worst pain from 7.48 to 3.60, P<.0001, and functional impact of TMDs from 3.74 to 1.15, P<.0052. Only 4 women were clinically diagnosed with TMDs at the end of treatment.

A comparison of dental treatment utilization and costs by HMO members living in fluoridated and nonfluoridated areas.

OBJECTIVES: To compare dental treatment experiences and costs in members of a health maintenance organization (HMO) in areas with and without community water fluoridation. METHODS: HMO members with continuous dental eligibility (January 1, 1990 to December 31, 1995) who resided in Oregon and Washington were identified using administrative databases. Fluoridation status was determined by geocoding subscriber address. Measures were utilization of dental procedures, fluoride dispensings, and associated costs. Costs were based on nonmember fees, adjusted to 1995 dollar values. Data were analyzed using analysis of covariance, controlling for age and interactions. RESULTS: About 85 percent of eligible members (n = 51,683) were classified as residing either in a fluoridated (n = 12,194) or nonfluoridated (n = 39,489) area. Mean age was 40.0 years; 52.3 percent were women. More than 92 percent of members had one or more dental visits. Community water fluoridation was associated with reduced total and restorative costs among members with one or more visits, but the magnitude and direction of the effect varied with locale and age and the effects were generally small. In two locales, the cost of restorations was higher in nonfluoridated areas in young people (age 58). In younger adults, the opposite effect was observed. The impact of fluoridation may be attenuated by higher use of preventive procedures, in particular supplemental fluorides, in the nonfluoridated areas. CONCLUSIONS: These results are particularly relevant to insured populations with established access to dental care. Differences in treatment costs (savings) associated with water fluoridation should be estimated and included in future cost-effectiveness analyses of community water fluoridation.

Predicting patient follow-through on telephone nursing advice.

Although use of telephone advice nursing services continues to grow, little research has addressed factors that affect crucial call outcomes like follow-through on the advice given. This article describes aspects of the advice call process and examines predictors of caller follow-through, using a conceptual model derived from the literature and the authors' preliminary work. Calls to call centers and medical offices of a large health maintenance organization were taped, then content was coded and matched with caller questionnaire (CQ) data. Out of 1,863 participants, 1,489 reported following all the advice. In the final multivariate predictive model, statistically significant predictors of follow-through were patient health status, caller's rating of nurse helpfulness, and the extent to which caller expectations for collaboration were met and the caller understood the advice given. Results suggest that nurses should receive continuous training on effective communication techniques, and advice nurse performance standards that create barriers to communication should be modified.

Predictors of patient satisfaction with telephone nursing services.

Patient satisfaction has been shown to be a factor in clinical outcomes, health care quality, and patient follow-through. Thus, a high level of satisfaction is a desired outcome of patient care. This article examines predictors of patient satisfaction with telephone nursing services among a sample of 1,939 respondents, using a conceptual model derived from the literature and preliminary work. The study was conducted in medical offices and call centers of a large national health maintenance organization. Calls were taped and content coded and then matched with caller questionnaire data. In the final multivariate predictive models, patient health status; caller ratings of expectations met by the nurse for listening, clarity, and collaboration; and nurse competence were the strongest predictors of satisfaction. Consistent with the literature, findings suggest that nurses should expand interpersonal communication skills, and systems should reduce barriers to effective listening, clarity, and collaboration with callers.

Impact of comorbidities on mortality in managed care patients with CKD.

BACKGROUND: Our previous work showed that patients with chronic kidney disease (CKD) were 10 times more likely to die than progress to end-stage renal disease. This study examines the impact of comorbidities on mortality risk in a cohort with CKD at 3 levels of progression and a sex- and age-matched comparison group. METHODS: In a historical, prospective, cohort study, we selected electronic medical record data for health maintenance organization (HMO) members with an index and repeated glomerular filtration rate (GFR) in the range of 15 to 90 mL/min/1.73 m(2) (0.25 to 1.50 mL/s/1.73 m(2)) in 1996 who were followed up for at least 54 months or died during this period. These were matched for birth year and sex with HMO members not meeting GFR criteria, but with the same follow-up criteria. Major comorbid chronic conditions also were identified based on International Classification of Diseases, Ninth Revision, diagnostic codes in the electronic medical record. Conditional logistic regression was used to estimate the relative risk for mortality versus comparison subjects as a function of GFR, age, and other chronic conditions. RESULTS: In the final sample of 19,945 pairs, we found that risk for mortality increases as GFR decreases, but also that both age and other chronic conditions are significant risk factors for mortality. CONCLUSION: Baseline levels of estimated GFR and other major chronic disorders all contributed negatively to survival. The relative impact of these comorbidities was greatest among younger (<60 years) patients with CKD, and their relative effect diminished with age.

Cognitive Behavioral Therapy in Primary Care for Youth Declining Antidepressants: A Randomized Trial.

BACKGROUND AND OBJECTIVE: Health care providers have few alternatives for youth depression other than antidepressants. We examined whether brief cognitive behavioral therapy (CBT) is a viable alternative in primary care. METHODS: A total of 212 adolescents aged 12 to 18 with major depression who had recently declined or quickly discontinued new antidepressant treatment were randomized to self-selected treatment as usual (TAU) control condition or TAU plus brief individual CBT. Blinded evaluators followed youth for 2 years. The primary outcome was time to major depression diagnostic recovery. RESULTS: CBT was superior to the control condition on the primary outcome of time to diagnostic recovery from major depression, with number needed to treat from 4 to 10 across follow-up. A similar CBT advantage was found for time to depression diagnosis response, with number needed to treat of 5 to 50 across time points. We observed a significant advantage for CBT on many secondary outcomes over the first year of follow-up but not the second year. Cohen's d effect sizes for significant continuous measures ranged from 0.28 to 0.44, in the small to medium effect range. Most TAU health care services did not differ across conditions, except for psychiatric hospitalizations, which occurred at a significantly higher rate in the control condition through the first year of follow-up. CONCLUSIONS: Observed results were consistent with recent meta-analyses of CBT for youth depression. The initial year of CBT superiority imparted an important clinical benefit and may reduce the risk of future recurrent depression episodes.

Longitudinal follow-up and outcomes among a population with chronic kidney disease in a large managed care organization.

BACKGROUND: Chronic kidney disease is the primary cause of end-stage renal disease in the United States. The purpose of this study was to understand the natural history of chronic kidney disease with regard to progression to renal replacement therapy (transplant or dialysis) and death in a representative patient population. METHODS: In 1996 we identified 27 998 patients in our health plan who had estimated glomerular filtration rates of less than 90 mL/min per 1.73 m(2) on 2 separate measurements at least 90 days apart. We followed up patients from the index date of the first glomerular filtration rates of less than 90 mL/min per 1.73 m(2) until renal replacement therapy, death, disenrollment from the health plan, or June 30, 2001. We extracted from the computerized medical records the prevalence of the following comorbidities at the index date and end point: hypertension, diabetes mellitus, coronary artery disease, congestive heart failure, hyperlipidemia, and renal anemia. RESULTS: Our data showed that the rate of renal replacement therapy over the 5-year observation period was 1.1%, 1.3%, and 19.9%, respectively, for the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) stages 2, 3, and 4, but that the mortality rate was 19.5%, 24.3%, and 45.7%. Thus, death was far more common than dialysis at all stages. In addition, congestive heart failure, coronary artery disease, diabetes, and anemia were more prevalent in the patients who died but hypertension prevalence was similar across all stages. CONCLUSION: Our data suggest that efforts to reduce mortality in this population should be focused on treatment and prevention of coronary artery disease, congestive heart failure, diabetes mellitus, and anemia.

The incidence of congestive heart failure in type 2 diabetes: an update.

OBJECTIVE: The aims of this study were to update previous estimates of the congestive heart failure (CHF) incidence rate in patients with type 2 diabetes, compare it with an age- and sex-matched nondiabetic group, and describe risk factors for developing CHF in diabetic patients over 6 years of follow-up. RESEARCH DESIGN AND METHODS: We performed a retrospective cohort study of 8,231 patients with type 2 diabetes and 8,845 nondiabetic patients of similar age and sex who did not have CHF as of 1 January 1997, following them for up to 72 months to estimate the CHF incidence rate. In the diabetic cohort, we constructed a Cox regression model to identify risk factors for CHF development. RESULTS: Patients with diabetes were much more likely to develop CHF than patients without diabetes (incidence rate 30.9 vs. 12.4 cases per 1,000 person-years, rate ratio 2.5, 95% CI 2.3-2.7). The difference in CHF development rates between persons with and without diabetes was much greater in younger age-groups. In addition to age and ischemic heart disease, poorer glycemic control (hazard ratio 1.32 per percentage point of HbA(1c)) and greater BMI (1.12 per 2.5 units of BMI) were important predictors of CHF development. CONCLUSIONS: The CHF incidence rate in type 2 diabetes may be much greater than previously believed. Our multivariate results emphasize the importance of controlling modifiable risk factors for CHF, namely hyperglycemia, elevated blood pressure, and obesity. Younger patients may benefit most from risk factor modification.

Cognitive-behavioral treatment of insomnia and depression in adolescents: A pilot randomized trial.

We tested whether augmenting conventional depression treatment in youth by treating sleep issues with cognitive behavioral therapy for insomnia (CBT-I) improved depression outcomes. We randomized youth 12-20 years of age to 10 weekly sessions of a sleep hygiene control condition (SH) combined with CBT for depression (CBT-D) (n = 20), or an experimental condition consisting of CBT-I combined with CBT-D (n = 21). We assessed outcomes through 26 weeks of follow-up and found medium-large effects favoring the experimental CBT-I arm on some sleep outcomes (actigraphy total sleep time and Insomnia Severity Index "caseness") and depression outcomes (higher percentage recovered, faster time to recovery), but little effect on other measures. Total sleep time improved by 99 min from baseline to week 12 in the CBT-I arm, but not in the SH arm. In addition, our pilot yielded important products to facilitate future studies: the youth-adapted CBT-I program; the study protocol; estimates of recruitment, retention, and attrition; and performance and parameters of candidate outcome measures. ClinicalTrials.gov Identifier NCT00949689.

Tool development for measuring caller satisfaction and outcome with telephone advice nursing.

Caller descriptions and evaluations of their experiences with telephone advice services provide unique information that correlates highly with objective measures of quality and can help interpret data from other sources. An author-developed questionnaire assessed caller outcomes of telephone nursing advice in Phase I an iterative, purposive sample of 40 callers was interviewed by phone. An emergent design was used to develop questions, analyze constructs of interest, and test questions for a draft caller questionnaire, which was tested in Phase II. Responses to the questionnaire provided information about caller characteristics, advice call characteristics, and nurse practice behaviors that caused the authors to further revise the questionnaire. The resulting tool provides feedback to advice nurses about the outcomes of their practice and information to design orientation and development programs and support fund allocation decisions.

Telephone advice nursing services in a US health maintenance organization.

We studied telephone advice nursing (TAN) in the US. We recorded 4269 TAN calls in four regions served by Kaiser Permanente, a health maintenance organization. A call description form was used to record information regarding both calls and callers. The mean call length was 5.9 min (SD 3.6, range 0.3-35.8); 300 calls lasted less than 2 min. The mean call length differed significantly across regions, from 4.4 min in Hawaii to 8.7 min in Southern California. Calls to call centres lasted an average of 6.5 min (SD 3.8), compared with 4.2 min (SD 2.9) for those to medical offices. These differences were significant. Although 42% of calls required some further medical management, only 18% (n = 754) resulted in an urgent disposition, and only 16% (n = 121; 3% of all calls) of the urgent dispositions involved referral to emergency services. The likelihood of urgent disposition varied significantly by region. Callers generally used the TAN services for the right reasons, that is, with questions or concerns that could be reasonably handled by telephone advice nurses.