Human papillomavirus (HPV) vaccine trials have demonstrated high efficacy in preventing HPV infections and HPV related disease in females ages 16–26. However, there is no source data to demonstrate the impact of the vaccine in other populations who may be at higher risk for HPV related disease. This study examines the impact of HPV vaccination on subsequent HPV detection and sexual behaviors among urban adolescents in a clinical setting.
A cohort of adolescent women, ages 14 to 17, were recruited prospectively and matched to historical controls to assess the impact of HPV vaccination. All women completed the same questionnaire and face-to-face interview that assessed sexual behaviors; all provided a clinician or self-collected vaginal swab that was used to test for sexually transmitted infections, including HPV. Logistic regression models, incorporating random pair effects, were used to assess the impact of the HPV vaccine on HPV detection and sexual behaviors between the two groups.
Each woman recruited (N=75) was matched to 2 historical controls (HC); most of the recruited women (89.3%) had received one or more doses of the HPV vaccine. At enrollment, detection of quadrivalent vaccine types (HPV 6, 11, 16 and 18) was significantly less in the recruited group (5.3%) as compared to the HC (24%): OR=5.6 (CI=1.9, 16.5), p=.002. Adolescent women in the HC had a 9.5 times greater odds of HPV infection when the analysis was adjusted to compare those who had 2 or more vaccine doses to their matched controls. The only behavioral difference found was that the recruited women used condoms more frequently.
This study demonstrates that HPV vaccination was associated with fewer vaccine-type HPV infections despite incomplete vaccination and high risk sexual behaviors. These data also suggest that sexual behaviors were not altered because of the vaccine.
Human papillomavirus vaccination; human papillomavirus infection; adolescent
To determine the predictors of pain improvement among patients being treated for cancer-related pain over 12 months.
A secondary analysis of the Indiana Cancer Pain and Depression (INCPAD) trial was performed. Patients participating in this telephone care management pain and depression intervention trial (N=274, mean age=58.1±10.5 years, 66.1% women) were interviewed at baseline, and 1, 3, 6, and 12 months. Pain improvement outcomes included both a continuous measure (Brief Pain Inventory score) and a categorical measure (pain improved vs. pain not improved). Predictor variables included change in depression, age, gender, race, marital status, socioeconomic disadvantage, medical comorbidity, type of cancer, and phase of cancer. Multivariable repeated measures were conducted adjusting for intervention group assignment, baseline pain severity, and time in months since baseline assessment.
Factors predicting both continuous and categorical pain improvement included participating in the intervention group (beta=−.92, p<.001; OR=2.53, CI=1.65–3.89), greater improvement in depression (beta=−.31, p=.003; OR=1.84, CI=1.35–2.51), higher socioeconomic status (Socioeconomic Disadvantage Index; beta=.25, p=.034; OR=.73, CI=.56–.94), and fewer comorbid conditions (beta=.20, p=.002; OR=.84, CI=.73–.96). Conversely, patients with more severe pain at baseline or with recurrent or progressive cancer were less likely to experience continuous or categorical pain improvement, respectively.
Effective management of depression and comorbid conditions along with improvement of social services could be critical components of a comprehensive pain management plan. Also, patients with more severe pain or with recurrent or progressive cancers may require closer monitoring and adequate treatment of pain.
Clinical Trial Registration Number
Cancer-related pain; pain improvement; predictors; longitudinal study
Research has demonstrated that adolescent peer group affiliations are consistent predictors ofsubstance use initiation and maintenance; it is less clear how adolescent romantic relationships influence substance use behavior. Data were drawn from the National Longitudinal Study of Adolescent Health. Participants in the final dataset for the current study includedadolescents (321 males and 321 females) who were identified in reciprocated romantic relationships at Wave 1 (1994-1995; mean age 16.7 years) that were followed into young adulthood and reassessed at two different time points (Wave 2 in 1996, mean age 17.7, and Wave 3 in 2001-2002, mean age 23.1). Data were gathered from both partners, and included demographic variables, longitudinal measures of substance use (alcohol, tobacco, and marijuana), and relationship seriousness. Hierarchical linear modeling using SAS PROC MIXED were utilized to test for individual versus partner influences. Results revealed individual and partner effects for the prediction of alcohol and tobacco, although individual effects were generally greater than partner influences. For marijuana use, as self-reported relationship seriousness increased, future marijuana use decreased. These findings suggest the developmental significance of adolescent romantic relationships on the prediction of future substance use behavior during young adulthood.
Adolescence; romantic relationships; development; longitudinal; substance use
A simple method of identifying elders at high risk for Activity of Daily Living dependence (ADL) could facilitate essential research and implementation of cost-effective clinical care programs.
We used a nationally representative sample of 9,446 older adults free from ADL dependence in 2006 to develop simple models for predicting ADL dependence at 2008 follow-up and to compare the models to the most predictive published model. Candidate predictor variables were those of published models that could be obtained from interview or medical records data.
Variable selection was performed using logistic regression with backwards elimination in a two-thirds random sample (n=6,233) and validated in a one-third random sample (n=3,213). Model fit was determined using the c-statistic and evaluated vis-à-vis our replication of a published model.
At 2-year follow-up, 8.0% and 7.3% of initially independent persons were ADL dependent in the development and validation samples, respectively. The best fitting, simple model consisted of age and number of hospitalizations in past 2 years, plus diagnoses of diabetes, chronic lung disease, congestive heart failure, stroke, and arthritis. This model had a c-statistic of 0.74 in the validation sample. A model of just age and number of hospitalizations achieved a c-statistic of 0.71. These compared to a c-statistic of 0.79 for the published model. Sensitivity analyses demonstrated model robustness.
Models based on widely available data achieve very good validity for predicting ADL dependence. Future work will assess the validity of these models using medical records data.
Older Adults; Activities of Daily Living; Models of Care
We consider frailty models with additive semiparametric covariate effects
for clustered failure time data. We propose a doubly penalized partial
likelihood (DPPL) procedure to estimate the nonparametric functions using
smoothing splines. We show that the DPPL estimators could be obtained from
fitting an augmented working frailty model with parametric covariate effects,
whereas the nonparametric functions being estimated as linear combinations of
fixed and random effects, and the smoothing parameters being estimated as extra
variance components. This approach allows us to conveniently estimate all model
components within a unified frailty model framework. We evaluate the finite
sample performance of the proposed method via a simulation study, and apply the
method to analyze data from a study of sexually transmitted infections
Doubly penalized partial likelihood; smoothing spline; Gaussian frailty; sexually transmitted disease; Smoothing parameter; Variance components
Transition to nursing facilities is often viewed as the final stage of care for persons with dementia in a progression toward dependency
Describe transitions in care among persons with dementia with attention to nursing facility transitions
public health system
4,197 community-dwelling older adults
Subjects’ electronic medical records were merged with Medicare claims, Medicaid claims, the Minimum Dataset (MDS), and the Outcome and Assessment Information Set (OASIS) from 2001–2008 with a mean follow-up of 5.2 years
Compared to subjects never diagnosed (n=2,674), older adults with prevalent (n=524) or incident dementia (n=999) had greater Medicare (11.4% v. 44.7% v. 44.8%, p=<.0001) and Medicaid (1.4% v. 21.0% v. 16.8%, p<.0001) nursing facility use, greater hospital (51.2% v. 76.2% v. 86.0%, p< .0001) and home health use (27.3% v. 55.7%, 65.2%, p< .0001), more transitions in care per person year of follow-up (1.4 v. 2.6 v. 2.7, p<.0001), and more mean total transitions (3.8 v. 11.2 v. 9.2, p<.0001). Among the 1,523 subjects with dementia, 74.5% of transitions to nursing facilities were transfers from hospitals. Among transitions from nursing facilities, the conditional probability was 41.0% for a return home without home health care, 10.7% for home health care, and 39.8% for a hospital transfer. Among subjects with dementia with a ≤30-day rehospitalization, 45% had been discharged to nursing facilities from the index hospitalization. At time of death, 46% of subjects with dementia were at home, 35% in the hospital, and 19% in a nursing facility.
Patients with dementia live and frequently die in community settings. Nursing facilities are part of a dynamic network of care characterized by frequent transitions.
Although the cross-sectional association between cancer-related pain and disability is well-established, their longitudinal relationship has been less studied.
Data from the Indiana Cancer Pain and Depression (INCPAD) trial was analyzed to determine whether baseline cancer-related pain and changes in pain over time predict disability over 12 months.
A total of 274 cancer survivors with cancer-related pain were accrued in the INCPAD trial. Data were collected at baseline, 1, 3, 6, and 12 months by interviewers blinded to treatment arm. Disability outcomes included a continuous measure (Sheehan Disability Scale score) and a categorical measure (≥ 14 days in the past four weeks with a ≥ 50% reduction in usual activities). Predictor variables, operationalized by the Brief Pain Inventory, included baseline pain severity and changes in pain severity scores between each time point. Multivariable analyses were conducted adjusting for treatment group, baseline disability, and selected covariates including depression.
Baseline pain severity did not predict disability outcomes at 12 months. However, improvement in pain severity predicted less disability over 12 months both in terms of Sheehan Disability Scale scores (b = −0.17, t = −5.33, P< 0.001) and ≥ 14 disability days in the past month (odds ratio = 0.85; 95% confidence interval, 0.79–0.93; P< 0.001).
Disability over 12 months in patients with cancer-related pain is predicted by changes in pain severity over time. Results suggest that effective pain management may reduce subsequent disability among cancer survivors.
Cancer-related pain; disability; longitudinal study
In children, blood pressure (BP) and risk for hypertension are proportional to degree of adiposity. Whether the relationship to BP is similar over the full range of adiposity is less clear. Subjects from a cohort study (n=1,111; 50% male and 42% black) contributed 9,102 semiannual BP and height/weight assessments. The mean enrollment age was 10.2 years and mean follow-up was 4.5 years. Adiposity was expressed as body mass index (BMI) percentile, which accounted for effects of age and sex. The following observations were made. The effect of relative adiposity on BP was minimal until the BMI percentile reached 85, beginning of the overweight category, at which point the effect of adiposity on BP increased by four-fold. Similarly intensified adiposity effects on BP were observed in children aged 10 or younger, 11 to 14 years, and 15 years or older. Serum levels of the adipose tissue-derived hormone, leptin, together with heart rate showed an almost identically patterned relation to BP to that of BMI percentile and BP thus implicating a possible mediating role for leptin. In conclusion, there is a marked intensification of the influence of adiposity on BP when children reach the categories of overweight and obese. Among the possible pathways, leptin may be a potentially important mediator acting through the sympathetic nervous system (reflected in heart rate). The findings have relevance to interventions designed to prevent or treat adiposity-related increases in BP and to the analytical approaches used in epidemiologic studies.
Hypertension; obesity; leptin; heart rate; sympathetic nervous system
Nonsteroidal anti-inflammatory drugs (NSAIDs) may disrupt control of blood pressure in hypertensive patients and increase their risk of morbidity, mortality, and the costs of care. The objective of this study was to examine the association between incident use of NSAIDs and blood pressure in patients with hypertension.
We conducted a retrospective cohort study of adult hypertensive patients to determine the effects of their first prescription for NSAID on systolic blood pressure and antihypertensive drug intensification. Data were collected from an electronic medical record serving an academic general medicine practice in Indianapolis, Indiana, USA. Using propensity scores to minimize bias, we matched a cohort of 1,340 users of NSAIDs with 1,340 users of acetaminophen. Propensity score models included covariates likely to affect blood pressure or the use of NSAIDs. The study outcomes were the mean systolic blood pressure measurement after starting NSAIDs and changes in antihypertensive therapy.
Compared to patients using acetaminophen, NSAID users had a 2 mmHg increase in systolic blood pressure (95% CI, 0.7 to 3.3). Ibuprofen was associated with a 3 mmHg increase in systolic blood pressure compared to naproxen (95% CI, 0.5 to 4.6), and a 5 mmHg increase compared to celecoxib (95% CI, 0.4 to 10). The systolic blood pressure increase was 3 mmHg in a subgroup of patients concomitantly prescribed angiotensin converting enzyme inhibitors or calcium channel blockers and 6 mmHg among those prescribed a beta-adrenergic blocker. Blood pressure changes in patients prescribed diuretics or multiple antihypertensives were not statistically significant.
Compared to acetaminophen, incident use of NSAIDs, particularly ibuprofen, is associated with a small increase in systolic blood pressure in hypertensive patients. Effects in patients prescribed diuretics or multiple antihypertensives are negligible.
NSAIDs; Hypertension; Blood pressure; Propensity score
Bacterium Chlamydia trachomatis causes genital chlamydia infection. Yet little is known about the transmission efficiency of this organism. Ethical constraint against exposing healthy subjects to infected partners precludes the possibility of quantifying transmission risk through controlled experiments. This research proposes an alternative strategy that relies on observational data. Specifically, we present a stochastic model that treats longitudinally observed infection states in a group of young women as a Markov process. The proposed model explicitly accommodates the parameters of C. trachomatis transmission, including per-encounter sexually transmitted infection (STI) acquisition risks, with and without condom protection, and the probability of antibiotic treatment failure. The male-to-female transmission probability of C. trachomatis is then estimated by combining the per-encounter disease acquisition risk and the organism’s prevalence in the male partner population. The proposed model is fitted in a Bayesian computational framework.
Binary outcome; Bacterial infection; Transmission probability; Longitudinal study; Markov model; MCMC; Observational data
Pain and depression are the most prevalent physical and psychological symptom-based disorders, respectively, and co-occur 30–50% of the time. However, their reciprocal relationship and potentially causative effects on one another have been inadequately studied. Longitudinal data analysis involving 500 primary care patients with persistent back, hip or knee pain were enrolled in the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study. Half of the participants had comorbid depression and were randomized to a stepped care intervention (n = 123) or treatment as usual (n = 127). Another 250 nondepressed patients with similar pain were followed in a parallel cohort. Outcomes were assessed at baseline, 3, 6, and 12 months. Mixed effects model repeated measures (MMRM) multivariable analyses were conducted to determine if change in pain severity predicted subsequent depression severity, and vice-versa. Change in pain was a strong predictor of subsequent depression severity (t-value = 6.63, p < .0001). Likewise, change in depression severity was an equally strong predictor of subsequent pain severity (t-value = 7.28, p < .0001). Results from the full cohort were similar in the clinical trial subgroup. In summary, pain and depression have strong and similar effects on one another when assessed longitudinally over 12 months.
pain; depression; causation; prognosis; primary care; longitudinal
Observational data are increasingly being used for pharmacoepidemiological, health services and clinical effectiveness research. Since pharmacies first introduced low-cost prescription programs (LCPP), researchers have worried that data about the medications provided through these programs might not be available in observational data derived from administrative sources, such as payer claims or pharmacy benefit management (PBM) company transactions.
We used data from the Indiana Network for Patient Care to estimate the proportion of patients with type 2 diabetes to whom an oral hypoglycemic agent was dispensed. Based on these estimates, we compared the proportions of patients who received medications from chains that do and do not offer an LCPP, the proportion trend over time based on claims data from a single payer, and to proportions estimated from the Medical Expenditure Panel Survey (MEPS).
We found that the proportion of patients with type 2 diabetes who received oral hypoglycemic medications did not vary based on whether the chain that dispensed the drug offered an LCPP or over time. Additionally, the rates were comparable to those estimated from MEPS.
Researchers can be reassured that data for medications available through LCPPs continue to be available through administrative data sources.
Low-cost prescription program; Oral antihyperglycemic agents; Pharmacy benefit manager; Claims data
Selective cyclooxygenase-2 (COX-2) inhibitors have been linked to cardiac death. The mechanism for this adverse effect appears to be by ischemic insult; however another mechanism could involve hyperkalemia. The objective of this study was to determine the effects of selective COX-2 inhibitors and non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) on serum potassium concentration and the electrocardiogram.
A retrospective cohort study was conducted using propensity score matching of patients from an inner-city academic medical center at Indianapolis, Indiana. Two hundred and two patients prescribed selective COX-2 inhibitors were matched to 202 patients prescribed non-selective NSAIDs using propensity scores methods. Outcomes included change in serum potassium concentration from baseline and the risk of an abnormal electrocardiogram.
Compared to patients prescribed non-selective NSAIDs, those prescribed a selective COX-2 inhibitor had a higher risk of serum potassium increase greater than 5 mEq/L (OR, 2.56; 95%CI, 1.03–6.36). However, patients prescribed selective COX-2 inhibitors had no greater risk of electrocardiogram abnormality (OR, 1.16; 95%CI, 0.74–1.82).
Selective COX-2 inhibitors may have a greater risk of hyperkalemia than non-selective NSAIDs. This study was exploratory with small numbers of patients. Further studies are needed to confirm these results and any association with cardiovascular events.
hyperkalemia; NSAIDs; selective COX-2 inhibitors; retrospective cohort study; propensity score
The adverse impact of high somatic symptom burden is well established for primary care and other noncancer populations with chronic medical disorders. This study examines the impact of somatic symptom burden on disability and health care use in cancer patients suffering from pain and/or depression.
Secondary analysis of baseline data from 405 cancer patients enrolled in a telecare management trial for pain and/or depression. Somatic symptom burden was measured with a 22-item scale. Multivariable models were conducted to determine the association of somatic symptom burden with the Sheehan Disability Scale (SDS) score, the number of self-reported disability days in the past 3 months, and health care use. Models were adjusted for sociodemographic characteristics, medical comorbidity, and depression and pain severity.
Somatic symptoms were highly prevalent, with 15 of the 22 symptoms reported by more than 50% of patients. Somatic symptom burden was similar across different types and phases of cancer. The mean SDS (scored 0 to 10) was 5.4 and the mean number of self-reported disability days in the past 4 weeks was 16.9 days. In multivariable models, somatic symptom burden was associated with both SDS (P < .001) and the likelihood of ≥ 14 disability days in the past 4 weeks (OR=1.51; 95% CI, 1.19–1.92) but was not with increased health care use.
Somatic symptom burden is high in cancer patients with pain and/or depression. Given the strong association with disability and the high prevalence of many types of symptoms, recognizing and managing somatic symptoms may be important in improving quality of life and functional status regardless of type or phase of cancer.
cancer; somatic symptoms; somatization; pain; depression; disability; quality of life; health care use
Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20-30% of oncology patients.
To determine the associations of pain and depression with health-related quality of life (HRQL), disability, and health care use in cancer patients.
The Indiana Cancer Pain and Depression (INCPAD) study is a randomized clinical trial comparing telecare management vs. usual care for patients with cancer-related pain and/or clinically significant depression. In this paper, baseline data on patients enrolled from 16 urban or rural community-based oncology practices are analyzed to test the associations of pain and depression with HRQL, disability, and health care use.
Of the 405 participants, 32% had depression only, 24% pain only, and 44% both depression and pain. The average Hopkins Symptom Checklist 20-item (HSCL-20) depression score in the 309 depressed participants was 1.64 (on 0-4 scale), and the average Brief Pain Inventory (BPI) severity score in the 274 participants with pain was 5.2 (on 0-10 scale), representing at least moderate levels of symptom severity. Symptom-specific disability was high, with participants reporting an average of 16.8 days out of the past 28 (i.e., 60% of their days in the past four weeks) in which they were either confined to bed (5.6 days) or had to reduce their usual activities by 50% (11.2 days) due to pain or depression. Moreover, 176 (43%) reported being unable to work due to health-related reasons. Depression and pain had both individual and additive adverse associations with quality of life. Most patients were currently not receiving care from a mental health or pain specialist.
Depression and pain are prevalent and disabling across a wide range of types and phases of cancer, commonly co-occur, and have additive adverse effects. Enhanced detection and management of this disabling symptom dyad is warranted.
Cancer; pain; depression; disability; quality of life; health care use
Pain and depression are two of the most prevalent and treatable cancer-related symptoms, yet frequently go unrecognized and/or undertreated.
To determine whether centralized telephone-based care management coupled with automated symptom monitoring can improve depression and pain in cancer patients.
Design, Setting, and Patients
Randomized controlled trial conducted in 16 community-based urban and rural oncology practices across the state of Indiana. Recruitment occurred from March 2006 through August 2008 and follow-up concluded in August 2009. The 405 patients had depression (Patient Health Questionnaire-9 score ≥ 10), cancer-related pain (Brief Pain Inventory worst pain score ≥ 6), or both.
Patients were randomly assigned to the intervention (n=202) or to usual care (n=203), stratified by symptom type. Intervention patients received centralized telecare management by a nurse-physician specialist team coupled with automated home-based symptom monitoring by interactive voice recording or internet.
Main Outcome Measures
Blinded assessment at baseline, 1, 3, 6, and 12 months for depression (20-item Hopkins Symptom Checklist [HSCL-20]) and pain (Brief Pain Inventory [BPI]) severity.
There were 131 patients enrolled with depression only, 96 with pain only, and 178 with both depression and pain. Of the 274 patients enrolled for pain, the 137 intervention patients had greater improvements than the 137 usual care patients in BPI pain severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical pain responder (P < .0001 for both). Similarly, of the 309 patients enrolled for depression, the 154 intervention patients had greater improvements than the 155 usual care patients in HSCL-20 depression severity over the 12 months of the trial whether measured as a continuous severity score (P < .0001) or as a categorical depression responder (P < .001). The standardized effect size for between-group differences at 3 and 12 months was .67 and .39 for pain, and .42 and .44 for depression.
Centralized telecare management coupled with automated symptom monitoring resulted in improved pain and depression outcomes in cancer patients receiving care in geographically-dispersed urban and rural oncology practices.
cancer; pain; depression; antidepressants; analgesics; telemedicine; care management
Depression is known to be a major problem in cancer patients, and evidence is emerging about the importance of anxiety. Because the disorders are highly comorbid, we examined the relationship of anxiety and depression with health-related quality of life (HRQL) in cancer patients.
Sample included 405 adult oncology patients participating in a randomized controlled trial of telecare management for pain and depression. This secondary cross-sectional analysis of baseline data examined independent and additive effects of anxiety and depression on HRQL, disability, and somatic symptom severity.
In 397 patients who screened positive for either pain or depression or both, 135 had comorbid anxiety and depression, 174 had depression but not anxiety, and 88 had neither. Differences existed across all non-physical HRQL domains and were more pronounced incrementally across the 3 groups in the expected direction. In GLM modeling, anxiety and depression were each associated with all domains when modeled separately (p < 0.0001). When modeled together, anxiety and depression had independent and additive effects on the mental health domains of HRQL and on somatic symptom burden. In other domains (vitality, perceived disability, overall quality of life, and general health perceptions), only depression had an effect.
Anxiety and depression have strong and independent associations with mental health domains and somatic symptom burden in cancer patients. However, depression has a more pervasive association with multiple other domains of HRQL. Paying attention to both anxiety and depression may be particularly important when addressing mental health needs and somatic symptom distress.
Cancer; oncology; anxiety; depression; symptoms; health-related quality of life
Adolescent pregnancy prevention is difficult because sex itself is intermittent, occurring after days, weeks or months of abstinence. An understanding of why sexually experienced adolescents decide to have sex after a period of abstinence will allow clinicians to better tailor counseling.
For up to 4.5 years, 354 adolescent women were interviewed and STI tested every three months, and asked to complete 3 months of daily diaries twice a year. We examined periods of abstinence in the daily diaries, using survival analysis to estimate the effect of intrapersonal, relationship, and STI-related factors on the risk of ending an abstinence period with sex.
Participants reported 9236 abstinence periods, mean 30.9 days. Shorter, intermediate and longer abstinence periods were identified from the cumulative hazard plot. The risk of ending a shorter abstinence period increased with age (Hazard Ratio = 1.07), sexual interest (HR = 1.14), positive mood (HR = 1.03), daily partner support (HR=1.14), quarterly relationship quality (HR=1.02) and distant STI (HR=1.16); the risk decreased with negative mood (HR=0.98) and recent STI (HR=0.91). During intermediate periods the association with recent STI switched directions (HR=1.40). Longer periods showed associations only with age (HR=1.24), sexual interest (HR=1.33), and relationship quality (HR=1.10).
Intrapersonal, relationship, and STI related factors influence the decision to have sex after a period of abstinence. The direction and strength of these associations varied with the length of abstinence, highlighting the importance of a young woman's recent patterns of sexual activity.
Sexual Abstinence; Adolescent; Sexually Transmitted Disease; Sexual Behavior; Affect; Survival Analysis; Sexual Desire; Sexual Partner
Mood and sexual interest changes are commonly cited reasons for discontinuing hormonal contraceptives. Data, however, are inconsistent and limited to adult users. We examined associations of hormonal contraceptive use with mood and sexual interest among adolescents. We recruited 14-17 year old women primary care clinics and followed them longitudinally for up to 41 months. Participants completed face-to-face interviews quarterly and two 12 week periods of daily diary collection per year. On daily diaries, participants recorded positive mood, negative mood, and sexual interest. We classified 12 week diary periods as “stable OCP use,” “non-use,” “initiated use,” “stopped use,” and “DMPA use” based on self-report of oral contraceptive pill (OCP) use and depot medroxyprogesterone acetate (DMPA) use from medical charts. Diary periods were the unit of analysis. Participants could contribute more than one diary period. We analyzed data using linear models with a random intercept and slope across weeks in a diary period, an effect for contraceptive group, and an adjustment for age at the start of a diary period. Mean weekly positive mood was higher in diary periods characterized by stable OCP use, compared to other groups. Mean weekly negative mood was lower in diary periods characterized by stable OCP use and higher in periods characterized by DMPA use. Periods characterized by stable OCP use additionally showed less mood variation than other groups. Changes in mood among adolescent hormonal contraceptive users differed from those anticipated for adult users. Attention to adolescent-specific changes in mood and sexual interest may improve contraceptive adherence.
adolescent; oral contraceptives; sexual interest; sexual desire; mood; daily diaries; depot medroxyprogesterone acetate
To determine the time between first intercourse and first sexually transmitted infection (STI) with Chlamydia trachomatis, Neisseria gonorrhoeae, or Trichomonas vaginalis and time between repeated infections.
Three adolescent medicine clinics.
A cohort of 386 urban young women aged 14 to 17 years at enrollment.
Main Outcome Measures
Age at first intercourse; organism-specific interval between first intercourse and first STI diagnosis; interval between repeated infections; and age at first STI test prior to study participation.
Participants had first intercourse at a young age (first, second, and third quartiles were 13, 14, and 15 years of age, respectively). By age 15 years, 25% of the women acquired their first STI, most often C trachomatis. Median interval between first intercourse and first STI diagnosis was 2 years. Within 1 year of first intercourse, 25% had their first C trachomatis infection. Repeated infections were common; within 3.6, 6, and 4.8 months, 25% of the women with prior C trachomatis, N gonorrhoeae, and T vaginalis infection were reinfected with the respective organisms. Considerable delay in STI testing was found for those who began sex at a younger age. The median interval between first sex and first test were 4.9, 3.5, 2.1, 1.8, and 1.2 years for those who had first sex at ages 10, 11, 12, 13, and 14 years, respectively.
Timely screening and treatment are important for prevention of STI sequelae. For urban adolescent women, STI screening (especially for C trachomatis) should begin within a year after first intercourse and infected individuals should be retested every 3 to 4 months.
Repeated C. trachomatis infections are common among young sexually active women. The relative frequency of re-infection and antibiotic treatment failure is undefined.
Adolescent women enrolled in a longitudinal cohort had behavioral and sexually transmitted infection assessment every 3 months, including amplification tests for C. trachomatis, ompA genotyping and interviews and diary entries to document partner-specific coitus and event-specific condom use. Repeated infections were classified as re-infection or treatment failure using an algorithm. All infections with treatment outcomes were used to estimate antibiotic use-effectiveness.
We observed 478 infection episodes among 210 participants; 176 women remained uninfected. Incidence rate was 34 per 100-woman years. Of those infected, 121 had ≥1 repeat infections forming 268 episode pairs; 183 pairs had complete data and were classified with the algorithm. Of repeated infections, 84.2% were definite, probable or possible re-infections, 13.7% were probable or possible treatment failures and 2.2% persisted without documented treatment. For 318 evaluable infections, we estimated a 92.2% treatment use-effectiveness.
Most repeat chlamydial infections in this high incidence cohort were re-infections, but treatment failures occurred as well. Our results have implications for male screening and partner notification programs and suggest the need for improved antibiotic therapies.
Chlamydia trachomatis; genital infections; repeated infections; re-infections; treatment failures; adolescent women
The Central Indiana Beacon Community leads efforts for improving adherence to oral hypoglycemic agents (OHA) to achieve improvements in glycemic control for patients with type 2 diabetes. In this study, we explored how OHA adherence affected hemoglobin A1C (HbA1c) level in different racial groups. OHA adherence was measured by 6-month proportion of days covered (PDC). Of 3,976 eligible subjects, 12,874 pairs of 6-month PDC and HbA1c levels were formed between 2002 and 2008. The average HbA1c levels were 7.4% for African-Americans and 6.5% for Whites. The average 6-month PDCs were 40% for African-Americans and 50% for Whites. In mixed effect generalized linear regression analyses, OHA adherence was inversely correlated with HbA1c level for both African-Americans (−0.80, p<0.0001) and Whites (−0.53, p<0.0001). The coefficient was −0.26 (p<0.0001) for the interaction of 6-month PDC and African-Americans. Significant risk factors for OHA non-adherence were race, young age, non-commercial insurance, newly-treated status, and polypharmacy.
Pain and depression are the most common physical and psychological symptoms in primary care, respectively. Moreover, they co-occur 30-50% of the time and have adverse reciprocal effects on quality of life, disability, and health care costs.
To determine if a combined pharmacological and behavioral intervention improves both depression and pain in primary care patients with musculoskeletal pain and comorbid depression.
Design, Setting, and Patients
Randomized controlled trial conducted at 6 community-based clinics of 1 university primary care system and 5 general medicine clinics of 1 Department of Veterans Affairs Medical Center. Recruitment occurred from January 2005 to June 2007 and follow-up concluded in June 2008. The 250 patients had low back, hip or knee pain for ≥ 3 months and at least moderate depression severity (Patient Health Questionnaire-9 score ≥ 10).
Patients were randomly assigned to the intervention (n=123) or to usual care (n=127). The intervention consisted of 12 weeks of optimized antidepressant therapy (step 1) followed by 6 sessions of a pain self-management (PSM) program over 12 weeks (step 2) and, lastly, a continuation phase of therapy for 6 months (step 3).
Main Outcome Measures
Assessments at baseline, 1, 3, 6, and 12 months for depression (20-item Hopkins Symptom Checklist [HSCL-20]), pain severity and interference (Brief Pain Inventory [BPI]) and global improvement in pain.
At 12 months, 46 (37.4%) of the 123 intervention patients had a 50% or greater reduction in depression severity from baseline compared with 21 (16.5%) of 127 usual care patients (relative risk [RR], 2.3; 95% CI, 1.5 to 3.2), corresponding to a much lower number with major depression (50 [40.7%] vs. 87 [68.5%]; RR, 0.6; 95% CI, 0.4-0.6). Also, a clinically significant (≥ 30%) reduction in pain was much more likely in intervention patients (51 [41.5%] vs. 22 [17.3%]; RR, 2.4; 95% CI, 1.6-3.2), as was global improvement in pain (58 [47.2%] vs. 16 [12.6%]; RR 3.7, 95% CI, 2.3-6.1). More intervention patients also experienced benefits in terms of our primary outcome, which was a combined improvement in both depression and pain (32 [26.0%] vs. 10 [7.9%]; RR = 3.3; 95% CI, 1.8 to 5.4).
Optimized antidepressant therapy followed by a pain self-management program resulted in substantial improvement in depression as well as moderate reductions in pain severity and disability.
Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20-30% of oncology patients. Both symptoms, however, are frequently either unrecognized and/or undertreated. The objective is to describe a telecare management intervention delivered by a nurse-psychiatrist team that is designed to improve recognition and treatment of pain and depression. The enrolled sample is also described.
The Indiana Cancer Pain and Depression (INCPAD) study is an NCI-sponsored randomized clinical trial. A total of 405 patients with cancer-related pain and/or clinically significant depression from 16 urban or rural oncology practices throughout Indiana have been enrolled and randomized to either the intervention or a usual care control group. Intervention patients receive centralized telecare management coupled with automated home-based symptom monitoring. Outcomes will be assessed at 1, 3, 6 and 12 months by research assistants blinded to treatment arm.
Of 4465 patients screened, 2185 (49%) endorsed symptoms of pain or depression. Of screen-positive patients, about one-third were ineligible (most commonly due to pain or depression not meeting severity thresholds, or pain that is not cancer-related). Of the 405 patients enrolled, 32% have depression only, 24% pain only, and 44% both depression and pain. At baseline, participants report an average of 16.8 days out of the past 4 weeks in which they were confined to bed or had to reduce their usual activities by ≥ 50% due to pain or depression. Also, 176 (44%) report being unable to work due to health reasons.
When completed, the INCPAD trial will test whether centralized telecare management coupled with automated home-based symptom monitoring improves outcomes in cancer patients with depression and/or pain. Findings will be important for both oncologists and mental health clinicians confronted with oncology patients' depression or pain.
cancer; pain; depression; antidepressants; analgesics; telemedicine; care management
Determine if psychosocial stress and anxiety were associated with depression severity in primary care patients with chronic musculoskeletal pain.
A cross-sectional sample of 500 primary care patients with musculoskeletal pain (250 with depression and 250 without depression) were assessed for anxiety, psychosocial stress, depression severity, and demographics. The depressed and nondepressed participants were compared using t-test and chi-square analyses. Multiple linear regression analyses evaluated the respective associations of psychosocial stressors and anxiety with SCL-20 depression severity across all 500 participants.
Compared with nondepressed patients, the depressed patients reported significantly more psychosocial stressors and more severe anxiety. Depressed patients reported a higher frequency of difficulties with every psychosocial stressor assessed. After controlling for covariates, both anxiety and psychosocial stressors were associated with depression severity.
Both anxiety and psychosocial stress should be considered in the assessment and treatment of patients with musculoskeletal pain and depression. Psychosocial stressors among patients with pain may have an impact on depression beyond that of anxiety. Tailored, integrated treatments that target the psychosocial needs of patients with pain and depression are needed. In addition to pharmacotherapy, psychotherapy and other behavioral treatments may be especially important for depression complicated by anxiety or psychosocial stress.
Depression; pain; psychosocial stress; anxiety