Assessing program or intervention fidelity/integrity is an important methodological consideration in clinical and educational research. These critical variables influence the degree to which outcomes can be attributed to the program and the success of the transition from research to practice and back again. Research in the Mindfulness-Based Program (MBP) field has been expanding rapidly over the last 20 years, but little attention has been given to how to assess intervention integrity within research and practice settings. The proliferation of different program forms, inconsistency in adhering to published curriculum guides, and variability of training levels and competency of trial teachers all pose grave risks to the sustainable development of the science of MBPs going forward. Three tools for assessing intervention integrity in the MBP field have been developed and researched to assess adherence and/or teaching competence: the Mindfulness-Based Cognitive Therapy-Adherence Scale (MBCT-AS), the Mindfulness-Based Relapse Prevention-Adherence and Competence Scale (MBRP-AC), and the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC). Further research is needed on these tools to better define their inter-rater reliability and their ability to measure elements of teaching competence that are important for participant outcomes. Research going forward needs to include systematic and consistent methods for demonstrating and verifying that the MBP was delivered as intended, both to ensure the rigor of individual studies and to enable different studies of the same MBP to be fairly and validly compared with each other. The critical variable of the teaching also needs direct investigation in future research. We recommend the use of the "Template for Intervention Description and Replication" (TIDieR) guidelines for addressing and reporting on intervention integrity during the various phases of the conduct of research and provide specific suggestions about how to implement these guidelines when reporting studies of mindfulness-based programs.

Background

Poor adherence is the main barrier to the effectiveness of HIV medication. The objective of this study was to explore and conceptualize patterns and difficulties in physicians' work with patients' adherence to HIV medication. No previous studies on this subject have directly observed physicians' behavior.

Methods

This is a qualitative, cross-sectional study. We used a Grounded Theory approach to let the main issues in physicians' work with patients' adherence emerge without preconceiving the focus of the study. We included physicians from HIV clinics in San Francisco, U.S.A. as well as from Copenhagen, Denmark. Physicians were observed during their clinical work and subsequently interviewed with a semi-structured interview guide. Notes on observations and transcribed interviews were analyzed with NVivo software.

Results

We enrolled 16 physicians from San Francisco and 18 from Copenhagen. When we discovered that physicians and patients seldom discussed adherence issues in depth, we made adherence communication and its barriers the focus of the study. The main patterns in physicians' communication with patients about adherence were similar in both settings. An important barrier to in-depth adherence communication was that some physicians felt it was awkward to explore the possibility of non-adherence if there were no objective signs of treatment failure, because patients could feel "accused." To overcome this awkwardness, some physicians consciously tried to "de-shame" patients regarding non-adherence. However, a recurring theme was that physicians often suspected non-adherence even when patients did not admit to have missed any doses, and physicians had difficulties handling this low believability of patient statements. We here develop a simple four-step, three-factor model of physicians' adherence communication. The four steps are: deciding whether to ask about adherence or not, pre-questioning preparations, phrasing the question, and responding to the patient's answer. The three factors/determinants are: physicians' perceptions of adherence, awkwardness, and believability.

Conclusion

Communication difficulties were a main barrier in physicians' work with patients' adherence to HIV medication. The proposed model of physicians' communication with patients about adherence--and the identification of awkwardness and believability as key issues--may aid thinking on the subject for use in clinical practice and future research.

Objectives

To describe cancer inpatients' prior-year use of complementary and integrative health (CIH) therapies and interest in receiving CIH therapies while in the hospital.

Design

Observational, cross-sectional survey of prior-year use of 12 different CIH approaches and interest in receiving any of 7 CIH services in the hospital.

Setting

Surgical oncology ward of an academic medical center.

Participants

166 hospitalized oncology patients, with an average age of 54 years.

Results

The most commonly used CIH approach was vitamins/nutritional supplements (67%), followed by use of a special diet (42%) and manual therapies (39%). More than 40% of patients expressed interest in each of the therapies if it was offered during their hospital stay, and 95% of patients were interested in at least one. More than 75% expressed interest in nutritional counseling and in massage. CIH use and interest varied somewhat by demographic and clinical characteristics.

Conclusion

Rates of CIH use among patients with cancer were high, as were their preferences to have these services available in the inpatient setting. Hospitals have the opportunity to provide patient-centered care by developing capacity to provide inpatient CIH services.

Background context

Primary care clinicians need to identify candidates for early interventions to prevent patients with acute pain from developing chronic pain.

Purpose

We conducted a 2-year prospective cohort study of risk factors for the progression to chronic pain and developed and internally validated a clinical decision rule (CDR) that stratifies patients into low-, medium-, and high-risk groups for chronic pain.

Study design/setting

This is a prospective cohort study in primary care.

Patient sample

Patients with acute low back pain (LBP, ≤30 days duration) were included.

Outcome measures

Outcome measures were self-reported perceived nonrecovery and chronic pain.

Methods

Patients were surveyed at baseline, 6 months, and 2 years. We conducted bivariate and multivariate regression analyses of demographic, clinical, and psychosocial variables for chronic pain outcomes, developed a CDR, and assessed its performance by calculating the bootstrapped areas under the receiver-operating characteristic curve (AUC) and likelihood ratios.

Results

Six hundred five patients enrolled: 13% had chronic pain at 6 months and 19% at 2 years. An eight-item CDR was most parsimonious for classifying patients into three risk levels. Bootstrapped AUC was 0.76 (0.70-0.82) for the 6-month CDR. Each 10-point score increase (60-point range) was associated with an odds ratio of 11.1 (10.8-11.4) for developing chronic pain. Using a less than 5% probability of chronic pain as the cutoff for low risk and a greater than 40% probability for high risk, likelihood ratios were 0.26 (0.14-0.48) and 4.4 (3.0-6.3) for these groups, respectively.

Conclusions

A CDR was developed that may help primary care clinicians classify patients with strictly defined acute LBP into low-, moderate-, and high-risk groups for developing chronic pain and performed acceptably in 1,000 bootstrapped replications. Validation in a separate sample is needed.

Objective

To investigate the changes in running biomechanics after training in form-focused running using ChiRunning versus not-form focused training and self-directed training in untrained individuals.

Design

Pilot study-randomized controlled trial.

Setting

Research institution with tertiary care medical center.

Participants

Seventeen subjects (9 men, 8 women) with prehypertension.

Methods

Twenty-two participants were randomized to 3 study arms but 17 completed the study. The study arms were: (1) group-based Form-Focused running using ChiRunning (enrolled, n = 10; completed, n = 7); (2) group-based conventional running (enrolled, n = 6; completed, n = 4); and (3) self-directed training with educational materials (enrolled, n = 6; completed, n = 6). The training schedule was prescribed for 8 weeks with 4 weeks of follow-up. All subjects completed overground running motion analyses before and after training. ClinicalTrials.gov identifier for this study is NCT0158718.

Outcomes

Ankle, knee, hip joint peak moments, and powers; average vertical loading rate (AVLR); impact peak; cadence; stride length; strike index; and stride reach. Paired t tests were used to compare differences within groups over time.

Results

Form-focused group reduced their Stride Reach (P = .047) after the training but not the other groups. Form-focused group showed a close to significant reduction in knee adduction moment (P = .051) and a reduction in the peak ankle eversion moment (P = .027). Self-directed group showed an increase in the running speed (P = .056) and increases in ankle and knee joint powers and moments.

Conclusions

There are differences in the changes in running biomechanics between individuals trained in running form that emphasizes mid-foot strike, greater cadence, and shorter stride compared with those not trained in the these techniques. These differences may be associated with reduced lower extremity stress in individuals trained in this running form, but more studies are needed to confirm these findings in larger samples.

CD8+ lymphocytes can suppress HIV replication without killing the infected cells. This CD8+ cell noncytotoxic anti-HIV response (CNAR) is associated with a beneficial clinical course. In this longitudinal study of 16 participants in the Options Project at UCSF, we measured the ability of CD8+ lymphocytes to suppress HIV replication in CD4+ cells during primary HIV infection, early antiretroviral therapy, and after treatment. CD8+ lymphocytes from subjects with untreated primary HIV-1 infection strongly suppressed HIV replication. Initiation of antiretroviral therapy during primary HIV-1 infection caused a marked decline in this CNAR. CD8+ cells from these subjects regained anti-HIV activity when early therapy was discontinued. The timing of the appearance of CD8+ cell anti-HIV activity directly correlated with the emergence of detectable virus levels. Maximal CNAR activity coincided with a decay in the kinetics of HIV replication. In addition, peak viral loads during treatment interruption were lower than pre-treatment virus levels (median reduction = 0.8 logs, p = 0.005) and CD4+ T cell counts were maintained for a 24-week period of follow-up. These results suggest that CNAR plays an important role in suppressing HIV replication in the setting of antiretroviral treatment interruption in HIV-infected individuals.

Objective

Existing pharmacologic approaches for painful diabetic neuropathy (PDN) are limited in efficacy and have side effects. We examined the feasibility, acceptability, and effects of group acupuncture for PDN.

Design and setting

We randomized patients with PDN from a public safety net hospital to 1) usual care, 2) usual care plus 12 weeks of group acupuncture once weekly, or 3) usual care plus 12 weeks of group acupuncture twice weekly.

Methods

The primary outcome was change in weekly pain intensity (daily 0-10 numerical rating scale [NRS] averaged over seven days) from baseline to week 12. We also assessed health-related quality of life and related symptoms at baseline and weeks 6, 12, and 18.

Results

We enrolled 40 patients with PDN (baseline pain = 5.3). Among participants randomized to acupuncture, 92% attended at least one treatment (mean treatments = 10.1). We observed no significant differences between once- vs twice-weekly acupuncture and combined those groups for the main analyses. Compared with usual care, participants randomized to acupuncture experienced greater decreases in pain during the 12-week intervention period (between-group differences from baseline = -2.06, 95% confidence interval [CI] = -3.01 to -1.10), but benefits were not maintained after acupuncture ended (baseline to week 18 = -0.61, 95% CI = -1.46 to 0.24). Quality of life improved for acupuncture participants (baseline to week 12 difference = 11.79, 95% CI = 1.92 to 21.66), but group differences were not significant compared with usual care (25.58, 95% CI = -3.90 to 55.06).

Conclusions

Group acupuncture is feasible and acceptable among linguistically and racially diverse safety net patients. Findings suggest clinically relevant reduction in pain from PDN and quality of life improvements associated with acupuncture, with no differences based on frequency.

While negative emotions are associated with risk behaviors and risk avoidance among people with HIV, emerging evidence indicates that negative self-conscious emotions, those evoked by self-reflection or self-evaluation (e.g., shame, guilt, and embarrassment), may differentially influence health-risk behaviors by producing avoidance or, conversely, pro-social behaviors. Positive emotions are associated with beneficial health behaviors, and may account for inconsistent findings related to negative self-conscious emotions. Using multinomial logistic regression, we tested whether positive emotion moderated the relationships between negative emotion and negative self-conscious emotions and level of condomless sex risk: (1) seroconcordant; (2) serodiscordant with undetectable viral load; and (3) serodiscordant with detectable viral load [potentially amplified transmission (PAT)] among people recently diagnosed with HIV (n = 276). While positive emotion did not moderate the relationship between negative emotion and condomless sex, it did moderate the relationship between negative self-conscious emotion and PAT (AOR = 0.60; 95% CI 0.41, 0.87); high negative self-conscious and high positive emotion were associated with lower PAT risk. Acknowledgment of both positive and negative self-conscious emotion may reduce transmission risk behavior among people with HIV.

We estimate the relative transmission rate in early versus later infection among men who have sex with men (MSM) in San Francisco, California, by studying the characteristics of a sample of transmitters, recruited through newly diagnosed, recently infected MSM between 1996 and 2009. Of 36 transmitters identified, 9 were determined on the basis of testing history and serologic testing to have been recently infected. The unadjusted odds ratio of transmitting during early infection was 15.2 (95% confidence interval [CI], 6.3-33.4; P < .001); the odds ratio was 8.9 (95% CI, 4.1-19.4) after adjustment for self-reported antiretroviral treatment. This high transmissibility could be due to both high infectiousness and high rates of sex partner change or concurrent partnerships.