The LIFE study is a two-phase randomized clinical trial comparing two approaches to maintaining weight loss following guided weight loss. Phase I provided a nonrandomized intensive 6-month behavioral ...weight loss intervention to 472 obese (body mass index 30-50) adult participants. Phase II is the randomized weight loss maintenance portion of the study. This paper focuses on Phase I measures of sleep, screen time, depression and stress.
The Phase I intervention consisted of 22 group sessions led over 26 weeks by behavioral counselors. Recommendations included reducing dietary intake by 500 calories per day, adopting the Dietary Approaches to Stop Hypertension (DASH) dietary pattern and increasing physical exercise to at least 180 min per week. Measures reported here are sleep time, insomnia, screen time, depression and stress at entry and post-weight loss intervention follow-up.
The mean weight loss for all participants over the intensive Phase I weight loss intervention was 6.3 kg (s.d. 7.1). Sixty percent (N=285) of participants lost at least 4.5 kg (10 lbs) and were randomized into Phase II. Participants (N=472) attended a mean of 73.1% (s.d. 26.7) of sessions, completed 5.1 (s.d. 1.9) daily food records/week, and reported 195.1 min (s.d. 123.1) of exercise per week. Using logistic regression, sleep time (quadratic trend, P=0.030) and lower stress (P=0.024) at entry predicted success in the weight loss program, and lower stress predicted greater weight loss during Phase I (P=0.021). In addition, weight loss was significantly correlated with declines in stress (P=0.048) and depression (P=0.035).
Results suggest that clinicians and investigators might consider targeting sleep, depression and stress as part of a behavioral weight loss intervention.
The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel ...systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.
To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.
In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.
A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.
Drawing on advances in chronic pain metrics, a simplified Graded Chronic Pain Scale-Revised was developed to differentiate mild, bothersome, and high-impact chronic pain. Graded Chronic Pain ...Scale-Revised was validated among adult enrollees of 2 health plans (N = 2021). In this population, the prevalence of chronic pain (pain present most or every day, prior 3 months) was 40.5%: 15.4% with mild chronic pain (lower pain intensity and interference); 10.1% bothersome chronic pain (moderate to severe pain intensity with lower interference with life activities); and 15.0% high-impact chronic pain (sustained pain-related activity limitations). Persons with mild chronic pain vs those without chronic pain showed small differences on 10 health status indicators (unfavorable health perceptions, activity limitations, and receiving long-term opioid therapy), with nonsignificant differences for 7 of 10 indicators. Persons with bothersome vs mild chronic pain differed significantly on 6 of 10 indicators (eg, negative pain coping beliefs, psychological distress, unfavorable health perceptions, and pain-related interference with overall activities). Persons with high-impact chronic pain differed significantly from those with mild chronic pain on all 10 indicators. Persons with high-impact chronic pain, relative to those with bothersome chronic pain, were more likely to have substantial activity limitations (significant differences for 4 of 5 disability indicators) and more often received long-term opioid therapy. Graded Chronic Pain Scale-Revised strongly predicted 5 activity-limitation indicators with area under receiver operating characteristic curve coefficients of 0.76 to 0.89. We conclude that the 5-item Graded Chronic Pain Scale-Revised and its scoring rules provide a brief, simple, and valid method for assessing chronic pain.
In 1979, Marvin Zelen proposed a new design for randomized clinical trials intended to facilitate clinicians' and patients' participation. The defining innovation of Zelen's proposal was random ...assignment of treatment prior to patient or participant consent. Following randomization, a participant would receive information and asked to consent to the assigned treatment.
This narrative review examined recent examples of Zelen design trials evaluating clinical and public health interventions.
Zelen designs have often been applied to questions regarding real-world treatment or intervention effects under conditions of incomplete adherence. Examples include evaluating outreach or engagement interventions (especially for stigmatized conditions), evaluating treatments for which benefit may vary according to participant motivation, and situations when assignment to a control or usual care condition might prompt a disappointment effect. Specific practical considerations determine whether a Zelen design is scientifically appropriate or practicable. Zelen design trials usually depend on identifying participants automatically from existing records rather than by advertising, referral, or active recruitment. Assessments of baseline or prognostic characteristics usually depend on available records data rather than research-specific assessments. Because investigators must consider how exposure to treatments or interventions might bias ascertainment of outcomes, assessment of outcomes from routinely created records is often necessary. A Zelen design requires a waiver of the usual requirement for informed consent prior to random assignment of treatment. The Revised Common Rule includes specific criteria for such a waiver, and those criteria are most often met for evaluation of a low-risk and potentially beneficial intervention added to usual care. Investigators and Institutional Review Boards must also consider whether the scientific or public health benefit of a Zelen design trial outweighs the autonomy interests of potential participants. Analysis of Zelen trials compares outcomes according to original assignment, regardless of any refusal to accept or participate in the assigned treatment.
A Zelen design trial assesses the real-world consequences of a specific strategy to prompt or promote uptake of a specific treatment. While such trials are poorly suited to address explanatory or efficacy questions, they are often preferred for addressing pragmatic or policy questions.
Objective
Cognitive behavioral therapy for chronic pain (CBT‐CP) is an evidence‐based treatment for improving functioning and pain intensity for people with chronic pain with extensive evidence of ...effectiveness. However, there has been relatively little investigation of the factors associated with successful implementation and uptake of CBT‐CP, particularly clinician and system level factors. This formative evaluation examined barriers and facilitators to the successful implementation and uptake of CBT‐CP from the perspective of CBT‐CP clinicians and referring primary care clinicians.
Methods
Qualitative interviews guided by the Consolidated Framework for Implementation Research were conducted at nine geographically diverse Veterans Affairs sites as part of a pragmatic clinical trial comparing synchronous, clinician‐delivered CBT‐CP and remotely delivered, technology‐assisted CBT‐CP. Analysis was informed by a grounded theory approach.
Results
Twenty‐six clinicians (CBT‐CP clinicians = 17, primary care clinicians = 9) from nine VA medical centers participated in individual qualitative interviews conducted by telephone from April 2019 to August 2020. Four themes emerged in the qualitative interviews: (1) the complexity and variability of referral pathways across sites, (2) referring clinician's lack of knowledge about CBT‐CP, (3) referring clinician's difficulty identifying suitable candidates for CBT‐CP, and (4) preference for interventions that can be completed from home.
Conclusions
This formative evaluation identified clinician and system barriers to widespread implementation of CBT‐CP and allowed for refinement of the subsequent implementation of two forms of CBT‐CP in an ongoing pragmatic trial. Identification of relative difference in barriers and facilitators in the two forms of CBT‐CP may emerge more clearly in a pragmatic trial that evaluates how treatments perform in real‐world settings and may provide important information to guide future system‐wide implementation efforts.
Since the early 2000s, telehealth has been used to provide behavior analytic intervention to individuals with autism spectrum disorder (ASD). Evaluating evidence supporting telehealth remains ...valuable, especially as there has been increased accessibility since the COVID-19 pandemic. Although there is empirical support for telehealth as an effective service-delivery option, important variables (e.g., costs, implementer training) remain unknown. Despite potential roles in telehealth service-delivery models, a careful review of participant prerequisite skills, implementer characteristics (e.g., experience, education), technology variables (e.g., HIPAA compliance), and skill(s) targeted (i.e., mastered or untrained skills) have not been considered. Therefore, we aimed to extend prior telehealth literature reviews by evaluating current research across variables important for telehealth service-delivery involving individuals with ASD. We found thorough descriptions of participants and implementers, implementer training, and social validity evaluations. Limitations of telehealth literature include exclusion of teen and adult participants, limited description of prerequisite skills and evaluations of direct telehealth interventions. Future research areas were identified.
Chronic pain is widely prevalent among Veterans and can have serious negative consequences for functional status and quality of life among other domains. The Veterans Health Administration (VHA) ...convened a state-of-the-art (SOTA) conference to develop research priorities for advancing the science and clinical practice of non-pharmacological management of chronic musculoskeletal pain. In this perspective article, we present the methods and consensus recommendations for research priorities emanating from the SOTA. In the months leading up to the SOTA, a core group of researchers defined four areas of focus: psychological/behavioral therapies; exercise/movement therapies; manual therapies; and models for delivering multi-modal pain care and divided into workgroups. Each workgroup, in their respective areas of focus, identified seminal studies capturing the state of the evidence. Herein, we present consensus recommendations ranging from efficacy to effectiveness to implementation/dissemination research depending on the state of the evidence as assessed by participants, including commentary on common elements across workgroups and future areas of innovation in study design, measurement, and outcome ascertainment.
Adolescent offspring of depressed parents are at markedly increased risk of developing depressive disorders. Although some smaller targeted prevention trials have found that depression risk can be ...reduced, these results have yet to be replicated and extended to large-scale, at-risk populations in different settings.
To determine the effects of a group cognitive behavioral (CB) prevention program compared with usual care in preventing the onset of depression.
A multicenter randomized controlled trial conducted in 4 US cities in which 316 adolescent (aged 13-17 years) offspring of parents with current or prior depressive disorders were recruited from August 2003 through February 2006. Adolescents had a past history of depression, current elevated but subdiagnostic depressive symptoms, or both. Assessments were conducted at baseline, after the 8-week intervention, and after the 6-month continuation phase.
Adolescents were randomly assigned to the CB prevention program consisting of 8 weekly, 90-minute group sessions followed by 6 monthly continuation sessions or assigned to receive usual care alone.
Rate and hazard ratio (HR) of a probable or definite depressive episode (ie, depressive symptom rating score of > or = 4) for at least 2 weeks as diagnosed by clinical interviewers.
Through the postcontinuation session follow-up, the rate and HR of incident depressive episodes were lower for those in the CB prevention program than for those in usual care (21.4% vs 32.7%; HR, 0.63; 95% confidence interval CI, 0.40-0.98). Adolescents in the CB prevention program also showed significantly greater improvement in self-reported depressive symptoms than those in usual care (coefficient, -1.1; z = -2.2; P = .03). Current parental depression at baseline moderated intervention effects (HR, 5.98; 95% CI, 2.29-15.58; P = .001). Among adolescents whose parents were not depressed at baseline, the CB prevention program was more effective in preventing onset of depression than usual care (11.7% vs 40.5%; HR, 0.24; 95% CI, 0.11-0.50), whereas for adolescents with a currently depressed parent, the CB prevention program was not more effective than usual care in preventing incident depression (31.2% vs 24.3%; HR, 1.43; 95% CI, 0.76-2.67).
The CB prevention program had a significant prevention effect through the 9-month follow-up period based on both clinical diagnoses and self-reported depressive symptoms, but this effect was not evident for adolescents with a currently depressed parent.
clinicaltrials.gov Identifier: NCT00073671.
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