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The goal of this study was to document current hospital-based animal-assisted activities (AAA) practices.We contacted 20 hospitals and asked about their AAA programs, including COVID-19 precautions.Eighteen of 20 hospitals responded. Before 2020, all offered either in-person only (n = 17) or both in-person and virtual AAA visits (n = 1). In early 2022, 13 provided in-person visits; the five hospitals that had not resumed in-person visits planned to restart. Most hospitals stopped group visits. Most required that patients and handlers be free of COVID-19 symptoms and that handlers be vaccinated and wear masks and eye protection. Most did not require COVID-19 vaccination for patients. None required handlers to test negative for COVID-19.The COVID-19 pandemic impacted hospital-based pediatric AAA. Future studies should assess the effectiveness of virtual AAA and of precautions to prevent COVID-19 transmission between patients and AAA volunteers.

Objectives To examine the circumstances and needs of older adults who were “kinless,” defined as having no living spouse or children, when they developed dementia. Methods We conducted a secondary analysis of information from the Adult Changes in Thought study. Among 848 participants diagnosed with dementia between 1994 and 2016, we identified 64 who had no living spouse or child at dementia onset. We then conducted a qualitative analysis of administrative documents pertaining to these participants: handwritten comments recorded after each study visit, and medical history documents containing clinical chart notes from participants’ medical records. Results In this community-dwelling cohort of older adults diagnosed with dementia, 8.4% were kinless at dementia onset. Participants in this sample had an average age of 87 years old, half lived alone, and one third lived with unrelated persons. Through inductive content analysis, we identified 4 themes that describe their circumstances and needs: (1) life trajectories, (2) caregiving resources, (3) care needs and gaps, and (4) turning points in caregiving arrangements. Discussion Our qualitative analysis reveals that the life trajectories that led members of the analytic cohort to be kinless at dementia onset were quite varied. This research highlights the importance of nonfamily caregivers and participants’ own roles as caregivers. Our findings suggest that clinicians and health systems may need to work with other parties to directly provide dementia caregiving support rather than rely on family, and address factors such as neighborhood affordability that particularly affect older adults who have limited family support.

Background Evidence-based interventions (EBIs) could reduce cervical cancer deaths by 90%, colorectal cancer deaths by 70%, and lung cancer deaths by 95% if widely and effectively implemented in the USA. Yet, EBI implementation, when it occurs, is often suboptimal. This manuscript outlines the protocol for Optimizing Implementation in Cancer Control (OPTICC), a new implementation science center funded as part of the National Cancer Institute Implementation Science Consortium. OPTICC is designed to address three aims. Aim 1 is to develop a research program that supports developing, testing, and refining of innovative, efficient methods for optimizing EBI implementation in cancer control. Aim 2 is to support a diverse implementation laboratory of clinical and community partners to conduct rapid, implementation studies anywhere along the cancer care continuum for a wide range of cancers. Aim 3 is to build implementation science capacity in cancer control by training new investigators, engaging established investigators in cancer-focused implementation science, and contributing to the Implementation Science Consortium in Cancer. Methods Three cores serve as OPTICC’s foundation. The Administrative Core plans coordinates and evaluates the Center’s activities and leads its capacity-building efforts. The Implementation Laboratory Core (I-Lab) coordinates a network of diverse clinical and community sites, wherein studies are conducted to optimize EBI implementation, implement cancer control EBIs, and shape the Center’s agenda. The Research Program Core conducts innovative implementation studies, measurement and methods studies, and pilot studies that advance the Center’s theme. A three-stage approach to optimizing EBI implementation is taken—(I) identify and prioritize determinants, (II) match strategies, and (III) optimize strategies—that is informed by a transdisciplinary team of experts leveraging multiphase optimization strategies and criteria, user-centered design, and agile science. Discussion OPTICC will develop, test, and refine efficient and economical methods for optimizing EBI implementation by building implementation science capacity in cancer researchers through applications with our I-Lab partners. Once refined, OPTICC will disseminate its methods as toolkits accompanied by massive open online courses, and an interactive website, the latter of which seeks to simultaneously accumulate knowledge across OPTICC studies.

Objective: To determine the perceived benefits of t'ai chi in older adults with chronic low-back pain (cLBP). Design: A qualitative analysis from a randomized controlled feasibility trial. Subjects: Eighteen participants (65+ years old) with cLBP of at least moderate intensity. Intervention: A 36-week intervention beginning with twice weekly classes for 12 weeks, weekly classes for 6 weeks, biweekly classes for 6 weeks, and monthly classes for 12 weeks. Participants were asked to practice at home on nonclass days and videos were provided to assist in that process. Outcome Measures: Participants in the focus groups were asked to provide feedback on their experiences with the study as well as the benefits of their t'ai chi practice. We used demographic and class attendance data to describe the sample. Results: Regarding the benefits of t'ai chi practice, five major themes were identified: functional benefits, pain reduction/pain relief, psychospiritual benefits, the importance of social support in learning t'ai chi, and the integration of t'ai chi into daily activities. The most common functional benefits were improvements in balance, flexibility, leg strength, and posture. Some reported pain reduction or pain relief, but others did not. Increased relaxation, mindfulness, and a sense of connectedness were subthemes that emerged from psychospiritual benefits. Social support benefits included motivation to attend class and group support while learning a new skill. Finally, improved body awareness allowed participants to integrate t'ai chi skills into their daily activities. Conclusions: This qualitative analysis demonstrates the multifaceted benefits of t'ai chi for older adults living with cLBP.

Objectives: T'ai chi (TC) has been found effective for improving chronic low back pain (cLBP). However, such studies did not include adults over 65 years of age. This study was designed to evaluate the feasibility and acceptability of TC in this population compared with Health Education (HE) and with Usual Care (UC). Design: Feasibility randomized controlled trial. Settings/Location: Participants were recruited from Kaiser Permanente Washington and classes took place in a Kaiser facility. Patients: Adults 65 years of age and older with cLBP. Interventions: Twenty-eight participants were randomized to 12 weeks of TC followed by a 24-week tapered TC program, 12 were assigned to a 12-week HE intervention and 17 were assigned to UC only. Outcome Measures: Feasibility and acceptability were determined by recruitment, retention and 12-, 26-, and 52-week follow-up rates, instructor adherence to protocol, class attendance, TC home practice, class satisfaction, and adverse events. Results: Fifty-seven participants were enrolled in two cohorts of 28 and 29 during two 4-month recruitment periods. Questionnaire follow-up completion rates ranged between 88% and 93%. Two major class protocol deviations were noted in TC and none in HE. Sixty-two percent of TC participants versus 50% of HE participants attended at least 70% of the classes during the 12-week initial intervention period. Weekly rates of TC home practice were high among class attendees (median of 4.2 days) at 12 weeks, with fewer people practicing at 26 and 52 weeks. By 52 weeks, 70% of TC participants reported practicing the week before, with a median of 3 days per week and 15 min/session. TC participants rated the helpfulness of their classes significantly higher than did HE participants, but the groups were similarly likely to recommend the classes. Conclusion: The TC intervention is feasible in this population, while the HE group requires modifications in delivery.

Animal-assisted interventions (AAIs) use human-animal interactions to positive effect in various contexts including cancer care. As the first installment of a 2-part series, this systematic literature review focuses on the research methods and quantitative results of AAI studies in oncology. We find methodological consistency in the use of canines as therapy animals, in the types of high-risk patients excluded from studies, and in the infection precautions taken with therapy animals throughout cancer wards. The investigated patient endpoints are not significantly affected by AAI, with the exceptions of improvements in oxygen consumption, quality of life, depression, mood, and satisfaction with therapy. The AAI field in oncology has progressed significantly since its inception and has great potential to positively affect future patient outcomes. To advance the field, future research should consistently improve the methodological design of studies, report data more completely, and focus more on the therapy animal’s well-being.

This study assessed the feasibility of studying animal-assisted activities (AAA) in inpatient pediatric oncology and collected preliminary data on potential benefits of AAA for this population. Patients at a large pediatric hospital were identified using electronic medical records and approached with physician approval. Patients completed surveys before and after a therapy dog visit in their private hospital room. Data on infections were ascertained by electronic medical record review. Provider surveys were placed in provider common areas and distributed through a link in an e-mail. We summarized resultsusing descriptive statistics and estimated mean changes in pre- and postintervention distress and conducted hypothesis tests using the paired t test. The study population (mean age = 12.9 years) consisted of 9 females and 10 males. Following the therapy dog visit, patients had lower distress and significant decreases in worry, tiredness, fear, sadness, and pain. Providers were generally supportive of the intervention. Eight patients developed infections during the 14 days after the dog visit but none could be clearly attributed to the therapy dog visit. The study’s primary limitation was that there was no control group. However, results support the feasibility of and need for future studies on AAA in pediatric oncology.

OBJECTIVE: To evaluate the effect of vaccine hesitancy screening on childhood vaccine uptake. METHODS: We conducted a cluster randomized controlled trial in pediatric primary care clinics in Washington state. Vaccine-hesitant parents (VHPs) with a healthy newborn receiving health supervision at participating clinics were eligible. VHPs were identified by using a 4-item version of the validated Parent Attitudes About Childhood Vaccines Survey (PACV). Before their child’s 2- and 6-month health supervision visits, VHPs at intervention clinics completed the 15-item PACV embedded in a survey containing placebo items. Intervention providers received a summary of parents’ 15-item PACV responses and interpretation of their PACV score; discretion was given to providers regarding how they acted on this information. VHPs at control clinics completed only the placebo survey items, and their child’s provider received a summary of their responses; control providers remained blinded to parent VHP status. Our outcome was child immunization status at 8 months of age expressed as percent of days underimmunized. We compared outcomes in control and intervention participants using t test and linear mixed-effects regression. RESULTS: We enrolled 24 clinics (12 in each arm) and 156 parents (65 in the intervention arm). Parent characteristics were similar across arms except more intervention (versus control) parents had a first-born child (60.9% vs 44%; P = .04). No significant difference in outcome was detected between arms (25.2% [95% confidence interval: 16.0% to 34.5%] vs 19.1% [95% confidence interval: 12.0% to 26.3%] mean days underimmunized in the intervention and control arms, respectively). CONCLUSION: Vaccine hesitancy screening was not significantly associated with days underimmunized.

BACKGROUND: The STarT Back strategy for categorizing and treating patients with low back pain (LBP) improved patients’ function while reducing costs in England. OBJECTIVE: This trial evaluated the effect of implementing an adaptation of this approach in a US setting. DESIGN: The Matching Appropriate Treatments to Consumer Healthcare needs (MATCH) trial was a pragmatic cluster randomized trial with a pre-intervention baseline period. Six primary care clinics were pair randomized, three to training in the STarT Back strategy and three to serve as controls. PARTICIPANTS: Adults receiving primary care for non-specific LBP were invited to provide data 2 weeks after their primary care visit and follow-up data 2 and 6 months (primary endpoint) later. INTERVENTIONS: The STarT Back risk-stratification strategy matches treatments for LBP to physical and psychosocial obstacles to recovery using patient-reported data (the STarT Back Tool) to categorize patients’ risk of persistent disabling pain. Primary care clinicians in the intervention clinics attended six didactic sessions to improve their understanding LBP management and received in-person training in the use of the tool that had been incorporated into the electronic health record (EHR). Physical therapists received 5 days of intensive training. Control clinics received no training. MAIN MEASURES: Primary outcomes were back-related physical function and pain severity. Intervention effects were estimated by comparing mean changes in patient outcomes after 2 and 6 months between intervention and control clinics. Differences in change scores by trial arm and time period were estimated using linear mixed effect models. Secondary outcomes included healthcare utilization. KEY RESULTS: Although clinicians used the tool for about half of their patients, they did not change the treatments they recommended. The intervention had no significant effect on patient outcomes or healthcare use. CONCLUSIONS: A resource-intensive intervention to support stratified care for LBP in a US healthcare setting had no effect on patient outcomes or healthcare use. TRIAL REGISTRATION: National Clinical Trial Number NCT02286141.

Animal-assisted activities (AAA) are increasingly common, yet little is known about practices in pediatric oncology. To address this gap, we surveyed the top 20 pediatric oncology hospitals in the United States in May and June of 2014. Questionnaires were sent via e-mail and generally returned by e-mail or postal mail. Among the 19 responding hospitals, the 18 that offered AAA to pediatric patients formed the basis of our analysis. All sites had written AAA policies. Most programs were restricted to dogs. At 11 hospitals, children with cancer could participate in AAA activities. Outpatient waiting rooms and individual inpatient rooms were the most common locations for AAA with pediatric oncology patients. Safety precautions varied by hospital, but all required hand sanitation after visits and that animals receive an annual health examination, be on a leash or in a carrier, be ≥1 year old, and not be directly from a shelter. Our findings reveal consistencies and variations in practice that may help other hospitals develop their own programs and researchers identify areas of future study.

Objectives Chronic low back pain (CLBP) is a common health problem with challenges for providing satisfactory care. This study was undertaken to identify opportunities to improve key aspects of physicians' communications with CLBP-affected patients. Methods A series of 3 focus groups, each with 7 to 11 patients with CLBP, were recruited from primary care settings and grouped by risk level of reduced function resulting from back pain, to elicit perspectives about interactions with their primary care physicians. Analysis of focus group transcripts used an iterative process based on a thematic approach and a priori concepts. Results A total of 28 patients participated in the focus groups. Patient comments about communicating with physicians around CLBP fit into themes of listening and empathy, validating pain experiences, conducting effective CLBP assessment, providing clear diagnosis and information, and collaboratively working on treatment. Patients shared that physicians can foster positive interactions with CLBP-affected patients by sharing personal experiences of chronic pain, being truthful about not having all the answers and being clear about how patients can benefit from referrals, reviewing the patient's previous treatments before beginning conversations about treatment options, providing follow-up instructions, giving patients a diagnosis beyond "chronic pain," and explaining the role of imaging in their care. Conclusion This study provides specific steps that physicians in the US can take to improve physician-patient interactions during primary care visits pertaining to CLBP. The findings could inform physician training, development of educational materials for patients, and future research.

Background Despite numerous options for treating back pain and the increasing healthcare resources devoted to this problem, the prevalence and impact of back pain-related disability has not improved. It is now recognized that psychosocial factors, as well as physical factors, are important predictors of poor outcomes for back pain. A promising new approach that matches treatments to the physical and psychosocial obstacles to recovery, the STarT Back risk stratification approach, improved patients’ physical function while reducing costs of care in the United Kingdom (UK). This trial evaluates implementation of this strategy in a United States (US) healthcare setting. Methods Six large primary care clinics in an integrated healthcare system in Washington State were block-randomized, three to receive an intensive quality improvement intervention for back pain and three to serve as controls for secular trends. The intervention included 6 one-hour training sessions for physicians, 5 days of training for physical therapists, individualized and group coaching of clinicians, and integration of the STarT Back tool into the electronic health record. This prognostic tool uses 9 questions to categorize patients at low, medium or high risk of persistent disabling pain with recommendations about evidence-based treatment options appropriate for each subgroup. Patients at least 18 years of age, receiving primary care for non-specific low back pain, were invited to provide data 1–3 weeks after their primary care visit and follow-up data 2 months and 6 months (primary endpoint) later. The primary outcomes are back-related physical function and pain severity. Using an intention to treat approach, intervention effects on patient outcomes will be estimated by comparing mean changes at the 2 and 6 month follow-up between the pre- and post-implementation periods. The inclusion of control clinics permits adjustment for secular trends. Differences in change scores by intervention group and time period will be estimated using linear mixed models with random effects. Secondary outcomes include healthcare utilization and adherence to clinical guidelines. Discussion This trial will provide the first randomized trial evidence of the clinical effectiveness of implementing risk stratification with matched treatment options for low back pain in a United States health care delivery system. Trial registration NCT02286141. Registered November 5, 2014. Electronic supplementary material The online version of this article (doi:10.1186/s12891-016-1219-0) contains supplementary material, which is available to authorized users.

Although massage is one of the most popular complementary and alternative medical (CAM) treatments for anxiety, its effectiveness has never been rigorously evaluated for a diagnosed anxiety disorder. This study evaluates the effectiveness of therapeutic massage for persons with generalized anxiety disorder (GAD).Sixty-eight persons with GAD were randomized to therapeutic massage (n=23), thermotherapy (n=22), or relaxing room therapy (n=23) for a total of 10 sessions over 12 weeks. Mean reduction in anxiety was measured by the Hamilton Anxiety Rating Scale (HARS). Secondary outcomes included 50% reduction in HARS and symptom resolution of GAD, changes in depressive symptoms (Patient Health Questionnaire (PHQ-8)), worry and GAD-related disability. We compared changes in these outcomes in the massage and control groups posttreatment and at 6 months using generalized estimating equation (GEE) regression.All groups had improved by the end of treatment (adjusted mean change scores for the HARS ranged from -10.0 to -13.0; P.001) and maintained their gains at the 26-week followup. No differences were seen between groups (P=.39). Symptom reduction and resolution of GAD, depressive symptoms, worry and disability showed similar patterns.Massage was not superior to the control treatments, and all showed some clinically important improvements, likely due to some beneficial but generalized relaxation response. Because the relaxing room treatment is substantially less expensive than the other treatments, a similar treatment packaged in a clinically credible manner might be the most cost effective option for persons with GAD who want to try relaxation-oriented CAM therapies.

The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. Clinicaltrials.gov Identifier: NCT01467843 .

PURPOSE This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. METHODS We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0–50 points) and pain intensity with a numerical rating scale (range, 0–10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (≥5 points on Neck Disability Index) or pain intensity (≥30% improvement) by treatment group. RESULTS After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively). CONCLUSIONS After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment.

Background Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low “doses” of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. Methods/design In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. Discussion A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836

Background Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM) therapies. Yoga is an increasingly popular "mind-body" CAM therapy often used for relieving back pain and several small studies have found yoga effective for this condition. This study will assess whether yoga is effective for treating chronic low back pain compared with self care and exercise and will explore the mechanisms responsible for any observed benefits. Methods/Design A total of 210 participants with low back pain lasting at least 3 months will be recruited from primary care clinics of a large healthcare system based in Seattle. They will be randomized in a 2:2:1 ratio to receive 12 weekly yoga classes, 12 weekly conventional therapeutic exercise classes of comparable physical exertion, or a self-care book. Interviewers masked to participants' treatment group will assess outcomes at baseline and 6, 12 and 26 weeks after randomization. Primary outcomes will be back-related dysfunction and symptom bothersomeness. In addition, data will be collected on physical measurements (e.g., flexion) at baseline and 12 weeks and saliva samples will be obtained at baseline, 6 and 12 weeks. Information will be collected on specific physical, psychological, and physiological factors to allow exploration of possible mechanisms of action through which yoga could relieve back pain and dysfunction. The effectiveness of yoga will be assessed using analysis of covariance (using general estimating equations - GEE) within an intention-to-treat context. If yoga is found effective, further analyses will explore whether yoga's benefits are attributable to physical, psychological and/or physiological factors. Conclusions This study will provide the clearest evidence to date about the value of yoga as a therapeutic option for treating chronic back pain, and if the results are positive, will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number of NCT00447668.

Background Meeting recruitment goals is challenging for many clinical trials conducted in primary care populations. Little is known about how the use of different recruitment strategies affects the types of individuals choosing to participate or the conclusions of the study. Methods A secondary analysis was performed using data from participants recruited to a clinical trial evaluating acupuncture for chronic back pain among primary care patients in a large integrated health care organization. We used two recruitment methods: mailed letters of invitation and an advertisement in the health plan's magazine. For these two recruitment methods, we compared recruitment success (% randomized, treatment completers, drop outs and losses to follow-up), participant characteristics, and primary clinical outcomes. A linear regression model was used to test for interaction between treatment group and recruitment method. Results Participants recruited via mailed letters closely resembled those responding to the advertisement in terms of demographic characteristics, most aspects of their back pain history and current episode and beliefs and expectations about acupuncture. No interaction between method of recruitment and treatment group was seen, suggesting that study outcomes were not affected by recruitment strategy. Conclusion In this trial, the two recruitment strategies yielded similar estimates of treatment effectiveness. However, because this finding may not apply to other recruitment strategies or trial circumstances, trials employing multiple recruitment strategies should evaluate the effect of recruitment strategy on outcome. Trial registration Clinical Trials.gov NCT00065585.

Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain.A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks.At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P.001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P.001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P.001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P.05).Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

Objectives Little is known about the effectiveness of therapeutic massage, one of the most popular complementary medical treatments for neck pain. A randomized controlled trial was conducted to evaluate whether therapeutic massage is more beneficial than a self-care book for patients with chronic neck pain. Methods Sixty-four such patients were randomized to receive up to 10 massages over 10 weeks or a self-care book. Follow-up telephone interviews after 4, 10, and 26 weeks assessed outcomes including dysfunction and symptoms. Log-binomial regression was used to assess whether there were differences in the percentages of participants with clinically meaningful improvements in dysfunction and symptoms (ie, >5-point improvement on the Neck Disability Index; >30% improvement from baseline on the symptom bothersomeness scale) at each time point. Results At 10 weeks, more participants randomized to massage experienced clinically significant improvement on the Neck Disability Index [39% vs. 14% of book group; relative risk (RR)=2.7; 95% confidence interval (CI), 0.99-7.5] and on the symptom bothersomeness scale (55% vs. 25% of book group; RR=2.2; 95% CI, 1.04-4.2). After 26 weeks, massage group members tended to be more likely to report improved function (RR=1.8; 95% CI, 0.97-3.5), but not symptom bothersomeness (RR=1.1; 95% CI, 0.6-2.0). Mean differences between groups were strongest at 4 weeks and not evident by 26 weeks. No serious adverse experiences were reported. Conclusions This study suggests that massage is safe and may have clinical benefits for treating chronic neck pain at least in the short term. A larger trial is warranted to confirm these results.

PURPOSE We wanted to understand the views of patients and clinicians on the central concept of healing and to identify major facilitators of and barriers to promoting healing in primary care. METHODS We undertook a qualitative analysis of focus group discussions. Participants were drawn from primary care clinics of a large, integrated, health care system in Washington State in 2005. Nine focus groups included 84 participants: 28 patients, 23 primary care physicians (19 family physicians), 20 registered nurses, 11 licensed practical nurses, and 2 medical assistants. Randomly sampled established patients were aged from 21 to 65 years; 71% were female. RESULTS We found remarkable concordance across focus groups and among types of participants in the definition of healing: Healing is a dynamic process of recovering from a trauma or illness by working toward realistic goals, restoring function, and regaining a personal sense of balance and peace. Healing is a multidimensional process with physical, emotional, and spiritual dimensions. The key themes are as follows: (1) healing is multidimensional and holistic; (2) healing is a process, a journey; (3) the goal of healing is recovery or restoration; (4) healing requires the person to reach a place of personal balance and acceptance; and (5) relationships are essential to healing. Factors that facilitate healing help build relationships, improve communication, and share responsibility between the patient and clinician. Major barriers are logistical factors that limit high-quality time with healing professionals. CONCLUSIONS Patients and health care team members share a vision of healing and agree on ways to enhance the process in primary care.

Background: Chronic low back pain is a common problem lacking highly effective treatment options. Small trials suggest that yoga may have benefits for this condition. This trial was designed to determine whether yoga is more effective than conventional stretching exercises or a selfcare book for primary care patients with chronic low back pain. Methods: A total of 228 adults with chronic low back pain were randomized to 12 weekly classes of yoga (92 patients) or conventional stretching exercises (91 patients) or a self-care book (45 patients). Back-related functional status (modified Roland Disability Questionnaire, a 23-point scale) and bothersomeness of pain (an 11-point numerical scale) at 12 weeks were the primary outcomes. Outcomes were assessed at baseline, 6, 12, and 26 weeks by interviewers unaware of treatment group. Results: After adjustment for baseline values, 12-week outcomes for the yoga group were superior to those for the self-care group (mean difference for function, �2.5 [95% CI, �3.7 to �1.3]; P .001; mean difference for symptoms, �1.1 [95% CI, �1.7 to �0.4]; P.001). At 26 weeks, function for the yoga group remained superior (mean difference, �1.8 [95% CI, �3.1 to �0.5];P.001). Yoga was not superior to conventional stretching exercises at any time point. Conclusion: Yoga classes were more effective than a selfcare book, but not more effective than stretching classes, in improving function and reducing symptoms due to chronic low back pain, with benefits lasting at least several months. Trial Registration: clinicaltrials.gov Identifier: NCT00447668