One-year retrospective analysis of anti-FXa apixaban and rivaroxaban levels demonstrates utility for management decisions in various urgent and nonurgent clinical situations.

OBJECTIVES: Quantification of direct oral anticoagulant (DOAC) plasma levels can guide clinical management, but insight into clinical scenarios surrounding DOAC-calibrated anti-FXa assays is limited. METHODS: Apixaban- and rivaroxaban-calibrated chromogenic anti-Xa assays performed over a 1-year period were retrospectively analyzed. Patient demographics, DOAC history, concomitant medications, and renal/liver comorbidities were obtained. Indications for testing and associated clinical actions were reviewed. Machine learning (ML) models predicting clinical actions were evaluated. RESULTS: In total, 371 anti-FXa apixaban and 89 anti-FXa rivaroxaban tests were performed for 259 and 67 patients in recurring urgent (acute bleeding, unplanned procedures) and nonurgent situations, including several scenarios not captured by existing testing recommendations (eg, drug monitoring, recurrent thromboembolic events, bleeding tendency). In urgent settings, andexanet reversal was guided by radiologic and clinical findings over DOAC levels in 14 of 32 instances, while 51% of apixaban patients qualified for nonreversal strategies through the availability of levels. Levels also informed procedure/intervention timing and supported management decisions when DOAC clearance or DOAC target levels were in question. The importance of clinical context was emphasized by exploratory ML models predicting particular clinical actions. CONCLUSIONS: Although clinical situations are complex, DOAC testing facilitates clinical decision-making, including reversal, justifying more widespread implementation of these assays.

Self-efficacy and embodiment associated with Alexander Technique lessons or with acupuncture sessions: A longitudinal qualitative sub-study within the ATLAS trial.

BACKGROUND AND PURPOSE: A large randomised controlled trial found that the provision of either Alexander Technique lessons or acupuncture, for those with chronic neck pain, resulted in significantly increased self-efficacy when compared with usual care alone. In turn, enhanced self-efficacy was associated with significant reductions in neck pain at 6 and 12 months. In this analysis we explore the perspectives of participants within the trial, with the aim of gaining a better understanding of how these interventions had an impact. METHODS: We used a longitudinal qualitative approach; in-depth interviews, informed by a topic guide, were conducted with a sample of the trial population. Participants were interviewed twice: at around six months (n = 30) and twelve months (n = 26) after trial entry. Analysis was guided by the principles of grounded theory, and key themes were developed. RESULTS: Five key themes emerged: pre-trial experiences of biomedical treatment against which subsequent interventions were compared; emergence of tangible benefits from the interventions; factors that contributed to the observed benefits, notably growing self-care and self-efficacy; a developing sense of embodiment as an integral part of the transformative process; and contribution of these factors to sustaining benefits over the longer term. CONCLUSIONS: In-depth interviews revealed a rich array of experiences. They gave insight into the positive impact of the interventions on development of self-care, self-efficacy and embodiment. These findings complement the quantitative trial data, providing a more nuanced understanding of the factors that underpin the previously quantified improvement in self-efficacy and its association with longer-term reductions in pain.

Self-efficacy and self-care-related outcomes following Alexander Technique lessons for people with chronic neck pain in the ATLAS randomised, controlled trial.

INTRODUCTION: ATLAS was a pragmatic randomised (1:1:1 ratio), controlled trial recruiting patients with chronic neck pain (N = 517) and evaluating one-to-one Alexander Technique lessons, or acupuncture, each plus usual care, compared with usual care alone. The primary outcome (12-month Northwick Park Neck Pain Questionnaire [NPQ]) demonstrated significant and clinically meaningful reductions in neck pain and associated disability for both interventions compared with usual care alone. Here we describe pre-specified, self-efficacy and other self-care-related outcomes for the Alexander group compared with usual care. METHODS: Participants reported on 11 self-efficacy/self-care-related outcome measures at 6 and 12 months. Linear or logistic regression models evaluated changes in parameters and impact on NPQ. Alexander teachers reported on lesson content. RESULTS: Lesson content reflected standard UK practice. The Alexander group (n = 172) reported significantly greater improvements, compared with usual care alone (n = 172), in most of the self-efficacy/self-care measures (9/11 measures at 6 months, and 8/11 at 12 months), including the ability to reduce pain in daily life. At 6 months, 81% (106/131) of Alexander participants reported significant improvement in the way they lived and cared for themselves (versus 23% for usual care), increasing to 87% (117/135) at 12 months (usual care: 25%). NPQ scores at both 6 and 12 months were related to improvement in self-efficacy and ability to reduce pain during daily life. CONCLUSIONS: Alexander Technique lessons led to long-term improvements in the way participants lived their daily lives and managed their neck pain. Alexander lessons promote self-efficacy and self-care, with consequent reductions in chronic neck pain.

An economic evaluation of Alexander Technique lessons or acupuncture sessions for patients with chronic neck pain: A randomized trial (ATLAS).

OBJECTIVES: To assess the cost-effectiveness of acupuncture and usual care, and Alexander Technique lessons and usual care, compared with usual GP care alone for chronic neck pain patients. METHODS: An economic evaluation was undertaken alongside the ATLAS trial, taking both NHS and wider societal viewpoints. Participants were offered up to twelve acupuncture sessions or twenty Alexander lessons (equivalent overall contact time). Costs were in pounds sterling. Effectiveness was measured using the generic EQ-5D to calculate quality adjusted life years (QALYs), as well as using a specific neck pain measure-the Northwick Park Neck Pain Questionnaire (NPQ). RESULTS: In the base case analysis, incremental QALY gains were 0.032 and 0.025 in the acupuncture and Alexander groups, respectively, in comparison to usual GP care, indicating moderate health benefits for both interventions. Incremental costs were £451 for acupuncture and £667 for Alexander, mainly driven by intervention costs. Acupuncture was likely to be cost-effective (ICER = £18,767/QALY bootstrapped 95% CI £4,426 to £74,562) and was robust to most sensitivity analyses. Alexander lessons were not cost-effective at the lower NICE threshold of £20,000/QALY (£25,101/QALY bootstrapped 95% CI -£150,208 to £248,697) but may be at £30,000/QALY, however, there was considerable statistical uncertainty in all tested scenarios. CONCLUSIONS: In comparison with usual care, acupuncture is likely to be cost-effective for chronic neck pain, whereas, largely due to higher intervention costs, Alexander lessons are unlikely to be cost-effective. However, there were high levels of missing data and further research is needed to assess the long-term cost-effectiveness of these interventions.

Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial.

BACKGROUND: Management of chronic neck pain may benefit from additional active self-care-oriented approaches. OBJECTIVE: To evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain. DESIGN: Three-group randomized, controlled trial. (Current Controlled Trials: ISRCTN15186354). SETTING: U.K. primary care. PARTICIPANTS: Persons with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology. INTERVENTION: 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. MEASUREMENTS: NPQ score (primary outcome) at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes). RESULTS: 517 patients were recruited, and the median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention. LIMITATION: Practitioners belonged to the 2 main U.K.-based professional associations, which may limit generalizability of the findings. CONCLUSION: Acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained. PRIMARY FUNDING SOURCE: Arthritis Research UK.

Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial.

BACKGROUND: Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study. METHODS/DESIGN: We will recruit 500 patients who have been diagnosed with neck pain in primary care, who have continued to experience neck pain for at least three months with 28% minimum cut-off score on the Northwick Park Neck Pain Questionnaire (NPQ). We will exclude patients with serious underlying pathology, prior cervical spine surgery, history of psychosis, rheumatoid arthritis, ankylosing spondylitis, osteoporosis, haemophilia, cancer, HIV or hepatitis, or with alcohol or drug dependency currently or in the last 12 months, or actively pursuing compensation or with pending litigation.The York Trials Unit will randomly allocate participants using a secure computer-based system. We will use block randomisation with allocation to each intervention arm being unambiguously concealed from anyone who might subvert the randomisation process.Participants will be randomised in equal proportions to Alexander Technique lessons, acupuncture or usual care alone. Twenty 30-minute Alexander Technique lessons will be provided by teachers registered with the Society of Teachers of the Alexander Technique and twelve 50-minute sessions of acupuncture will be provided by acupuncturists registered with the British Acupuncture Council. All participants will continue to receive usual GP care.The primary outcome will be the NPQ at 12 months, with the secondary time point at 6 months, and an area-under-curve analysis will include 3, 6 and 12 month time-points. Adverse events will be documented. Potential intervention effect modifiers and mediators to be explored include: self-efficacy, stress management, and the incorporation of practitioner advice about self-care and lifestyle. Qualitative material will be used to address issues of safety, acceptability and factors that impact on longer term outcomes. DISCUSSION: This study will provide robust evidence on whether there are significant clinical benefits to patients, economic benefits demonstrating value for money, and sufficient levels of acceptability and safety. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15186354.

Regional differences in nonadherence to dialysis among southern dialysis patients: a comparative cross-sectional study to the dialysis outcomes and practice patterns study.

INTRODUCTION: Treatment outcomes of end-stage renal disease (ESRD) vary significantly between European, Japanese, and American populations. The Dialysis Outcomes and Practice Patterns Study (DOPPS) described multiple differences between these cohorts; however, remarkable outcome differences exist among regions within the American population. Southern networks continue to have higher degrees of adverse outcomes despite improvements in healthcare delivery. METHODS: We examined the demographic indices and the degree of nonadherence to dialysis prescription among a sample of 97 patients with ESRD from the Northwestern Louisiana, Southern Arkansas and Northeast Texas area through face-to-face interviews and chart review and compared them with the published DOPPS results. RESULTS: We found a significant difference between this Southern ESRD population and the overall American DOPPS cohort in demographics and dialysis adherence. Most (95.8%) patients were of African American ancestry and had a longer vintage on dialysis. Most patients were nonadherent as assessed by 2 of 4 measures of dialysis adherence: 29.2% of patients did not attend at least 1 dialysis session per month, and 86.4% shortened their dialysis session by 10 minutes or more at least 1 per month. These parameters were identified as major risk factors for adverse outcome in the DOPPS study. CONCLUSION: This Southern patient cohort is different from the rest of the American ESRD population in terms of important measures of dialysis adherence. Such differences might contribute to our understanding of regional disparity in outcomes.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation.

OBJECTIVE: An economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain. DESIGN: Cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial. PARTICIPANTS: 579 patients with chronic or recurrent low back pain recruited from primary care. INTERVENTIONS: Normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse. MAIN OUTCOME MEASURES: Costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves. RESULTS: Intervention costs ranged from pound30 for exercise prescription to pound596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from pound50 for 24 lessons in Alexander technique to pound124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value ( pound61 per point on disability score, pound9 per additional pain-free day, pound2847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional pound64 per point on disability score, pound43 per additional pain-free day, pound5332 per QALY gain). CONCLUSIONS: An exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above pound20 000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain.

OBJECTIVE: To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. DESIGN: Factorial randomised trial. Setting 64 general practices in England. PARTICIPANTS: 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. INTERVENTIONS: Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. MAIN OUTCOME MEASURES: Roland Morris disability score (number of activities impaired by pain) and number of days in pain. RESULTS: Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks were lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. CONCLUSIONS: One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain.

OBJECTIVE: To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. DESIGN: Factorial randomised trial. SETTING: 64 general practices in England. PARTICIPANTS: 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. INTERVENTIONS: Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. MAIN OUTCOME MEASURES: Roland Morris disability score (number of activities impaired by pain) and number of days in pain. RESULTS: Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. CONCLUSIONS: One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons. TRIAL REGISTRATION: National Research Register N0028108728.