Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach

<p>Abstract</p> <p>Background</p> <p>Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM) and conventional therapies, while also incorporating patient choice, has yet to be tested for chronic LBP.</p> <p>The primary aim of this study is to determine the relative clinical effectiveness of 1) monodisciplinary chiropractic care and 2) multidisciplinary integrative care in 200 adults with non-acute LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure is patient-rated back pain. Secondary aims compare the treatment approaches in terms of frequency of symptoms, low back disability, fear avoidance, self-efficacy, general health status, improvement, satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods, and cost-effectiveness and cost utility will be assessed.</p> <p>Methods and Design</p> <p>This paper describes the design of a randomized clinical trial (RCT), with cost-effectiveness and qualitative studies conducted alongside the RCT. Two hundred participants ages 18 and older are being recruited and randomized to one of two 12-week treatment interventions. Patient-rated outcome measures are collected via self-report questionnaires at baseline, and at 4, 12, 26, and 52 weeks post-randomization. Objective outcome measures are assessed at baseline and 12 weeks by examiners blinded to treatment assignment. Health care cost data is collected by self-report questionnaires and treatment records during the intervention phase and by monthly phone interviews thereafter. Qualitative interviews, using a semi-structured format, are conducted with patients at the end of the 12-week treatment period and also with providers at the end of the trial.</p> <p>Discussion</p> <p>This mixed-methods randomized clinical trial assesses clinical effectiveness, cost-effectiveness, and patients' and providers' perceptions of care, in treating non-acute LBP through evidence-based individualized care delivered by monodisciplinary or multidisciplinary care teams.</p> <p>Trial registration</p> <p>ClinicalTrials.gov NCT00567333</p

The dorzolamide/timolol combination versus timolol plus pilocarpine : patient preference and impact on daily life

Purpose: To compare the 2.0% dorzolamide/0.5% timolol fixed combination (COSOPT; Merck & Co., Whitehouse Station: NJ) to 0.5% timolol plus 2.0% pilocarpine given concomitantly, and to determine patient preference, tolerability, and impact on daily life in patients with elevated intraocular pressure (IOP). Methods: Two multi-center, randomized, cross-over, observer masked studies were conducted, one in the United States (97 patients) and one in Europe (93 patients). The Comparison of Ophthalmic Medications for Tolerability questionnaire was used to assess patient preference and perception of side effects and activity limitations resulting from study medications. Intraocular pressure was measured before and 2 hours after the morning dose of study medication (hour 0 and hour 2). Results: In both studies, among patients with a preference, the combination was preferred to timolol plus pilocarpine by a ratio of 4 to 1. The most commonly cited reason for this preference was side effects. Patients in both studies also reported that the combination interfered significantly less with daily life in terms of side effects and activity limitations. They also reported missing significantly fewer doses of study medication while taking the combination and being significantly more satisfied with it. The efficacy of these two treatments was not significantly different, based on IOP measurements at hour 0 and 2 hours after administration. Patients reported significantly more adverse events while receiving timolol plus pilocarpine in both studies, and in the U.S. study, significantly more patients discontinued therapy while receiving timolol plus pilocarpine than while receiving the combination. Conclusion: Compared with timolol plus pilocarpine, patients preferred the combination of 2% dorzolamide/0.5% timolol, and reported less interference in daily activities, better tolerability, and better compliance with therapy

Legal Issues in Medical Management of Violent and Threatening Patients

The responsibility of professionals in the medical management of violent and threatening patients is discussed using the Tarasoff case (American) and the Lawson case (Canadian) as landmark cases influencing subsequent jurisprudence. It is becoming increasingly important to be aware of the court's interpretations in such areas as confidentiality, predictions regarding dangerousness, the duty to warn, and the legal duty to strangers to the therapist/patient relationship. A number of other issues relating to the risks involved in management of patients potentially dangerous as a result of the use of drugs are also discussed

QUALITY of PULP AND JELLIES of TAMARIND FROM THE BRAZILIAN CERRADO

This study aimed assess the physical characteristics (mass, length and width) of tamarind fruit (Tamarindus indica L.) and the physical-chemical characteristics (moisture, ash, proteins, lipids, dietary fiber, titratable acidity, soluble solids and pH) of the pulp and jellies of tamarind. The jelly formulations were prepared containing different concentrations of tamarind juice (40 and 50%) and pectin (1.0 and 1.2%). The formulations were subjected to preference and acceptance tests. The tamarind presented a high pulp yield (50.3%) as well as high contents of carbohydrates (68.60g 100g-1), fiber (5.55g 100g-1) and titratable acidity (18.56g tartaric acid 100g-1). There were no significant differences in the chemical composition and acceptance of the jellies. The acceptance of the formulations was higher than 5 (I liked) for all parameters evaluated (appearance, color, odor, texture, flavor and overall evaluation). In conclusion, the tamarind was rich in carbohydrates, fiber and organic acids. The jellies were well accepted by the panelists. The tamarind jelly production was feasible and represents an effective option for the better utilization and conservation of the fruit