Baseline Characteristics May Help Indicate the Best Choice of Health Care Provider for Back Pain Patients in Primary Care: Results From a Prospective Cohort Study.

OBJECTIVE: Baseline characteristics of patients low back pain differ substantially between care settings, but it is largely unknown whether predictors are of equal importance across settings. The aim of this study was to investigate whether 8 known predictors relate differently to outcomes in chiropractic practice and in general practice and to which degree these factors may be helpful in selecting patients benefiting more from one setting or the other. METHODS: Patient characteristics were collected at baseline, and outcomes of pain intensity (numeric rating scale 0-10) and activity limitation (Roland-Morris Disability Questionnaire 0-100) after 2, 12, and 52 weeks. Differences in the prognostic strength between settings were investigated for each prognostic factor separately by estimating the interaction between setting and the prognostic factor using regression models. Between-setting differences in outcome in high-risk and low-risk subgroups, formed by single prognostic factors, were assessed in similar models adjusted for a propensity score to take baseline differences between settings into account. RESULTS: Prognostic factors were generally associated more strongly with outcomes in general practice compared with chiropractic practice. The difference was statistically significant for general health, duration of pain, and musculoskeletal comorbidity. After propensity score adjustment, differences in outcomes between settings were insignificant, but negative prognostic factors tended to be less influential in chiropractic practice except for leg pain and depression, which tended to have less negative impact in general practice. CONCLUSION: Known prognostic factors related differently to outcomes in the 2 settings, suggesting that some subgroups of patients might benefit more from one setting than the other.

Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial.

BACKGROUND: Recent data suggest that 10-20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decline in quality of life. A preliminary randomized control trial suggested that this condition may be induced by the stress experienced during the event or emergency room (ER) stay and can be prevented in up to 75% of patients with a single, early, short eye movement desensitization and reprocessing (EMDR) psychotherapeutic session delivered in the ER. The protocol of the SOFTER 3 study was designed to compare the impact on 3-month PCLS of early EMDR intervention and usual care in patients presenting at the ER. Secondary outcomes included 3-month post-traumatic stress disorder, 12-month PCLS, self-reported stress at the ER, self-assessed recovery expectation at discharge and 3 months, and self-reported chronic pain at discharge and 3 months. METHODS: This is a two-group, open-label, multicenter, comparative, randomized controlled trial with 3- and 12-month phone follow-up for reports of persisting symptoms (PCLS and post-traumatic stress disorder). Those eligible for inclusion were adults (≥18 years old) presenting at the ER departments of the University Hospital of Bordeaux and University Hospital of Lyon, assessed as being at high risk of PCLS using a three-item scoring rule. The intervention groups were a (1) EMDR Recent Traumatic Episode Protocol intervention performed by a trained psychologist during ER stay or (2) usual care. The number of patients to be enrolled in each group was 223 to evidence a 15% decrease in PCLS prevalence in the EMDR group. DISCUSSION: In 2012, the year of the last national survey in France, 10.6 million people attended the ER, some of whom did so several times since 18 million visits were recorded in the same year. The SOFTER 3 study therefore addresses a major public health challenge. TRIAL REGISTRATION: Clinical Trials. NCT03400813 . Registered 17 January 2018 - retrospectively registered.

Emergency room intervention to prevent post concussion-like symptoms and post-traumatic stress disorder. A pilot randomized controlled study of a brief eye movement desensitization and reprocessing intervention versus reassurance or usual care.

Up to 20% of patients presenting at an emergency room (ER) after a stressful event will for several months suffer from very diverse long-lasting symptoms and a potentially significant decline in quality of life, often described as post concussion-like symptoms (PCLS). The objectives of our randomized open-label single-center study were to assess the feasibility of psychologist-led interventions in the context of the ER and to compare the effect of eye movement desensitization and reprocessing (EMDR) with reassurance and usual care. Conducted in the ER of Bordeaux University Hospital, the study included patients with a high risk of PCLS randomized in three groups: a 15-min reassurance session, a 60-min session of EMDR, and usual care. Main outcomes were the proportion of interventions that could be carried out and the prevalence of PCSL and post-traumatic stress disorder (PTSD) three months after the ER visit. One hundred and thirty patients with a high risk of PCLS were randomized. No logistic problem or patient refusal was observed. In the EMDR, reassurance and control groups, proportions of patients with PCLS at three months were 18%, 37% and 65% and those with PTSD were 3%, 16% and 19% respectively. The risk ratio for PCLS adjusted for the type of event (injury, non-injury) for the comparison between EMDR and control was 0.36 [95% CI 0.20-0.66]. This is the first randomized controlled trial that shows that a short EMDR intervention is feasible and potentially effective in the context of the ER. The study was registered at ClinicalTrials.gov (NCT03194386).

Does a Diagnostic Classification Algorithm Help to Predict the Course of Low Back Pain? A Study of Danish Chiropractic Patients With 1-Year Follow-up.

BACKGROUND: A diagnostic classification algorithm, "the Petersen classification," consisting of 12 categories based on a standardized examination protocol, was developed for the primary purpose of identifying clinically homogeneous subgroups of individuals with low back pain (LBP). OBJECTIVES: To investigate whether a diagnostic classification algorithm is associated with activity limitation and LBP intensity at follow-up assessments of 2 weeks, 3 months, and 1 year, and whether the algorithm improves outcome prediction when added to a set of known predictors. METHODS: This was a prospective observational study of 934 consecutive adult patients with new episodes of LBP who were visiting chiropractic practices in primary care and categorized according to the Petersen classification. Outcomes were disability and pain intensity measured with questionnaires at 2 weeks and 3 months, and 1-year trajectories of LBP based on weekly responses to text messages. Associations were analyzed with linear and logistic regression models. In a subgroup of patients, the numbers of visits to primary and secondary care were described. RESULTS: The Petersen classification was statistically significantly associated with all outcomes (P<.001) but explained very little of the variance (R2 = 0.00-0.05). Patients in the nerve root involvement category had the most pain and activity limitation and the most visits to primary and secondary care. Patients in the myofascial pain category were the least affected. CONCLUSION: The Petersen classification was not helpful in determining individual prognosis in patients with LBP receiving usual care in chiropractic practice. However, patients should be examined for potential nerve root involvement to improve prediction of likely outcomes. LEVEL OF EVIDENCE: Prognosis, level 1b. J Orthop Sports Phys Ther 2018;48(11):837-846. Epub 8 May 2018. doi:10.2519/jospt.2018.8083.

Protocole of a controlled before-after evaluation of a national health information technology-based program to improve healthcare coordination and access to information.

BACKGROUND: Improvement of coordination of all health and social care actors in the patient pathways is an important issue in many countries. Health Information (HI) technology has been considered as a potentially effective answer to this issue. The French Health Ministry first funded the development of five TSN ("Territoire de Soins Numérique"/Digital health territories) projects, aiming at improving healthcare coordination and access to information for healthcare providers, patients and the population, and at improving healthcare professionals work organization. The French Health Ministry then launched a call for grant to fund one research project consisting in evaluating the TSN projects implementation and impact and in developing a model for HI technology evaluation. METHODS: EvaTSN is mainly based on a controlled before-after study design. Data collection covers three periods: before TSN program implementation, during early TSN program implementation and at late TSN program implementation, in the five TSN projects' territories and in five comparison territories. Three populations will be considered: "TSN-targeted people" (healthcare system users and people having characteristics targeted by the TSN projects), "TSN patient users" (people included in TSN experimentations or using particular services) and "TSN professional users" (healthcare professionals involved in TSN projects). Several samples will be made in each population depending on the objective, axis and stage of the study. Four types of data sources are considered: 1) extractions from the French National Heath Insurance Database (SNIIRAM) and the French Autonomy Personalized Allowance database, 2) Ad hoc surveys collecting information on knowledge of TSN projects, TSN program use, ease of use, satisfaction and understanding, TSN pathway experience and appropriateness of hospital admissions, 3) qualitative analyses using semi-directive interviews and focus groups and document analyses and 4) extractions of TSN implementation indicators from TSN program database. DISCUSSION: EvaTSN is a challenging French national project for the production of evidenced-based information on HI technologies impact and on the context and conditions of their effectiveness and efficiency. We will be able to support health care management in order to implement HI technologies. We will also be able to produce an evaluation toolkit for HI technology evaluation. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02837406 , 08/18/2016.

A cost-utility analysis of sacral anterior root stimulation (SARS) compared with medical treatment in patients with complete spinal cord injury with a neurogenic bladder.

BACKGROUND CONTEXT: Sacral anterior root stimulation (SARS) and posterior sacral rhizotomy restores the ability to urinate on demand with low residual volumes, which is a key for preventing urinary complications that account for 10% of the causes of death in patients with spinal cord injury with a neurogenic bladder. Nevertheless, comparative cost-effectiveness results on a long time horizon are lacking to adequately inform decisions of reimbursement. PURPOSE: This study aimed to estimate the long-term cost-utility of SARS using the Finetech-Brindley device compared with medical treatment (anticholinergics+catheterization). STUDY DESIGN/SETTINGS: The following study design is used for the paper: Markov model elaborated with a 10-year time horizon; with four irreversible states: (1) initial treatment, (2) year 1 of surgery for urinary complication, (3) year >1 of surgery for urinary complication, and (4) death; and reversible states: urinary calculi; Finetech-Brindley device failures. PATIENT SAMPLE: The sample consisted of theoretical cohorts of patients with a complete spinal cord lesion since ≥1 year, and a neurogenic bladder. OUTCOME MEASURES: Effectiveness was expressed as quality adjusted life years (QALYs). Costs were valued in EUR 2013 in the perspective of the French health system. METHODS: A systematic review and meta-analyses were performed to estimate transition probabilities and QALYs. Costs were estimated from the literature, and through simulations using the 2013 French prospective payment system classification. Probabilistic analyses were conducted to handle parameter uncertainty. RESULTS: In the base case analysis (2.5% discount rate), the cost-utility ratio was 12,710 EUR per QALY gained. At a threshold of 30,000 EUR per QALY the probability of SARS being cost-effective compared with medical treatment was 60%. If the French Healthcare System reimbursed SARS for 80 patients per year during 10 years (anticipated target population), the expected incremental net health benefit would be 174 QALYs, and the expected value of perfect information (EVPI) would be 4.735 million EUR. The highest partial EVPI is reached for utility values and costs (1.3-1.6 million EUR). CONCLUSIONS: Our model shows that SARS using Finetech-Brindley device offers the most important benefit and should be considered cost-effective at a cost-effectiveness threshold of 30,000 EUR per QALY. Despite a high uncertainty, EVPI and partial EVPI may indicate that further research would not be profitable to inform decision-making.

Determinants of allogeneic transfusion among patients who had an autologous blood procedure, France.

Autologous transfusion techniques have been proposed to decrease viral contamination related to allogeneic transfusion. Epidemiological studies looking at the actual effect of such policy are scarce. The aim of this study was to assess factors associated to the transfusion of additional allogeneic units among autologous blood recipients in France. We used a subgroup of data of RECEPT, a representative study of transfusion in French hospitals, and described blood recipients and components during the first 24 hours following a transfusion in 175 teaching and non teaching hospitals. We analysed data regarding patients included in the original study, who received autologous blood transfusion (376 patients). Almost one fifth of patients transfused with autologous blood was exposed to additional allogeneic transfusion. Patients undergoing cardiovascular surgery and who were transfused with blood salvage received allogeneic transfusion more frequently than patients undergoing orthopaedic surgery. Further implication of epidemiologists in studies of transfusion or other health technologies could help better formulate policies purported at decreasing risks.