[Nausea: Current view]. / Les nausées : données actuelles.

Nausea is a common feeling felt by the subject as a state likely to evolve into vomiting. However a lot of nausea is maintained without being followed by vomiting. Nausea can be isolated or accompanied by a clinical picture. Some situations are often accompanied by nausea like dizziness, migraines, transport sickness, pregnancy, acute or chronic digestive disorders or anxious state. Outside of a know pathological context, there must be an etiologic investigation. When they are accompanied by vomiting and general signs - especially a fever - nausea must first eliminate a potentially serious disease (intracranial hypertension, meningitis, occlusion…). Nausea resounds on the patient's quality of life, they can decrease concentration and professional activities. Many patients do not treat nausea and use rest and waiting for the resolution of symptoms. In the absence of signs of gravity taking a treatment without a medical prescription can be considered (recommendation ANSM 2008) especially for recurrent crisis whose cause can be precisely identified. They are many pharmacological substances with antinausea effects. If the etiological approach is essential and sometimes sufficient, symptomatic relief can be helped by some agents with less intense nausea and shorter duration especially by using of antihistaminics, anticholinergic agents and derivatives of phenothiazines.

Cost savings using a test-based de-escalation strategy for patients with Crohn's disease in remission on optimized infliximab: A discrete event model study.

BACKGROUND: Drug de-escalation is considered in Crohn's disease patients in sustained remission on optimized infliximab treatment. AIM: We built a model to evaluate the magnitude of cost savings in patients' disease course with or without drug de-escalation guided by infliximab trough levels. METHODS: We designed 4 virtual cohorts (P1-P4) of 10,000 patients in clinical remission on optimized infliximab treatment followed for 2 years. P1: no drug de-escalation - 10 mg/kg/8 weeks; P2: drug de-escalation from 10 mg/kg/8 weeks to 5 mg/kg/8 weeks according to trough levels; P3: no drug de-escalation - 10 mg/kg/6 weeks; and P4: drug de-escalation from 10 mg/kg/6 weeks to 10 mg/kg/8 weeks according to trough levels. For P2 and P4 cohorts, drug de-escalation was decided if trough levels were ≥7 µg/mL and no de-escalation if trough levels were <7 µg/mL. Only costs related to drug administration were considered. RESULTS: The cost differences when comparing P1 versus P2 and P3 versus P4 were 7.6% and 4.6%, respectively, corresponding to costs savings of €30.5 millions and €20.3 million for 10,000 patients. CONCLUSION: Over a 2-year period, infliximab de-escalation according to trough levels led to cost saving of about 6%, corresponding to around €25.4 million.

Cost savings of anti-TNF therapy using a test-based strategy versus an empirical dose escalation in Crohn's disease patients who lose response to infliximab.

BACKGROUND: The use of pharmacokinetics is associated with cost savings in anti-tumor necrosis factor (anti-TNF) therapy, but the long-term cost savings in a large cohort of Crohn's disease (CD) patients are unknown. AIM: The goal of this study was to compare the cost of anti-TNF therapy in two cohorts of CD patients losing response to infliximab, one using a test-based strategy and one an empirical dose escalation. METHODS: We used a selected mathematical model to describe the trajectories of CD patients based on a discrete event system. This design allowed us to track over a given period a double cohort of patients who moved randomly and asynchronously from one state to another, while keeping all the information on their entire trajectory. Both cohorts were modeled using state diagram parameters where transition probabilities from one state to another are derived from literature data. Costs were estimated based on the French health care system. RESULTS: Cost savings among the 10,000 CD patients using a test-based strategy were €131,300,293 at 5 years. At 5 years the mean cost saving was €13,130 per patient. The direct cost of the test had no impact on the results until the cost per test reached €2,000. CONCLUSIONS: A test-based strategy leads to major cost savings related to anti-TNF therapy in CD.

Efficacy of a CO2-releasing suppository in dyschezia: a double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Constipation has a significant impact on quality of life. Aim of this study was to evaluate the safety and the efficacy for relieving dyschezia symptoms of a CO2-releasing suppository in a randomized, placebo-controlled, clinical trial. METHODS: Fifty-three office-based primary care physicians and 24 gastroenterologists conducted the study in France, between November 2010 and January 2012. Patients (aged 18-75 years) with dyschezia were eligible. Patients were randomly allocated a once-a-day suppository (CO2-releasing suppository or placebo) for 21 days. Primary endpoint was the change, from Day 0 to Day 21, in the intensity of discomfort related to dyschezia based on a self-assessed 0-100 visual analogue scale. RESULTS: A total of 323 patients were randomized, i.e. 166 into the intervention group and 157 into the placebo group. Co-variance analysis showed a greater reduction in discomfort visual analogue scale score in the intervention group (-34.5mm; standard error of the mean: 1.8mm) than in the placebo group (-26.2mm; standard error of the mean: 1.9 mm; p<0.001). The greater efficacy of the CO2-releasing suppository was confirmed for all secondary efficacy parameters. No significant side effects for either treatment were observed. CONCLUSION: A CO2-releasing suppository is more effective than a placebo for the relief of symptoms of dyschezia. This efficacy is associated with a good safety profile.

A concomitant treatment by CO2-releasing suppositories improves the results of anorectal biofeedback training in patients with dyschezia: results of a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Dyschezia is a defecatory disorder that places a heavy burden on a patient's quality of life. Biofeedback is the recommended treatment in most cases. OBJECTIVE: The objective of our study was to test whether a CO2-releasing suppository for patients with dyschezia could be effective in improving biofeedback training results. DESIGN: A randomized, double-blind, multicenter, placebo-controlled study was conducted in patients (18-75 years of age) with dyschezia defined according to the modified Rome III criteria. Patients were randomly assigned to either a CO2-releasing suppository or placebo suppository once per day for 21 days. SETTINGS: This was a multicenter trial. PATIENTS: A total of 122 patients were randomly assigned (62 intervention group and 60 placebo group). MAIN OUTCOME MEASURES: The primary end point was the change from day 0 to day 21 in intensity of symptoms on the basis of a self-assessed dyschezia using a visual analog scale (range, 0-100). Analyses were performed using intention-to-treat principles. RESULTS: A greater reduction from baseline to day 21 in symptom visual analog scale score was observed in the intervention group (-41.3 mm) than in the control group (-22.3 mm). Some secondary efficacy parameters improved more in the intervention group, including the percentage of patients who improved ≥50%, symptom intensity over 21 days, stool stains on underwear or pads, and need to practice manual maneuvers to facilitate defecation at day 21. At day 21, rectal sensitivity in the intervention group (31.4 mL) was lower than in the control group (39.1 mL). LIMITATIONS: There was a lower number of patients recruited than planned by the protocol. The sponsor stopped the trial before the inclusion of 306 participants, with no intermediate analysis. In addition, the main analysis conducted on the full analysis set population could have led to a statistical bias. CONCLUSIONS: The results of this multicenter trial demonstrate the added benefits of a CO2-releasing suppository in patients with dyschezia who were treated by anorectal biofeedback training.

Development and validation of a questionnaire assessing volitional competencies to enhance the performance of physical activities in chronic low back pain patients.

BACKGROUND: Motivation has long been emphasized as the most important determinant of action. However, there is a substantial gap between people's goals and their attainment. Patients may be motivated and yet unable to take action if their volitional competencies are insufficient. One of the important tasks of volition is goal-maintenance. Research has stressed the importance of a volitional tool, the implementation intentions. Implementation intentions indicate where, when, and how the action leading to the goal will be performed. Forming implementation intentions favours the execution of goal-directed efforts, and reinforces the relationship between intentions and behaviours. Results from various studies clearly suggest that volitional competencies and implementation intentions could play a role in low back pain (LBP) patients. However, there is at present no questionnaire allowing assessing the capacity of implementation intentions of physical activities in LBP patients. METHODS/DESIGN: This study will develop such a questionnaire, using a 3-step approach. A first qualitative step to build categories and generate items; 30 patients suffering chronic LBP will be invited to participate in semi-structured interviews; verbatim and derived items will then be submitted to a panel of experts, using a Delphi method; a second quantitative step to examine the properties of items, and determine the factorial structure of the questionnaire; 100 patients suffering chronic LBP will be recruited to respond to this phase; and third, preliminary psychometric analyses (item-scale correlations, construct validity, reliability); 180 chronic LBP patients will be recruited for this phase of the study. The relationships between implementation intentions and variables affecting physical activity on chronic LBP patients, i.e. pain, physical capacities, fear-avoidance beliefs, kinesiophobia, work status, and level of physical activity will be considered. DISCUSSION: Developing a questionnaire to assess implementation intentions would allow investigating the role of these intentions in the transition from acute to chronic LBP. The results of this study should contribute to the understanding of the psychological processes at stake in the development of chronic LBP, and in particular to the identification of factors eventually favouring patients' participation in and adherence to active physical treatments.

Management recommendations for knee osteoarthritis: how usable are they?

OBJECTIVES: Despite the availability of practice guidelines for the management of knee osteoarthritis, inadequacies in practices of clinicians and patients have been found, leading to suboptimal outcomes. Literature has shown that simply disseminating management recommendations does not lead to adherence. Research suggests that barriers to use should be identified and addressed to improve adherence. The objective of this study was to identify barriers to use of conservative management recommendations for knee osteoarthritis by patients, general practitioners and physiotherapists. METHODS: Following systematic reviews of evidence and guidelines, 12 key management recommendations were elaborated on four themes: medication, exercise, self-management and occupation. Focus groups were separately done with patients with knee osteoarthritis, general practitioners and physiotherapists to assess barriers to the use of recommendations. RESULTS: Patients and general practitioners appeared generally fatalistic with regards to knee osteoarthritis, with physiotherapists being more positive regarding long-term improvement of knee osteoarthritis. For medication, discrepancies were found between recommendations and views of clinicians. Both patients and general practitioners appeared ambivalent towards exercise and activity, recognizing its usefulness but identifying it at the same time as a cause of knee osteoarthritis. Patients and general practitioners appeared to consider weight loss particularly difficult. DISCUSSION/CONCLUSIONS: Barriers specific to each knee osteoarthritis management recommendation and stakeholder group were identified. Recommendations to address these barriers were elaborated. Results of this study can be used to develop implementation strategies to overcome identified barriers, with the goal of facilitating the use of guideline recommendations and improving outcomes.

Validation of the KOFUS (Knee Osteoarthritis Flare-Ups Score).

OBJECTIVE: To develop a diagnostic score for knee osteoarthritis flare-ups and to evaluate its sensitivity and specificity. METHODS: We used two epidemiological databases built using the same methodology. One database was from a general-practice study and served to develop the score, whereas the other was from a rheumatology study and served to validate the score. Physicians determined the flare-up status of each patient. The rheumatologist diagnosis was the reference standard. Logistic regression was performed to identify factors significantly associated with having a flare-up. RESULTS: Of the 6085 patients in the general-practice database, 52.3% had a knee osteoarthritis flare-up. The score was built by assigning points to features that were present, with a weighting system based on the odds ratio of each feature for having a flare-up (0, feature absent; 1, morning stiffness for longer than 20 min; 2, pain causing nocturnal awakenings and knee effusion; 3, limping, joint swelling, and increased warmth over the knee). The score could range from 0 to 14. The receiver-operating characteristic curve showed that 7 was the best cutoff for diagnosing a flare-up. In the rheumatologist database, the numbers of patients having a flare-up were 274 (46.4%) based on the score and 270 (45.7%) based on the rheumatologist diagnosis. Sensitivity of the score was 87.0%, specificity 87.9%, positive predictive value 85.8%, and negative predictive value 89.0%. The Youden index was 0.75. CONCLUSION: A score equal to or greater than 7 points correlated well with a rheumatologist diagnosis of flare-up. Our score may constitute a valid objective criterion for standardizing the diagnosis of knee osteoarthritis flare-up, most notably when screening patients for inclusion in therapeutic trials.

[Clinical aspects and management of adult patients with acute gastroenteritis in primary care]. / Profil symptomatique et modalités de prise en charge des gastro-entérites aiguës de l'adulte en médecine générale Résultats d'une enquête transversale à grande échelle portant sur 17 273 patients.

AIM: In patients with acute gastroenteritis, general behaviour of patients as well as medical care remain poorly documented. The aim of this work was to determine clinical and demographic characteristics, reason for visiting a doctor, and medical care in adult patients with acute gastroenteritis. METHODS: During the winter epidemic peak of acute diarrhea, 2,217 general practitioners filled in standardized clinical observations of 17,273 patients (mean age 40 yrs) with acute gastroenteritis. RESULTS: There were abdominal pain, nausea, and vomiting in respectively 72%, 53% and 43% of patients. Thirty one percent of patients had fever. Nausea and vomiting were more frequently observed in younger patients (15-25 yrs) than in older ones. More severe diarrhea more frequent nausea, vomiting and abdominal pain (p<0.0001). Time for consulting was less than 24 and 48h in respectively 42% and 87% of patients, and was different according to professional classes. Predominant reason for consulting was the physical consequences of the disease (78%). Self medication was reported in 42% of patients and was different according to age and professional classes. Prescription of antidiarrheal drugs was reported by 91% of patients, sometimes in association with antiemetic (43%) and/or antispasmodic agents (35%). Additional explorations (mainly biological work-up) were rare but they were more frequently considered in older and female patients as well as in patients with severe and prolonged diarrhea. Stoppage of work was different among professional classes. It was reported in one third of patients, and was more frequent in patients with severe diarrhea. CONCLUSIONS: This study describes the behaviour of patients and doctors facing acute gastroenteritis and illustrates important fluctuations according age and professional classes. It shows high discomfort and repercussions of acute gastroenteritis especially regarding stoppage of work.

A critical appraisal of guidelines for the management of knee osteoarthritis using Appraisal of Guidelines Research and Evaluation criteria.

Clinical practice guidelines have been elaborated to summarize evidence related to the management of knee osteoarthritis and to facilitate uptake of evidence-based knowledge by clinicians. The objectives of the present review were summarizing the recommendations of existing guidelines on knee osteoarthritis, and assessing the quality of the guidelines using a standardized and validated instrument--the Appraisal of Guidelines Research and Evaluation (AGREE) tool. Internet medical literature databases from 2001 to 2006 were searched for guidelines, with six guidelines being identified. Thirteen clinician researchers participated in the review. Each reviewer was trained in the AGREE instrument. The guidelines were distributed to four groups of three or four reviewers, each group reviewing one guideline with the exception of one group that reviewed two guidelines. One independent evaluator reviewed all guidelines. All guidelines effectively addressed only a minority of AGREE domains. Clarity/presentation was effectively addressed in three out of six guidelines, scope/purpose and rigour of development in two guidelines, editorial independence in one guideline, and stakeholder involvement and applicability in none. The clinical management recommendation tended to be similar among guidelines, although interventions addressed varied. Acetaminophen was recommended for initial pain treatment, combined with exercise and education. Nonsteroidal anti-inflammatory drugs were recommended if acetaminophen failed to control pain, but cautiously because of gastrointestinal risks. Surgery was recommended in the presence of persistent pain and disability. Education and activity management interventions were superficially addressed in most guidelines. Guideline creators should use the AGREE criteria when developing guidelines. Innovative and effective methods of knowledge translation to health professionals are needed.

Effect of an oral bulking agent and a rectal laxative administered alone or in combination for the treatment of constipation.

OBJECTIVES: The aim of the present study was to search for a synergetic action between psyllium and a defecation-inducing drug, Eductyl, for symptom relief in patients suffering from chronic constipation. METHODS: Twenty healthy volunteers and 20 patients complaining of chronic constipation were included in a randomized crossover study. The study was divided into four 2-weeks periods: pre-inclusion and three periods of treatment with psyllium, Eductyl, and Eductyl + psyllium respectively. Colonic transit time was determined at the end of each period of treatment. During each of the four periods, a self-administered questionnaire was used to assess symptoms of constipation. RESULTS: For constipated patients, treatment with Eductyl and Eductyl-psyllium improved clinical symptoms of constipation: increased stool frequency, resulted in fewer hard stools and less sensation of incomplete evacuation and less straining to defecate. The improvement was associated with a decrease in total and segmental colonic transit time. The Eductyl-psyllium combination did not exhibit any synergetic effect. CONCLUSION: Treatment with Eductyl alone is more efficient than with psyllium alone in providing symptom relief. Combination with psyllium is not synergetic.

Compliance among general practitioners in France with recommendations not to prescribe bed rest for acute low back pain.

UNLABELLED: Acute low back pain is a very common reason for general practitioner visits. OBJECTIVE: To evaluate practices among French general practitioners regarding the prescription of bed rest in patients with low back pain. METHODS: 2000 general practitioners were to include the first three patients presenting within the first 3 d of onset of acute low back pain without nerve root pain. The characteristics of the pain, social and demographic characteristics of the patients, and treatments prescribed by the physicians were recorded. RESULTS: 5355 patients were included, of whom more than half had a history of one or more episodes of low back pain. The mean pain severity score on a 100-mm visual analog scale was 57.2 +/- 22.7 mm. Bed rest was recommended to 27.6% of the patients, for a mean duration of 4.4 d. Patients to whom bed rest was recommended were significantly more likely than the other patients to have chronic low back pain (32.1% vs. 26.5%) and received a greater number of medications. Bed rest was associated with significantly poorer outcomes in the multivariable analysis adjusting for confounding factors. CONCLUSION: Recommendations to avoid bed rest in patients with acute low back pain are widely followed in France. Furthermore, our results confirm that bed rest is associated with poorer outcomes.