Are mind-body therapies effective for relieving cancer-related pain in adults? A systematic review and meta-analysis.

OBJECTIVE: To assess whether mind-body therapies are effective for relieving cancer-related pain in adults, since at least one-third of adults with cancer are affected by moderate or severe pain. METHODS: We searched for all randomized or quasi-randomized controlled trials that included adults (≥18 years) with cancer-related pain who were treated with mind-body therapies (mindfulness, hypnosis, yoga, guided imagery, and progressive muscle relaxation) in MEDLINE, Embase, CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Science Citation Index, Web of Science, trials registers, and reference lists. The primary outcome was pain intensity. We calculated the standardized mean differences and 95% confidence intervals (CIs) and assessed the risk of bias. RESULTS: We identified 40 primary studies involving a total of 3569 participants. The meta-analysis included 24 studies (2404 participants) and showed a significant effect of -0.39 (95% CI -0.62 to -0.16) with considerable heterogeneity (I2  = 86.3%, p < 0.001). After we excluded four "outlier" studies in sensitivity analyses, the effect size remained significant but weaker. There was a high risk of bias in all studies, for example, performance bias due to lack of participant blinding. Patients in multiple settings were included but many studies were of low quality. CONCLUSIONS: Mind-body therapies may be effective in improving cancer pain, but the quality of the evidence is low. There is a need for further high-quality clinical trials.

[New technology of diabetes management: learning together and in situation]. / Nouvelle technologie de gestion du diabète: apprendre ensemble et en situation.

The introduction of a new technology for the management of diabetes raises questions about their actual use. This is the case with the Freestyle Libre sensor, a tool that measures the interstitial glucose levels. Some studies have provided recommendations about its use, but little is known about how users learn to use it in the daily management of the disease. This ethnographic research explores this issue in the context of a summer camp for young people living with diabetes. The results describe three different levels (material, epistemic and moral) at which learning occurs. They show that its use requires an active appropriation process, the importance of a setting that promotes interactions between the participants and that the features of the tend to reconfigure the expert-lay person relationship.

L'introduction d'une nouvelle technologie de gestion du diabète soulève des questions sur son usage effectif. C'est le cas du capteur FreeStyle Libre, un outil mesurant la glycémie interstitielle. Des études ont fourni des recommandations sur son usage, mais on en sait peu sur la manière dont les usager-ère-s apprennent à l'utiliser dans la gestion quotidienne du diabète. Cette recherche ethnographique étudie cette question dans le cadre d'un camp d'été pour jeunes vivant avec un diabète. Les résultats décrivent trois niveaux différents (matériel, épistémique et moral) auxquels cet apprentissage se réalise. Ils montrent que son usage requiert un travail d'appropriation actif, l'intérêt d'un dispositif qui favorise les interactions entre participant-e-s et que les caractéristiques de l'outil tendent à reconfigurer la relation expert-profane.

A cross-sectional study of Swiss ambulatory care services use by multimorbid patients in primary care in the light of the Andersen model.

BACKGROUND: Multimorbidity is frequently encountered in primary care and is associated with increasing use of healthcare services. The Andersen Behavioral Model of Health Services Use is a multilevel framework classifying societal, contextual, and individual characteristics about the use of healthcare services into three categories: 1. predisposing factors, 2. enabling factors, and 3. need factors. The present study aimed to explore multimorbid patients' use of ambulatory healthcare in terms of homecare and other allied health services, visits to GPs, and number of specialists involved. A secondary aim was to apply Andersen's model to explore factors associated with this use. METHOD: In a cross-sectional study, 100 Swiss GPs enrolled up to 10 multimorbid patients each. After descriptive analyses, we tested the associations of each determinant and outcome variable of healthcare use, according to the Andersen model: predisposing factors (patient's demographics), enabling factors (health literacy (HLS-EU-Q6), deprivation (DipCare)), and need factors (patient's quality of life (EQ-5D-3L), treatment burden (TBQ), severity index (CIRS), number of chronic conditions, and of medications). Logistic regressions (dichotomous variables) and negative binomial regressions (count variables) were calculated to identify predictors of multimorbid patients' healthcare use. RESULTS: Analyses included 843 multimorbid patients; mean age 73.0 (SD 12.0), 28-98 years old; 48.3% men; 15.1% (127/843) used homecare. Social deprivation (OR 0.75, 95%CI 0.62-0.89) and absence of an informal caregiver (OR 0.50, 95%CI 0.28-0.88) were related to less homecare services use. The use of other allied health services (34.9% (294/843)) was associated with experiencing pain (OR 2.49, 95%CI 1.59-3.90). The number of contacts with a GP (median 11 (IQR 7-16)) was, among other factors, related to the absence of an informal caregiver (IRR 0.90, 95%CI 0.83-0.98). The number of specialists involved (mean 1.9 (SD 1.4)) was linked to the treatment burden (IRR 1.06, 95%CI 1.02-1.10). CONCLUSION: Multimorbid patients in primary care reported high use of ambulatory healthcare services variably associated with the Andersen model's factors: healthcare use was associated with objective medical needs but also with contextual or individual predisposing or enabling factors. These findings emphasize the importance of adapting care coordination to individual patient profiles.

Biomedical risk assessment as an aid for smoking cessation.

BACKGROUND: A possible strategy for increasing smoking cessation rates could be to provide smokers with feedback on the current or potential future biomedical effects of smoking using, for example, measurement of exhaled carbon monoxide (CO), lung function, or genetic susceptibility to lung cancer or other diseases. OBJECTIVES: The main objective was to determine the efficacy of providing smokers with feedback on their exhaled CO measurement, spirometry results, atherosclerotic plaque imaging, and genetic susceptibility to smoking-related diseases in helping them to quit smoking. SEARCH METHODS: For the most recent update, we searched the Cochrane Tobacco Addiction Group Specialized Register in March 2018 and ClinicalTrials.gov and the WHO ICTRP in September 2018 for studies added since the last update in 2012. SELECTION CRITERIA: Inclusion criteria for the review were: a randomised controlled trial design; participants being current smokers; interventions based on a biomedical test to increase smoking cessation rates; control groups receiving all other components of intervention; and an outcome of smoking cessation rate at least six months after the start of the intervention. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We expressed results as a risk ratio (RR) for smoking cessation with 95% confidence intervals (CI). Where appropriate, we pooled studies using a Mantel-Haenszel random-effects method. MAIN RESULTS: We included 20 trials using a variety of biomedical tests interventions; one trial included two interventions, for a total of 21 interventions. We included a total of 9262 participants, all of whom were adult smokers. All studies included both men and women adult smokers at different stages of change and motivation for smoking cessation. We judged all but three studies to be at high or unclear risk of bias in at least one domain. We pooled trials in three categories according to the type of biofeedback provided: feedback on risk exposure (five studies); feedback on smoking-related disease risk (five studies); and feedback on smoking-related harm (11 studies). There was no evidence of increased cessation rates from feedback on risk exposure, consisting mainly of feedback on CO measurement, in five pooled trials (RR 1.00, 95% CI 0.83 to 1.21; I2 = 0%; n = 2368). Feedback on smoking-related disease risk, including four studies testing feedback on genetic markers for cancer risk and one study with feedback on genetic markers for risk of Crohn's disease, did not show a benefit in smoking cessation (RR 0.80, 95% CI 0.63 to 1.01; I2 = 0%; n = 2064). Feedback on smoking-related harm, including nine studies testing spirometry with or without feedback on lung age and two studies on feedback on carotid ultrasound, also did not show a benefit (RR 1.26, 95% CI 0.99 to 1.61; I2 = 34%; n = 3314). Only one study directly compared multiple forms of measurement with a single form of measurement, and did not detect a significant difference in effect between measurement of CO plus genetic susceptibility to lung cancer and measurement of CO only (RR 0.82, 95% CI 0.43 to 1.56; n = 189). AUTHORS' CONCLUSIONS: There is little evidence about the effects of biomedical risk assessment as an aid for smoking cessation. The most promising results relate to spirometry and carotid ultrasound, where moderate-certainty evidence, limited by imprecision and risk of bias, did not detect a statistically significant benefit, but confidence intervals very narrowly missed one, and the point estimate favoured the intervention. A sensitivity analysis removing those studies at high risk of bias did detect a benefit. Moderate-certainty evidence limited by risk of bias did not detect an effect of feedback on smoking exposure by CO monitoring. Low-certainty evidence, limited by risk of bias and imprecision, did not detect a benefit from feedback on smoking-related risk by genetic marker testing. There is insufficient evidence with which to evaluate the hypothesis that multiple types of assessment are more effective than single forms of assessment.

Implementing a case management intervention for frequent users of the emergency department (I-CaM): an effectiveness-implementation hybrid trial study protocol.

BACKGROUND: ED overcrowding represents a significant public health problem in developed countries. Frequent users of the emergency departments (FUEDs; reporting 5 or more ED visits in the past year) are often affected by medical, psychological, social, and substance use problems and account for a disproportionately high number of ED visits. Past research indicates that case management (CM) interventions are a promising way to reduce ED overcrowding and improve FUEDs' quality of life. There is, however, very limited knowledge about how to disseminate and implement this intervention on a large scale to diverse clinical settings, including community hospitals and non-academic centers. This paper describes the protocol of a research project aiming to implement a CM intervention tailored to FUEDs in the public hospitals with ED in the French-speaking region of Switzerland and evaluate both the implementation process and effectiveness of the CM intervention. METHODS: This research project uses a hybrid study design assessing both implementation and clinical outcomes. The implementation part of the study uses mixed methods a) to describe quantitatively and qualitatively factors that influence the implementation process, and b) to examine implementation effectiveness. The clinical part of the study uses a within-subject design (pre-post intervention) to evaluate participants' trajectories on clinical variables (e.g., quality of life, ED use) after receiving the CM intervention. We designed the study based on two implementation science frameworks. The Generic Implementation Framework guided the overall research protocol design, whereas the RE-AIM (reach, efficacy, adoption, implementation and maintenance) framework guided the implementation and effectiveness evaluations. DISCUSSION: This research project will contribute to implementation science by providing key insights into the processes of implementing CM into broader practice. This research project is also likely to have both clinical and public health implications. TRIAL REGISTRATION: NCT03641274 , Registered 20 August 2018.

Clinical and Health System Determinants of Venous Thromboembolism Event Rates After Hip Arthroplasty: An International Comparison.

BACKGROUND: Routinely collected hospital data provide increasing opportunities to assess the performance of health care systems. Several factors may, however, influence performance measures and their interpretation between countries. OBJECTIVE: We compared the occurrence of in-hospital venous thromboembolism (VTE) in patients undergoing hip replacement across 5 countries and explored factors that could explain differences across these countries. METHODS: We performed cross-sectional studies independently in 5 countries: Canada; France; New Zealand; the state of California; and Switzerland. We first calculated the proportion of hospital inpatients with at least one deep vein thrombosis (DVT) or pulmonary embolism by using numerator codes from the corresponding Patient Safety Indicator. We then compared estimates from each country against a reference value (benchmark) that displayed the baseline risk of VTE in such patients. Finally, we explored length of stay, number of secondary diagnoses coded, and systematic use of ultrasound to detect DVT as potential factors that could explain between-country differences. RESULTS: The rates of VTE were 0.16% in Canada, 1.41% in France, 0.84% in New Zealand, 0.66% in California, and 0.37% in Switzerland, while the benchmark was 0.58% (95% confidence interval, 0.35-0.81). Factors that could partially explain differences in VTE rates between countries were hospital length of stay, number of secondary diagnoses coded, and proportion of patients who received lower limb ultrasound to screen for DVT systematically before hospital discharge. An exploration of the French data showed that the systematic use of ultrasound may be associated with over detection of DVT but not pulmonary embolism. CONCLUSIONS: In-hospital VTE rates after arthroplasty vary widely across countries, and a combination of clinical, data-related, and health system factors explain some of the variations in VTE rates across countries.

Using case management in a universal health coverage system to improve quality of life of frequent Emergency Department users: a randomized controlled trial.

PURPOSE: Frequent Emergency Department users are likely to experience poor quality of life (QOL). Case management interventions are efficient in responding to the complex needs of this population, but their effects on QOL have not been tested yet. Therefore, the aim of our study was to examine to what extent a case management intervention improved frequent Emergency Department users' QOL in a universal health coverage system. METHODS: Data were part of a randomized controlled trial designed to improve frequent Emergency Department users' QOL at the Lausanne University Hospital, Switzerland. A total of 250 frequent Emergency Department users (≥ 5 attendances during the previous 12 months) were randomly assigned to the control (n = 125) or the intervention group (n = 125). The latter benefited from case management intervention. QOL was evaluated using the WHOQOL-BREF at baseline, two, five and a half, nine, and twelve months later. It included four dimensions: physical health, psychological health, social relationship, and environment. Linear mixed-effects models were used to analyze the change in the patients' QOL over time. RESULTS: Patients' QOL improved significantly (p < 0.001) in both groups for all dimensions after two months. However, environment QOL dimension improved significantly more in the intervention group after 12 months. CONCLUSIONS: Environment QOL dimension was the most responsive dimension for short-term interventions. This may have been due to case management's assistance in obtaining income entitlements, health insurance coverage, stable housing, or finding general health care practitioners. Case management in general should be developed to enhance frequent users' QOL. TRIAL REGISTRATION: http://www.clinicaltrials.gov , Unique identifier: NCT01934322.

Effectiveness of brief alcohol interventions in primary care populations.

BACKGROUND: Excessive drinking is a significant cause of mortality, morbidity and social problems in many countries. Brief interventions aim to reduce alcohol consumption and related harm in hazardous and harmful drinkers who are not actively seeking help for alcohol problems. Interventions usually take the form of a conversation with a primary care provider and may include feedback on the person's alcohol use, information about potential harms and benefits of reducing intake, and advice on how to reduce consumption. Discussion informs the development of a personal plan to help reduce consumption. Brief interventions can also include behaviour change or motivationally-focused counselling.This is an update of a Cochrane Review published in 2007. OBJECTIVES: To assess the effectiveness of screening and brief alcohol intervention to reduce excessive alcohol consumption in hazardous or harmful drinkers in general practice or emergency care settings. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and 12 other bibliographic databases to September 2017. We searched Alcohol and Alcohol Problems Science Database (to December 2003, after which the database was discontinued), trials registries, and websites. We carried out handsearching and checked reference lists of included studies and relevant reviews. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of brief interventions to reduce hazardous or harmful alcohol consumption in people attending general practice, emergency care or other primary care settings for reasons other than alcohol treatment. The comparison group was no or minimal intervention, where a measure of alcohol consumption was reported. 'Brief intervention' was defined as a conversation comprising five or fewer sessions of brief advice or brief lifestyle counselling and a total duration of less than 60 minutes. Any more was considered an extended intervention. Digital interventions were not included in this review. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We carried out subgroup analyses where possible to investigate the impact of factors such as gender, age, setting (general practice versus emergency care), treatment exposure and baseline consumption. MAIN RESULTS: We included 69 studies that randomised a total of 33,642 participants. Of these, 42 studies were added for this update (24,057 participants). Most interventions were delivered in general practice (38 studies, 55%) or emergency care (27 studies, 39%) settings. Most studies (61 studies, 88%) compared brief intervention to minimal or no intervention. Extended interventions were compared with brief (4 studies, 6%), minimal or no intervention (7 studies, 10%). Few studies targeted particular age groups: adolescents or young adults (6 studies, 9%) and older adults (4 studies, 6%). Mean baseline alcohol consumption was 244 g/week (30.5 standard UK units) among the studies that reported these data. Main sources of bias were attrition and lack of provider or participant blinding. The primary meta-analysis included 34 studies (15,197 participants) and provided moderate-quality evidence that participants who received brief intervention consumed less alcohol than minimal or no intervention participants after one year (mean difference (MD) -20 g/week, 95% confidence interval (CI) -28 to -12). There was substantial heterogeneity among studies (I² = 73%). A subgroup analysis by gender demonstrated that both men and women reduced alcohol consumption after receiving a brief intervention.We found moderate-quality evidence that brief alcohol interventions have little impact on frequency of binges per week (MD -0.08, 95% CI -0.14 to -0.02; 15 studies, 6946 participants); drinking days per week (MD -0.13, 95% CI -0.23 to -0.04; 11 studies, 5469 participants); or drinking intensity (-0.2 g/drinking day, 95% CI -3.1 to 2.7; 10 studies, 3128 participants).We found moderate-quality evidence of little difference in quantity of alcohol consumed when extended and no or minimal interventions were compared (-14 g/week, 95% CI -37 to 9; 6 studies, 1296 participants). There was little difference in binges per week (-0.08, 95% CI -0.28 to 0.12; 2 studies, 456 participants; moderate-quality evidence) or difference in days drinking per week (-0.45, 95% CI -0.81 to -0.09; 2 studies, 319 participants; moderate-quality evidence). Extended versus no or minimal intervention provided little impact on drinking intensity (9 g/drinking day, 95% CI -26 to 9; 1 study, 158 participants; low-quality evidence).Extended intervention had no greater impact than brief intervention on alcohol consumption, although findings were imprecise (MD 2 g/week, 95% CI -42 to 45; 3 studies, 552 participants; low-quality evidence). Numbers of binges were not reported for this comparison, but one trial suggested a possible drop in days drinking per week (-0.5, 95% CI -1.2 to 0.2; 147 participants; low-quality evidence). Results from this trial also suggested very little impact on drinking intensity (-1.7 g/drinking day, 95% CI -18.9 to 15.5; 147 participants; very low-quality evidence).Only five studies reported adverse effects (very low-quality evidence). No participants experienced any adverse effects in two studies; one study reported that the intervention increased binge drinking for women and two studies reported adverse events related to driving outcomes but concluded they were equivalent in both study arms.Sources of funding were reported by 67 studies (87%). With two exceptions, studies were funded by government institutes, research bodies or charitable foundations. One study was partly funded by a pharmaceutical company and a brewers association, another by a company developing diagnostic testing equipment. AUTHORS' CONCLUSIONS: We found moderate-quality evidence that brief interventions can reduce alcohol consumption in hazardous and harmful drinkers compared to minimal or no intervention. Longer counselling duration probably has little additional effect. Future studies should focus on identifying the components of interventions which are most closely associated with effectiveness.

Multimorbidity: can general practitioners identify the health conditions most important to their patients? Results from a national cross-sectional study in Switzerland.

BACKGROUND: Faced with patients suffering from more than one chronic condition, or multimorbidity, general practitioners (GPs) must establish diagnostic and treatment priorities. Patients also set their own priorities to handle the everyday burdens associated with their multimorbidity and these may be different from the priorities established by their GP. A shared patient-GP agenda, driven by knowledge of each other's priorities, would seem central to managing patients with multimorbidity. We evaluated GPs' ability to identify the health condition most important to their patients. METHODS: Data on 888 patients were collected as part of a cross-sectional Swiss study on multimorbidity in family medicine. For the main analyses on patients-GP agreement, data from 572 of these patients could be included. GPs were asked to identify the two conditions which their patient considered most important, and we tested whether either of them agreed with the condition mentioned as most important by the patient. In the main analysis, we studied the agreement rate between GPs and patients by grouping items medically-related into 46 groups of conditions. Socio-demographic and clinical variables were fitted into univariate and multivariate models. RESULTS: In 54.9% of cases, GPs were able to identify the health condition most important to the patient. In the multivariate model, the only variable significantly associated with patient-GP agreement was the number of chronic conditions: the higher the number of conditions, the less likely the agreement. CONCLUSION: GPs were able to correctly identify the health condition most important to their patients in half of the cases. It therefore seems important that GPs learn how to better adapt treatment targets and priorities by taking patients' perspectives into account.

Premature Discontinuation of Pediatric Randomized Controlled Trials: A Retrospective Cohort Study.

OBJECTIVES: To determine the proportion of pediatric randomized controlled trials (RCTs) that are prematurely discontinued, examine the reasons for discontinuation, and compare the risk for recruitment failure in pediatric and adult RCTs. STUDY DESIGN: A retrospective cohort study of RCTs approved by 1 of 6 Research Ethics Committees (RECs) in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics, trial discontinuation, and reasons for discontinuation from protocols, corresponding publications, REC files, and a survey of trialists. RESULTS: We included 894 RCTs, of which 86 enrolled children and 808 enrolled adults. Forty percent of the pediatric RCTs and 29% of the adult RCTs were discontinued. Slow recruitment accounted for 56% of pediatric RCT discontinuations and 43% of adult RCT discontinuations. Multivariable logistic regression analyses suggested that pediatric RCT was not an independent risk factor for recruitment failure after adjustment for other potential risk factors (aOR, 1.22; 95% CI, 0.57-2.63). Independent risk factors were acute care setting (aOR, 4.00; 95% CI, 1.72-9.31), nonindustry sponsorship (aOR, 4.45; 95% CI, 2.59-7.65), and smaller planned sample size (aOR, 1.05; 95% CI 1.01-1.09, in decrements of 100 participants). CONCLUSION: Forty percent of pediatric RCTs were discontinued prematurely, owing predominately to slow recruitment. Enrollment of children was not an independent risk factor for recruitment failure.

Deriving ICD-10 Codes for Patient Safety Indicators for Large-scale Surveillance Using Administrative Hospital Data.

BACKGROUND: Existing administrative data patient safety indicators (PSIs) have been limited by uncertainty around the timing of onset of included diagnoses. OBJECTIVE: We undertook de novo PSI development through a data-driven approach that drew upon "diagnosis timing" information available in some countries' administrative hospital data. RESEARCH DESIGN: Administrative database analysis and modified Delphi rating process. SUBJECTS: All hospitalized adults in Canada in 2009. MEASURES: We queried all hospitalizations for ICD-10-CA diagnosis codes arising during hospital stay. We then undertook a modified Delphi panel process to rate the extent to which each of the identified diagnoses has a potential link to suboptimal quality of care. We grouped the identified quality/safety-related diagnoses into relevant clinical categories. Lastly, we queried Alberta hospital discharge data to assess the frequency of the newly defined PSI events. RESULTS: Among 2,416,413 national hospitalizations, we found 2590 unique ICD-10-CA codes flagged as having arisen after admission. Seven panelists evaluated these in a 2-round review process, and identified a listing of 640 ICD-10-CA diagnosis codes judged to be linked to suboptimal quality of care and thus appropriate for inclusion in PSIs. These were then grouped by patient safety experts into 18 clinically relevant PSI categories. We then analyzed data on 2,381,652 Alberta hospital discharges from 2005 through 2012, and found that 134,299 (5.2%) hospitalizations had at least 1 PSI diagnosis. CONCLUSION: The resulting work creates a foundation for a new set of PSIs for routine large-scale surveillance of hospital and health system performance.

Case Management may Reduce Emergency Department Frequent use in a Universal Health Coverage System: a Randomized Controlled Trial.

BACKGROUND: Frequent emergency department (ED) users account for a disproportionately high number of ED visits. Studies on case management (CM) interventions to reduce frequent ED use have shown mixed results, and few studies have been conducted within a universal health coverage system. OBJECTIVE: To determine whether a CM intervention-compared to standard emergency care-reduces ED attendance. DESIGN: Randomized controlled trial. PARTICIPANTS: Two hundred fifty frequent ED users (5 or more visits in the prior 12 months) who visited a public urban ED at the Lausanne University Hospital between May 2012 and July 2013 were allocated to either an intervention (n = 125) or control (n = 125) group, and monitored for 12 months. INTERVENTIONS: An individualized CM intervention consisting of concrete assistance in obtaining income entitlements, referral to primary or specialty medical care, access to mental health care or substance abuse treatment, and counseling on at-risk behaviors and health care utilization (in addition to standard care) at baseline and 1, 3, and 5 months. MAIN MEASURES: We used a generalized linear model for count data (negative binomial distribution) to compare the number of ED visits during the 12-month follow-up between CM and usual care, from an intention-to-treat perspective. KEY RESULTS: At 12 months, there were 2.71 (±0.23) ED visits in the intervention group versus 3.35 (±0.32) visits among controls (ratio = 0.81, 95 % CI = 0.63; 1.02). In the multivariate model, the effect of the CM intervention on the number of ED visits approached statistical significance (b = -0.219, p = 0.075). The presence of poor social determinants of health was a significant predictor of ED use in the multivariate model (b = 0.280, p = 0.048). CONCLUSIONS: CM may reduce ED use by frequent users through an improved orientation to the health care system. Poor social determinants of health significantly increase use of the ED by frequent users.

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial.

BACKGROUND: Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice. METHODS/DESIGN: The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland. A total of 110 patients are being recruited and randomized to TBC (TBC: N = 55) or usual care group (UC: N = 55). Patients allocated to the TBC group receive the TBC intervention conducted by an interprofessional team, involving an ambulatory clinic nurse, a community pharmacist and a physician. A nurse and a community pharmacist meet patients every 6 weeks to measure BP, to assess lifestyle, to estimate medication adherence, and to provide education to the patient about disease, treatment and lifestyle. After each visit, the nurse and pharmacist write a summary report with recommendations related to medication adherence, lifestyle, and changes in therapy. The physician then adjusts antihypertensive therapy accordingly. Patients in the UC group receive usual routine care without sessions with a nurse and a pharmacist. The primary outcome is the difference in daytime ambulatory BP between TBC and UC patients at 6-month of follow-up. Secondary outcomes include patients' and healthcare professionals' satisfaction with the TBC intervention and BP control at 12 months (6 months after the end of the intervention). DISCUSSION: This ongoing study aims to evaluate the effect of a newly developed team-based care intervention engaging different healthcare professionals on BP control in a primary care setting in Switzerland. The results will inform policymakers on implementable strategies for routine clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT02511093 . Retrospectively registered on 28 July 2015.

Computer-generated reminders delivered on paper to healthcare professionals: effects on professional practice and healthcare outcomes.

BACKGROUND: Clinical practice does not always reflect best practice and evidence, partly because of unconscious acts of omission, information overload, or inaccessible information. Reminders may help clinicians overcome these problems by prompting them to recall information that they already know or would be expected to know and by providing information or guidance in a more accessible and relevant format, at a particularly appropriate time. This is an update of a previously published review. OBJECTIVES: To evaluate the effects of reminders automatically generated through a computerized system (computer-generated) and delivered on paper to healthcare professionals on quality of care (outcomes related to healthcare professionals' practice) and patient outcomes (outcomes related to patients' health condition). SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers up to 21 September 2016 together with reference checking, citation searching and contact with study authors to identify additional studies. SELECTION CRITERIA: We included individual- or cluster-randomized and non-randomized trials that evaluated the impact of computer-generated reminders delivered on paper to healthcare professionals, alone (single-component intervention) or in addition to one or more co-interventions (multi-component intervention), compared with usual care or the co-intervention(s) without the reminder component. DATA COLLECTION AND ANALYSIS: Review authors working in pairs independently screened studies for eligibility and abstracted data. For each study, we extracted the primary outcome when it was defined or calculated the median effect size across all reported outcomes. We then calculated the median improvement and interquartile range (IQR) across included studies using the primary outcome or median outcome as representative outcome. We assessed the certainty of the evidence according to the GRADE approach. MAIN RESULTS: We identified 35 studies (30 randomized trials and five non-randomized trials) and analyzed 34 studies (40 comparisons). Twenty-nine studies took place in the USA and six studies took place in Canada, France, Israel, and Kenya. All studies except two took place in outpatient care. Reminders were aimed at enhancing compliance with preventive guidelines (e.g. cancer screening tests, vaccination) in half the studies and at enhancing compliance with disease management guidelines for acute or chronic conditions (e.g. annual follow-ups, laboratory tests, medication adjustment, counseling) in the other half.Computer-generated reminders delivered on paper to healthcare professionals, alone or in addition to co-intervention(s), probably improves quality of care slightly compared with usual care or the co-intervention(s) without the reminder component (median improvement 6.8% (IQR: 3.8% to 17.5%); 34 studies (40 comparisons); moderate-certainty evidence).Computer-generated reminders delivered on paper to healthcare professionals alone (single-component intervention) probably improves quality of care compared with usual care (median improvement 11.0% (IQR 5.4% to 20.0%); 27 studies (27 comparisons); moderate-certainty evidence). Adding computer-generated reminders delivered on paper to healthcare professionals to one or more co-interventions (multi-component intervention) probably improves quality of care slightly compared with the co-intervention(s) without the reminder component (median improvement 4.0% (IQR 3.0% to 6.0%); 11 studies (13 comparisons); moderate-certainty evidence).We are uncertain whether reminders, alone or in addition to co-intervention(s), improve patient outcomes as the certainty of the evidence is very low (n = 6 studies (seven comparisons)). None of the included studies reported outcomes related to harms or adverse effects of the intervention. AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that computer-generated reminders delivered on paper to healthcare professionals probably slightly improves quality of care, in terms of compliance with preventive guidelines and compliance with disease management guidelines. It is uncertain whether reminders improve patient outcomes because the certainty of the evidence is very low. The heterogeneity of the reminder interventions included in this review also suggests that reminders can probably improve quality of care in various settings under various conditions.

Complementary medicine use among general internal medicine inpatients in a Swiss university hospital.

BACKGROUND: Complementary Medicine (CM) is frequently used by the general population, but data about prevalence among hospitalised patients are scarce. We evaluated the prevalence and determinants of CM use by inpatients, lifetime, 2 months before and during their hospitalisation in a general internal medicine ward. METHODS: Cross-sectional survey conducted in September 2014 among adult (≥18 years) patients hospitalised for at least 1 day in the general internal medicine ward of the Lausanne University Hospital, Switzerland. The association between the socio-demographic data and CM used were assessed using logistic regression model. RESULTS: Among the 289 eligible patients, 130 (45%, mean age 68.9±16.4 years, 59.2% male) were included. The lifetime prevalence of CM use was 74.6%. One-third (31.5%) and one-tenth of patients reported CM use 2 months prior or during hospitalisation, respectively. The four most reported CM used during lifetime were homeopathy (54.6%), herbal medicine (49.5%), therapeutic massage (47.4%), and osteopathy (44.3%). Herbal medicine, homeopathy, meditation and therapeutic massage were the four main CM used during hospitalisation. On bivariate analysis, lifetime use of CM was significantly associated with higher level of education (apprenticeship: OR 3.2, 95% CI [1.20-8.51], high school/university: OR 7.67, 95% CI [2.59-22.70]; P=.004) and healthcare coverage for CM (OR 3.53, 95% CI [1.32-9.46]; P=.014), but not with age and gender. During hospitalisation only 3.8% of patients were asked about CM use by physicians. CONCLUSION: One-third of hospitalised patients used CM 2 months before hospitalisation and one-tenth during hospital stay. CM use is seldom queried by hospital staff; better assessment of CM use among hospitalised patients could prevent potential adverse events or interactions.

Adverse events related to hospital care: a retrospective medical records review in a Swiss hospital.

OBJECTIVE: Retrospective records reviews carried out in several countries have shown substantial rates of adverse events (AE) among hospitalized patients, preventable in half the cases. As no such data have been recorded in Switzerland, we estimated the incidence of AE in one acute care hospital as a basis for a safety improvement program. DESIGN: A two steps retrospective records review (screening criteria and full review of positively screened records). SETTING: A medium size community hospital. PARTICIPANTS: A stratified sample of 400 surgical and 600 medical hospitalizations whose records fulfilled a set of information quality criteria. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Adverse events, preventable adverse events and extent of resulting harm. RESULTS: The proportion of hospitalizations with at least one AE was 12.3% (95% CI: 10.4-14.1) whereas the overall hospital incidence rate was 14.1% (95% CI: 12.0-16.2). Nearly half of AE were judged preventable, corresponding to one or more preventable AE in 6.4% of hospitalizations (95% CI: 5.0-7.8). Sixty percent of AE resulted in no or minor impairment at discharge whereas 23% resulted in severe disability. AE were twice more frequent in surgical patients, and preventable AE resulted more often in severe impairment than unpreventable AE. No death was attributed to an AE. The proportion of stays with an AE increased with age and length of stay. CONCLUSIONS: The incidence of preventable AE in patients hospitalized in one Swiss hospital is comparable to previously reported rates. Further, patient safety improvement is needed, especially among older patients, and for surgical procedures.

Chronic low back pain patients' use of, level of knowledge of and perceived benefits of complementary medicine: a cross-sectional study at an academic pain center.

BACKGROUND: Chronic pain patients often use complementary medicine (CM) to alleviate their pain; however, little is known about the use of CM by chronic low back pain (cLBP) patients. We investigated the frequency of use of CM by cLBP patients, the perceived effects of these therapies, patients' knowledge regarding CM, and patient-physician communication regarding CM. METHOD: A cross-sectional survey was conducted from November 2014 to February 2015. A questionnaire was distributed by physicians to 238 consecutive patients consulting for cLBP at the Pain Center of Lausanne University Hospital, Switzerland. Poisson regression model was used to analyze patients' level of knowledge regarding various CMs, and the logistic regression model was used to assess CM use for cLBP. RESULTS: The questionnaire was returned by 168 cLBP patients (response rate: 70.6%). Lifetime prevalence of CM use for cLBP was 77.3%. The most commonly used therapies were osteopathy (48.8%), massage (45.2%) and acupuncture (31.6%), rated for their usefulness on a 0-10 scale as a mean ± SD of 5.4 ± 2.7, 5.9 ± 2.5 and 3.8 ± 3.2, respectively. The CM treatment best known by patients was osteopathy, followed by massage and acupuncture. If their doctors proposed CM as a treatment for cLBP, 78% of participants reported being very or somewhat likely to try CM. Respondents with CM health insurance were more likely to use CM (OR = 2.26; 95%CI: 1.07-4.78; p = 0.031) for cLBP. Respondents having experienced cLBP for more than five years were more likely to use CM to treat their cLBP than respondents having experienced cLBP for one year or less (OR = 2.84; 95%CI: 1.02-7.88; p = 0.044). CONCLUSIONS: More than three-quarters of cLBP patients in our sample did use CM to treat their cLBP. The results showed that the most commonly used therapies were not necessarily the highest rated in terms of perceived usefulness. These results highlight the importance of developing integrative pain centers in which patients may obtain advice regarding CM treatments.

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

BACKGROUND: Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. METHODS AND FINDINGS: We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. CONCLUSIONS: Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.

Premature Discontinuation of Randomized Trials in Critical and Emergency Care: A Retrospective Cohort Study.

OBJECTIVES: Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials. DESIGN: Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003. SETTING: Randomized clinical trials involving patients in an acute or nonacute care setting. SUBJECTS AND INTERVENTIONS: We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators. MEASUREMENTS AND MAIN RESULTS: Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72-9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size. CONCLUSIONS: Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.

Patients and gastroenterologists' perceptions of treatments for inflammatory bowel diseases: do their perspectives match?

BACKGROUND: Perceptions of appropriateness of treatments may differ between gastroenterologists (GIs) and inflammatory bowel disease (IBD) patients. The aim of this study was to explore and compare GIs' and patients' perceptions of risks and benefits of treatments and prioritization of expected outcomes. METHODS: Four vignette cases were drawn from clinical situations and used in three independent focus groups with GIs (n = 7), ulcerative colitis (UC-p, n = 8) and Crohn's disease patients (CD-p, n = 6). Content analysis was performed based on the conversation transcripts. RESULTS: UC-p agreed more often with GIs' treatment choices than CD-p. CD-p often considered 5-ASA as a placebo. UC-p saw topical 5-ASA as a temporary solution, neither comfortable nor practical when professionally active. Azathioprine was considered as the treatment for which the risks versus benefits were perceived as the highest. The main risk perceived by patients on anti-TNFs was a potential loss of response. Divergences were observed on 1) stop of treatment: UC-p did not easily concur with stopping a treatment, which differed from GIs' expectation of patients' perceptions; CD-p were more prone to consider stopping treatment than GIs, 2) perception of outcomes: physicians had a focus on long-term objective goals. Patients' expectations were of shorter term and mainly concerned stress management, nutritional advice, and information on the treatments effects. CONCLUSIONS: Overall, patients and GIs agreed on perceptions of IBD treatments. GIs seemed more concerned about objective and scientific measures of remission whereas patients focused on quality of life and social outcomes when it came to evaluating a therapy.