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.

Complementary and alternative medicine use by pediatric oncology patients before, during, and after treatment.

BACKGROUND: The prevalence of complementary and alternative medicine (CAM) use and the modalities used by pediatric oncology patients vary widely across studies. In addition, the changes in the use of CAM over the course of treatment are understudied. Thus, this study aimed to explore (1) CAM use by pediatric oncology patients in relation to specific time intervals and (2) communication about CAM use between parents and oncologists. METHODS: This retrospective cross-sectional study was conducted among parents of children diagnosed with cancer at a Swiss pediatric hematology-oncology center by means of an online questionnaire. Questions were related to their child's CAM use over different time intervals, sources of information about CAM use, and communication with the oncologists. RESULTS: Among 140 respondents, CAM was used by 54.3% of patients before diagnosis and 69.3% of patients after diagnosis. During each defined time interval, between 50 and 58.8% of the patients used at least one CAM. Homeopathy was the most popular CAM modality used during oncology treatment, during the first year after treatment, and between 1 and 5 years after the end of treatment. Osteopathy was the most popular CAM ≥5 years after the end of oncology treatment. Forty percent of respondents did not discuss CAM with their oncologist. CONCLUSIONS: The high prevalence of CAM use and the different trends of use during the oncology care pathway and afterward underline the need to increase communication about CAM in the pediatric oncology setting, notably regarding benefits and risks of interaction with oncology treatment.

Osteopathy in the French-speaking part of Switzerland: Practitioners' profile and scope of back pain management.

BACKGROUND: Osteopathy is commonly used for spinal pain, but knowledge about back pain management by osteopaths is scarce. OBJECTIVE: The aim of this study was to survey osteopaths across the French-speaking part of Switzerland about the scope of their practice and their management of patients with back pain. DESIGN: This cross-sectional observational study was based on an online survey conducted from March to June 2017. Setting and participants: All registered osteopaths of the French-speaking part of Switzerland were asked to complete the survey. Outcome measures: In addition to descriptive statistics (practice characteristics, patients' profiles, scope of treatment modalities, health promotion, research, and osteopathic practice), we explored variables associated with osteopaths' practice, such as age and gender. RESULTS: A total of 241 osteopaths completed the questionnaire (response rate: 28.8%). Almost two thirds of osteopaths were female. Ages ranged from 25 to 72 years with an overall mean of 42.0 (SD 10.7) years. Male osteopaths reported more weekly working hours than female osteopaths did (38.2 [SD 11.0] vs 31.6 [SD 8.9], respectively, p<0.001). Almost a third (27.8%,) of osteopaths could arrange an appointment for acute conditions on the same day and 62.0% within a week. Acute or subacute spinal conditions, mainly low back and neck pain, were the most frequent conditions seen by our respondents. For 94.4% of osteopaths, one to three consultations were required for the management of such conditions. CONCLUSION: Osteopaths play a role in the management of spinal conditions, especially for acute problems. These findings, combined with short waiting times for consultations for acute conditions, as well as prompt management capabilities for acute low back and acute neck pain, support the view that the osteopathic profession constitutes an added value to primary care.

Complementary Medicine Use and Self-perceived Discrimination Among Asylum Seekers in Switzerland: A Cross-sectional Study.

Scarce data exist on the use of complementary and alternative medicine (CAM) by asylum seekers in Switzerland and their perception of discrimination. A cross-sectional study assessed the prevalence and type of CAM used by asylum seekers in one region of Switzerland and evaluated their self-perceived discrimination. Among the 61 asylum seekers who participated, lifetime prevalence of CAM use was 46%, with 28% reporting its use during the last year. Herbal medicine was the most frequently used CAM. Self-perceived discrimination was reported by 36% of asylum seekers, mainly related to their national origins. CAM users had a tendency to report more discrimination than non-users (44% vs. 30%). CAM use is prevalent among asylum seekers. Considering the importance of herbal medicine use and that only half of the respondents disclosed CAM use to their physician, clinicians should ask about it, notably because of potential risks of herb-drug interaction.

Characteristics of complementary medicine therapists in Switzerland: A cross-sectional study.

OBJECTIVE: More than 27,000 complementary medicine (CM) therapists are registered in Switzerland, but limited data are available on their occupational profile and role in the healthcare system. Herein we aimed to gain a better understanding of the professional profile of non-physician licensed therapists, focusing on acupuncture, osteopathy, and European naturopathy. DESIGN: This cross-sectional study was based on an online anonymous survey conducted from March to June 2017. SETTING AND PARTICIPANTS: All 1549 non-physician registered osteopaths, acupuncturists, and naturopaths in the French-speaking part of Switzerland were asked to complete the survey. MAIN OUTCOME MEASURES: We measured the therapists' demographics, training and practice characteristics, and workload. RESULTS: A total of 426 therapists returned the questionnaire (response rate: 27.5%). The mean age of the respondents was 46.0 years (SD 11.6) and most were women (67.8%). CM represented the main professional activity for a majority of therapists (82.8%), most of whom were independent (86.3%). The length and number of consultations per month varied across professions. Multivariate analysis showed that acupuncturists and naturopaths performed significantly fewer consults per month than osteopaths did. However, consultation length was significantly longer for acupuncturists and naturopaths than for osteopaths. Acupuncturists (71.6%) and naturopaths (64.4%) were significantly more favorable than osteopaths (27.7%) to have consultation costs covered by basic health insurance. Professional profiles differed between osteopaths, on the one hand, and naturopaths and acupuncturists, on the other, mainly regarding workload, treatment duration, and main reasons to consult. CONCLUSIONS: This first study to investigate a variety of therapist profiles in Switzerland provides useful information about their activities and role within the Swiss healthcare system. Although all three professions are encompassed under the same umbrella term (CM), our study showed that they have specific work cultures and areas of intervention in the healthcare system.

Primary care patients' use of conventional and complementary medicine for chronic low back pain.

PURPOSE: To investigate among primary care patients and their physicians in western Switzerland the prevalence of use, perceived usefulness, and communication about common treatments for chronic or recurrent low back pain (crLBP) including complementary medicine (CM). PATIENTS AND METHODS: A cross-sectional cluster observational study involving 499 crLBP patients visiting 45 primary care physicians (PCPs) was conducted from November 1, 2015, to May 31, 2016. Patients and primary care physicians completed questionnaires about lifetime use and usefulness of 30 crLBP therapies. We conducted multivariate analyses of factors associated with therapy use, including sociodemographic variables, pain duration, insurance coverage, and primary care physicians' characteristics. RESULTS: The five most frequent modalities used at least once by patients were physiotherapy (81.8%), osteopathic treatment (63.4%), exercise therapy (53.4%), opioids (52.5%), and therapeutic massage (50.8%). For their PCPs, the five most useful therapies were physiotherapy, osteopathic treatment, yoga, meditation, and manual therapy. In multivariate analysis, the use of physiotherapy was significantly associated with longer pain duration; osteopathic treatment was associated with age under 75 years, female gender, higher education, and CM insurance coverage. Exercise therapy was associated with non-smoking and longer pain duration. Smokers were more likely and patients of PCPs with CM training were less likely to have used opioids. During their lifetime, 86.6% of the participants had used at least one CM therapy to manage their crLBP, with a mean of 3.3 (SD=2.9) therapies used per participant; 46.1% of participants reported that their PCP did not enquire about CM use. Among CM users, 64.7% informed their PCP about it. CONCLUSION: Patients with crLBP use a variety of treatments, including self-prescribed and unreimbursed therapies, most frequently physiotherapy and osteopathy. The results suggest that PCPs should systematically discuss with their patients the treatments they tried to manage crLBP, including CM.

Complementary Medicine Provision in an Academic Hospital: Evaluation and Structuring Project.

Objectives: Complementary medicine (CM) has become increasingly available in hospital settings in several countries. Nonetheless, there are disparities in the provision and organization of CM between hospitals and even within a single hospital. This was the case at Lausanne University Hospital, where neither a registry of CM practices nor homogeneous guidelines for the provision of CM existed. The board of directors mandated the use of an internal consultant to assess practices, delineate the ward's needs, and draft proposals to structure the provision of CM services. Design: Lescarbeau et al.'s integrated model of consultation was used. Settings/Location: Academic medical center, Switzerland. Subjects: Heads of departments, medical and nurse directors, and CM practitioners. Interventions: Semi-structured interviews, online survey, and focus groups were used to focus on CM availability, needs, and practices; CM practitioner background, training, and position in the hospital; and the type of patients treated. Results: The assessment identified 15 types of CM in 51 wards, provided by CM practitioners who represented the profiles of 8 types of health care professionals. Three barriers to implementing CM were identified: heterogeneity in CM practitioners' training and project implementation, lack of CM information for patients and health care professionals, and variable access to CM among hospital wards and resulting lack in continuity of care. Three main needs regarding CM were delineated: to ensure CM quality, to provide structured interdepartmental CM clinical services, and to provide CM information to patients and health care professionals. Three action priorities were selected by the board of directors: to develop structured CM clinical services; to select CM provision based on the specific criteria of scientific evidence, therapies already available at hospital, and specific ward's needs; and to provide CM information to patients and health care professionals. Conclusions: This assessment permitted to structure CM provision according to internal consultation.

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.

Primary care physicians' attitude and reported prescribing behavior for chronic low back pain: An exploratory cross-sectional study.

OBJECTIVE: Recent guidelines for chronic or recurrent low back pain recommend non-pharmacologic treatments as first-line options. The objective of this study was thus to explore the perceived usefulness of several conventional and complementary medicine treatments for chronic or recurrent low back pain by primary care physicians and their reported prescribing behavior. DESIGN: An exploratory cross-sectional study. SETTING AND PARTICIPANTS: Primary care physicians of the French-speaking part of Switzerland. MAIN OUTCOME MEASURES: Primary care physicians' perceived usefulness of each conventional and complementary medicine treatment and their reported recommendation behavior were considered dependent variables in multivariate logistic regression models. All correlations were computed between binary variables, and phi coefficients were calculated to estimate correlation strengths. RESULTS: 533 primary care physicians answered the questionnaire (response rate: 25.6%). The top 3 conventional treatments most often considered useful by primary care physicians for chronic or recurrent low back pain were physiotherapy (94.8%), nonsteroidal anti-inflammatory drugs (87.9%), and manual therapy (82.5%), whereas the most prescribed conventional treatments were physiotherapy (99.2%), nonsteroidal anti-inflammatory drugs (97.4%), and acetaminophen (94.4%). Osteopathic treatment (78.4%), yoga (69.3%), and therapeutic massage (63.9%) were the complementary medicine treatments most often considered useful by primary care physicians in managing chronic or recurrent low back pain. Being a female physician, younger than 56 years, trained in complementary medicine, or using complementary medicine were all associated with higher perceived usefulness of complementary medicine treatments in general. The most recommended complementary medicine treatments by primary care physicians were osteopathic treatment (87.3%), acupuncture (69.3%), and therapeutic massage (58.7%). Being a female physician, younger than 56, and using complementary medicine were all associated with more complementary medicine recommendation in general. CONCLUSION: Our results highlight the importance of better understanding the prescribing patterns of primary care physicians for chronic or recurrent low back pain. Considering the frequency and burden of chronic or recurrent low back pain, programs focusing on the most (cost-) effective treatments should be implemented.

Effectiveness of drug interventions to prevent sudden cardiac death in patients with heart failure and reduced ejection fraction: an overview of systematic reviews.

OBJECTIVES: To summarise and synthesise the current evidence regarding the effectiveness of drug interventions to prevent sudden cardiac death (SCD) and all-cause mortality in patients with heart failure with reduced ejection fraction (HFrEF). DESIGN: Overview of systematic reviews. DATA SOURCES: MEDLINE, Embase, ISI Web of Science and Cochrane Library from inception to May 2017; manual search of references of included studies for potentially relevant reviews. ELIGIBILITY CRITERIA FOR STUDY SELECTION: We reviewed the effectiveness of drug interventions for SCD and all-cause mortality prevention in patients with HFrEF. We included overviews, systematic reviews and meta-analyses of randomised controlled trials of beta-blockers, angiotensin-converting enzyme inhibitors (ACE-i), angiotensin receptor blockers (ARBs), antialdosterones or mineralocorticoid-receptor antagonists, amiodarone, other antiarrhythmic drugs, combined ARB/neprilysin inhibitors, statins and fish oil supplementation. REVIEW METHODS: Two independent reviewers extracted data and assessed the methodological quality of the reviews and the quality of evidence for the primary studies for each drug intervention, using Assessing the Methodological Quality of Systematic Reviews (AMSTAR) and Grading of Recommendations, Assessment, Development and Evaluation(GRADE), respectively. RESULTS: We identified 41 reviews. Beta-blockers, antialdosterones and combined ARB/neprilysin inhibitors appeared effective to prevent SCD and all-cause mortality. ACE-i significantly reduced all-cause mortality but not SCD events. ARBs and statins were ineffective where antiarrhythmic drugs and omega-3 fatty acids had unclear evidence of effectiveness for prevention of SCD and all-cause mortality. CONCLUSIONS: This comprehensive overview of systematic reviews confirms that beta-blockers, antialdosterone agents and combined ARB/neprilysin inhibitors are effective on SCD prevention but not ACE-i or ARBs. In patients with high risk of SCD, an alternative therapeutic strategy should be explored in future research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2017: CRD42017067442.

Feasibility, acceptability and effectiveness of integrated care for COPD patients: a mixed methods evaluation of a pilot community-based programme.

QUESTION UNDER STUDY: The aim of this study was to assess the feasibility, acceptability and effectiveness of a pilot COPD integrated care programme implemented in Valais, Switzerland. METHODS: The programme was adapted from the self-management programme Living Well with COPD, and included the following elements: self-management patient-education group sessions, telephone and medical follow-ups, multidisciplinary teams, training of healthcare professionals, and evidence-based COPD care. A process and outcome evaluation of the pilot phase of the programme was conducted by means of qualitative and quantitative methods. Reach (coverage, participation rates), dosage (interventions carried out), fidelity (delivered as intended) and stakeholders' acceptance of the programme were evaluated through data monitoring and conduct of focus groups with patients and healthcare professionals. Effectiveness was assessed with pre-post analyses (before and after the intervention). The primary outcome measures were; (1) generic and disease-specific quality of life (36-Item Short Form Health Survey, Chronic Respiratory Questionnaire); and (2) hospitalisations (all-cause and for acute exacerbations) in the past 12 months. Secondary outcomes included self-efficacy, number of exacerbations and exercise capacity. Finally, controlled pre-post comparisons were also made with patients from the Swiss COPD Cohort for three common outcome measures (dyspnoea [mMRC score], number of exacerbations and smoking status). RESULTS: During the first 2 years of the programme, eight series of group-based education sessions were delivered to 57 patients with COPD in three different locations of the canton of Valais. Coverage objectives were achieved and attendance rate at the education sessions was high (83.6%). Patients' and healthcare professionals' reported a high degree of satisfaction, except for multidisciplinarity and transfer of information. Exploration of the effectiveness of this pilot programme suggested positive pre-post results at 12 months, with improvements in terms of health-related quality of life, self-efficacy, exercise capacity, immunisation coverage and Patient Assessment of Chronic Illness Care score. No other outcome, including the number of hospital admissions, differed significantly after 12 months. We observed no differences from the control group. CONCLUSIONS: The evaluation demonstrated the feasibility and acceptability of the programme and confirmed the relevance of mixed method process evaluation to adjust and improve programme implementation. The introduction of multidisciplinary teams in a context characterised by fragmentation of care was identified as the main challenge in the programme implementation and could not be achieved as expected. Despite this area for improvement, patients' feedback and early effectiveness results confirmed the benefits of COPD integrated care programmes emphasising self-management education.

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.

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.

Patient self-reported concerns in inflammatory bowel diseases: A gender-specific subjective quality-of-life indicator.

BACKGROUND: Patient-reported disease perceptions are important components to be considered within a holistic model of quality of care. Gender may have an influence on these perceptions. We aimed to explore gender-specific concerns of patients included in a national bilingual inflammatory bowel disease cohort. METHODS: Following a qualitative study, we built a questionnaire comprising 37 items of concern. Answers were collected on a visual analog scale ranging from 0 to 100. Principal axis factor analysis was used to explore concern domains. Linear multiple regressions were conducted to assess associations with patient characteristics. RESULTS: Of 1102 patients who replied to the survey, 54% were female and 54% had Crohn's disease. We identified six domains of concern: socialization and stigmatization, disease-related constraints and uncertainty, symptoms and their impact on body and mind, loss of body control (including sexuality), disease transmission, and long-term impact of the disease. Cancer concerns were among the highest scored by all patients (median 61.8). Severity of symptoms was the only factor associated with concerns, unrelated to dimension and gender (p<0.015). In women, being >40 years decreased disease-related constraints and uncertainty concerns, and being at home or unemployed increased them. Treatments were associated with increased socialization and stigmatization and with increased disease-related constraints and uncertainty concerns in men. Overall, psychosomatic characteristics were highly associated with concerns for both men and women. Depending on the concern dimensions, increased levels of concern were associated with the highest signs of anxiety in women or depression in men, as well as lower health-related quality of life in men. CONCLUSIONS: Patients have numerous concerns related to their illness that need to be reassessed regularly. Concerns differ between men and women, suggesting that information and communication about the disease should take gender differences and subjective perceptions of quality of life into consideration.

Adding non-randomised studies to a Cochrane review brings complementary information for healthcare stakeholders: an augmented systematic review and meta-analysis.

BACKGROUND: To reduce the burden of asthma, chronic disease management (CDM) programmes have been widely implemented and evaluated. Reviews including randomised controlled trials (RCTs) suggest that CDM programmes for asthma are effective. Other study designs are however often used for pragmatic reasons, but excluded from these reviews because of their design. We aimed to examine what complementary information could be retrieved from the addition of non-randomised studies to the studies included in a published Cochrane review on asthma CDM programmes, for healthcare stakeholders involved in the development, implementation, conduct or long-term sustainability of such programmes. METHODS: Extending a previously published Cochrane review, we performed a systematic review (augmented review) including any type of study designs instead of only those initially accepted by Cochrane and the Effective Practice and Organization of Care Review group. After double data selection and extraction, we compared study and intervention characteristics, assessed methodological quality and ran meta-analyses, by study design. RESULTS: We added 37 studies to the 20 studies included in the Cochrane review. The applicability of results was increased because of the larger variety of settings and asthma population considered. Also, adding non-randomised studies provided new evidence of improvements associated with CDM intervention (i.e. healthcare utilisation, days off work, use of action plan). Finally, evidence of CDM effectiveness in the added studies was consistent with the Cochrane review in terms of direction of effects. CONCLUSIONS: The evidence of this augmented review is applicable to a broader set of patients and settings than those in the original Cochrane review. It also strengthens the message that CDM programmes have a beneficial effect on quality of life and disease severity, meaningful outcomes for the everyday life of patients with asthma. Despite the moderate to low methodological quality of all studies included, calling for caution in results interpretation and improvements in CDM evaluation methods and reporting, the inclusion of a broader set of study designs in systematic reviews of complex interventions, such as chronic disease management, is likely to be of high value and interest to patients, policymakers and other healthcare stakeholders.

Biomedical risk assessment as an aid for smoking cessation.

BACKGROUND: A possible strategy for increasing smoking cessation rates could be to provide smokers who have contact with healthcare systems with feedback on the biomedical or potential future effects of smoking, e.g. measurement of exhaled carbon monoxide (CO), lung function, or genetic susceptibility to lung cancer. OBJECTIVES: To determine the efficacy of biomedical risk assessment provided in addition to various levels of counselling, as a contributing aid to smoking cessation. SEARCH METHODS: For the most recent update, we searched the Cochrane Collaboration Tobacco Addiction Group Specialized Register in July 2012 for studies added since the last update in 2009. SELECTION CRITERIA: Inclusion criteria were: a randomized controlled trial design; subjects participating in smoking cessation interventions; interventions based on a biomedical test to increase motivation to quit; control groups receiving all other components of intervention; an outcome of smoking cessation rate at least six months after the start of the intervention. DATA COLLECTION AND ANALYSIS: Two assessors independently conducted data extraction on each paper, with disagreements resolved by consensus. Results were expressed as a relative risk (RR) for smoking cessation with 95% confidence intervals (CI). Where appropriate, a pooled effect was estimated using a Mantel-Haenszel fixed-effect method. MAIN RESULTS: We included 15 trials using a variety of biomedical tests. Two pairs of trials had sufficiently similar recruitment, setting and interventions to calculate a pooled effect; there was no evidence that carbon monoxide (CO) measurement in primary care (RR 1.06, 95% CI 0.85 to 1.32) or spirometry in primary care (RR 1.18, 95% CI 0.77 to 1.81) increased cessation rates. We did not pool the other 11 trials due to the presence of substantial clinical heterogeneity. Of the remaining 11 trials, two trials detected statistically significant benefits: one trial in primary care detected a significant benefit of lung age feedback after spirometry (RR 2.12, 95% CI 1.24 to 3.62) and one trial that used ultrasonography of carotid and femoral arteries and photographs of plaques detected a benefit (RR 2.77, 95% CI 1.04 to 7.41) but enrolled a population of light smokers and was judged to be at unclear risk of bias in two domains. Nine further trials did not detect significant effects. One of these tested CO feedback alone and CO combined with genetic susceptibility as two different interventions; none of the three possible comparisons detected significant effects. One trial used CO measurement, one used ultrasonography of carotid arteries and two tested for genetic markers. The four remaining trials used a combination of CO and spirometry feedback in different settings. AUTHORS' CONCLUSIONS: There is little evidence about the effects of most types of biomedical tests for risk assessment on smoking cessation. Of the fifteen included studies, only two detected a significant effect of the intervention. Spirometry combined with an interpretation of the results in terms of 'lung age' had a significant effect in a single good quality trial but the evidence is not optimal. A trial of carotid plaque screening using ultrasound also detected a significant effect, but a second larger study of a similar feedback mechanism did not detect evidence of an effect. Only two pairs of studies were similar enough in terms of recruitment, setting, and intervention to allow meta-analyses; neither of these found evidence of an effect. Mixed quality evidence does not support the hypothesis that other types of biomedical risk assessment increase smoking cessation in comparison to standard treatment. There is insufficient evidence with which to evaluate the hypothesis that multiple types of assessment are more effective than single forms of assessment.

Oral vitamin B12 for patients suspected of subtle cobalamin deficiency: a multicentre pragmatic randomised controlled trial.

BACKGROUND: Evidence regarding the effectiveness of oral vitamin B12 in patients with serum vitamin B12 levels between 125-200 pM/l is lacking. We compared the effectiveness of one-month oral vitamin B12 supplementation in patients with a subtle vitamin B12 deficiency to that of a placebo. METHODS: This multicentre (13 general practices, two nursing homes, and one primary care center in western Switzerland), parallel, randomised, controlled, closed-label, observer-blind trial included 50 patients with serum vitamin B12 levels between 125-200 pM/l who were randomized to receive either oral vitamin B12 (1000 µg daily, N = 26) or placebo (N = 24) for four weeks. The institution's pharmacist used simple randomisation to generate a table and allocate treatments. The primary outcome was the change in serum methylmalonic acid (MMA) levels after one month of treatment. Secondary outcomes were changes in total homocysteine and serum vitamin B12 levels. Blood samples were centralised for analysis and adherence to treatment was verified by an electronic device (MEMS; Aardex Europe, Switzerland). TRIAL REGISTRATION: ISRCTN 22063938. RESULTS: Baseline characteristics and adherence to treatment were similar in both groups. After one month, one patient in the placebo group was lost to follow-up. Data were evaluated by intention-to-treat analysis. One month of vitamin B12 treatment (N = 26) lowered serum MMA levels by 0.13 µmol/l (95%CI 0.06-0.19) more than the change observed in the placebo group (N = 23). The number of patients needed to treat to detect a metabolic response in MMA after one month was 2.6 (95% CI 1.7-6.4). A significant change was observed for the B12 serum level, but not for the homocysteine level, hematocrit, or mean corpuscular volume. After three months without active treatment (at four months), significant differences in MMA levels were no longer detected. CONCLUSIONS: Oral vitamin B12 treatment normalised the metabolic markers of vitamin B12 deficiency. However, a one-month daily treatment with 1000 µg oral vitamin B12 was not sufficient to normalise the deficiency markers for four months, and treatment had no effect on haematological signs of B12 deficiency.

Biomedical risk assessment as an aid for smoking cessation.

BACKGROUND: A possible strategy for increasing smoking cessation rates could be to provide smokers who have contact with healthcare systems with feedback on the biomedical or potential future effects of smoking, e.g. measurement of exhaled carbon monoxide (CO), lung function, or genetic susceptibility to lung cancer. OBJECTIVES: To determine the efficacy of biomedical risk assessment provided in addition to various levels of counselling, as a contributing aid to smoking cessation. SEARCH STRATEGY: We systematically searched the Cochrane Collaboration Tobacco Addiction Group Specialized Register, Cochrane Central Register of Controlled Trials 2008 Issue 4, MEDLINE (1966 to January 2009), and EMBASE (1980 to January 2009). We combined methodological terms with terms related to smoking cessation counselling and biomedical measurements. SELECTION CRITERIA: Inclusion criteria were: a randomized controlled trial design; subjects participating in smoking cessation interventions; interventions based on a biomedical test to increase motivation to quit; control groups receiving all other components of intervention; an outcome of smoking cessation rate at least six months after the start of the intervention. DATA COLLECTION AND ANALYSIS: Two assessors independently conducted data extraction on each paper, with disagreements resolved by consensus. Results were expressed as a relative risk (RR) for smoking cessation with 95% confidence intervals (CI). Where appropriate a pooled effect was estimated using a Mantel-Haenszel fixed effect method. MAIN RESULTS: We included eleven trials using a variety of biomedical tests. Two pairs of trials had sufficiently similar recruitment, setting and interventions to calculate a pooled effect; there was no evidence that CO measurement in primary care (RR 1.06, 95% CI 0.85 to 1.32) or spirometry in primary care (RR 1.18, 95% CI 0.77 to 1.81) increased cessation rates. We did not pool the other seven trials. One trial in primary care detected a significant benefit of lung age feedback after spirometry (RR 2.12; 95% CI 1.24 to 3.62). One trial that used ultrasonography of carotid and femoral arteries and photographs of plaques detected a benefit (RR 2.77; 95% CI 1.04 to 7.41) but enrolled a population of light smokers. Five trials failed to detect evidence of a significant effect. One of these tested CO feedback alone and CO + genetic susceptibility as two different intervention; none of the three possible comparisons detected significant effects. Three others used a combination of CO and spirometry feedback in different settings, and one tested for a genetic marker. AUTHORS' CONCLUSIONS: There is little evidence about the effects of most types of biomedical tests for risk assessment. Spirometry combined with an interpretation of the results in terms of 'lung age' had a significant effect in a single good quality trial. Mixed quality evidence does not support the hypothesis that other types of biomedical risk assessment increase smoking cessation in comparison to standard treatment. Only two pairs of studies were similar enough in term of recruitment, setting, and intervention to allow meta-analysis.

Effectiveness of biomedical risk assessment as an aid for smoking cessation: a systematic review.

OBJECTIVE: To determine the efficacy of biomedical risk assessment (eg, exhaled carbon monoxide (CO), or genetic susceptibility to lung cancer) as an aid for smoking cessation. DATA SOURCES: Cochrane Tobacco Addiction Group Specialized Register, Cochrane Central Register of Controlled Trials, Medline (1966-2004) and EMBASE (1980-2004). STUDY SELECTION: Randomised controlled smoking cessation interventions using biomedical tests with at least 6 months follow-up. DATA EXTRACTION: Two reviewers independently screened all search results (titles and abstracts) for possible inclusion. Each reviewer then extracted data from the selected studies, and assessed their methodological quality based on the CONSORT (Consolidated Standards of Reporting Trials) statement criteria. DATA SYNTHESIS: Of 4049 retrieved references, eight trials were retained for data extraction and analysis. Three trials isolated the effect of exhaled CO on smoking cessation rates resulting in the following ORs and 95% CIs: 0.73 (0.38 to 1.39), 0.93 (0.62 to 1.41) and 1.18 (0.84 to 1.64). Measurement of exhaled CO and spirometry were used together in three trials, resulting in the following ORs (95% CI): 0.60 (0.25 to 1.46), 2.45 (0.73 to 8.25) and 3.50 (0.88 to 13.92). Spirometry results alone were used in one other trial with an OR (95% CI) of 1.21 (0.60 to 2.42). Ultrasonography of carotid and femoral arteries performed on light smokers gave an OR (95% CI) of 3.15 (1.06 to 9.31). CONCLUSIONS: Scarcity and limited quality of the current evidence does not support the hypothesis that biomedical risk assessment increases smoking cessation as compared with the standard treatment.

Use, appropriateness, and diagnostic yield of screening colonoscopy: an international observational study (EPAGE).

BACKGROUND: Screening for colorectal cancer (CRC) has been shown to decrease mortality. OBJECTIVE: To examine determinants associated with having (1) a screening colonoscopy, (2) an appropriate indication for screening, and (3) a significant diagnosis at screening. DESIGN: Prospective observational study. SETTING: Twenty-one endoscopy centers from 11 countries. PATIENTS: Asymptomatic patients who underwent a colonoscopy for the purpose of detecting CRC and who did not have a history of polyps or CRC, a lesion observed at a recent barium enema or sigmoidoscopy, or a recent positive fecal occult blood test. INTERVENTION: Screening colonoscopy. MAIN OUTCOME MEASUREMENTS: Appropriateness according to the European Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE) criteria and significant diagnoses (cancer, adenomatous polyps, new diagnoses of inflammatory bowel disease, angiodysplasia). RESULTS: Of 5069 colonoscopies, 561 (11%) were performed for screening purposes. Patients were more likely to have a screening colonoscopy if they were aged 45 to 54 years (odds ratio [OR] 2.53, 95% confidence interval [CI] 1.60-3.99). Screening colonoscopies were appropriate, uncertain, and inappropriate in 26%, 60%, and 14% of cases, respectively. Eighty-one significant diagnoses were made, including 4 cancers. Significant diagnoses were more often made for uncertain/appropriate indications (OR 3.20, 95% CI 1.12-9.17) than for inappropriate indications. LIMITATIONS: Although data completeness was asked of all centers, it is possible that not all consecutive patients were included. Participating centers were a convenience sample and thus may not be representative. CONCLUSIONS: About 1 of 10 colonoscopies were performed for screening, preferentially in middle-aged individuals. A higher diagnostic yield in uncertain/appropriate indications suggests that the use of appropriateness criteria may enhance the efficient use of colonoscopy for screening.