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Peer-reviewed works with DOI and abstract, discovered from MEDLINE-indexed literature. Candidates: no tier, no stated finding, not yet read.
The Economic Impact of Smoking and of Reducing Smoking Prevalence: Review of Evidence.
Background: Tobacco smoking is the cause of many preventable diseases and premature deaths in the UK and around the world. It poses enormous health- and non-health-related costs to the affected individuals, employers, and the society at large. The World Health Organization (WHO) estimates that, globally, smoking causes over US$500 billion in economic damage each year.
Objectives: This paper examines global and UK evidence on the economic impact of smoking prevalence and evaluates the effectiveness and cost effectiveness of smoking cessation measures.
Study selection: SEARCH METHODS We used two major health care/economic research databases, namely PubMed and the National Institute for Health Research (NIHR) database that contains the British National Health Service (NHS) Economic Evaluation Database; Cochrane Library of systematic reviews in health care and health policy; and other health-care-related bibliographic sources. We also performed hand searching of relevant articles, health reports, and white papers issued by government bodies, international health organizations, and health intervention campaign agencies. SELECTION CRITERIA The paper includes cost-effectiveness studies from medical journals, health reports, and white papers published between 1992 and July 2014, but included only eight relevant studies before 1992. Most of the papers reviewed reported outcomes on smoking prevalence, as well as the direct and indirect costs of smoking and the costs and benefits of smoking cessation interventions. We excluded papers that merely described the effectiveness of an intervention without including economic or cost considerations. We also excluded papers that combine smoking cessation with the reduction in the risk of other diseases. DATA COLLECTION AND ANALYSIS The included studies were assessed against criteria indicated in the Cochrane Reviewers Handbook version 5.0.0. OUTCOMES ASSESSED IN THE REVIEWPrimary outcomes of the selected studies are smoking prevalence, direct and indirect costs of smoking, and the costs and benefits of smoking cessation interventions (eg, "cost per quitter", "cost per life year saved", "cost per quality-adjusted life year gained," "present value" or "net benefits" from smoking cessation, and "cost savings" from personal health care expenditure).
Main results: The main findings of this study are as follows: The costs of smoking can be classified into direct, indirect, and intangible costs. About 15% of the aggregate health care expenditure in high-income countries can be attributed to smoking. In the US, the proportion of health care expenditure attributable to smoking ranges between 6% and 18% across different states. In the UK, the direct costs of smoking to the NHS have been estimated at between £2.7 billion and £5.2 billion, which is equivalent to around 5% of the total NHS budget each year. The economic burden of smoking estimated in terms of GDP reveals that smoking accounts for approximately 0.7% of China's GDP and approximately 1% of US GDP. As part of the indirect (non-health-related) costs of smoking, the total productivity losses caused by smoking each year in the US have been estimated at US$151 billion. The costs of smoking notwithstanding, it produces some potential economic benefits. The economic activities generated from the production and consumption of tobacco provides economic stimulus. It also produces huge tax revenues for most governments, especially in high-income countries, as well as employment in the tobacco industry. Income from the tobacco industry accounts for up to 7.4% of centrally collected government revenue in China. Smoking also yields cost savings in pension payments from the premature death of smokers. Smoking cessation measures could range from pharmacological treatment interventions to policy-based measures, community-based interventions, telecoms, media, and technology (TMT)-based interventions, school-based interventions, and workplace interventions. The cost per life year saved from the use of pharmacological treatment interventions ranged between US$128 and US$1,450 and up to US$4,400 per quality-adjusted life years (QALYs) saved. The use of pharmacotherapies such as varenicline, NRT, and Bupropion, when combined with GP counseling or other behavioral treatment interventions (such as proactive telephone counseling and Web-based delivery), is both clinically effective and cost effective to primary health care providers. Price-based policy measures such as increase in tobacco taxes are unarguably the most effective means of reducing the consumption of tobacco. A 10% tax-induced cigarette price increase anywhere in the world reduces smoking prevalence by between 4% and 8%. Net public benefits from tobacco tax, however, remain positive only when tax rates are between 42.9% and 91.1%. The cost effectiveness ratio of implementing non-price-based smoking cessation legislations (such as smoking restrictions in work places, public places, bans on tobacco advertisement, and raising the legal age of smokers) range from US$2 to US$112 per life year gained (LYG) while reducing smoking prevalence by up to 30%-82% in the long term (over a 50-year period).Smoking cessation classes are known to be most effective among community-based measures, as they could lead to a quit rate of up to 35%, but they usually incur higher costs than other measures such as self-help quit-smoking kits. On average, community pharmacist-based smoking cessation programs yield cost savings to the health system of between US$500 and US$614 per LYG.Advertising media, telecommunications, and other technology-based interventions (such as TV, radio, print, telephone, the Internet, PC, and other electronic media) usually have positive synergistic effects in reducing smoking prevalence especially when combined to deliver smoking cessation messages and counseling support. However, the outcomes on the cost effectiveness of TMT-based measures have been inconsistent, and this made it difficult to attribute results to specific media. The differences in reported cost effectiveness may be partly attributed to varying methodological approaches including varying parametric inputs, differences in national contexts, differences in advertising campaigns tested on different media, and disparate levels of resourcing between campaigns. Due to its universal reach and low implementation costs, online campaign appears to be substantially more cost effective than other media, though it may not be as effective in reducing smoking prevalence. School-based smoking prevalence programs tend to reduce short-term smoking prevalence by between 30% and 70%. Total intervention costs could range from US$16,400 to US$580,000 depending on the scale and scope of intervention. The cost effectiveness of school-based programs show that one could expect a saving of approximately between US$2,000 and US$20,000 per QALY saved due to averted smoking after 2-4 years of follow-up. Workplace-based interventions could represent a sound economic investment to both employers and the society at large, achieving a benefit-cost ratio of up to 8.75 and generating 12-month employer cost savings of between $150 and $540 per nonsmoking employee. Implementing smoke-free workplaces would also produce myriads of new quitters and reduce the amount of cigarette consumption, leading to cost savings in direct medical costs to primary health care providers. Workplace interventions are, however, likely to yield far greater economic benefits over the long term, as reduced prevalence will lead to a healthier and more productive workforce.
Conclusions: We conclude that the direct costs and externalities to society of smoking far outweigh any benefits that might be accruable at least when considered from the perspective of socially desirable outcomes (ie, in terms of a healthy population and a productive workforce). There are enormous differences in the application and economic measurement of smoking cessation measures across various types of interventions, methodologies, countries, economic settings, and health care systems, and these may have affected the comparability of the results of the studies reviewed. However, on the balance of probabilities, most of the cessation measures reviewed have not only proved effective but also cost effective in delivering the much desired cost savings and net gains to individuals and primary health care providers.
Tobacco use insights · review · 189 citationsread the source →
Psychological therapies for post-traumatic stress disorder and comorbid substance use disorder.
Background: Post-traumatic stress disorder (PTSD) is a debilitating mental health disorder that may develop after exposure to traumatic events. Substance use disorder (SUD) is a behavioural disorder in which the use of one or more substances is associated with heightened levels of distress, clinically significant impairment of functioning, or both. PTSD and SUD frequently occur together. The comorbidity is widely recognised as being difficult to treat and is associated with poorer treatment completion and poorer outcomes than for either condition alone. Several psychological therapies have been developed to treat the comorbidity, however there is no consensus about which therapies are most effective.
Objectives: To determine the efficacy of psychological therapies aimed at treating traumatic stress symptoms, substance misuse symptoms, or both in people with comorbid PTSD and SUD in comparison with control conditions (usual care, waiting-list conditions, and no treatment) and other psychological therapies.
Search methods: We searched the Cochrane Depression, Anxiety and Neurosis Group's Specialised Register (CCDANCTR) all years to 11 March 2015. This register contains relevant randomised controlled trials from the Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). We also searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov, contacted experts, searched bibliographies of included studies, and performed citation searches of identified articles.
Selection criteria: Randomised controlled trials of individual or group psychological therapies delivered to individuals with PTSD and comorbid substance use, compared with waiting-list conditions, usual care, or minimal intervention or to other psychological therapies.
Data collection and analysis: We used standard methodological procedures expected by Cochrane.
Main results: We included 14 studies with 1506 participants, of which 13 studies were included in the quantitative synthesis. Most studies involved adult populations. Studies were conducted in a variety of settings. We performed four comparisons investigating the effects of psychological therapies with a trauma-focused component and non-trauma-focused interventions against treatment as usual/minimal intervention and other active psychological therapies. Comparisons were stratified for individual- or group-based therapies. All active interventions were based on cognitive behavioural therapy. Our main findings were as follows. Individual-based psychological therapies with a trauma-focused component plus adjunctive SUD intervention was more effective than treatment as usual (TAU)/minimal intervention for PTSD severity post-treatment (standardised mean difference (SMD) -0.41; 95% confidence interval (CI) -0.72 to -0.10; 4 studies; n = 405; very low-quality evidence) and at 3 to 4 and 5 to 7 months' follow-up. There was no evidence of an effect for level of drug/alcohol use post-treatment (SMD -0.13; 95% CI -0.41 to 0.15; 3 studies; n = 388; very low-quality evidence), but there was a small effect in favour of individual psychological therapy at 5 to 7 months (SMD -0.28; 95% CI -0.48 to -0.07; 3 studies; n = 388) when compared against TAU. Fewer participants completed trauma-focused therapy than TAU (risk ratio (RR) 0.78; 95% CI 0.64 to 0.96; 3 studies; n = 316; low-quality evidence).Individual-based psychological therapy with a trauma-focused component did not perform better than psychological therapy for SUD only for PTSD severity (mean difference (MD) -3.91; 95% CI -19.16 to 11.34; 1 study; n = 46; low-quality evidence) or drug/alcohol use (MD -1.27; 95% CI -5.76 to 3.22; 1 study; n = 46; low-quality evidence). Findings were based on one small study. No effects were observed for rates of therapy completion (RR 1.00; 95% CI 0.74 to 1.36; 1 study; n = 62; low-quality evidence).Non-trauma-focused psychological therapies did not perform better than TAU/minimal intervention for PTSD severity when delivered on an individual (SMD -0.22; 95% CI -0.83 to 0.39; 1 study; n = 44; low-quality evidence) or group basis (SMD -0.02; 95% CI -0.19 to 0.16; 4 studies; n = 513; low-quality evidence). There were no data on the effects on drug/alcohol use for individual therapy. There was no evidence of an effect on the level of drug/alcohol use for group-based therapy (SMD -0.03; 95% CI -0.37 to 0.31; 4 studies; n = 414; very low-quality evidence). A post-hoc analysis for full dose of a widely established group therapy called Seeking Safety showed reduced drug/alcohol use post-treatment (SMD -0.67; 95% CI -1.14 to -0.19; 2 studies; n = 111), but not at subsequent follow-ups. Data on the number of participants completing therapy were not for individual-based therapy. No effects were observed for rates of therapy completion for group-based therapy (RR 1.13; 95% CI 0.88 to 1.45; 2 studies; n = 217; low-quality evidence).Non-trauma-focused psychological therapy did not perform better than psychological therapy for SUD only for PTSD severity (SMD -0.26; 95% CI -1.29 to 0.77; 2 studies; n = 128; very low-quality evidence) or drug/alcohol use (SMD 0.22; 95% CI -0.13 to 0.57; 2 studies; n = 128; low-quality evidence). No effects were observed for rates of therapy completion (RR 0.91; 95% CI 0.68 to 1.20; 2 studies; n = 128; very low-quality evidence).Several studies reported on adverse events. There were no differences between rates of such events in any comparison. We rated several studies as being at 'high' or 'unclear' risk of bias in multiple domains, including for detection bias and attrition bias.
Authors' conclusions: We assessed the evidence in this review as mostly low to very low quality. Evidence showed that individual trauma-focused psychological therapy delivered alongside SUD therapy did better than TAU/minimal intervention in reducing PTSD severity post-treatment and at long-term follow-up, but only reduced SUD at long-term follow-up. All effects were small, and follow-up periods were generally quite short. There was evidence that fewer participants receiving trauma-focused therapy completed treatment. There was very little evidence to support use of non-trauma-focused individual- or group-based integrated therapies. Individuals with more severe and complex presentations (e.g. serious mental illness, individuals with cognitive impairment, and suicidal individuals) were excluded from most studies in this review, and so the findings from this review are not generalisable to such individuals. Some studies suffered from significant methodological problems and some were underpowered, limiting the conclusions that can be drawn. Further research is needed in this area.
The Cochrane database of systematic reviews · meta-analysis · 67 citationsread the source →
Behavioural and cognitive-behavioural interventions for outwardly directed aggressive behaviour in people with intellectual disabilities.
Background: Outwardly directed aggressive behaviour in people with intellectual disabilities is a significant issue that may lead to poor quality of life, social exclusion and inpatient psychiatric admissions. Cognitive and behavioural approaches have been developed to manage aggressive behaviour but the effectiveness of these interventions on reducing aggressive behaviour and other outcomes are unclear. This is the third update of this review and adds nine new studies, resulting in a total of 15 studies in this review.
Objectives: To evaluate the efficacy of behavioural and cognitive-behavioural interventions on outwardly directed aggressive behaviour compared to usual care, wait-list controls or no treatment in people with intellectual disability. We also evaluated enhanced interventions compared to non-enhanced interventions.
Search methods: We used standard, extensive Cochrane search methods. The latest search date was March 2022. We revised the search terms to include positive behaviour support (PBS).
Selection criteria: We included randomised and quasi-randomised trials of children and adults with intellectual disability of any duration, setting and any eligible comparator.
Data collection and analysis: We used standard Cochrane methods. Our primary outcomes were change in 1. aggressive behaviour, 2. ability to control anger, and 3. adaptive functioning, and 4.
Adverse effects: Our secondary outcomes were change in 5. mental state, 6. medication, 7. care needs and 8. quality of life, and 9. frequency of service utilisation and 10. user satisfaction data. We used GRADE to assess certainty of evidence for each outcome. We expressed treatment effects as mean differences (MD) or odds ratios (OR), with 95% confidence intervals (CI). Where possible, we pooled data using a fixed-effect model.
Main results: This updated version comprises nine new studies giving 15 included studies and 921 participants. The update also adds new interventions including parent training (two studies), mindfulness-based positive behaviour support (MBPBS) (two studies), reciprocal imitation training (RIT; one study) and dialectical behavioural therapy (DBT; one study). It also adds two new studies on PBS. Most studies were based in the community (14 studies), and one was in an inpatient forensic service. Eleven studies involved adults only. The remaining studies involved children (one study), children and adolescents (one study), adolescents (one study), and adolescents and adults (one study). One study included boys with fragile X syndrome. Six studies were conducted in the UK, seven in the USA, one in Canada and one in Germany. Only five studies described sources of funding. Four studies compared anger management based on cognitive behaviour therapy to a wait-list or no treatment control group (n = 263); two studies compared PBS with treatment as usual (TAU) (n = 308); two studies compared carer training on mindfulness and PBS with PBS only (n = 128); two studies involving parent training on behavioural approaches compared to wait-list control or TAU (n = 99); one study of mindfulness to a wait-list control (n = 34); one study of adapted dialectal behavioural therapy compared to wait-list control (n = 21); one study of RIT compared to an active control (n = 20) and one study of modified relaxation compared to an active control group (n = 12). There was moderate-certainty evidence that anger management may improve severity of aggressive behaviour post-treatment (MD -3.50, 95% CI -6.21 to -0.79; P = 0.01; 1 study, 158 participants); very low-certainty evidence that it might improve self-reported ability to control anger (MD -8.38, 95% CI -14.05 to -2.71; P = 0.004, I2 = 2%; 3 studies, 212 participants), adaptive functioning (MD -21.73, 95% CI -36.44 to -7.02; P = 0.004; 1 study, 28 participants) and psychiatric symptoms (MD -0.48, 95% CI -0.79 to -0.17; P = 0.002; 1 study, 28 participants) post-treatment; and very low-certainty evidence that it does not improve quality of life post-treatment (MD -5.60, 95% CI -18.11 to 6.91; P = 0.38; 1 study, 129 participants) or reduce service utilisation and costs at 10 months (MD 102.99 British pounds, 95% CI -117.16 to 323.14; P = 0.36; 1 study, 133 participants). There was moderate-certainty evidence that PBS may reduce aggressive behaviour post-treatment (MD -7.78, 95% CI -15.23 to -0.32; P = 0.04, I2 = 0%; 2 studies, 275 participants) and low-certainty evidence that it probably does not reduce aggressive behaviour at 12 months (MD -5.20, 95% CI -13.27 to 2.87; P = 0.21; 1 study, 225 participants). There was low-certainty evidence that PBS does not improve mental state post-treatment (OR 1.44, 95% CI 0.83 to 2.49; P = 1.21; 1 study, 214 participants) and very low-certainty evidence that it might not reduce service utilisation at 12 months (MD -448.00 British pounds, 95% CI -1660.83 to 764.83; P = 0.47; 1 study, 225 participants). There was very low-certainty evidence that mindfulness may reduce incidents of physical aggression (MD -2.80, 95% CI -4.37 to -1.23; P < 0.001; 1 study; 34 participants) and low-certainty evidence that MBPBS may reduce incidents of aggression post-treatment (MD -10.27, 95% CI -14.86 to -5.67; P < 0.001, I2 = 87%; 2 studies, 128 participants). Reasons for downgrading the certainty of evidence were risk of bias (particularly selection and performance bias); imprecision (results from single, often small studies, wide CIs, and CIs crossing the null effect); and inconsistency (statistical heterogeneity).
Authors' conclusions: There is moderate-certainty evidence that cognitive-behavioural approaches such as anger management and PBS may reduce outwardly directed aggressive behaviour in the short term but there is less certainty about the evidence in the medium and long term, particularly in relation to other outcomes such as quality of life. There is some evidence to suggest that combining more than one intervention may have cumulative benefits. Most studies were small and there is a need for larger, robust randomised controlled trials, particularly for interventions where the certainty of evidence is very low. More trials are needed that focus on children and whether psychological interventions lead to reductions in the use of psychotropic medications.
The Cochrane database of systematic reviews · systematic review · 6 citationsread the source →
The Amagugu intervention for disclosure of maternal HIV to uninfected primary school-aged children in South Africa: a randomised controlled trial.
Background: Increasing populations of children who are HIV-exposed but uninfected will face the challenge of disclosure of parental HIV infection status. We aimed to test the efficacy of an intervention to increase maternal HIV-disclosure to primary school-aged HIV-uninfected children.
Methods: This randomised controlled trial was done at the Africa Health Research Institute in KwaZulu-Natal, South Africa. Women who had tested HIV positive at least 6 months prior, had initiated HIV treatment or been enrolled in pretreatment HIV care, and had an HIV-uninfected child (aged 6-10 years) were randomly allocated to either the Amagugu intervention or enhanced standard of care, using a computerised algorithm based on simple randomisation and equal probabilities of being assigned to each group. Lay counsellors delivered the Amagugu intervention, which included six home-based counselling sessions of 1-2 h and materials and activities to support HIV disclosure and parent-led health promotion. The enhanced standard of care included one clinic-based counselling session. Outcome measures at 3 months, 6 months, and 9 months post baseline were done by follow-up assessors who were masked to participants' group and counsellor allocation. The primary outcome was maternal HIV disclosure (full [using the word HIV], partial [using the word virus], or none) at 9 months post baseline. We did the analysis in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT01922882).
Findings: Between July 1, 2013, and Dec 31, 2014, we randomly assigned 464 participants to the Amagugu intervention (n=235) or enhanced standard of care (n=229). 428 (92%) participants completed the 9 month assessment by Sept 3, 2015. Disclosure at any level was more common in the Amagugu intervention group (n=204 [87%]) than in the enhanced standard-of-care group (n=128 [56%]; adjusted odds ratio 9·88, 95% CI 5·55-17·57; p<0·0001). Full disclosure was also more common in the Amagugu intervention group (n=150 [64%]) than in the enhanced standard-of-care group (n=98 [43%]; 4·13, 2·80-6·11; p<0·0001). Treatment-unrelated adverse effects were reported for 17 participants in the Amagugu intervention group versus six in the enhanced standard-of-care group; adverse effects included domestic violence (five [2%] in the Amagugu intervention group vs one [<1%] in the enhanced standard-of-care group), sexual assault (four [2%] vs one [<1%]), participant illness or death (four [2%] vs four [2%]), and family member illness or death (four [2%] vs none). No treatment-related deaths occurred.
Interpretation: The lay-counsellor-driven Amagugu intervention to aid parental disclosure has potential for wide-scale implementation after further effectiveness research and could be adapted to other target populations and other diseases. Further follow-up and effectiveness research is required.
Funding: National Institutes of Health.
The lancet. HIV · randomised controlled trial · 19 citationsread the source →
Log in and breathe out: internet-based recovery training for sleepless employees with work-related strain - results of a randomized controlled trial.
Objectives: The primary purpose of this randomized controlled trial (RCT) was to evaluate the efficacy of a guided internet-based recovery training for employees who suffer from both work-related strain and sleep problems (GET.ON Recovery). The recovery training consisted of six lessons, employing well-established methods from cognitive behavioral therapy for insomnia (CBT-I) such as sleep restriction, stimulus control, and hygiene interventions as well as techniques targeted at reducing rumination and promoting recreational activities.
Methods: In a two-arm RCT (N=128), the effects of GET.ON Recovery were compared to a waitlist-control condition (WLC) on the basis of intention-to-treat analyses. German teachers with clinical insomnia complaints (Insomnia Severity Index ≥15) and work-related rumination (Irritation Scale, cognitive irritation subscale ≥15) were included. The primary outcome measure was insomnia severity.
Results: Analyses of covariance (ANCOVA) revealed that, compared to the WLC, insomnia severity of the intervention group decreased significantly stronger (F=74.11, P<0.001) with a d=1.45 [95% confidence interval (95% CI) 1.06-1.84] The number needed to treat (NNT) was <2 for reliable change and NNT <4 for reduction in expert-rated diagnosis of primary insomnia.
Conclusion: The training significantly reduces sleep problems and fosters mental detachment from work and recreational behavior among adult stressed employees at post-test and 6-months follow up. Given the low threshold access this training could reach out to a large group of stressed employees when results are replicated in other studies.
Scandinavian journal of work, environment & health · randomised controlled trial · 87 citationsread the source →
Sleep quality, depression state, and health status of older adults after silver yoga exercises: cluster randomized trial.
Background: Sleep disturbances, depression, and low perception of health status are commonly seen in elderly population; however, clinicians tend to underestimate or overlook the presence of these symptoms and assume them to be a part of normal aging. Non-pharmacological methods that promote a mind-body interaction should be tested to enhance the mental health of older adults.
Objective: To test the effects of 6 months of silver yoga exercises in promoting the mental health of older adults in senior activity centers, especially their sleep quality, depression, and self-perception of health status.
Design: Cluster randomized trial.
Settings: Eight senior activity centers, southern Taiwan.
Participants: A sample of 139 participants was recruited, and 128 of them completed the study.
Inclusion criteria: (1) community-dwelling older adults ages 60 and over, (2) no previous training in yoga, (3) able to walk without assistance, (4) cognitively alert based on the Short Portable Mental Status Questionnaire (SPMSQ) score of eight or higher, and (5) independent or mildly dependent in self-care based on a Barthel Index (BI) score of 91 or higher. The mean age of the participants was 69.20 +/- 6.23 years, and the average number of chronic illness was 0.83 +/- 0.90. The average BI score of the participants was 99.92 +/- 0.62, and the mean SPMSQ score was 9.90 +/- 0.30.
Methods: Participants were randomly assigned into either the experimental (n=62) or the control (n=66) group based on attendance at selected senior activity centers. A 70-min silver yoga exercise program was implemented three times per week for 6 months as the intervention for the participants in the experimental group.
Results: Most of the mental health indicators of the participants in the experimental group had significantly improved after the silver yoga interventions, and many of the indicators improved after 3 months of intervention and were maintained throughout the 6 months study. The mental health indicators of the participants in the experimental group were all better than the participants in the control group (all p<.05).
Conclusions: After 6 months of silver yoga exercises, the sleep quality, depression, and health status of older adults were all improved.
International journal of nursing studies · randomised controlled trial · 116 citationsread the source →
Attainment of treatment goals by people with Alzheimer's disease receiving galantamine: a randomized controlled trial.
Background: Although cholinesterase inhibitors have produced statistically significant treatment effects, their clinical meaningfulness in Alzheimer's disease is disputed. An important aspect of clinical meaningfulness is the extent to which an intervention meets the goals of treatment.
Methods: In this randomized controlled trial, patients with mild to moderate Alzheimer's disease were treated with either galantamine or placebo for 4 months, followed by a 4-month open-label extension during which all patients received galantamine. The primary outcome measures were Goal Attainment Scaling (GAS) scores from assessments by clinicians and by patients or caregivers of treatment goals set before treatment and evaluated every 2 months. Secondary outcome measures included the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), the Clinician's Interview-based Impression of Change plus Caregiver Input (CIBIC-plus), the Disability Assessment for Dementia (DAD) and the Caregiving Burden Scale (CBS). To evaluate treatment effect, we calculated effect sizes (as standardized response means [SRMs]) and p values.
Results: Of 159 patients screened, 130 (mean age 77 [standard deviation (SD) 7.7]; 63% women) were enrolled in the study (64 in the galantamine group and 66 in the placebo group); 128 were included in the analysis because they had at least one post-baseline evaluation. In the intention-to-treat analysis, the clinician-rated GAS scores showed a significantly greater improvement in goal attainment among patients in the galantamine group than among those in the placebo group (change from baseline score 4.8 [SD 9.6]) v. 0.9 [SD 9.5] respectively; SRM = 0.41, p = 0.02). The patient- caregiver-rated GAS scores showed a similar improvement in the galantamine group (change from baseline score 4.2 [SD 10.6]); however, because of the improvement also seen in the placebo group (2.3 [SD 9.0]), the difference between groups was not statistically significant (SRM = 0.20, p = 0.27). Of the secondary outcome measures, the ADAS-cog scores differed significantly between groups (SRM = -0.36, p = 0.04), as did the CIBIC-plus scores (SRM = -0.40, p = 0.03); no significant differences were in either the DAD scores (SRM = 0.28, p = 0.13) or the CBS scores (SRM = -0.17, p = 0.38).
Interpretation: Clinicians, but not patients and caregivers, observed a significantly greater improvement in goal attainment among patients with mild to moderate Alzheimer's disease who were taking galantamine than among those who were taking placebo.
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · randomised controlled trial · 112 citationsread the source →
Enhancing oral health via sense of coherence: a cluster-randomized trial.
Sense of coherence (SOC) has been related to oral health behaviors and oral-health-related quality of life (OHRQoL) in observational studies. This cluster-randomized trial aimed to test the effect of an intervention to enhance SOC on OHRQoL in children. Twelve primary schools were randomly allocated to intervention and control groups. The intervention was comprised of 7 sessions over 2 mos, focusing on child participation and empowerment. The first 4 sessions were classroom activities, and the last 3 involved working on healthy school projects. Trained teachers who received a one-day course delivered the intervention. Socio-demographic and clinical data, together with self-reported measures of OHRQoL, SOC, and oral health beliefs, were obtained from 261 total 10- to 12-year-olds (133 in the intervention and 128 in the control groups). Data were collected at baseline, 2 wks after the intervention, and at three-month follow-up. Mixed-effects models indicated that the intervention increased SOC and improved OHRQoL, together with oral health beliefs and gingival health. The findings offer experimental evidence that OHRQoL can be influenced by SOC. SOC may also provide an avenue for oral health promotion (Australian New Zealand Clinical Trials Registry ACTRN12612000547842).
Journal of dental research · randomised controlled trial · 52 citationsread the source →
Molenaar CJL, Minnella EM, Coca-Martinez M, Ten Cate DWG, Regis M, Awasthi R, Martínez-Palli G, López-Baamonde M, Sebio-Garcia R, Feo CV, van Rooijen SJ, Schreinemakers JMJ, Bojesen RD, Gögenur I, van den Heuvel ER, Carli F, Slooter GD, PREHAB Study Group. (2023)MEDLINE-indexed journal, not yet read by usJAMA surgery Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial.
Importance: Colorectal surgery is associated with substantial morbidity rates and a lowered functional capacity. Optimization of the patient's condition in the weeks prior to surgery may attenuate these unfavorable sequelae.
Objective: To determine whether multimodal prehabilitation before colorectal cancer surgery can reduce postoperative complications and enhance functional recovery.
Design, setting, and participants: The PREHAB randomized clinical trial was an international, multicenter trial conducted in teaching hospitals with implemented enhanced recovery after surgery programs. Adult patients with nonmetastasized colorectal cancer were assessed for eligibility and randomized to either prehabilitation or standard care. Both arms received standard perioperative care. Patients were enrolled from June 2017 to December 2020, and follow-up was completed in December 2021. However, this trial was prematurely stopped due to the COVID-19 pandemic.
Interventions: The 4-week in-hospital supervised multimodal prehabilitation program consisted of a high-intensity exercise program 3 times per week, a nutritional intervention, psychological support, and a smoking cessation program when needed.
Main outcomes and measures: Comprehensive Complication Index (CCI) score, number of patients with CCI score more than 20, and improved walking capacity expressed as the 6-minute walking distance 4 weeks postoperatively.
Results: In the intention-to-treat population of 251 participants (median [IQR] age, 69 [60-76] years; 138 [55%] male), 206 (82%) had tumors located in the colon and 234 (93%) underwent laparoscopic- or robotic-assisted surgery. The number of severe complications (CCI score >20) was significantly lower favoring prehabilitation compared with standard care (21 of 123 [17.1%] vs 38 of 128 [29.7%]; odds ratio, 0.47 [95% CI, 0.26-0.87]; P = .02). Participants in prehabilitation encountered fewer medical complications (eg, respiratory) compared with participants receiving standard care (19 of 123 [15.4%] vs 35 of 128 [27.3%]; odds ratio, 0.48 [95% CI, 0.26-0.89]; P = .02). Four weeks after surgery, 6-minute walking distance did not differ significantly between groups when compared with baseline (mean difference prehabilitation vs standard care 15.6 m [95% CI, -1.4 to 32.6]; P = .07). Secondary parameters of functional capacity in the postoperative period generally favored prehabilitation compared with standard care.
Conclusions and relevance: This PREHAB trial demonstrates the benefit of a multimodal prehabilitation program before colorectal cancer surgery as reflected by fewer severe and medical complications postoperatively and an optimized postoperative recovery compared with standard care.
Trial registration: trialregister.nl Identifier: NTR5947.
JAMA surgery · 362 citationsread the source →
Bartholomew CL, Muhlestein JB, May HT, Le VT, Galenko O, Garrett KD, Brunker C, Hopkins RO, Carlquist JF, Knowlton KU, Anderson JL, Bailey BW, Horne BD. (2021)MEDLINE-indexed journal, not yet read by usEuropean heart journal open Randomized controlled trial of once-per-week intermittent fasting for health improvement: the WONDERFUL trial.
Aims: Low-density lipoprotein cholesterol (LDL-C) predicts heart disease onset and may be reduced by intermittent fasting. Some studies, though, reported that fasting increased LDL-C; however, no study evaluated LDL-C as the primary endpoint. This randomized controlled trial evaluated the effect of low-frequency intermittent fasting on LDL-C and other biomarkers.
Methods and results: Adults aged 21-70 years were enrolled who were not taking a statin, had modestly elevated LDL-C, had ≥1 metabolic syndrome feature or type 2 diabetes, and were not taking anti-diabetic medication (N = 103). Water-only 24-h fasting was performed twice weekly for 4 weeks and then once weekly for 22 weeks; controls ate ad libitum. The primary outcome was 26-week LDL-C change score. Secondary outcomes (requiring P ≤ 0.01) were 26-week changes in homeostatic model assessment of insulin resistance (HOMA-IR), Metabolic Syndrome Score (MSS), brain-derived neurotrophic factor (BDNF), and MicroCog general cognitive proficiency index (GCPi). Intermittent fasting (n = 50) and control (n = 53) subjects were, respectively, aged 49.3 ± 12.0 and 47.0 ± 9.8 years, predominantly female (66.0% and 67.9%), and overweight (103 ± 24 and 100 ± 21 kg) and had modest LDL-C elevation (124 ± 19 and 128 ± 20 mg/dL). Drop-outs (n = 12 fasting, n = 20 control) provided an evaluable sample of n = 71 (n = 38 fasting, n = 33 control). Intermittent fasting did not change LDL-C (0.2 ± 16.7 mg/dL) vs. control (2.5 ± 19.4 mg/dL; P = 0.59), but it improved HOMA-IR (-0.75 ± 0.79 vs. -0.10 ± 1.06; P = 0.004) and MSS (-0.34 ± 4.72 vs. 0.31 ± 1.98, P = 0.006). BDNF (P = 0.58), GCPi (P = 0.17), and weight (-1.7 ± 4.7 kg vs. 0.2 ± 3.5 kg, P = 0.06) were unchanged.
Conclusions: A low-frequency intermittent fasting regimen did not reduce LDL-C or improve cognitive function but significantly reduced both HOMA-IR and MSS.
Trial registration: clinicaltrials.gov, NCT02770313.
European heart journal open · 30 citationsread the source →
Lintzeris N, Bhardwaj A, Mills L, Dunlop A, Copeland J, McGregor I, Bruno R, Gugusheff J, Phung N, Montebello M, Chan T, Kirby A, Hall M, Jefferies M, Luksza J, Shanahan M, Kevin R, Allsop D, Agonist Replacement for Cannabis Dependence (ARCD) study group. (2019)MEDLINE-indexed journal, not yet read by usJAMA internal medicine Nabiximols for the Treatment of Cannabis Dependence: A Randomized Clinical Trial.
Importance: There are no effective medications for treating dependence on cannabis.
Objective: To examine the safety and efficacy of nabiximols in the treatment of patients with cannabis dependence.
Design, setting, and participants: This parallel double-blind randomized clinical trial comparing nabiximols with placebo in a 12-week, multisite outpatient study recruited participants from February 3, 2016, to June 14, 2017, at 4 outpatient specialist alcohol and drug treatment services in New South Wales, Australia. Participants had cannabis dependence (as defined by the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision) and were seeking treatment, were nonresponsive to prior treatment attempts, were 18 to 64 years of age, had no other substance use disorder, had no severe medical or psychiatric conditions, were not pregnant, were not mandated by a court to undergo treatment, and provided informed consent. Results for primary efficacy measures and all secondary outcomes were obtained using a modified intention-to-treat data set.
Interventions: Participants received 12-week treatment involving weekly clinical reviews, structured counseling, and flexible medication doses-up to 32 sprays daily (tetrahydrocannabinol, 86.4 mg, and cannabidiol, 80 mg), dispensed weekly.
Main outcomes and measures: Primary outcome was self-reported number of days using illicit cannabis during the 12-week period. Other outcomes included alternate cannabis use parameters (periods of abstinence, withdrawal, cravings, and problems), safety parameters (adverse events and aberrant medication use), health status, other substance use, and treatment retention.
Results: A total of 128 participants (30 women and 98 men; mean [SD] age, 35.0 [10.9] years) were randomized and received at least 1 dose of study medication. Participants had used a mean (SD) of 2.3 (2.1) g of cannabis on a mean (SD) of 25.7 (4.5) days in the past 28 days. Treatment retention was comparable for the 2 groups (placebo, 30 of 67 participants [44.8%]; nabiximols, 30 of 61 participants [49.2%]), and both groups used similar mean (SD) doses (placebo, 18.5 [9.5] sprays daily; nabiximols, 17.6 [9.5] sprays daily, equivalent to a mean [SD] of 47.5 [25.7] mg of tetrahydrocannabinol and 44.0 [23.8] mg of cannabidiol). For the primary end point, the placebo group reported significantly more days using cannabis during the 12 weeks (mean [SD], 53.1 [33.0] days) than the nabiximols group (mean [SD], 35.0 [32.4] days; estimated difference, 18.6 days; 95% CI, 3.5-33.7 days; P = .02). Both groups showed comparable improvements in health status, with no substantial changes in other substance use. Medication was well tolerated with few adverse events.
Conclusions and relevance: This study demonstrates that cannabinoid agonist treatment, in this case using nabiximols, in combination with psychosocial interventions is a safe approach for reducing cannabis use among individuals with cannabis dependence who are seeking treatment.
Trial registration: anzctr.org.au Identifier: ACTRN12616000103460.
JAMA internal medicine · 68 citationsread the source →
In Orthopaedic Speciality Care, Longer Explanations Are Not More Caring or More Satisfying.
Background: Research consistently documents no correlation between the duration of a musculoskeletal specialty care visit and patient experience (perceived empathy of the specialist and satisfaction with care). Based on a combination of clinical experience and other lines of research, we speculate that longer visits are often related to discordance between specialist and patient interpretation of symptoms and weighting of available test and treatment options. If this is true, then the specific duration of time discussing the specialist's interpretations and options with the patient (expertise transfer) might correlate with satisfaction with care and perceived empathy of the clinician even if the total visit time does not.
Questions/purposes: (1) What demographic or mental health factors are associated with the duration of expertise transfer? (2) What factors, including the duration of expertise transfer, are associated with the patient's satisfaction with the visit and perceived clinician empathy?
Methods: In a cross-sectional study, 128 new and returning English-speaking adult outpatients seeking care from one of three orthopaedic specialists in two urban practices between September and November 2019 were enrolled and agreed to audio recording of the visit. A total of 92% (118) of patients completed the questionnaire and had a usable recording. Participants completed a sociodemographic survey, the Patient-Reported Outcome Measure Information System Depression computer adaptive test (PROMIS Depression CAT; a measure of symptoms of depression), the Short Health Anxiety Index (SHAI-5; a measure of symptoms of hypochondriasis, a form of symptoms misinterpretation), the Pain Catastrophizing Scale (PCS-4; a measure of misinterpretation of symptoms), an ordinal measure of patient satisfaction (dichotomized into satisfied or not because of strong ceiling effects), and the Jefferson Scale of Patient Perception of Physician Empathy (JSPPPE; a measure of perceived clinician empathy). The duration of expertise transfer and the total duration of the visit were measured by two raters with acceptable reliability using software that facilitates segmentation of the visit audio recording. To determine factors associated with the duration of expertise transfer, satisfaction, and empathy, we planned a multivariable analysis controlling for potential confounding variables identified in exploratory bivariable analysis. However, there were insufficient associations to merit multivariable analysis.
Results: A longer duration of expertise transfer had a modest correlation with catastrophic thinking (r = 0.24; p = 0.01). Complete satisfaction with the visit was associated with less health anxiety (6 [interquartile range 5 to 7] for complete satisfaction versus 7 [5 to 7] for less than complete satisfaction; p = 0.02) and catastrophic thinking (4 [1 to 7] versus 5 [3 to 11]; p = 0.02), but not with the duration of expertise transfer. Greater perceived clinician empathy had a slight correlation with less health anxiety (r = -0.19; p = 0.04).
Conclusion: Patients with greater misinterpretation of symptoms experience a slightly less satisfying visit and less empathetic relationship with a musculoskeletal specialist despite a longer duration of expertise transfer. This supports the concept that directive strategies (such as teaching healthy interpretation of symptoms) may be less effective then guiding strategies (such as nurturing openness to alternative, healthier interpretation of symptoms using motivational interviewing tactics, often over more than one visit or point of contact).
Level of evidence: Level II, therapeutic study.
Clinical orthopaedics and related research · 11 citationsread the source →
Lost in thoughts: neural markers of low alertness during mind wandering.
During concentration tasks, spontaneous attention shifts occurs towards self-centered matters. Little is known about the brain oscillatory activity underlying these mental phenomena. We recorded 128-channels electroencephalographic activity from 12 subjects performing a breath-counting task. Subjects were instructed to press a button whenever, based on their introspective experience, they realized their attention had drifted away from the task. Theta (4-7 Hz) and delta (2-3.5 Hz) EEG activity increased during mind wandering whereas alpha (9-11 Hz) and beta (15-30 Hz) decreased. A passive auditory oddball protocol was presented to the subjects to test brain-evoked responses to perceptual stimuli during mind wandering. Mismatch negativity evoked at 100 ms after oddball stimuli onset decreased during mind wandering whereas the brain-evoked responses at 200 ms after stimuli onset increased. Spectral analyses and evoked related potential results suggest decreased alertness and sensory processing during mind wandering. To our knowledge, our experiment is one of the first neuro-imaging studies that relies purely on subjects' introspective judgment, and shows that such judgment may be used to contrast different brain activity patterns.
NeuroImage · 238 citationsread the source →