Mindfulness-based Practices in Workers to Address Mental Health Conditions: A Systematic Review.

The effectiveness of mindfulness techniques in addressing mental health conditions in workers is uncertain. However, it could represent a therapeutic tool for workers presenting with such conditions. Our objective was to assess the effects of mindfulness-based practices for workers diagnosed with mental health conditions. We conducted a systematic review of randomized controlled trials. Participants included were workers with a mental health condition. Interventions included any mindfulness technique, compared to any nonmindfulness interventions. Outcomes were scores on validated psychiatric rating scales. A total of 4,407 records were screened; 202 were included for full-text analysis; 2 studies were included. The first study (Finnes et al., 2017) used Acceptance and Commitment Therapy (ACT) associated or not with Workplace Dialogue Intervention (WDI), compared to treatment as usual. At 9 months follow-up, for the ACT group, depression scores improved marginally (standardized mean difference [SMD]: -0.06, p = 0.021), but anxiety scores were worse (SMD: 0.15, p = 0.036). Changes in mental health outcomes were not statistically significant for the ACT + WDI group. In the second study (Grensman et al., 2018), no statistically significant change in mental health scales has been observed after completion of mindfulness-based cognitive therapy compared to cognitive behavioral therapy. Substantial heterogeneity precluded meta-analysis. This systematic review did not find evidence that mindfulness-based practices provide a durable and substantial improvement of mental health outcomes in workers diagnosed with mental health conditions.

High-dose opioids for chronic non-cancer pain: an overview of Cochrane Reviews.

BACKGROUND: This overview was originally published in 2017, and is being updated in 2022.  Chronic pain is typically described as pain on most days for at least three months. Chronic non-cancer pain (CNCP) is any chronic pain that is not due to a malignancy. Chronic non-cancer pain in adults is a common and complex clinical issue, for which opioids are prescribed by some physicians for pain management. There are concerns that the use of high doses of opioids for CNCP lacks evidence of effectiveness, and may increase the risk of adverse events. OBJECTIVES: To describe the evidence from Cochrane Reviews and overviews regarding the efficacy and safety of high-dose opioids (defined as 200 mg morphine equivalent or more per day) for CNCP. METHODS: We identified Cochrane Reviews and overviews by searching the Cochrane Database of Systematic Reviews in The Cochrane Library. The date of the last search was 21 July 2022. Two overview authors independently assessed the search results. We planned to analyse data on any opioid agent used at a high dose for two weeks or more for the treatment of CNCP in adults. MAIN RESULTS: We did not identify any reviews or overviews that met the inclusion criteria. The excluded reviews largely reflected low doses or titrated doses, where all doses were analysed as a single group; we were unable to extract any data for high-dose use only. AUTHORS' CONCLUSIONS: There is a critical lack of high-quality evidence, in the form of Cochrane Reviews, about how well high-dose opioids work for the management of CNCP in adults, and regarding the presence and severity of adverse events.  No evidence-based argument can be made on the use of high-dose opioids, i.e. 200 mg morphine equivalent or more daily, in clinical practice. Considering that high-dose opioids have been, and are still being used in clinical practice to treat CNCP, knowing about the efficacy and safety of these higher doses is imperative.

Risk Factors for Developing Concurrent Posttraumatic Stress Injury After Work-Related Musculoskeletal Injury: A Case-Control Study.

OBJECTIVE: This study aimed to study risk factors for developing concurrent posttraumatic stress injury (PTSI) among workers experiencing work-related musculoskeletal injury (MSI). METHODS: A case-control study was conducted using workers' compensation data on injured workers undergoing rehabilitation programs for concurrent MSI and PTSI (cases) and MSI only (controls). A variety of measures known at the time of the compensable injury were entered into logistic regression models. RESULTS: Of the 1948 workers included, 215 had concurrent MSI and PTSI. Concurrent MSI and PTSI were predicted by type of accident (adjusted odds ratio [OR], 25.8), experiencing fracture or dislocation fracture or dislocation (adjusted OR, 3.7), being public safety personnel (adjusted OR, 3.1), and lower level of education (adjusted OR, 1.9). CONCLUSIONS: Experiencing a concurrent PTSI diagnosis with MSI after work-related accident and injury appears related to occupation, type of accident, and educational background.

Characteristics and Prognostic Factors for Return to Work in Public Safety Personnel with Work-Related Posttraumatic Stress Injury Undergoing Rehabilitation.

PURPOSE: Public safety personnel (PSP) are at risk of developing posttraumatic stress injury (PTSI) due to exposure to traumatic experiences and accidents. Rehabilitation programs are available, but their success varies. We studied: (1) characteristics of PSP undergoing PTSI rehabilitation in comparison to non-PSP workers; and (2) predictive value of various factors for return to work. Methods A population-based cohort study was conducted using data on injured workers undergoing PTSI rehabilitation. Of the 488 workers included, 131 were PSP. Outcome measures were: (1) return to pre-accident work at rehabilitation discharge; (2) days receiving wage replacement benefits in the year following rehabilitation. Results PSP were mainly employed (90.8%), male (59.5%), paramedics/ambulance workers (58.0%); a minority (43.5%) returned to pre-accident work after rehabilitation. Compared to non-PSP workers, PSP were more likely to initially be diagnosed with psychological injuries (94.7% versus 59.4%, p < 0.001) rather than musculoskeletal injuries. Return to pre-accident work was predicted by shorter injury duration, having a primary mental health diagnosis, working at time of admission, and not having symptoms requiring treatment in a complex rehabilitation program. PSPs were slower to experience full recovery in the year after rehabilitation. Factors predicting fewer benefit days included not having a secondary psychological injury, being employed, and working at time of admission. Conclusions Most PSP did not return to work in full after PTSI rehabilitation. Outcomes are likely to improve by starting treatment earlier and maintaining connections with the workplace.

Random drug and alcohol testing for preventing injury in workers.

BACKGROUND: Drug- and alcohol-related impairment in the workplace has been linked to an increased risk of injury for workers. Randomly testing populations of workers for these substances has become a practice in many jurisdictions, with the intention of reducing the risk of workplace incidents and accidents. Despite the proliferation of random drug and alcohol testing (RDAT), there is currently a lack of consensus about whether it is effective at preventing workplace injury, or improving other non-injury accident outcomes in the work place. OBJECTIVES: To assess the effectiveness of workplace RDAT to prevent injuries and improve non-injury accident outcomes (unplanned events that result in damage or loss of property) in workers compared with no workplace RDAT. SEARCH METHODS: We conducted a systematic literature search to identify eligible published and unpublished studies. The date of the last search was 1 November 2020. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, two other databases, Google Scholar, and three trials registers. We also screened the reference lists of relevant publications known to us. SELECTION CRITERIA: Study designs that were eligible for inclusion in our review included randomised controlled trials (RCTs), cluster-randomised trials (CRTs), interrupted time-series (ITS) studies, and controlled before-after (CBA) studies. Studies needed to evaluate the effectiveness of RDAT in preventing workplace injury or improving other non-injury workplace outcomes. We also considered unpublished data from clinical trial registries. We included employees working in all safety-sensitive occupations, except for commercial drivers, who are the subject of another Cochrane Review. DATA COLLECTION AND ANALYSIS: Independently, two review authors used a data collection form to extract relevant characteristics from the included study. They then analysed a line graph included in the study of the prevalence rate of alcohol violations per year. Independently, the review authors completed a GRADE assessment, as a means of rating the quality of the evidence. MAIN RESULTS: Although our searching originally identified 4198 unique hits, only one study was eligible for inclusion in this review. This was an ITS study that measured the effect of random alcohol testing (RAT) on the test positivity rate of employees of major airlines in the USA from 1995 to 2002. The study included data from 511,745 random alcohol tests, and reported no information about testing for other substances. The rate of positive results was the only outcome of interest reported by the study. The average rate of positive results found by RAT increased from 0.07% to 0.11% when the minimum percentage of workers who underwent RAT annually was reduced from 25% to 10%. Our analyses found this change to be a statistically significant increase (estimated change in level, where the level reflects the average percentage points of positive tests = 0.040, 95% confidence interval 0.005 to 0.075; P = 0.031). Our GRADE assessment, for the observed effect of lower minimum testing percentages associating with a higher rate of positive test results, found the quality of the evidence to be 'very low' across the five GRADE domains. The one included study did not address the following outcomes of interest: fatal injuries; non-fatal injuries; non-injury accidents; absenteeism; and adverse effects associated with RDAT. AUTHORS' CONCLUSIONS: In the aviation industry in the USA, the only setting for which the eligible study reported data, there was a statistically significant increase in the rate of positive RAT results following a reduction in the percentage of workers tested, which we deem to be clinically relevant. This result suggests an inverse relationship between the proportion of positive test results and the rate of testing, which is consistent with a deterrent effect for testing. No data were reported on adverse effects related to RDAT. We could not draw definitive conclusions regarding the effectiveness of RDAT for employees in safety-sensitive occupations (not including commercial driving), or with safety-sensitive job functions. We identified only one eligible study that reflected one industry in one country, was of non-randomised design, and tested only for alcohol, not for drugs or other substances. Our GRADE assessment resulted in a 'very low' rating for the quality of the evidence on the only outcome reported. The paucity of eligible research was a major limitation in our review, and additional studies evaluating the effect of RDAT on safety outcomes are needed.

Varenicline: mode of action, efficacy, safety and accumulated experience salient for clinical populations.

Objective: Varenicline, a selective partial agonist of the α4ß2 nicotinic acetylcholine receptor, is a smoking cessation pharmacotherapy that more than doubles the chance of quitting smoking at 6 months compared with placebo. This article reviews salient knowledge of the discovery, pharmacological characteristics, and the efficacy and safety of varenicline in general and in specific populations of smokers and provides recommendations to support use in clinical practice.Methods: Literature searches for varenicline were conducted using PubMed, with date limitations of 2000-2018 inclusive, using search terms covering the discovery, mechanism of action, pharmacokinetics, efficacy and safety in different populations of smokers, alternative quit approaches and combination therapy. Selection of safety and efficacy data was limited to clinical trials, meta-analyses and observational studies.Results: Standard administration of varenicline is efficacious in helping smokers to quit, including smokers with cardiovascular disease and chronic obstructive pulmonary disease. Furthermore, varenicline efficacy may be improved with pre-loading, a gradual quitting approach for smokers unwilling or unable to quit abruptly, and extended treatment in smokers who have recently quit to help maintain abstinence. Initial concerns regarding the association of varenicline with increased risk of neuropsychiatric and cardiovascular adverse events have been disproven after extensive clinical evaluations, and the benefit-risk profile of varenicline is considered favorable.Conclusions: Varenicline is efficacious and safe for all adult smokers with a range of clinical characteristics. Evidence suggests that approaches offering greater flexibility in timing and duration of treatment may further extend treatment efficacy and clinical reach.

A bidirectional path analysis model of smoking cessation self-efficacy and concurrent smoking status: impact on abstinence outcomes.

Self-efficacy is routinely associated with abstinence in the addictions literature, and is a major component relapse-prevention models. The magnitude of this relationship has been brought into question following equivocal results in studies controlling for concurrent smoking status. The aim of our study was to clarify the relationship between cessation self-efficacy, smoking status, and cessation outcomes in a cohort of treatment-seeking smokers. Smokers participating in the FLEX trial, a randomized trial investigating the efficacy of three pharmacologic treatments for smoking cessation, completed questionnaires assessing cessation self-efficacy at baseline and at weeks 1, 3, 5 and 10 post-target quit date; smoking status was verified using expired carbon monoxide. Structural models were fit in order to ascertain the relationship between cessation self-efficacy and concurrent smoking at each time-point, and to assess the association between cessation self-efficacy, smoking and seven-day point prevalence smoking status at week 10. A total of 737 treatment-seeking smokers participated. In our path model, self-efficacy and smoking status at all time points were associated with week 10 abstinence (except week 3 self-efficacy), after controlling these values' previous time-points. All direct pathways between cessation self-efficacy and smoking were also significant, supporting a bidirectional relationship. Our results support a bidirectional and reciprocal relationship between cessation self-efficacy and concurrent smoking behavior; participants with higher confidence were more likely to be smoke-free, and concurrent smoking status predicted levels of confidence over the ensuing weeks. Both measures were associated with week 10 abstinence. Our results indicate that while correlated, both cessation self-efficacy and current smoking behavior during a cessation attempt are important independent markers of ultimate cessation success.

Nicotine metabolite ratio and smoking outcomes using nicotine replacement therapy and varenicline among smokers with and without psychiatric illness.

INTRODUCTION: It has been suggested that the effectiveness of nicotine replacement smoking cessation pharmacotherapy may be enhanced by assessing rates of nicotine metabolism using the nicotine metabolite ratio - which reflects differences in the activity of the CYP2A6 hepatic enzyme - and titrating doses appropriately. To date, supporting evidence is equivocal, with little information regarding the assessment and effectiveness of the nicotine metabolite ratio among smokers with psychiatric conditions. METHODS: The nicotine metabolite ratio of 499 smokers from the FLEX trial was determined using urine samples obtained at baseline. They were randomized to receive either: standard transdermal nicotine (nicotine replacement therapy); extended nicotine replacement therapy + adjunct nicotine agent; or varenicline. Primary cessation outcomes were seven-day point prevalence at 5, 10, 22, and 52 weeks post-target quit date, comparing across treatment and psychiatric status. Our principal analysis employed logistic regression (outcome: abstinence), using slow metabolizers as the reference category. RESULTS: No differences were observed by nicotine metabolite ratio classification (slow, moderate, fast) with respect to any demographic or smoking-related variables. Nicotine metabolite ratio class did not predict smoking cessation in either the overall sample, or by treatment condition at any time-point (week 52 moderate metabolizers: odds ratio 1.34, 95% confidence interval (0.68-2.63), p=0.394; fast metabolizers: odds ratio 1.04 (0.56-1.91), p=0. 906). CONCLUSION: Our results did not find any associations between nicotine metabolite ratio and cessation outcomes among smokers using nicotine replacement therapy or varenicline with and without lifetime psychiatric conditions.

Determination of Death in Execution by Lethal Injection in China.

Since 1997, execution in China has been increasingly performed by lethal injection. The current criteria for determination of death for execution by lethal injection (cessation of heartbeat, cessation of respiration, and dilated pupils) neither conform to current medical science nor to any standard of medical ethics. In practice, death is pronounced in China within tens of seconds after starting the lethal injection. At this stage, however, neither the common criteria for cardiopulmonary death (irreversible cessation of heartbeat and breathing) nor that of brain death (irreversible cessation of brain functions) have been met. To declare a still-living person dead is incompatible with human dignity, regardless of the processes following death pronouncement. This ethical concern is further aggravated if organs are procured from the prisoners. Analysis of postmortem blood thiopental level data from the United States indicates that thiopental, as used, may not provide sufficient surgical anesthesia. The dose of thiopental used in China is kept secret. It cannot be excluded that some of the organ explantation surgeries on prisoners subjected to lethal injection are performed under insufficient anesthesia in China. In such cases, the inmate may potentially experience asphyxiation and pain. Yet this can be easily overlooked by the medical professionals performing the explantation surgery because pancuronium prevents muscle responses to pain, resulting in an extremely inhumane situation. We call for an immediate revision of the death determination criteria in execution by lethal injection in China. Biological death must be ensured before death pronouncement, regardless of whether organ procurement is involved or not.

Adverse events associated with medium- and long-term use of opioids for chronic non-cancer pain: an overview of Cochrane Reviews.

BACKGROUND: Chronic pain is common and can be challenging to manage. Despite increased utilisation of opioids, the safety and efficacy of long-term use of these compounds for chronic non-cancer pain (CNCP) remains controversial. This overview of Cochrane Reviews complements the overview entitled 'High-dose opioids for chronic non-cancer pain: an overview of Cochrane Reviews'. OBJECTIVES: To provide an overview of the occurrence and nature of adverse events associated with any opioid agent (any dose, frequency, or route of administration) used on a medium- or long-term basis for the treatment of CNCP in adults. METHODS: We searched the Cochrane Database of Systematic Reviews (the Cochrane Library) Issue 3, 2017 on 8 March 2017 to identify all Cochrane Reviews of studies of medium- or long-term opioid use (2 weeks or more) for CNCP in adults aged 18 and over. We assessed the quality of the reviews using the AMSTAR criteria (Assessing the Methodological Quality of Systematic Reviews) as adapted for Cochrane Overviews. We assessed the quality of the evidence for the outcomes using the GRADE framework. MAIN RESULTS: We included a total of 16 reviews in our overview, of which 14 presented unique quantitative data. These 14 Cochrane Reviews investigated 14 different opioid agents that were administered for time periods of two weeks or longer. The longest study was 13 months in duration, with most in the 6- to 16-week range. The quality of the included reviews was high using AMSTAR criteria, with 11 reviews meeting all 10 criteria, and 5 of the reviews meeting 9 out of 10, not scoring a point for either duplicate study selection and data extraction, or searching for articles irrespective of language and publication type. The quality of the evidence for the generic adverse event outcomes according to GRADE ranged from very low to moderate, with risk of bias and imprecision being identified for the following generic adverse event outcomes: any adverse event, any serious adverse event, and withdrawals due to adverse events. A GRADE assessment of the quality of the evidence for specific adverse events led to a downgrading to very low- to moderate-quality evidence due to risk of bias, indirectness, and imprecision.We calculated the equivalent milligrams of morphine per 24 hours for each opioid studied (buprenorphine, codeine, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, levorphanol, methadone, morphine, oxycodone, oxymorphone, tapentadol, tilidine, and tramadol). In the 14 Cochrane Reviews providing unique quantitative data, there were 61 studies with a total of 18,679 randomised participants; 12 of these studies had a cross-over design with two to four arms and a total of 796 participants. Based on the 14 selected Cochrane Reviews, there was a significantly increased risk of experiencing any adverse event with opioids compared to placebo (risk ratio (RR) 1.42, 95% confidence interval (CI) 1.22 to 1.66) as well as with opioids compared to a non-opioid active pharmacological comparator, with a similar risk ratio (RR 1.21, 95% CI 1.10 to 1.33). There was also a significantly increased risk of experiencing a serious adverse event with opioids compared to placebo (RR 2.75, 95% CI 2.06 to 3.67). Furthermore, we found significantly increased risk ratios with opioids compared to placebo for a number of specific adverse events: constipation, dizziness, drowsiness, fatigue, hot flushes, increased sweating, nausea, pruritus, and vomiting.There was no data on any of the following prespecified adverse events of interest in any of the included reviews in this overview of Cochrane Reviews: addiction, cognitive dysfunction, depressive symptoms or mood disturbances, hypogonadism or other endocrine dysfunction, respiratory depression, sexual dysfunction, and sleep apnoea or sleep-disordered breathing. We found no data for adverse events analysed by sex or ethnicity. AUTHORS' CONCLUSIONS: A number of adverse events, including serious adverse events, are associated with the medium- and long-term use of opioids for CNCP. The absolute event rate for any adverse event with opioids in trials using a placebo as comparison was 78%, with an absolute event rate of 7.5% for any serious adverse event. Based on the adverse events identified, clinically relevant benefit would need to be clearly demonstrated before long-term use could be considered in people with CNCP in clinical practice. A number of adverse events that we would have expected to occur with opioid use were not reported in the included Cochrane Reviews. Going forward, we recommend more rigorous identification and reporting of all adverse events in randomised controlled trials and systematic reviews on opioid therapy. The absence of data for many adverse events represents a serious limitation of the evidence on opioids. We also recommend extending study follow-up, as a latency of onset may exist for some adverse events.

High-dose opioids for chronic non-cancer pain: an overview of Cochrane Reviews.

BACKGROUND: Chronic pain is typically described as pain on most days for at least three months. Chronic non-cancer pain (CNCP) is any chronic pain that is not due to a malignancy. Chronic non-cancer pain in adults is a common and complex clinical issue where opioids are routinely used for pain management. There are concerns that the use of high doses of opioids for chronic non-cancer pain lacks evidence of effectiveness and may increase the risk of adverse events. OBJECTIVES: To describe the evidence from Cochrane Reviews and Overviews regarding the efficacy and safety of high-dose opioids (here defined as 200 mg morphine equivalent or more per day) for chronic non-cancer pain. METHODS: We identified Cochrane Reviews and Overviews through a search of the Cochrane Database of Systematic Reviews (The Cochrane Library). The date of the last search was 18 April 2017. Two review authors independently assessed the search results. We planned to analyse data on any opioid agent used at high dose for two weeks or more for the treatment of chronic non-cancer pain in adults. MAIN RESULTS: We did not identify any reviews or overviews meeting the inclusion criteria. The excluded reviews largely reflected low doses or titrated doses where all doses were analysed as a single group; no data for high dose only could be extracted. AUTHORS' CONCLUSIONS: There is a critical lack of high-quality evidence regarding how well high-dose opioids work for the management of chronic non-cancer pain in adults, and regarding the presence and severity of adverse events. No evidence-based argument can be made on the use of high-dose opioids, i.e. 200 mg morphine equivalent or more daily, in clinical practice. Trials typically used doses below our cut-off; we need to know the efficacy and harm of higher doses, which are often used in clinical practice.

Human rights violations in organ procurement practice in China.

BACKGROUND: Over 90% of the organs transplanted in China before 2010 were procured from prisoners. Although Chinese officials announced in December 2014 that the country would completely cease using organs harvested from prisoners, no regulatory adjustments or changes in China's organ donation laws followed. As a result, the use of prisoner organs remains legal in China if consent is obtained. DISCUSSION: We have collected and analysed available evidence on human rights violations in the organ procurement practice in China. We demonstrate that the practice not only violates international ethics standards, it is also associated with a large scale neglect of fundamental human rights. This includes organ procurement without consent from prisoners or their families as well as procurement of organs from incompletely executed, still-living prisoners. The human rights critique of these practices will also address the specific situatedness of prisoners, often conditioned and traumatized by a cascade of human rights abuses in judicial structures. CONCLUSION: To end the unethical practice and the abuse associated with it, we suggest to inextricably bind the use of human organs procured in the Chinese transplant system to enacting Chinese legislation prohibiting the use of organs from executed prisoners and making explicit rules for law enforcement. Other than that, the international community must cease to abet the continuation of the present system by demanding an authoritative ban on the use of organs from executed Chinese prisoners.

Factor structure of the Smoking Cessation Self-Efficacy Questionnaire among smokers with and without a psychiatric diagnosis.

Cessation self-efficacy has been shown to be a consistent predictor of smoking cessation outcomes. To date, no scale assessing cessation self-efficacy has been validated across smokers with and without a psychiatric diagnosis (current or past). Smokers with a psychiatric diagnosis are typically heavy smokers, have a more difficult time quitting, and are more prone to experience lower self-efficacy. Determining whether smoking cessation self-efficacy scores are invariant across these populations is crucial for future research and intervention strategies. Data from the Flexible and Extended Dosing of Nicotine Replacement Therapy (NRT) and Varenicline in Comparison to Fixed Dose NRT for Smoking Cessation: The FLEX Trial, a randomized control trial for smoking cessation, was used to assess the factor structure of the Smoking Cessation Self-Efficacy Questionnaire (SEQ-12), a 12-item scale assessing an individual's confidence to refrain from smoking. Confirmatory factor analysis (CFA) was used to compare the model's fit between the original factor structure and the present data, and to test for measurement invariance across with a current, past, or no psychiatric diagnosis. Initial support was found for both a 2- and 3-factor structure. Using CFA, only the 3-factor model displayed adequate fit indices (Global Fit Index [GFI] = 0.924). Results from the model comparisons showed no differences between those with a current, past, or no psychiatric diagnosis (cmin (30) = 38.64, p = .134). The 3 factors were highly correlated, indicative of an underlying global factor. The SEQ-12 was found to be measurement invariant across treatment-seeking smokers, with preliminary evidence suggesting it is a valid measurement scale for evaluating overall cessation self-efficacy, regardless of psychiatric status. (PsycINFO Database Record

"Decision-critical" work: a conceptual framework.

"Safety-sensitive" workers, also termed "safety-critical" workers, have been subject to fitness to work assessments due to concerns that a performance error may result in worker injury, injury to coworkers or the general public, and/or disruption of equipment, production or the environment. However, there exists an additional category of "decision-critical" workers, distinct from "safety-sensitive" workers, in whom impairment may impact workplace performance, relationships, attendance, reliability and quality. Adverse consequences in these latter areas may not be immediately apparent, but a potential "orbit of harm" nevertheless exists. Workplace consequences arising from impairment in "decision-critical" workers differ from those in "safety-sensitive" personnel. Despite their importance in the occupational context, "decision-critical" workers have not previously been differentiated from other workers in the published literature, and we now outline an approach to fitness to work assessment in this group.

Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation: a randomized controlled trial.

BACKGROUND: Extended use of combined pharmacotherapies to treat tobacco dependence may increase smoking abstinence; few studies have examined their effectiveness. The objective of this study was to evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR). METHODS: A total of 737 smokers, including those with medical and psychiatric comorbidities, were randomly assigned to one of the above three treatment conditions. The NRT group received 10 weeks of patches (21 mg daily maximum); the NRT+ group received patches (35 mg daily maximum) and gum or inhaler for up to 22 weeks; and the VR group received 1 mg twice daily for up to 24 weeks (22 weeks post target quit date). All participants also received six standardized 15-minute smoking cessation counseling sessions by nurses experienced in tobacco dependence treatment. The primary outcome was carbon monoxide-confirmed continuous abstinence rates (CAR) from weeks 5-52. Secondary outcomes were: CAR from weeks 5-10 and 5-22, and carbon monoxide-confirmed 7-day point prevalence (7PP) at weeks 10, 22, and 52. Adjusted and unadjusted logistic regression analyses were conducted using intention-to-treat procedures. RESULTS: The CARs for weeks 5-52 were 10.0 %, 12.4 %, and 15.3 % in the NRT, NRT+, and VR groups, respectively; no group differences were observed. Results with 7PP showed that VR was superior to NRT at week 52 (odds ratio (OR), 1.84; 97.5 % Confidence Interval (CI), 1.04-3.26) in the adjusted intention-to-treat analysis. Those in the VR group had higher CAR at weeks 5-22 (OR, 2.01; CI, 1.20-3.36) than those in the NRT group. Results with 7PP revealed that both NRT+ (OR, 1.72; CI, 1.04-2.85) and VR (OR, 1.96; CI, 1.20-3.23) were more effective than NRT at 22 weeks. As compared to NRT monotherapy, NRT+ and VR produced significant increases in CAR for weeks 5-10 (OR, 1.52; CI, 1.00-2.30 and OR, 1.58; CI, 1.04-2.39, respectively); results were similar, but somewhat stronger, when 7PP was used at 10 weeks (OR, 1.57; CI, 1.03-2.41 and OR, 1.79; CI, 1.17-2.73, respectively). All medications were well tolerated, but participants in the VR group experienced more fatigue, digestive symptoms (e.g., nausea, diarrhea), and sleep-related concerns (e.g., abnormal dreams, insomnia), but less dermatologic symptoms than those in the NRT or NRT+ groups. The frequency of serious adverse events did not differ between groups. CONCLUSIONS: Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01623505 ; Retrospectively registered on July 13, 2011.

The Quit Experience and Concerns of Smokers With Psychiatric Illness.

INTRODUCTION: The purpose of this study is to better understand the quit experience and concerns of smokers with psychiatric illness (i.e., major depressive, anxiety, psychotic and bipolar disorders) in comparison with those without psychiatric illness. METHODS: Smokers (N=732) with (n=430, 59%) and without psychiatric illness, recruited between June 2010 and March 2013 to participate in the FLEX (Flexible and Extended Dosing of Nicotine Replacement Therapy [NRT] and Varenicline in Comparison to Fixed-Dose NRT for Smoking Cessation) smoking-cessation trial, completed questionnaires assessing previously used cessation aids and reasons for relapse, and motivation and concerns about their upcoming quit attempt. These supplementary data analyses were conducted in May 2015. RESULTS: The most commonly used cessation methods during previous attempts were nicotine replacement therapy (66.4%), cold turkey (59.7%), and bupropion (34.7%); no group differences were identified. Stress was the most common precipitator of relapse during previous attempts in all groups (43.6%), particularly among participants with depression and anxiety. Health was the most common motivation for the upcoming quit attempt (91%), followed by family/social pressures (28.1%) and cost (27.9%, particularly by smokers with psychotic disorders). Common pre-cessation concerns for the complete sample included: cravings (27.6%), stress (26.7%), and fear of failure (26%); participants with psychotic and anxiety disorders were most concerned about cravings, whereas the latter two concerns were more prominent for individuals with anxiety. CONCLUSIONS: Findings reveal differences in the quit histories and concerns of smokers with or without psychiatric illness. Smokers with psychiatric illness are particularly vulnerable to relapse at times of stress and negative affect; interventions that emphasize alternative coping strategies and facilitate mood management are required.

Historical development and current status of organ procurement from death-row prisoners in China.

BACKGROUND: In December 2014, China announced that only voluntarily donated organs from citizens would be used for transplantation after January 1, 2015. Many medical professionals worldwide believe that China has stopped using organs from death-row prisoners. DISCUSSION: In the present article, we briefly review the historical development of organ procurement from death-row prisoners in China and comprehensively analyze the social-political background and the legal basis of the announcement. The announcement was not accompanied by any change in organ sourcing legislations or regulations. As a fact, the use of prisoner organs remains legal in China. Even after January 2015, key Chinese transplant officials have repeatedly stated that death-row prisoners have the same right as regular citizens to "voluntarily donate" organs. This perpetuates an unethical organ procurement system in ongoing violation of international standards. CONCLUSIONS: Organ sourcing from death-row prisoners has not stopped in China. The 2014 announcement refers to the intention to stop the use of organs illegally harvested without the consent of the prisoners. Prisoner organs procured with "consent" are now simply labelled as "voluntarily donations from citizens". The semantic switch may whitewash sourcing from both death-row prisoners and prisoners of conscience. China can gain credibility only by enacting new legislation prohibiting use of prisoner organs and by making its organ sourcing system open to international inspections. Until international ethical standards are transparently met, sanctions should remain.

Are chronically ill patients high users of homecare services in Canada?

OBJECTIVES: Chronically ill patients often need healthcare and supportive services, with formal homecare services an important source of community-based assistance. Although people diagnosed with 1 or more chronic diseases are thought to be the most common homecare clients, and perhaps the highest users of homecare services, few studies have analyzed homecare services utilization by specific clients. A study was done to determine if a relationship exists between chronic illness and homecare services utilization. STUDY DESIGN: Descriptive-comparative, secondary analysis of population homecare data. METHODS: Three years (2003-2004, 2004-2005, and 2005-2006) of complete homecare client and services utilization data for 1 Canadian province were obtained and tested using 5 definitions of chronic illness to determine which clients among all 149,378 were high users in terms of annual homecare hours and service visits or episodes. RESULTS: Two definitions revealed clients with a disproportionately large share of homecare hours and service episodes: a) clients classified by homecare case managers as "long-term" and b) clients with service spans of ≥90 days. Definitions involving medical diagnoses and International Classification of Diseases, Ninth Revision, Clinical Modification codes or chapters did not reveal high users. Age and gender also did not predict services utilization. CONCLUSIONS: The comprehensive pre-service assessment completed by homecare case managers was the most successful at distinguishing people with substantial homecare service needs-people who could then be described as chronically ill. This assessment should be studied to develop a standardized minimum data tool for consistent and fair assessments.