Interventions for tobacco use cessation in people living with HIV.

BACKGROUND: The prevalence of tobacco use among people living with HIV (PLWH) is up to four times higher than in the general population. Unfortunately, tobacco use increases the risk of progression to AIDS and death. Individual- and group-level interventions, and system-change interventions that are effective in helping PLWH stop using tobacco can markedly improve the health and quality of life of this population. However, clear evidence to guide policy and practice is lacking, which hinders the integration of tobacco use cessation interventions into routine HIV care. This is an update of a review that was published in 2016. We include 11 new studies. OBJECTIVES: To assess the benefits, harms and tolerability of interventions for tobacco use cessation among people living with HIV. To compare the benefits, harms and tolerability of interventions for tobacco use cessation that are tailored to the needs of people living with HIV with that of non-tailored cessation interventions. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialised Register, CENTRAL, MEDLINE, Embase, and PsycINFO in December 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of individual-/group-level behavioural or pharmacological interventions, or both, for tobacco use cessation, delivered directly to PLWH aged 18 years and over, who use tobacco. We also included RCTs, quasi-RCTs, other non-randomised controlled studies (e.g. controlled before and after studies), and interrupted time series studies of system-change interventions for tobacco use cessation among PLWH. For system-change interventions, participants could be PLWH receiving care, or staff working in healthcare settings and providing care to PLWH; but studies where intervention delivery was by research personnel were excluded. For both individual-/group-level interventions, and system-change interventions, any comparator was eligible. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods, and used GRADE to assess certainty of the evidence. The primary measure of benefit was tobacco use cessation at a minimum of six months. Primary measures for harm were adverse events (AEs) and serious adverse events (SAEs). We also measured quit attempts or quit episodes, the receipt of a tobacco use cessation intervention, quality of life, HIV viral load, CD4 count, and the incidence of opportunistic infections. MAIN RESULTS: We identified 17 studies (16 RCTs and one non-randomised study) with a total of 9959 participants; 11 studies are new to this update. Nine studies contributed to meta-analyses (2741 participants). Fifteen studies evaluated individual-/group-level interventions, and two evaluated system-change interventions. Twelve studies were from the USA, two from Switzerland, and there were single studies for France, Russia and South Africa. All studies focused on cigarette smoking cessation. All studies received funding from independent national- or institutional-level funding. Three studies received study medication free of charge from a pharmaceutical company. Of the 16 RCTs, three were at low risk of bias overall, five were at high risk, and eight were at unclear risk. Behavioural support or system-change interventions versus no or less intensive behavioural support Low-certainty evidence (7 studies, 2314 participants) did not demonstrate a clear benefit for tobacco use cessation rates in PLWH randomised to receive behavioural support compared with brief advice or no intervention: risk ratio (RR) 1.11, 95% confidence interval (CI) 0.87 to 1.42, with no evidence of heterogeneity. Abstinence at six months or more was 10% (n = 108/1121) in the control group and 11% (n = 127/1193) in the intervention group. There was no evidence of an effect on tobacco use cessation on system-change interventions: calling the quitline and transferring the call to the patient whilst they are still in hospital ('warm handoff') versus fax referral (RR 3.18, 95% CI 0.76 to 13.99; 1 study, 25 participants; very low-certainty evidence). None of the studies in this comparison assessed SAE. Pharmacological interventions versus placebo, no intervention, or another pharmacotherapy Moderate-certainty evidence (2 studies, 427 participants) suggested that varenicline may help more PLWH to quit smoking than placebo (RR 1.95, 95% CI 1.05 to 3.62) with no evidence of heterogeneity. Abstinence at six months or more was 7% (n = 14/215) in the placebo control group and 13% (n = 27/212) in the varenicline group. There was no evidence of intervention effects from individual studies on behavioural support plus nicotine replacement therapy (NRT) versus brief advice (RR 8.00, 95% CI 0.51 to 126.67; 15 participants; very low-certainty evidence), behavioural support plus NRT versus behavioural support alone (RR 1.47, 95% CI 0.92 to 2.36; 560 participants; low-certainty evidence), varenicline versus NRT (RR 0.93, 95% CI 0.48 to 1.83; 200 participants; very low-certainty evidence), and cytisine versus NRT (RR 1.18, 95% CI 0.66 to 2.11; 200 participants; very low-certainty evidence). Low-certainty evidence (2 studies, 427 participants) did not detect a difference between varenicline and placebo in the proportion of participants experiencing SAEs (8% (n = 17/212) versus 7% (n = 15/215), respectively; RR 1.14, 95% CI 0.58 to 2.22) with no evidence of heterogeneity. Low-certainty evidence from one study indicated similar SAE rates between behavioural support plus NRT and behavioural support only (1.8% (n = 5/279) versus 1.4% (n = 4/281), respectively; RR 1.26, 95% CI 0.34 to 4.64). No studies assessed SAEs for the following: behavioural support plus NRT versus brief advice; varenicline versus NRT and cytisine versus NRT. AUTHORS' CONCLUSIONS: There is no clear evidence to support or refute the use of behavioural support over brief advice, one type of behavioural support over another, behavioural support plus NRT over behavioural support alone or brief advice, varenicline over NRT, or cytisine over NRT for tobacco use cessation for six months or more among PLWH. Nor is there clear evidence to support or refute the use of system-change interventions such as warm handoff over fax referral, to increase tobacco use cessation or receipt of cessation interventions among PLWH who use tobacco. However, the results must be considered in the context of the small number of studies included. Varenicline likely helps PLWH to quit smoking for six months or more compared to control. We did not find evidence of difference in SAE rates between varenicline and placebo, although the certainty of the evidence is low.

Socio-Economic Status Differences in Changing Affordability of Tobacco Products from 2011-2012 to 2018-2019 in India.

INTRODUCTION: We studied the change in affordability of tobacco products, an important determinant of tobacco use, across the different socio-economic status (SES) in India. AIMS AND METHODS: We calculated affordability in the form of relative income price (RIP-cost of tobacco products relative to income) for the years 2011-2012 and 2018-2019 using three different denominators, that is per capita gross domestic product (GDP) and net state domestic product at national and state levels, respectively; monthly per capita consumer expenditure (MPCE); and individual wages. We investigated RIP for cigarettes, bidis, and smokeless tobacco (SLT) across different SES groups (caste groups, type of employment, and education). RESULTS: RIP increased marginally for cigarettes, bidis and remained almost constant for SLT across casual workers. However, when RIP was adjusted with SES variables, there was no significant change (p > .05) in the affordability of products for casual workers in the year 2018-2019 as compared to 2011-2012. For regular workers, cigarettes and bidis became marginally less affordable (ß < 1), whereas affordability remained constant for SLT. All products became more affordable for backward caste groups within regular workers. When RIP was calculated using MPCE all tobacco products became less affordable in the year 2018-2019. However, after adjusting for SES variables SLT reported no change in affordability. There was a marginal increase in affordability for all products when RIP was calculated with GDP. CONCLUSIONS: Although implementation of GST has increased the price of tobacco products, it is still not sufficient to reduce the affordability of tobacco products, particularly SLT and especially for the lower SES group. IMPLICATIONS: Tobacco use and economic disadvantage conditions of the population are intricately linked. Affordability of tobacco products is influenced by socio-economic indicators like age, sex, income, education, etc. The literature measuring the affordability of tobacco products across different SES groups is scant in India. Additionally, existing literature measures affordability of tobacco products based on per capita GDP as a proxy for income. This is the first study in Indian context to report the change in affordability of tobacco products across different SES groups after adjusting for SES indicators, using individual-level income data. We have calculated the change in affordability of tobacco products between the year 2011-2012 and 2018-2019 using GDP, household income, and individual wages as a proxy for income.

Corrigendum to: Addressing tobacco smoking and drinking to improve TB treatment outcomes, in South Africa: a feasibility study of the ProLife program.

Alcohol and tobacco use may lead to negative treatment outcomes in tuberculosis (TB) patients, and even more so if they are HIV-infected. We developed and tested the feasibility of a complex behavioral intervention (ProLife) delivered by lay health workers (LHWs) to improve treatment outcomes in TB patients who smoke tobacco and/or drink alcohol, at nine clinics in South Africa. The intervention comprised three brief motivational interviewing (MI) sessions augmented with a short message service (SMS) program, targeting as appropriate: tobacco smoking, harmful or hazardous drinking and medication adherence. Patients received SMSs twice a week. We measured recruitment and retention rates and assessed fidelity to the MI technique (MI Treatment Integrity 4.1 tool). Finally, we explored LHWs' and patients' experiences through interviews and semistructured questionnaires, respectively. We screened 137 TB patients and identified 14 smokers, 13 alcohol drinkers, and 18 patients with both behaviors. Participants' mean age was 39.8 years, and 82.2% were men. The fidelity assessments pointed to the LHWs' successful application of key MI skills, but failure to reach MI competency thresholds. Nevertheless, most patients rated the MI sessions as helpful, ascribed positive attributes to their counselors, and reported behavioral changes. SMSs were perceived as reinforcing but difficult language and technical delivery problems were identified as problems. The LHWs' interview responses suggested that they (a) grasped the basic MI spirit but failed to understand specific MI techniques due to insufficient training practice; (b) perceived ProLife as having benefitted the patients (as well as themselves); (c) viewed the SMSs favorably; but (d) considered limited space and privacy at the clinics as key challenges. The ProLife program targeting multiple risk behaviors in TB patients is acceptable but LHW training protocol, and changes in wording and delivery of SMS are necessary to improve the intervention. Trial registration: ISRCTN14213432.

The association between the retail price of manufactured cigarettes and bidis on current smoking status in India.

INTRODUCTION: In India, the retail prices of bidis and cigarettes varied between the two Global Adult Tobacco Surveys (GATS) conducted in 2009-2010 and 2016-2017. The relationship between the retail price of smoked tobacco products and their use is unclear for India. Our study thus aimed to use available datasets to investigate the association between the retail price and current smoking status of bidis and cigarettes in India. METHODS: Current smoking status data for bidis and cigarettes were obtained from the two GATS rounds. The average state-level retail prices of bidis and cigarettes were obtained from India's Consumer Price Index- Industrial Workers database. Descriptive statistics were used to describe current smoking status patterns. Generalized Linear Mixed Models were used to investigate the association between the retail prices and current smoking status of bidis and cigarettes. RESULTS: For cigarettes, an increase in the average retail price by one Indian Rupee was associated with a reduction in the odds of being a current smoker of 7% (OR=0.925; 95% CI: 0.918-0.932, p<0.001). For bidis, the association between the retail price and current smoking status was not statistically significant (OR=1.01; 95% CI: 1.00-1.02, p=0.082). CONCLUSIONS: Current increases in the retail prices of tobacco products in India seem to have an impact on the use of cigarettes but not bidis. This highlights the need for tobacco product tax increases that result in sufficient retail prices increase to make all tobacco products less affordable and reduce their use.

HIV healthcare providers' perceptions on smoking behavior among PLHIV and smoking cessation service provision in HIV clinics in Uganda.

INTRODUCTION: Integration of smoking cessation interventions into HIV care can play a crucial role in reducing the growing burden of disease due to smoking among people living with HIV (PLHIV). However, there is a dearth of information on HIV care providers' perspectives towards integrating smoking cessation interventions into HIV care programs. We explored HIV healthcare providers' perceptions on the smoking behavior among PLHIV, and the provision of smoking cessation services to PLHIV who smoke within HIV care services in Uganda. METHODS: Semi-structured face-to-face qualitative interviews were conducted with 12 HIV care providers between October and November 2019. Data were collected on perceptions on smoking among HIV-positive patients enrolled in HIV care, support provided to PLHIV who smoke to quit and integrating smoking cessation services into HIV care programs. Data were analyzed deductively following a thematic framework approach. RESULTS: Findings show that: 1) HIV care providers in HIV clinics had low knowledge on the prevalence and magnitude of smoking among PLHIV who attended the clinics; 2) HIV care providers did not routinely screen HIV-positive patients for smoking and offered sub-optimal smoking cessation services; and 3) HIV care providers had a positive attitude towards integration of tobacco smoking cessation services into HIV care programs but called for support in form of guidelines, capacity building and strengthening of data collection and use as part of the integration process. CONCLUSIONS: Our study shows that HIV care providers did not routinely screen for tobacco use among PLHIV and offered suboptimal cessation support to smoking patients, but had a positive attitude towards the integration of tobacco smoking into HIV care programs. These findings suggest a favorable ground for integrating tobacco smoking cessation interventions into HIV care programs.

Impact of tobacco price and taxation on affordability and consumption of tobacco products in the South-East Asia Region: A systematic review.

INTRODUCTION: The objective of the review was to study the impact of tobacco taxes or prices on affordability and/or consumption of tobacco products in WHO South-East Asia Region (SEAR) countries, overall and by socioeconomic status; and change in consumption of one tobacco product for a given change in price/tax on another tobacco product. METHODS: The searches were made in five databases (Medline, Embase, Cinahl, EconLit, Tobacconomics) using keywords such as 'tobacco', 'tax', 'price', 'impact' with their synonyms. Additionally, the first 100 articles through google search and e-reports from targeted sources were also reviewed. Studies illustrating the impact of prices/taxes on consumption/affordability of tobacco products in SEAR, in English and with no limitation on year, were included in the review. After two steps of screening, data from 28 studies were extracted using a structured and pre-tested data extraction form. RESULTS: Of the 28 studies, 12 studies reported an inverse association between price and consumption/affordability, while 11 studies reported no or positive association between price and consumption/affordability of tobacco products. Five studies had unclear interpretations. The majority of studies estimated that the less affluent group were more price responsive compared to the more affluent group. Some studies indicated increased consumption of one product in response to price rise of another product, although, the findings were inconsistent. CONCLUSIONS: The findings of our review support the use of tobacco tax and price measures as effective tools to address the tobacco epidemic. Our findings, however, also emphasize the importance of increasing tobacco product taxes and prices sufficiently to outweigh the effects of income growth, in order for the measures to be effective in reducing the affordability and consumption of tobacco products.

Addressing tobacco smoking and drinking to improve TB treatment outcomes, in South Africa: a feasibility study of the ProLife program.

Alcohol and tobacco use may lead to negative treatment outcomes in tuberculosis (TB) patients, and even more so if they are HIV-infected. We developed and tested the feasibility of a complex behavioral intervention (ProLife) delivered by lay health workers (LHWs) to improve treatment outcomes in TB patients who smoke tobacco and/or drink alcohol, at nine clinics in South Africa. The intervention comprised three brief motivational interviewing (MI) sessions augmented with a short message service (SMS) program, targeting as appropriate: tobacco smoking, harmful or hazardous drinking and medication adherence. Patients received SMSs twice a week. We measured recruitment and retention rates and assessed fidelity to the MI technique (MI Treatment Integrity 4.1 tool). Finally, we explored LHWs' and patients' experiences through interviews and semi-structured questionnaires, respectively. We screened 137 TB patients and identified 14 smokers, 13 alcohol drinkers, and 18 patients with both behaviors. Participants' mean age was 39.8 years, and 82.2% were men. The fidelity assessments pointed to the LHWs' successful application of key MI skills, but failure to reach MI competency thresholds. Nevertheless, most patients rated the MI sessions as helpful, ascribed positive attributes to their counselors, and reported behavioral changes. SMSs were perceived as reinforcing but difficult language and technical delivery problems were identified as problems. The LHWs' interview responses suggested that they (a) grasped the basic MI spirit but failed to understand specific MI techniques due to insufficient training practice; (b) perceived ProLife as having benefitted the patients (as well as themselves); (c) viewed the SMSs favorably; but (d) considered limited space and privacy at the clinics as key challenges. The ProLife program targeting multiple risk behaviors in TB patients is acceptable but LHW training protocol, and changes in wording and delivery of SMS are necessary to improve the intervention. Trial registration: ISRCTN62728852.

The Effects of Positive Affect and Episodic Future Thinking on Temporal Discounting and Healthy Food Demand and Choice Among Overweight and Obese Individuals: Protocol for a Pilot 2×2 Factorial Randomized Controlled Study.

BACKGROUND: Unhealthy behaviors (eg, poor food choices) contribute to obesity and numerous negative health outcomes, including multiple types of cancer and cardiovascular and metabolic diseases. To promote healthy food choice, diet interventions should build on the dual-system model to target the regulation and reward mechanisms that guide eating behavior. Episodic future thinking (EFT) has been shown to strengthen regulation mechanisms by reducing unhealthy food choice and temporal discounting (TD), a process of placing greater value on smaller immediate rewards over larger future rewards. However, these interventions do not target the reward mechanisms that could support healthy eating and strengthen the impact of EFT-anchored programs. Increasing positive affect (PosA) related to healthy food choices may target reward mechanisms by enhancing the rewarding effects of healthy eating. An intervention that increases self-regulation regarding unhealthy foods and the reward value of healthy foods will likely have a greater impact on eating behavior compared with interventions focused on either process alone. OBJECTIVE: This study aimed to introduce a protocol that tests the independent and interactive effects of EFT and PosA on TD, food choice, and food demand in overweight and obese adults. METHODS: This protocol describes a factorial, randomized, controlled pilot study that employs a 2 (affective imagery: positive, neutral) by 2 (EFT: yes, no) design in which participants are randomized to 1 of 4 guided imagery intervention arms. In total, 156 eligible participants will complete 2 lab visits separated by 5 days. At visit 1, participants complete surveys; listen to the audio guided imagery intervention; and complete TD, food demand, and food choice tasks. At visit 2, participants complete TD, food demand, and food choice tasks and surveys. Participants complete a daily food frequency questionnaire between visits 1 and 2. Analyses will compare primary outcome measures at baseline, postintervention, and at follow-up across treatment arms. RESULTS: Funding notification was received on April 27, 2017, and the protocol was approved by the institutional review board on October 6, 2017. Feasibility testing of the protocol was conducted from February 21, 2018, to April 18, 2018, among the first 32 participants. As no major protocol changes were required at the end of the feasibility phase, these 32 participants were included in the target sample of 156 participants. Recruitment, therefore, continued immediately after the feasibility phase. When this manuscript was submitted, 84 participants had completed the protocol. CONCLUSIONS: Our research goal is to develop novel, theory-based interventions to promote and improve healthy decision-making and behaviors. The findings will advance decision-making research and have the potential to generate new neuroscience and psychological research to further understand these mechanisms and their interactions. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11704675; http://www.isrctn.com/ISRCTN11704675 (Archived by WebCite at http://www.webcitation.org/760ouOoKG). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12265.

Tobacco use among people living with HIV: analysis of data from Demographic and Health Surveys from 28 low-income and middle-income countries.

BACKGROUND: Tobacco use among people living with HIV results in excess morbidity and mortality. However, very little is known about the extent of tobacco use among people living with HIV in low-income and middle-income countries (LMICs). We assessed the prevalence of tobacco use among people living with HIV in LMICs. METHODS: We used Demographic and Health Survey data collected between 2003 and 2014 from 28 LMICs where both tobacco use and HIV test data were made publicly available. We estimated the country-specific, regional, and overall prevalence of current tobacco use (smoked, smokeless, and any tobacco use) among 6729 HIV-positive men from 27 LMICs (aged 15-59 years) and 11 495 HIV-positive women from 28 LMICs (aged 15-49 years), and compared them with those in 193 763 HIV-negative men and 222 808 HIV-negative women, respectively. We estimated prevalence separately for males and females as a proportion, and the analysis accounted for sampling weights, clustering, and stratification in the sampling design. We computed pooled regional and overall prevalence estimates through meta-analysis with the application of a random-effects model. We computed country, regional, and overall relative prevalence ratios for tobacco smoking, smokeless tobacco use, and any tobacco use separately for males and females to study differences in prevalence rates between HIV-positive and HIV-negative individuals. FINDINGS: The overall prevalence among HIV-positive men was 24·4% (95% CI 21·1-27·8) for tobacco smoking, 3·4% (1·8-5·6) for smokeless tobacco use, and 27·1% (22·8-31·7) for any tobacco use. We found a higher prevalence in HIV-positive men of any tobacco use (risk ratio [RR] 1·41 [95% CI 1·26-1·57]) and tobacco smoking (1·46 [1·30-1·65]) than in HIV-negative men (both p<0·0001). The difference in smokeless tobacco use prevalence between HIV-positive and HIV-negative men was not significant (1·26 [1·00-1·58]; p=0·050). The overall prevalence among HIV-positive women was 1·3% (95% CI 0·8-1·9) for tobacco smoking, 2·1% (1·1-3·4) for smokeless tobacco use, and 3·6% (95% CI 2·3-5·2) for any tobacco use. We found a higher prevalence in HIV-positive women of any tobacco use (RR 1·36 [95% CI 1·10-1·69]; p=0·0050), tobacco smoking (1·90 [1·38-2·62]; p<0·0001), and smokeless tobacco use (1·32 [1·03-1·69]; p=0·030) than in HIV-negative women. INTERPRETATION: The high prevalence of tobacco use in people living with HIV in LMICs mandates targeted policy, practice, and research action to promote tobacco cessation and to improve the health outcomes in this population. FUNDING: South African Medical Research Council and the UK Medical Research Council.

ADAPTA: A pilot randomised controlled trial of an alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting.

AIM: To examine the relative feasibility, acceptability, applicability, effectiveness and explore cost-effectiveness of a healthy living focused intervention (HL) compared to an alcohol-focused intervention (AF) for problem drinkers identified in hospital. METHODS: A pragmatic, randomised, controlled, open pilot trial. Feasibility and acceptability were measured by recruitment, attrition, follow-up rates and number of treatment sessions attended. Effectiveness was measured using the Alcohol Use Disorders Identification Test score at six months. Additional economic and secondary outcome measures were collected. RESULTS: Eighty-six participants were randomised and 72% (n=62) were retained in full participation. Forty-one participants attended at least one treatment session (48%). A greater proportion in the HL group attended all four treatment sessions (33% vs 19%). Follow-up rates were 29% at six months and 22% at twelve months. There was no evidence of a difference in AUDIT score between treatment groups at six months. Mean cost of health care and social services, policing and the criminal justice system use decreased while EQ-5D scores indicated minor improvement in both arms. However, this pilot trial was not powered to detect differences in either measure between groups. CONCLUSIONS: While no treatment effect was observed, this study demonstrated a potential to engage patients drinking at harmful or dependent levels in a healthy living intervention. However, recruitment proved challenging and follow-up rates were poor. Better ways need to be found to help these patients recognise the harms associated with their drinking and overcome the evident barriers to their engagement with specialist treatment.

Medical specialists' views on the impact of reducing alcohol consumption on prognosis of, and risk of, hospital admission due to specific medical conditions: results from a Delphi survey.

RATIONALE, AIMS AND OBJECTIVES: To find consensus, or lack thereof, on the impact of reducing alcohol consumption on prognosis and the risk of hospital admissions for a number of alcohol-attributable disorders. METHODS: A modified two-round Delphi survey utilizing web-based questionnaires to collect quantitative and qualitative data was used. Alcohol treatment experts from cardiology, emergency medicine, gastroenterology and oncology in the United Kingdom were invited to participate. The main outcomes were median impact ratings (on a scale of 1-9) and consensus (unanimous, strong, moderate, weak or no consensus). RESULTS: Of 192 experts invited to participate, 59 completed first questionnaires. The overall retention rate to the second questionnaires was about 51% (30/59). There was strong support that reducing alcohol consumption could result in improvement in prognosis for gastroenterology and emergency medicine patients; but uncertainty on the benefits for cardiology and oncology patients. Overall, the responses from the expert panel did not reflect the assumption that reducing alcohol consumption would result in benefits on hospital admissions for any of the specialties. The specialists viewed the severity of disorders as important when considering the impact of reducing alcohol consumption. CONCLUSIONS: The highest impact of treatment for problem drinking in hospitals is considered to be for alcohol-related disorders associated with gastroenterology and emergency medicine. At policy level, if targeted screening for alcohol problems by presenting disease or condition is the strategy of choice, it would be logical to implement screening and easily accessible interventions or addiction specialists within these areas where alcohol treatment is considered as having a high impact.

The 2 × 2 cluster randomized controlled factorial trial design is mainly used for efficiency and to explore intervention interactions: a systematic review.

OBJECTIVES: To describe the health care settings, purposes, and study reporting quality of the 2 × 2 cluster randomized controlled factorial trial design. STUDY DESIGN AND SETTING: This study is a systematic review. We searched Medline, Embase, Cochrane Library, and Web of Knowledge for articles published up to May 2012. Cluster randomized controlled 2 × 2 factorial trials in health, evaluating at least one complex intervention, were included. Two authors independently reviewed and extracted data from the studies. RESULTS: Twenty-nine studies covering a wide range of clinical areas and health care settings were included. The cluster design was mostly used to minimize contamination. The factorial design was mostly used to assess the effects of two interventions in the same study and to explore interactions between interventions. However, although most studies explored the presence or absence of intervention interactions, they were often either not sufficiently powered to detect any interactions or did not provide information on whether the study was sufficiently powered to detect any interactions. There was a considerable variability in the reporting of a number of study characteristics and methodological aspects. Study quality was also variable within and across studies. CONCLUSION: The design has been used in a wide range of health care settings and clinical areas to minimize contamination, assess the effects of two interventions in the same study, and explore intervention interactions. There is need for improvement on and guidelines for the reporting of factorial trials.

A systematic review of substance misuse assessment packages.

ISSUES: Health-care systems globally are moving away from process measures of performance to payments for outcomes achieved. It follows that there is a need for a selection of proven quality tools that are suitable for undertaking comprehensive assessments and outcomes assessments. This review aimed to identify and evaluate existing comprehensive assessment packages. The work is part of a national program in the UK, Collaborations in Leadership of Applied Health Research and Care. APPROACH: Systematic searches were carried out across major databases to identify instruments designed to assess substance misuse. For those instruments identified, searches were carried out using the Cochrane Library, Embase, Ovid MEDLINE(®) and PsychINFO to identify articles reporting psychometric data. KEY FINDINGS: From 595 instruments, six met the inclusion criteria: Addiction Severity Index; Chemical Use, Abuse and Dependence Scale; Form 90; Maudsley Addiction Profile; Measurements in the Addictions for Triage and Evaluation; and Substance Abuse Outcomes Module. The most common reasons for exclusion were that instruments were: (i) designed for a specific substance (239); (ii) not designed for use in addiction settings (136); (iii) not providing comprehensive assessment (89); and (iv) not suitable as an outcome measure (20). IMPLICATIONS: The six packages are very different and suited to different uses. No package had adequate evaluation of their properties and so the emphasis should be on refining a small number of tools with very general application rather than creating new ones. An alternative to using 'off-the-shelf' packages is to create bespoke packages from well-validated, single-construct scales. [

Interventions for reducing alcohol consumption among general hospital inpatient heavy alcohol users: a systematic review.

BACKGROUND: There is growing interest in pro-active detection and provision of interventions for heavy alcohol use in the general hospital inpatient population. We aimed to determine, from the available evidence, the effectiveness of interventions in reducing alcohol consumption among general hospital inpatient heavy alcohol users. METHODS: The following databases were searched for completed and on-going randomised and non-randomised controlled studies published up to November 2012: MEDLINE; C2-SPECTR; CINAHL; The Cochrane Library; Conference Proceedings Citation Index: Science; EMBASE; HMIC; PsycInfo; Public Health Interventions Cost Effectiveness Database (PHICED); and ClinicalTrials.gov. Studies were screened independently by two reviewers. Data extraction was performed by one reviewer and independently checked by a second. RESULTS: Twenty-two studies which met the inclusion criteria enrolled 5307 participants in total. All interventions were non-pharmacological and alcohol focused. Results from single session brief interventions and self-help literature showed no clear benefit on alcohol consumption outcomes, with indications of benefit from some studies but not others. However, results suggest brief interventions of more than one session could be beneficial on reducing alcohol consumption, especially for non-dependent patients. No active intervention was found superior over another on alcohol consumption and other outcomes. CONCLUSIONS: Brief interventions of more than one session could be beneficial on reducing alcohol consumption among hospital inpatients, especially for non-dependent patients. However, additional evidence is still needed before more definitive conclusions can be reached.

Screening instruments for detecting illicit drug use/abuse that could be useful in general hospital wards: a systematic review.

AIM: To identify and describe screening instruments for detecting illicit drug use/abuse that are appropriate for use in general hospital wards and review evidence for reliability, validity, feasibility and acceptability. METHODS: Instruments were identified from a number of screening instrument databases/libraries and Google Scholar. They were independently assessed for eligibility by two reviewers. MEDLINE, EMBASE, PSYCINFO, and Cochrane Library were searched for articles published up to February 2010. Two reviewers independently assessed the identified articles for eligibility and extracted data from the eligible studies. RESULTS: 13 instruments, ASSIST, CAGE-AID, DAST, DHQ/PDHQ, DUDIT, DUS, NMASSIST, SIP-AD, SDS, SMAST-AID, SSI-SA, TICS and UNCOPE were included in the review. They had 2 to 28 items and took less than 10 min to administer and score. Evidence on validity, reliability, acceptability and feasibility of instruments in adult patients not known to have a substance abuse problem was scarce. Of the 21 studies included in the review, only one included participants from general hospital wards. Reported sensitivity, specificity and predictive values varied widely both between studies of the same instrument and also between different instruments. No study was identified comparing two or more of the included instruments. CONCLUSION: The review identified and described 13 instruments that could be useful in general hospital wards. There is however lack of evaluation of illicit drug use screening instruments in general hospital wards. Currently clinicians or researchers searching for a simple, reliable, general screening instrument for current drug use to guide practice or research in general hospital wards do not have enough comparative evidence to choose between the available measures.

Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation.

OBJECTIVE: To describe the application of the stepped wedge cluster randomized controlled trial (CRCT) design. STUDY DESIGN AND SETTING: Systematic review. We searched Medline, Embase, PsycINFO, HMIC, CINAHL, Cochrane Library, Web of Knowledge, and Current Controlled Trials Register for articles published up to January 2010. Stepped wedge CRCTs from all fields of research were included. Two authors independently reviewed and extracted data from the studies. RESULTS: Twenty-five studies were included in the review. Motivations for using the design included ethical, logistical, financial, social, and political acceptability and methodological reasons. Most studies were evaluating an intervention during routine implementation. For most of the included studies, there was also a belief or empirical evidence suggesting that the intervention would do more good than harm. There was variation in data analysis methods and insufficient quality of reporting. CONCLUSIONS: The stepped wedge CRCT design has been mainly used for evaluating interventions during routine implementation, particularly for interventions that have been shown to be effective in more controlled research settings, or where there is lack of evidence of effectiveness but there is a strong belief that they will do more good than harm. There is need for consistent data analysis and reporting.