Risk Of Bias Criteria Research Articles

The Influence of Light Wavelength on Human HPA Axis Rhythms: A Systematic Review.

Environmental light entrains many physiological and behavioural processes to the 24 h solar cycle. Such light-driven circadian rhythms are centrally controlled by the suprachiasmatic nucleus (SCN), which receives information from the short-wavelength-sensitive intrinsically photosensitive retinal ganglion cells. The SCN synchronizes local clocks throughout the body affecting sleep/wake routines and the secretion of neuroendocrine-linked hormones such as melatonin from the pineal gland and cortisol via the hypothalamic pituitary adrenal (HPA) axis. Although the effects of light parameters on melatonin have been recently reviewed, whether the experimental variation of the spectral power distribution and intensity of light can induce changes in cortisol rhythms remains unclear. Thus, this systematic review evaluated the effects of daytime exposure to lights of different spectral wavelength characteristics and luminance intensity on the cortisol levels in healthy individuals. A search of the PubMed, Web of Science, EMBASE, CINAHL, Medline, PsycINFO and Cochrane Library databases on 19 June 2023 identified 3418 articles, of which 12 studies (profiling 337 participants) met the inclusion and risk of bias criteria. An analysis of the literature indicated that exposure to bright lights of any colour during the late night or early morning can induce significant increases in cortisol secretion relative to time-matched dim light comparison conditions. Furthermore, exposure to bright lights with stronger short-wavelength (blue/green) components in the early morning typically induced greater increases in cortisol relative to lights with stronger long-wavelength (red) components. Thus, the circadian regulation of cortisol is sensitive to the wavelength composition of environmental lighting, in line with the more commonly studied melatonin. As such, wavelength characteristics should be optimized and reported in light intervention studies (particularly for the investigation of cortisol-associated disorders and HPA axis function), and exposure to short-wavelength light during sensitive periods should be carefully considered in constructed environments (e.g., bedroom and classroom lighting and device screens).

Estimating the global health impact of gender-based violence and violence against children: a systematic review and meta-analysis protocol

IntroductionExposure to gender-based violence (GBV) and violence against children (VAC) can result in substantial morbidity and mortality. Previous reviews of health outcomes associated with GBV and VAC have focused on...

Acupuncture for Pain and Function in Patients with Nonspecific Low Back Pain: Study Protocol for an Up-to-Date Systematic Review and Meta-Analysis.

AimTo assess the pain and function of acupuncture in patients with nonspecific low back pain (NSLBP).DesignThis is a study protocol for an upcoming, updated systematic review and meta-analysis. We have registered on the PROSPERO platform, and the registration number is CRD42020149647.MethodsWe will identify studies in seven English databases, including Web of Science, Cochrane Library, CINAHL, Physiotherapy Evidence Database, Medline, Embase, and Scopus, and in four Chinese databases, including China National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBMdisc), Wanfang Database, and VIP database. We will also manually search key journals about acupuncture, the references of identified relevant trials, and the Clinical Trials Registry Platform. Different search strategies of Medical Subject Headings (MeSH) and non-MeSH terms will be applied alone or integrated. We will evaluate methodological quality by adopting Cochrane’s risk of bias criteria and perform a meta-analysis using RevMan V.5.4 software.ResultsThis study’s results will be reported according to the PRISMA checklist and presented at an authoritative scientific conference or an authoritative scientific journal.

A protocol for a systematic review of behaviour change techniques used in the context of stillbirth prevention.

Background: Stillbirth is a devastating pregnancy outcome that affects approximately 3.5 per 1000 births in high-income countries. Previous research has highlighted the importance of focusing prevention efforts on targeting risk factors and vulnerable groups. A wide range of risk factors has been associated with stillbirth before, including maternal behaviours such as back sleep position, smoking, alcohol intake, illicit drug use, and inadequate attendance at antenatal care. Given the modifiable nature of these risk factors, there has been an increase in the design of behaviour change interventions targeting such behaviours to reduce the risk of stillbirth. Objectives: The aim of this study is to identify all behavioural interventions with a behavioural component designed and trialled for the prevention of stillbirth in high-income countries, and to identify the behaviour change techniques (BCTs) used in such interventions using the Behaviour Change Techniques Taxonomy V1 (BCTTv1). Inclusion criteria: Interventions will be included in this review if they (1) have the objective of reducing stillbirth rates with a focus on behavioural risk factors; (2) are implemented in high-income countries; (3) target pregnant women or women of childbearing age; and (4) are published in research articles. Methods: A systematic search of the literature will be conducted. The results of the search will be screened against our inclusion criteria by two authors. The following data items will be extracted from the selected papers: general information, study characteristics, participant and intervention/approach details. The Cochrane Effective Practice and Organization of Care (EPOC) risk of bias criteria will be used to assess the methodological quality of included studies. Intervention content will be coded for BCTs as present (+) or absent (-) by two authors using the BCTTv1, discrepancies will be discussed with a third author. A narrative synthesis approach will be used to present the results of this systematic review.

Efficacy and Safety of Eucalyptus for Relieving Cough: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Objectives: To assess the efficacy and safety of Eucalyptus globulus Labill (Eucalyptus) on cough. Background: Cough is a common symptom of upper respiratory tract infections (URTIs) and bronchitis. Eucalyptus products are frequently used as over-the-counter cough medications but their efficacy and safety are uncertain. Methods: Randomized controlled trials (RCTs) investigating efficacy and safety of Eucalyptus for cough were systematically searched in electronic databases till February 2021. Two reviewers independently performed study selection, data extraction, and quality assessment. Clinical outcomes including improvement or resolution of overall cough symptoms, cough frequency (CF), and adverse events (AEs) of Eucalyptus were evaluated and analyzed using a random-effects model. Heterogeneity was evaluated using I2 and chi-squared test. Results: Six RCTs with 1,857 participants with cough were included in this study. Most of the included studies used Eucalyptus in combination formula (four of six studies). Based on Cochrane's risk of bias criteria, three of six studies (50%) were rated low risk of bias, whereas the remaining were judged as high risk of bias. This study found that Eucalyptus products are more effective than placebo in terms of improvement or resolution of overall cough symptoms with relative risk 1.45 (95% confidence interval (95% CI) 1.26-1.67). Whereas all Eucalyptus formulae reduced CF with weighted mean difference 0.44 (95% CI 0.28-0.60), when compared with placebo. There are no serious AEs associated with Eucalyptus during treatment periods. Mild-to-moderate gastrointestinal symptoms were common AEs reported in a comparable study between Eucalyptus and control groups. Conclusion: The findings indicate that Eucalyptus products are safe for use in cough related to respiratory diseases such as URTIs and bronchitis. However, their efficacy is minimal and of uncertain clinical importance. Further high-quality studies are still necessary to confirm this finding.

Instruments for assisted vaginal birth.

Instruments for assisted vaginal birth.

Physiological track-and-trigger/early warning systems for use in maternity care.

A considerable challenge for maternity care providers is recognising clinical deterioration early in pregnant women. Professional bodies recommend the use of clinical assessment protocols or evaluation tools, commonly referred to as physiological track-and-trigger systems (TTS) or early warning systems (EWS), as a means of helping maternity care providers recognise actual or potential clinical deterioration early. TTS/EWS are clinician-administered (midwife, obstetrician), bedside physiological assessment protocols, charts or tools designed to record routinely assessed clinical parameters; that is, blood pressure, temperature, heart rate, urine output and mental/neurological alertness. In general, these systems involve the application of scores or alert indicators to the observed physiological parameters based on their prespecified limits of normality. The overall system score or alert limit is then used to assist the maternity care provider identify a need to escalate care. This, in turn, may allow for earlier intervention(s) to alter the course of the emerging critical illness and ultimately reduce or avoid mortality and morbidity sequelae. To evaluate the clinical- and cost-effectiveness of maternal physiological TTS/EWS on pregnancy, labour and birth, postpartum (up to 42 days) and neonatal outcomes. We searched Cochrane Pregnancy and Childbirth's Trials Register (28 May 2021), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 June 2021), OpenGrey, the ProQuest Dissertations and Theses database (7 June 2021), and reference lists of retrieved studies. We included randomised and quasi-randomised controlled trials (RCTs), including cluster-RCTs, comparing physiological TTS/EWS with no system or another system. Participants were women who were pregnant or had given birth within the previous 42 days, at high risk and low risk for pregnancy, labour and birth, and postpartum complications. Two review authors (VS and MN) independently assessed all identified papers for inclusion and performed risk of bias assessments. Any discrepancies were resolved through discussion and consensus. Data extraction was also conducted independently by two review authors (VS and MN) and checked for accuracy. We used the summary odds ratio (OR) with 95% confidence intervals (CIs) to present the results for dichotomous data and the mean difference (MD) with 95% CI to present the results for continuous data. We included two studies, a parallel RCT involving 700 women and a stepped-wedge cluster trial involving 536,233 women. Both studies were published in 2019, and both were conducted in low-resource settings. The interventions were the 'Saving Mothers Score' (SMS) and the CRADLE Vital Sign Alert (VSA) device, and both interventions were compared with standard care. Both studies had low or unclear risk of bias on all seven risk of bias criteria. Evidence certainty, assessed using GRADE, ranged from very low to moderate certainty, mainly due to other bias as well as inconsistency and imprecision. For women randomised to TTS/EWS compared to standard care there is probably little to no difference in maternal death (OR 0.80, 95% CI 0.30 to 2.11; 1 study, 536,233 participants; moderate-certainty evidence). Use of TTS/EWS compared to standard care may reduce total haemorrhage (OR 0.36, 95% CI 0.19 to 0.69; 1 study, 700 participants; low-certainty evidence). For women randomised to TTS/EWS compared to standard care there may be little to no difference insepsis (OR 0.21, 95% CI 0.02 to 1.80; 1 study, 700 participants; low-certainty evidence), eclampsia (OR 1.50, 95% CI 0.74 to 3.03; 2 studies, 536,933 participants; low-certainty evidence) and HELLP (OR 0.21, 95% CI 0.01 to 4.40; 1 study, 700 participants; very low-certainty evidence), and probably little to no difference in maternal admission to the intensive care unit (ICU) (OR 0.78, 95% CI 0.53 to 1.15; 2 studies, 536,933 participants; moderate-certainty evidence). Use of TTS/EWS compared to standard care may reduce a woman's length of hospital stay (MD -1.21, 95% CI -1.78 to -0.64; 1 study, 700 participants; low-certainty evidence) but may result in little to no difference in neonatal death (OR 1.06, 95% CI 0.62 to 1.84; 1 study, 700 participants; low-certainty evidence). Cost-effectiveness measures were not measured in either of the two studies. AUTHORS' CONCLUSIONS: Use of TTS/EWS in maternity care may be helpful in reducing some maternal outcomes such as haemorrhage and maternal length of hospital stay, possibly through early identification of clinical deterioration and escalation of care. The evidence suggests that the use of TTS/EWS compared to standard care probably results in little to no difference in maternal death and may result in little to no difference in neonatal death. Both of the included studies were conducted in low-resource settings where the use of TTS/EWS might potentially confer a different effect to TTS/EWS use in high-resource settings. Further high-quality trials in high- and middle-resource settings, as well as in discrete populations of high- and low-risk women, are required.

A systematic review assessing the potential for release of vector species from competition following insecticide-based population suppression of Anopheles species in Africa

BackgroundWhile insecticide-based vector control can effectively target vector species in areas of high malaria endemicity, such as Anopheles gambiae in Africa, residual disease transmission can occur. Understanding the potential role of competitive displacement between vector species could inform both current insecticide-based vector control programmes and the development of future complementary interventions.MethodsA systematic review was conducted to identify published studies of insecticide-based vector control of Anopheles species in Africa that reported indices for absolute densities of vector species. After screening against inclusion, exclusion and risk of bias criteria, studies were assigned to three categories based on whether they showed population density changes involving decreases in two or more vector species (D), increases in two or more vector species (I), or increases in one vector species concomitant with decreases in another vector species (ID). Category ID studies could thus provide evidence consistent with the release of vector species from competition following the insecticide-based population suppression of Anopheles species.ResultsOf 5569 papers identified in searches, 30 were selected for quantitative and qualitative analysis. Nineteen studies were assigned to category D and one to category I. Ten studies categorised as ID provided evidence ranging from weak to persuasive that release from competition could have contributed to changes in species composition. Category ID showed no statistical differences from category D for reductions in malaria transmission and levels of insecticide resistance, but did so for insecticide type, pyrethroids being associated with category ID. A qualitative assessment identified five studies that provided the most convincing evidence that release from competition could have contributed to changes in species composition.ConclusionsThis review identified evidence that insecticide-based reductions in the density of Anopheles species in Africa could facilitate the release of other vector species from competition. While it remains uncertain whether this evidence is representative of most entomological sequelae of insecticide-based vector control in the field, five studies provided persuasive evidence that insecticide use could lead, at least under some circumstances, to competitive release of non-targeted vector species. These results should inform current and future integrated vector management approaches to malaria control.Graphical abstract

A protocol for a systematic review of behaviour change techniques used in the context of stillbirth prevention

Background: Stillbirth is a devastating pregnancy outcome that affects approximately 3.5 per 1000 births in high-income countries. Previous research has highlighted the importance of focusing prevention efforts on targeting risk factors and vulnerable groups. A wide range of risk factors has been associated with stillbirth before, including maternal behaviours such as back sleep position, smoking, alcohol intake, illicit drug use, and inadequate attendance at antenatal care. Given the modifiable nature of these risk factors, there has been an increase in the design of behaviour change interventions targeting such behaviours to reduce the risk of stillbirth. Objectives: The aim of this study is to identify all behavioural interventions with a behavioural component designed and trialled for the prevention of stillbirth in high-income countries, and to identify the behaviour change techniques (BCTs) used in such interventions using the Behaviour Change Techniques Taxonomy V1 (BCTTv1). Inclusion criteria: Interventions will be included in this review if they (1) have the objective of reducing stillbirth rates with a focus on behavioural risk factors; (2) are implemented in high-income countries; (3) target pregnant women or women of childbearing age; and (4) are published in research articles. Methods: A systematic search of the literature will be conducted. The results of the search will be screened against our inclusion criteria by two authors. The following data items will be extracted from the selected papers: general information, study characteristics, participant and intervention/approach details. The Cochrane Effective Practice and Organization of Care (EPOC) risk of bias criteria will be used to assess the methodological quality of included studies. Intervention content will be coded for BCTs as present (+) or absent (-) by two authors using the BCTTv1, discrepancies will be discussed with a third author. A narrative synthesis approach will be used to present the results of this systematic review.

Extended lymph node resection versus standard resection for pancreatic head and peri-ampullary adenocarcinoma: A systemic review

Abstract Objective For patients with pancreatic and peri-ampullary adenocarcinoma, it has been hypothesized that extended lymphadenectomy may result in higher R0 resection rates and improved survival. As such, the objective of this systematic review was to compare the oncologic outcomes after pancreaticoduodenectomy (PD) with standard lymphadenectomy (SLA) versus PD with extended lymphadenectomy (ELA). Methods A Cochrane systematic review was conducted to identify all randomized controlled trials comparing PD with SLA versus PD with ELA for participants with periampullary or pancreatic cancer. The following electronic databases were reviewed: the Cochrane Central Register of Controlled Trials; MEDLINE; PubMed and EMBASE. The methodological quality of the included studies was assessed using the Cochrane risk of bias criteria and the quality of evidence for important outcomes using GRADE. Extended lymphadenectomy included the interaortocaval space, left side of the celiac trunk, and superior mesenteric artery. Results Seven randomized controlled trials were included with 843 patients (421 ELA and 422 SLA). No difference in overall survival (1- and 3-years after surgery) was seen between groups. Mortality and morbidity rates (including pancreatic fistula, delayed gastric emptying, and postoperative bleeding) were similar between the two groups. Operative time was significantly longer following extended resection (Mean Difference 50.1 min; 95% CI 19.2 to 81.1 min; P = 0.001). Total amount of blood loss during surgery was significantly increased following extended resection (Mean Difference 137 ml; 95% CI 12 to 263 ml; P = 0.03), as well as transfusion requirements (Mean Difference 0.15 units; 95% CI 0.13 to 0.17 units; P < 0.00001). More lymph nodes were retrieved during ELA (Mean Difference 11 nodes; 95% CI 7 to 15 nodes; P < 0.00001). Incidence of positive resection margins was not different between groups. Conclusion There is no indication for extended lymphadenectomy in pancreatic head resection as a routine procedure.

Tuberculosis treatment intervention trials in Africa: A cross-sectional bibliographic study and spatial analysis.

Mycobacterium Tuberculosis (TB) poses a substantial burden in sub-Saharan Africa and is the leading cause of death amongst infectious diseases. Randomised controlled trials (RCTs) are regarded as the gold standard for evaluating the effectiveness of interventions. We aimed to describe published TB treatment trials conducted in Africa. This is a cross-sectional study of published TB trials conducted in at least one African country. In November 2019, we searched three databases using the validated Africa search filter and Cochrane's sensitive trial string. Published RCTs conducted in at least one African country were included for analysis. Records were screened for eligibility. Co-reviewers assisted with duplicate data extraction. Extracted data included: the country where studies were conducted, publication dates, ethics statement, trial registration number, participant's age range. We used Cochrane's Risk of Bias criteria to assess methodological quality. We identified 10,495 records; 175 trials were eligible for inclusion. RCTs were published between 1952 and 2019. The median sample size was 206 participants (interquartile range: 73-657). Most trials were conducted in South Africa (n = 83) and were drug therapy trials (n = 130). First authors were from 30 countries globally. South Africa had the most first authors (n = 55); followed by the United States of America (USA) (n = 28) and Great Britain (n = 14) with fewer other African countries contributing to the first author tally. Children under 13 years of age eligible to participate in the trials made up 17/175 trials (9.71%). International governments (n = 29) were the most prevalent funders. Ninety-four trials provided CONSORT flow diagrams. Methodological quality such as allocation concealment and blinding were poorly reported or unclear in most trials. By mapping African TB trials, we were able to identify potential research gaps. Many of the global north's researchers were found to be the lead authors in these African trials. Few trials tested behavioural interventions compared to drugs, and far fewer tested interventions on children compared to adults to improve TB outcomes. Lastly, funders and researchers should ensure better methodological quality reporting of trials.

Management of Mental Health Disorders, Substance Use Disorders, and Suicide in Adults with Spinal Cord Injury: Clinical Practice Guideline for Healthcare Providers.

Management of Mental Health Disorders, Substance Use Disorders, and Suicide in Adults with Spinal Cord Injury: Clinical Practice Guideline for Healthcare Providers.

Efficacy and Safety of Mecobalamin on Peripheral Neuropathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Objectives: To assess the efficacy and safety of mecobalamin on peripheral neuropathy. Background: Mecobalamin is an active form of vitamin B12 that has been suggested to be beneficial in improving nerve conduction and neuropathic pain symptoms. Although it is already widely used in Asia for the treatment of peripheral neuropathies, its efficacy remains unclear. Methods: Relevant electronic databases were systematically searched for randomized controlled trials investigating the efficacy and safety of mecobalamin on peripheral neuropathy, from inception through December 2019. Study selection, data extraction, and quality assessment were performed independently by two reviewers. The clinical therapeutic efficacy, pain score, neuropathic symptom score, nerve conduction velocities (NCVs), and adverse events of mecobalamin were assessed and were pooled by using a random-effects model. Heterogeneity was assessed by I2 and chi-squared tests. Results: Fifteen studies with 1707 peripheral neuropathy patients caused by diabetic peripheral neuropathy and herpetic neuropathy were included. Based on Cochrane's risk of bias criteria, most of the included studies (11/15, 73%) were rated high risk of bias, whereas 20% and 7% were rated some concerns and low risk of bias, respectively. In terms of the proportion of patients achieving clinical therapeutic efficacy, mecobalamin alone (risk ratio [RR] = 1.17; 95% confidence interval [CI] 1.03-1.33) and mecobalamin in combination (RR = 1.32; 95% CI 1.21-1.45) are more effective than active control. For NCV outcomes, only mecobalamin combination treatment was effective. Neither mecobalamin alone nor mecobalamin in combination is effective on the pain score and neuropathic symptom outcomes. No serious adverse events associated with mecobalamin were reported during the treatment periods. Conclusion: Our findings indicate that mecobalamin in combination may be effective in improving clinical therapeutic efficacy and NCV outcomes for peripheral neuropathy patients, but the evidence is not clear for mecobalamin alone. More high-quality studies are required to confirm this finding.

Systematic review of the characteristics of brief team interventions to clarify roles and improve functioning in healthcare teams.

Describe brief (less than half a day) interventions aimed at improving healthcare team functioning. A systematic review on brief team interventions aimed at role clarification and team functioning (PROSPERO Registration Number: CRD42018088922). Experimental or quasi-experimental studies were included. Database searches included CINAHL, Medline, EMBASE, PUBMED, Cochrane, RCT Registry-1990 to April 2020 and grey literature. Articles were screened independently by teams of two reviewers. Risk of bias was assessed. Data from the retained articles were extracted by one reviewer and checked by a second reviewer independently. A narrative synthesis was undertaken. Searches yielded 1928 unique records. Final sample contained twenty papers describing 19 studies, published between 2009 and 2020. Studies described brief training interventions conducted in acute care in-patient settings and included a total of 6338 participants. Participants' socio-demographic information was not routinely reported. Studies met between two to six of the eight risk of bias criteria. Interventions included simulations for technical skills, structured communications and speaking up for non-technical skills and debriefing. Debriefing sessions generally lasted between five to 10 minutes. Debriefing sessions reflected key content areas but it was not always possible to determine the influence of the debriefing session on participants' learning because of the limited information reported. Interest in short team interventions is recent. Single two-hour sessions appear to improve technical skills. Three to four 30- to 60-minute training sessions spread out over several weeks with structured facilitation and debriefing appear to improve non-technical skills. Monthly meetings appear to sustain change over time. Short team interventions show promise to improve team functioning. Effectiveness of interventions in primary care and the inclusion of patients and families needs to be examined. Primary care teams are structured differently than teams in acute care and they may have different priorities.

The perceived value of the academic library: a systematic review

Introduction. Academic libraries increasingly need to justify their contributions to their funding institution. Data on the impact and value of the library serves to render libraries' value visible. This review explores how funding institutions, the public, users and staff perceive the value of the academic library. Method. Scopus, Library and Information Science Abstracts, and ProQuest Dissertations & Theses Global were used as data sources for the comprehensive search strategy. Analysis. Study selection was done independently by two reviewers. Risk of bias criteria as well as a data extraction form was developed. Evaluation and data extraction were done by the first author and confirmed by the second author. Results. The included studies use quantitative as well as qualitative methods. They focus on varying groups (e.g., international students, librarians, faculty members) from institutions all over the world (e.g., United States, the United Arab Emirates, the United Kingdom). Conclusions. A number of facets of values are identified and they can be described as input (resources, space and staff) and services. Furthermore, a number of the facets indicate that the values of academic libraries are not solely understood by their input and services.

PROTOCOL: Effects of preventive nutrition interventions among adolescents on health and nutritional status in low- and middle-income countries: a systematic review.

PROTOCOL: Effects of preventive nutrition interventions among adolescents on health and nutritional status in low- and middle-income countries: a systematic review.

PROTOCOL: Effects of lifestyle modification interventions to prevent and manage child and adolescent obesity: a systematic review.

PROTOCOL: Effects of lifestyle modification interventions to prevent and manage child and adolescent obesity: a systematic review.

Fetal movement counting for assessment of fetal wellbeing.

Fetal movement counting for assessment of fetal wellbeing.

Family-based programmes for preventing smoking by children and adolescents.

There is evidence that family and friends influence children's decisions to smoke. To assess the effectiveness of interventions to help families stop children starting smoking. We searched 14 electronic bibliographic databases, including the Cochrane Tobacco Addiction Group specialized register, MEDLINE, EMBASE, PsycINFO, CINAHL unpublished material, and key articles' reference lists. We performed free-text internet searches and targeted searches of appropriate websites, and hand-searched key journals not available electronically. We consulted authors and experts in the field. The most recent search was 3 April 2014. There were no date or language limitations. Randomised controlled trials (RCTs) of interventions with children (aged 5-12) or adolescents (aged 13-18) and families to deter tobacco use. The primary outcome was the effect of the intervention on the smoking status of children who reported no use of tobacco at baseline. Included trials had to report outcomes measured at least six months from the start of the intervention. We reviewed all potentially relevant citations and retrieved the full text to determine whether the study was an RCT and matched our inclusion criteria. Two authors independently extracted study data for each RCT and assessed them for risk of bias. We pooled risk ratios using a Mantel-Haenszel fixed effect model. Twenty-seven RCTs were included. The interventions were very heterogeneous in the components of the family intervention, the other risk behaviours targeted alongside tobacco, the age of children at baseline and the length of follow-up. Two interventions were tested by two RCTs, one was tested by three RCTs and the remaining 20 distinct interventions were tested only by one RCT. Twenty-three interventions were tested in the USA, two in Europe, one in Australia and one in India.The control conditions fell into two main groups: no intervention or usual care; or school-based interventions provided to all participants. These two groups of studies were considered separately.Most studies had a judgement of 'unclear' for at least one risk of bias criteria, so the quality of evidence was downgraded to moderate. Although there was heterogeneity between studies there was little evidence of statistical heterogeneity in the results. We were unable to extract data from all studies in a format that allowed inclusion in a meta-analysis.There was moderate quality evidence family-based interventions had a positive impact on preventing smoking when compared to a no intervention control. Nine studies (4810 participants) reporting smoking uptake amongst baseline non-smokers could be pooled, but eight studies with about 5000 participants could not be pooled because of insufficient data. The pooled estimate detected a significant reduction in smoking behaviour in the intervention arms (risk ratio [RR] 0.76, 95% confidence interval [CI] 0.68 to 0.84). Most of these studies used intensive interventions. Estimates for the medium and low intensity subgroups were similar but confidence intervals were wide. Two studies in which some of the 4487 participants already had smoking experience at baseline did not detect evidence of effect (RR 1.04, 95% CI 0.93 to 1.17).Eight RCTs compared a combined family plus school intervention to a school intervention only. Of the three studies with data, two RCTS with outcomes for 2301 baseline never smokers detected evidence of an effect (RR 0.85, 95% CI 0.75 to 0.96) and one study with data for 1096 participants not restricted to never users at baseline also detected a benefit (RR 0.60, 95% CI 0.38 to 0.94). The other five studies with about 18,500 participants did not report data in a format allowing meta-analysis. One RCT also compared a family intervention to a school 'good behaviour' intervention and did not detect a difference between the two types of programme (RR 1.05, 95% CI 0.80 to 1.38, n = 388).No studies identified any adverse effects of intervention. There is moderate quality evidence to suggest that family-based interventions can have a positive effect on preventing children and adolescents from starting to smoke. There were more studies of high intensity programmes compared to a control group receiving no intervention, than there were for other compairsons. The evidence is therefore strongest for high intensity programmes used independently of school interventions. Programmes typically addressed family functioning, and were introduced when children were between 11 and 14 years old. Based on this moderate quality evidence a family intervention might reduce uptake or experimentation with smoking by between 16 and 32%. However, these findings should be interpreted cautiously because effect estimates could not include data from all studies. Our interpretation is that the common feature of the effective high intensity interventions was encouraging authoritative parenting (which is usually defined as showing strong interest in and care for the adolescent, often with rule setting). This is different from authoritarian parenting (do as I say) or neglectful or unsupervised parenting.

The Relationship between Risk of Bias Criteria, Research Outcomes, and Study Sponsorship in a Cohort of Preclinical Thiazolidinedione Animal Studies: A Meta-Analysis.

ABSTRACTIntroductionThere is little evidence regarding the influence of conflicts of interest on preclinical research. This study examines whether industry sponsorship is associated with increased risks of bias and/or effect sizes of outcomes in published preclinical thiazolidinedione (TZD) studies.MethodsWe identified preclinical TZD studies published between January 1, 1965, and November 14, 2012. Coders independently extracted information on study design criteria aimed at reducing bias, results for all relevant outcomes, sponsorship source and investigator financial ties from the 112 studies meeting the inclusion criteria. The average standardized mean difference (SMD) across studies was calculated for plasma glucose (efficacy outcome) and weight gain (harm outcome). In subgroup analyses, TZD outcomes were assessed by sponsorship source and risk of bias criteria.ResultsSeven studies were funded by industry alone, 17 studies funded by both industry and non‐industry, 49 studies funded by non‐industry alone and 39 studies had no disclosures. None of the studies used sample size calculations, intention‐to‐treat analyses, blinding of investigators or concealment of allocation. Most studies reported favourable results (88 of 112) and conclusions (95 of 112) supporting TZD use. Efficacy estimates were significantly larger in six studies sponsored by industry alone (−3.41; 95% CI −5.21, −1.53; I2 = 93%) versus 42 studies sponsored by non‐industry sources (−0.97; 95% CI −1.37, −0.56; I2 = 81%; p‐value = 0.01). Harms estimates were significantly larger in four studies sponsored by industry alone (5.00; 95% CI 1.22, 8.77; I2 = 93%) versus 38 studies sponsored by non‐industry sources (0.30; 95% CI −0.08, 0.68; I2 = 79%; p‐value = 0.02). TZD efficacy and harms did not differ by disclosure of financial COIs or risks of bias.ConclusionsIndustry‐sponsored TZD animal studies have exaggerated efficacy and harms outcomes compared with studies funded by non‐industry sources. There was poor reporting of COIs.