An investigation of the shortcomings of the CONSORT 2010 statement for the reporting of group sequential randomised controlled trials: a methodological systematic review

Background It can be argued that adaptive designs are underused in clinical research. We have explored concerns related to inadequate reporting of such trials, which may influence their uptake. Through a careful examination of the literature, we evaluated the standards of reporting of group sequential (GS) randomised controlled trials, one form of a confirmatory adaptive design. Methods We undertook a systematic review, by searching Ovid MEDLINE from the 1st January 2001 to 23rd September 2014, supplemented with trials from an audit study. We included parallel group, confirmatory, GS trials that were prospectively designed using a Frequentist approach. Eligible trials were examined for compliance in their reporting against the CONSORT 2010 checklist. In addition, as part of our evaluation, we developed a supplementary checklist to explicitly capture group sequential specific reporting aspects, and investigated how these are currently being reported. Results Of the 284 screened trials, 68(24%) were eligible. Most trials were published in “high impact” peer-reviewed journals. Examination of trials established that 46(68%) were stopped early, predominantly either for futility or efficacy. Suboptimal reporting compliance was found in general items relating to: access to full trials protocols; methods to generate randomisation list(s); details of randomisation concealment, and its implementation. Benchmarking against the supplementary checklist, GS aspects were largely inadequately reported. Only 3(7%) trials which stopped early reported use of statistical bias correction. Moreover, 52(76%) trials failed to disclose methods used to minimise the risk of operational bias, due to the knowledge or leakage of interim results. Occurrence of changes to trial methods and outcomes could not be determined in most trials, due to inaccessible protocols and amendments. Discussion and Conclusions There are issues with the reporting of GS trials, particularly those specific to the conduct of interim analyses. Suboptimal reporting of bias correction methods could potentially imply most GS trials stopping early are giving biased results of treatment effects. As a result, research consumers may question credibility of findings to change practice when trials are stopped early. These issues could be alleviated through a CONSORT extension. Assurance of scientific rigour through transparent adequate reporting is paramount to the credibility of findings from adaptive trials. Our systematic literature search was restricted to one database due to resource constraints.

Immediate loading of overdentures: systematic review

Introduction: The goal of implant treatment is the formation of a direct bone-implant interface contact. Purpose: This study aimed to evaluate the possibilities of immediate loading treatment for edentulous patients rehabilitated with mandibular and maxillary overdentures. Material and methods: A literature review using the PubMed and BIREME databases between the periods of 1977 and 2011 was performed. Results: From an initial yield of 218 titles, 78 articles were selected for text analysis, finally resulting in 23 studies (16 prospective, 6 prospective randomized, and 1 prospective multicenter) that met the inclusion criteria. Conclusion: The immediate loading protocol through which the implants are subjected to occlusal function immediately after their placement was introduced to overcome this limitation. © 2013 Springer-Verlag Berlin Heidelberg.

Contributions from the systematic review of economic evaluations: the case of childhood hepatitis A vaccination in Brazil

The aim of this study was to present the contributions of the systematic review of economic evaluations to the development of a national study on childhood hepatitis A vaccination. A literature review was performed in EMBASE, MEDLINE, WOPEC, HealthSTAR, SciELO and LILACS from 1995 to 2010. Most of the studies (8 of 10) showed favorable cost-effectiveness results. Sensitivity analysis indicated that the most important parameters for the results were cost of the vaccine, hepatitis A incidence, and medical costs of the disease. Variability was observed in methodological characteristics and estimates of key variables among the 10 studies reviewed. It is not possible to generalize results or transfer epidemiological estimates of resource utilization and costs associated with hepatitis A to the local context. Systematic review of economic evaluation studies of hepatitis A vaccine demonstrated the need for a national analysis and provided input for the development of a new decision-making model for Brazil.

Alveolar distraction osteogenesis: a systematic review

This literature review was performed to analyse the outcomes of clinical studies of alveolar distraction osteogenesis (DO) listed by PUBMED between January 1996 and December 2006. A PUBMED search identified 128 articles on alveolar DO. Twenty articles covering 209 cases were analysed, considering location, device and procedural parameters, rate of augmentation, aspect of final implant placement and follow up. The mean latency period was 7.26+/-2.31 days, distraction rate 0.71+/-0.27 mm/day, rate of augmentation 6.88+/-2.52 mm and consolidation period 12.22+/-5.58 weeks. A total of 469 implants were placed and followed post loading for an average of 14.19+/-11.03 months, with a survival rate of 97%. Of the different procedural parameters, only the difference between mean consolidation period for failed (8.10+/-2.51 weeks) and successful (12.43+/-5.62 weeks) implants was statistically significant (P=0.01). Use of DO may be advantageous in terms of the success rate of implants placed in augmented sites, but there is still a lack of sufficient data based on long-term follow up. Future experimental studies should evaluate the application of different methods with a view to shortening the overall treatment period and improving the performance of implants placed in distracted alveolar ridges.

Radiofrequency electromagnetic field exposure and non-specific symptoms of ill health: A systematic review

This article is a systematic review of whether everyday exposure to radiofrequency electromagnetic field (RF-EMF) causes symptoms, and whether some individuals are able to detect low-level RF-EMF (below the ICNIRP [International Commission on Non-Ionizing Radiation Protection] guidelines). Peer-reviewed articles published before August 2007 were identified by means of a systematic literature search. Meta-analytic techniques were used to pool the results from studies investigating the ability to discriminate active from sham RF-EMF exposure. RF-EMF discrimination was investigated in seven studies including a total of 182 self-declared electromagnetic hypersensitive (EHS) individuals and 332 non-EHS individuals. The pooled correct field detection rate was 4.2% better than expected by chance (95% CI: -2.1 to 10.5). There was no evidence that EHS individuals could detect presence or absence of RF-EMF better than other persons. There was little evidence that short-term exposure to a mobile phone or base station causes symptoms based on the results of eight randomized trials investigating 194 EHS and 346 non-EHS individuals in a laboratory. Some of the trials provided evidence for the occurrence of nocebo effects. In population based studies an association between symptoms and exposure to RF-EMF in the everyday environment was repeatedly observed. This review showed that the large majority of individuals who claims to be able to detect low level RF-EMF are not able to do so under double-blind conditions. If such individuals exist, they represent a small minority and have not been identified yet. The available observational studies do not allow differentiating between biophysical from EMF and nocebo effects.

Critical Analysis of Bladder Sparing with Trimodal Therapy in Muscle-invasive Bladder Cancer: A Systematic Review.

CONTEXT Aims of bladder preservation in muscle-invasive bladder cancer (MIBC) are to offer a quality-of-life advantage and avoid potential morbidity or mortality of radical cystectomy (RC) without compromising oncologic outcomes. Because of the lack of a completed randomised controlled trial, oncologic equivalence of bladder preservation modality treatments compared with RC remains unknown. OBJECTIVE This systematic review sought to assess the modern bladder-preservation treatment modalities, focusing on trimodal therapy (TMT) in MIBC. EVIDENCE ACQUISITION A systematic literature search in the PubMed and Cochrane databases was performed from 1980 to July 2013. EVIDENCE SYNTHESIS Optimal bladder-preservation treatment includes a safe transurethral resection of the bladder tumour as complete as possible followed by radiation therapy (RT) with concurrent radiosensitising chemotherapy. A standard radiation schedule includes external-beam RT to the bladder and limited pelvic lymph nodes to an initial dose of 40Gy, with a boost to the whole bladder to 54Gy and a further tumour boost to a total dose of 64-65Gy. Radiosensitising chemotherapy with phase 3 trial evidence in support exists for cisplatin and mitomycin C plus 5-fluorouracil. A cystoscopic assessment with systematic rebiopsy should be performed at TMT completion or early after TMT induction. Thus, nonresponders are identified early to promptly offer salvage RC. The 5-yr cancer-specific survival and overall survival rates range from 50% to 82% and from 36% to 74%, respectively, with salvage cystectomy rates of 25-30%. There are no definitive data to support the benefit of using of neoadjuvant or adjuvant chemotherapy. Critical to good outcomes is proper patient selection. The best cancers eligible for bladder preservation are those with low-volume T2 disease without hydronephrosis or extensive carcinoma in situ. CONCLUSIONS A growing body of accumulated data suggests that bladder preservation with TMT leads to acceptable outcomes and therefore may be considered a reasonable treatment option in well-selected patients. PATIENT SUMMARY Treatment based on a combination of resection, chemotherapy, and radiotherapy as bladder-sparing strategies may be considered as a reasonable treatment option in properly selected patients.

Understanding virtual experience and telepresence - a review and synthesis of literature

To enable buyers to be better informed before purchasing, products and services can be virtually experienced on the internet. Research into virtual experience (VE) and the related construct of telepresence (TP) as means of online marketing has made great progress in recent years. However, there is still disagreement in the literature concerning the exact understanding of these terms. In this study, the two terms are analyzed by means of a systematically executed literature review, differentiated from one another, and their understandings explained. This study is to our knowledge the first to compare the concepts of VE and TP in a systematic way. The analysis shows that TP is regarded as the feeling of presence conveyed by a communication medium. VE, on the other hand, is to be defined as an active state of a consumer through the use of computer-based presentation formats, and constituting a subtype of TP. These findings are intended to help VE and TP become more uniformly understood and make it easier to compare the results of future studies. Finally, from the literature review, it is possible to derive focal points for research in future studies.

Cone beam computed tomography (CBCT) for diagnosis and treatment planning in periodontology: A systematic review.

OBJECTIVE The improvement in diagnostic accuracy and optimization of treatment planning in periodontology through the use of three-dimensional imaging with cone beam computed tomography (CBCT) is discussed controversially in the literature. The objective was to identify the best available external evidence for the indications of CBCT for periodontal diagnosis and treatment planning in specific clinical situations. DATA SOURCES A systematic literature search was performed for articles published by 2 March 2015 using electronic databases and hand search. Two reviewers performed the study selection, data collection, and validity assessment. PICO and PRISMA criteria were applied. From the combined search, seven studies were finally included. CONCLUSION The case series were published from the years 2009 to 2014. Five of the included publications refer to maxillary and/or mandibular molars and two to aspects related to vertical bony defects. Two studies show a high accuracy of CBCT in detecting intrabony defect morphology when compared to periapical radiographs. Particularly, in maxillary molars, CBCT provides high accuracy for detecting furcation involvement and morphology of surrounding periodontal tissues. CBCT has demonstrated advantages, when more invasive treatment approaches were considered in terms of decision making and cost benefit. Within their limits, the available data suggest that CBCT may improve diagnostic accuracy and optimize treatment planning in periodontal defects, particularly in maxillary molars with furcation involvement, and that the higher irradiation doses and cost-benefit ratio should be carefully analyzed before using CBCT for periodontal diagnosis and treatment planning.

A systematic review of community-based colorectal cancer screening randomized controlled trials with multi-ethnic groups

Background. The CDC estimates that 40% of adults 50 years of age or older do not receive time-appropriate colorectal cancer screening. Sixty percent of colorectal cancer deaths could be prevented by regular screening of adults 50 years of age and older. Yet, in 2000 only 42.5% of adults age 50 or older in the U.S. had received recommended screening. Disparities by health care, nativity status, socioeconomic status, and race/ethnicity are evident. Disparities in minority, underserved populations prevent us from attaining Goal 2 of Healthy People 2010 to “eliminate health disparities.” This review focuses on community-based screening research among underserved populations that includes multiple ethnic groups for appropriate disparities analysis. There is a gap in the colorectal cancer screening literature describing the effectiveness of community-based randomized controlled trials. ^ Objective. To critically review the literature describing community-based colorectal cancer screening strategies that are randomized controlled trials, and that include multiple racial/ethnic groups. ^ Methods. The review includes a preliminary disparities analysis to assess whether interventions were appropriately targeted in communities to those groups experiencing the greatest health disparities. Review articles are from an original search using Ovid Medline and a cross-matching search in Pubmed, both from January 2001 to June 2009. The Ovid Medline literature review is divided into eight exclusionary stages, seven electronic, and the last stage consisting of final manual review. ^ Results. The final studies (n=15) are categorized into four categories: Patient mailings (n=3), Telephone outreach (n=3), Electronic/multimedia (n=4), and Counseling/community education (n=5). Of 15 studies, 11 (73%) demonstrated that screening rates increased for the intervention group compared to controls, including all studies (100%) from the Patient mailings and Telephone outreach groups, 4 of 5 (80%) Counseling/community education studies, and 1 of 4 (25%) Electronic/multimedia interventions. ^ Conclusions. Patient choice and tailoring education and/or messages to individuals have proven to be two important factors in improving colorectal cancer screening adherence rates. Technological strategies have not been overly successful with underserved populations in community-based trials. Based on limited findings to date, future community-based colorectal cancer screening trials should include diverse populations who are experiencing incidence, survival, mortality and screening disparities. ^

Access to oral care --- A systematic review of a continuing public health issue among older adults

Oral health is essential for the general well being of the individual and collectively for the health of the population. Oral health can be maintained by routine dental care and visits to dental professionals, but accessing professional dental care may be a continuing difficulty in vulnerable older adult population. Many older adults are not frequent users of dental care, though oral health is crucial to their well-being and overall health. Access to care is the timely use of personal health services to achieve the best possible health outcomes. ^ Objectives: The aims of this review are to (i) to analyze and elucidate the relationship between socio-economic disparities in gender, ethnicity, poverty status, education and the continuing public issue of access to oral care, (ii) to identify the underlying causes through which these factors can affect access to oral care. This review will provide a knowledgeable basis for development of interventions to provide adequate access to oral care in older adults and implementing policies to ensure access to oral care; through highlighting the various socio economic factors that affect access to oral care among older adults. ^ Methods: This paper used a purposeful review of literature on socioeconomic disparities in access to oral care among older adults. The references considered in this review included all the relevant articles, surveys and reports published in English language, since the year 1985 to 2010, in the United States. The articles selected were scrutinized for relevancy to the topic of access to oral care and which included discussions of the effects of gender, ethnicity, poverty status, educational status in accessing oral care. ^ Results: Evidence confirmed the continuing disparity in access to oral care among older adults. The possible links identified were gender inequality, ethnic differences, income levels and educational differences affecting access to oral care. The underlying causes linking these factors with access to oral care were established. ^ Conclusion: The analysis of the literature review findings supported the prevalence of disparities in gender, ethnicity, income and education with its possible links affecting access to oral care. The underlying causes helped to understand the reasons behind this growing issue of inaccessible oral care. Further research is needed to develop policies and target dental public health efforts towards specific problem areas ensuring equitable access to oral services and consequently, improve the health of older adults.^

Provider perceptions of physical activity counseling: A systematic review

Background: Although the health benefits of physical activity are well-established, the evidence regarding the efficacy of physical activity counseling by primary care providers is inconclusive. Healthy People 2020 recommends that physicians provide counseling on physical activity to their patients; however, few providers adhere to these guidelines. The primary objective of this review is to systematically summarize and evaluate primary care providers' perceptions and attitudes about physical activity counseling. ^ Methods: A systematic literature search of relevant articles was conducted between January and May 2011 using four databases: MEDLINE (1948 to the present), PsycInfo (1806 to the present), CINAHL Plus with Full Text (1981 to the present), and the Cochrane Library. Studies were included if 1) the study population consisted of primary care providers and, 2) the study evaluated providers' attitudes and perceptions pertaining to physical activity counseling. Both quantitative and studies were considered. ^ Results: Most primary care providers agree that physical activity counseling is important and that they have a role in promoting physical activity to their patients. Providers are uncertain about the effectiveness of counseling, feel only marginally comfortable providing more than general advice about physical activity, and cite major barriers to counseling such as lack of time, lack of training, and lack of reimbursement for their counseling efforts. The evidence in this review suggests that beyond these barriers, providers are more likely to counsel their patients about physical activity if they are active themselves, or if they feel that their patients' condition, such as cardiovascular disease or obesity, would strongly benefit from a lifestyle change. ^ Conclusion: While major barriers to physical activity counseling, such as lack of time for counseling and lack of counseling knowledge still exist, primary care providers are receptive to the idea of acting as physical activity promoters in their clinical practices. However, the barriers encountered need to be addressed on multiple levels (e.g. individual, organizational), and additional training is needed in order for providers to effectively promote the physical activity of their patients.^

Systematic review of mobile dental vans

Objectives. To assess the reach and effectiveness of mobile dental vans as a delivery method by providing access to underserved populations. ^ Methods. A literature review was conducted to identify mobile delivery methods whose aims are to address the increasing oral health disparity concern. Forty articles met the inclusion criteria. Of the 40 articles, only 7 analyzed the reach and coverage of the mobile dental clinics. Data was compiled from the literature to compare and assess the different mobile dental care delivery methods. ^ Results. There is a correlation between transportation barriers and lack of access to healthcare. Mobile dentistry helps to delivery dental care to vulnerable populations. ^ Conclusion. Mobile dental clinics are an effective method in improving access to care in underserved populations, as well as increasing overall oral health in these individuals.^

Medication errors in mental healthcare:a systematic review

Methods: It has been estimated that medication error harms 1-2% of patients admitted to general hospitals. There has been no previous systematic review of the incidence, cause or type of medication error in mental healthcare services. Methods: A systematic literature search for studies that examined the incidence or cause of medication error in one or more stage(s) of the medication-management process in the setting of a community or hospital-based mental healthcare service was undertaken. The results in the context of the design of the study and the denominator used were examined. Results: All studies examined medication management processes, as opposed to outcomes. The reported rate of error was highest in studies that retrospectively examined drug charts, intermediate in those that relied on reporting by pharmacists to identify error and lowest in those that relied on organisational incident reporting systems. Only a few of the errors identified by the studies caused actual harm, mostly because they were detected and remedial action was taken before the patient received the drug. The focus of the research was on inpatients and prescriptions dispensed by mental health pharmacists. Conclusion: Research about medication error in mental healthcare is limited. In particular, very little is known about the incidence of error in non-hospital settings or about the harm caused by it. Evidence is available from other sources that a substantial number of adverse drug events are caused by psychotropic drugs. Some of these are preventable and might probably, therefore, be due to medication error. On the basis of this and features of the organisation of mental healthcare that might predispose to medication error, priorities for future research are suggested.

How well does the theory of planned behaviour predict alcohol consumption? A systematic review and meta-analysis

This study aimed to quantify correlations between theory of planned behaviour (TPB) variables and (i) intentions to consume alcohol and (ii) alcohol consumption. Systematic literature searches identified 40 eligible studies that were meta-analysed. Three moderator analyses were conducted: pattern of consumption, gender of participants and age of participants. Across studies, intentions had the strongest relationship with attitudes (r+ = .62), followed by subjective norms (r+ = .47) and perceived behavioural control (PBC; r+ = .31). Self-efficacy (SE) had a stronger relationship with intentions (r+ = .48) compared with perceived control (PC; r+ = −.10). Intention had the strongest relationship with alcohol consumption (r+ = .54), followed by SE (r+ = .41). In contrast, PBC and PC had negative relationships with alcohol consumption (r+ = −.05 and −.13, respectively). All moderators affected TPB relationships. Patterns of consumption with clear definitions had stronger TPB relations, females reported stronger attitude–intention relations than males, and adults reported stronger attitude–intention and SE–intention relations than adolescents. Recommendations for future research include targeting attitudes and intentions in interventions to reduce alcohol consumption, using clear definitions of alcohol consumption in TPB items to improve prediction and assessing SE when investigating risk behaviours.

Medication review of children on long term medications:a review of the literature

INTRODUCTION: Children on long term medication may be under the care of more than one medical team including the patients GP. Children on chronic medication should be supported and their medications reviewed, especially in cases of polypharmacy. Medicines Use Reviews (MURs) were introduced into the pharmacy contract in 2005. The service was designed for community pharmacists to review patients on long term medication. The service specified that MURs were done on patients who can give consent and cannot be conducted with a parent or carer. Hence the service may be inaccessible to paediatric patients. This review aims to find studies that identify medication review services in primary care that cater for children on long term medication. METHODS: A literature search was conducted on 6th June 2015 using the keywords, ("Medication" or "review" or "Medication Review" or "Medicines use review" or "Medication use review" or "New Medicine Service") AND ("community pharmacy" OR "community pharmacist" OR "primary care" OR "General practice" OR "GP" OR "community paediatrician" OR "community pediatrician" OR "community nurse"). Bibliographic databases used were AMED, British Nursing Index, CINAHL, EMBASE, HMIC, MEDLINE, PsycINFO and Health Business Elite. Inclusion criteria were: paediatric specific medication review in primary care, for example by either a GP, community paediatrician, community nurse or community pharmacist. Exclusion criteria were studies of medication review in adults/unclear patient age and secondary care medication reviews. RESULTS: From the 417 articles, 6 relevant articles were found after abstract and full text review. 235 articles were excluded after title and abstract review (11 did not have full text in English); 96 were adult or non-age specified medication review/MUR/New Medicine Service studies; 63 referred to observational, evaluative studies of interventions in adults; 6 were non-paediatric specific systematic reviews and 17 were protocols, commentaries, news, and letters.The 6 relevant articles consisted of 1 literature review (published 2004), 3 research articles and 1 published protocol. The literature review[1] recommended that children's long term medication should be reviewed. The published protocol stated that the NMS minimum age for inclusion in the trial was for children aged over 13 years of age. The four studies were related to psychiatrists reviewing paediatric mental health patients in the USA, a pharmacist using Drug Related Problem to review patients in GP practices in Australia, a UK study based on an information prescription concept by providing children dispensed medications in community pharmacy with signposting them to health information and one GP practice based study observing pharmaceutical care issues in children and adults. CONCLUSION: The results show that there are currently no known studies on medication use reviews specific to children, whereas in adults, published evaluations are available. The terms of the MUR policy restrict children's access to the service and so more studies are necessary to determine whether children could benefit from such access.