Overinterpretation and misreporting of prognostic factor studies in oncology: a systematic review.

BACKGROUND: Cancer prognostic biomarkers have shown disappointing clinical applicability. The objective of this study was to classify and estimate how study results are overinterpreted and misreported in prognostic factor studies in oncology. METHODS: This systematic review focused on 17 oncology journals with an impact factor above 7. PubMed was searched for primary clinical studies published in 2015, evaluating prognostic factors. We developed a classification system, focusing on three domains: misleading reporting (selective, incomplete reporting, misreporting), misleading interpretation (unreliable statistical analysis, spin) and misleading extrapolation of the results (claiming irrelevant clinical applicability, ignoring uncertainty). RESULTS: Our search identified 10,844 articles. The 98 studies included investigated a median of two prognostic factors (Q1-Q3, 1-7). The prognostic factors' effects were selectively and incompletely reported in 35/98 and 24/98 full texts, respectively. Twenty-nine articles used linguistic spin in the form of strong statements. Linguistic spin rejecting non-significant results was found in 34 full-text results and 15 abstract results sections. One in five articles had discussion and/or abstract conclusions that were inconsistent with the study findings. Sixteen reports had discrepancies between their full-text and abstract conclusions. CONCLUSIONS: Our study provides evidence of frequent overinterpretation of findings of prognostic factor assessment in high-impact medical oncology journals.

Ten simple rules for measuring the impact of workshops.

Workshops are used to explore a specific topic, to transfer knowledge, to solve identified problems, or to create something new. In funded research projects and other research endeavours, workshops are the mechanism used to gather the wider project, community, or interested people together around a particular topic. However, natural questions arise: how do we measure the impact of these workshops? Do we know whether they are meeting the goals and objectives we set for them? What indicators should we use? In response to these questions, this paper will outline rules that will improve the measurement of the impact of workshops.

Reporting guidelines for oncology research: helping to maximise the impact of your research.

Many reports of health research omit important information needed to assess their methodological robustness and clinical relevance. Without clear and complete reporting, it is not possible to identify flaws or biases, reproduce successful interventions, or use the findings in systematic reviews or meta-analyses. The EQUATOR Network (http://www.equator-network.org/) promotes responsible reporting and the use of reporting guidelines to improve the accuracy, completeness, and transparency of health research. EQUATOR supports researchers by providing online resources and training. EQUATOR Oncology, a project funded by Cancer Research UK, aims to support cancer researchers reporting their research through the provision of online resources. In this article, our objective is to highlight reporting issues related to oncology research publications and to introduce reporting guidelines that are designed to aid high-quality reporting. We describe generic reporting guidelines for the main study types, and explain how these guidelines should and should not be used. We also describe 37 oncology-specific reporting guidelines, covering different clinical areas (e.g., haematology or urology) and sections of the report (e.g., methods or study characteristics); most of these are little-used. We also provide some background information on EQUATOR Oncology, which focuses on addressing the reporting needs of the oncology research community.

A proposed framework for developing quality assessment tools.

BACKGROUND: Assessment of the quality of included studies is an essential component of any systematic review. A formal quality assessment is facilitated by using a structured tool. There are currently no guidelines available for researchers wanting to develop a new quality assessment tool. METHODS: This paper provides a framework for developing quality assessment tools based on our experiences of developing a variety of quality assessment tools for studies of differing designs over the last 14 years. We have also drawn on experience from the work of the EQUATOR Network in producing guidance for developing reporting guidelines. RESULTS: We do not recommend a single 'best' approach. Instead, we provide a general framework with suggestions as to how the different stages can be approached. Our proposed framework is based around three key stages: initial steps, tool development and dissemination. CONCLUSIONS: We recommend that anyone who would like to develop a new quality assessment tool follow the stages outlined in this paper. We hope that our proposed framework will increase the number of tools developed using robust methods.

Reaching consensus on reporting patient and public involvement (PPI) in research: methods and lessons learned from the development of reporting guidelines.

INTRODUCTION: Patient and public involvement (PPI) is inconsistently reported in health and social care research. Improving the quality of how PPI is reported is critical in developing a higher quality evidence base to gain a better insight into the methods and impact of PPI. This paper describes the methods used to develop and gain consensus on guidelines for reporting PPI in research studies (updated version of the Guidance for Reporting Patient and Public Involvement (GRIPP2)). METHODS: There were three key stages in the development of GRIPP2: identification of key items for the guideline from systematic review evidence of the impact of PPI on health research and health services, a three-phase online Delphi survey with a diverse sample of experts in PPI to gain consensus on included items and a face-to-face consensus meeting to finalise and reach definitive agreement on GRIPP2. Challenges and lessons learnt during the development of the reporting guidelines are reported. DISCUSSION: The process of reaching consensus is vital within the development of guidelines and policy directions, although debate around how best to reach consensus is still needed. This paper discusses the critical stages of consensus development as applied to the development of consensus for GRIPP2 and discusses the benefits and challenges of consensus development.

A new forum for research on research integrity and peer review.

This editorial explains why we are launching Research Integrity and Peer Review, a new open-access journal that will provide a home to research on ethics, reporting, and evaluation of research. We discuss how the idea to launch this journal came about and identify the gaps in knowledge where we would like to encourage more research and interdisciplinary discussion. We are particularly keen to receive submissions presenting actual research that will increase our understanding and suggest potential solutions to issues related to peer review, study reporting, and research and publication ethics.

Do declarative titles affect readers' perceptions of research findings? A randomized trial.

BACKGROUND: Many journals prohibit the use of declarative titles that state study findings, yet a few journals encourage or even require them. We compared the effects of a declarative versus a descriptive title on readers' perceptions about the strength of evidence in a research abstract describing a randomized trial. METHODS: Study participants (medical or dental students or doctors attending lectures) read two abstracts describing studies of a fictitious treatment (Anticox) for a fictitious condition (Green's syndrome). The first abstract (A1) described an uncontrolled, 10-patient, case series, and the second (A2) described a randomized, placebo-controlled trial involving 48 patients. All participants rated identical A1 abstracts (with a descriptive title) to provide baseline ratings and thus reduce the effects of inter-individual variability. Participants were randomized so that half rated a version of A2 with a descriptive title and half with a declarative title. For each abstract, participants indicated their agreement with the statement "Anticox is an effective treatment for pain in Green's syndrome" using 100 mm visual analogue scales (VAS) ranging from "disagree completely" to "agree completely." VAS scores were measured by an investigator who was unaware of group allocation. RESULTS: One hundred forty-four participants from four centres completed the study. There was no significant difference between the declarative and the descriptive title groups' confidence in the study conclusions as expressed on VAS scales-in fact, the mean difference between A1 and A2 was smaller for the declarative title group than that for the descriptive title group (32.6 mm, SD 27.4 vs. 39.8 mm, SD 22.6, respectively, p = 0.09). CONCLUSIONS: We found no evidence that the use of a declarative title affected readers' perceptions about study conclusions. This suggests that editors' fears that declarative titles might unduly influence readers' judgements about study conclusions may be unfounded, at least in relation to reports of randomized trials. However, our study design had several limitations, and our findings may not be generalizable to other situations.

Interventions to reduce waiting times for elective procedures.

BACKGROUND: Long waiting times for elective healthcare procedures may cause distress among patients, may have adverse health consequences and may be perceived as inappropriate delivery and planning of health care. OBJECTIVES: To assess the effectiveness of interventions aimed at reducing waiting times for elective care, both diagnostic and therapeutic. SEARCH METHODS: We searched the following electronic databases: Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1946-), EMBASE (1947-), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ABI Inform, the Canadian Research Index, the Science, Social Sciences and Humanities Citation Indexes, a series of databases via Proquest: Dissertations & Theses (including UK & Ireland), EconLit, PAIS (Public Affairs International), Political Science Collection, Nursing Collection, Sociological Abstracts, Social Services Abstracts and Worldwide Political Science Abstracts. We sought related reviews by searching the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effectiveness (DARE). We searched trial registries, as well as grey literature sites and reference lists of relevant articles. SELECTION CRITERIA: We considered randomised controlled trials (RCTs), controlled before-after studies (CBAs) and interrupted time series (ITS) designs that met EPOC minimum criteria and evaluated the effectiveness of any intervention aimed at reducing waiting times for any type of elective procedure. We considered studies reporting one or more of the following outcomes: number or proportion of participants whose waiting times were above or below a specific time threshold, or participants' mean or median waiting times. Comparators could include any type of active intervention or standard practice. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from, and assessed risk of bias of, each included study, using a standardised form and the EPOC 'Risk of bias' tool. They classified interventions as follows: interventions aimed at (1) rationing and/or prioritising demand, (2) expanding capacity, or (3) restructuring the intake assessment/referral process.For RCTs when available, we reported preintervention and postintervention values of outcome for intervention and control groups, and we calculated the absolute change from baseline or the effect size with 95% confidence interval (CI). We reanalysed ITS studies that had been inappropriately analysed using segmented time-series regression, and obtained estimates for regression coefficients corresponding to two standardised effect sizes: change in level and change in slope. MAIN RESULTS: Eight studies met our inclusion criteria: three RCTs and five ITS studies involving a total of 135 general practices/primary care clinics, seven hospitals and one outpatient clinic. The studies were heterogeneous in terms of types of interventions, elective procedures and clinical conditions; this made meta-analysis unfeasible.One ITS study evaluating prioritisation of demand through a system for streamlining elective surgery services reduced the number of semi-urgent participants waiting longer than the recommended time (< 90 days) by 28 participants/mo, while no effects were found for urgent (< 30 days) versus non-urgent participants (< 365 days).Interventions aimed at restructuring the intake assessment/referral process were evaluated in seven studies. Four studies (two RCTs and two ITSs) evaluated open access, or direct booking/referral: One RCT, which showed that open access to laparoscopic sterilisation reduced waiting times, had very high attrition (87%); the other RCT showed that open access to investigative services reduced waiting times (30%) for participants with lower urinary tract syndrome (LUTS) but had no effect on waiting times for participants with microscopic haematuria. In one ITS study, same-day scheduling for paediatric health clinic appointments reduced waiting times (direct reduction of 25.2 days, and thereafter a decrease of 3.03 days per month), while another ITS study showed no effect of a direct booking system on proportions of participants receiving a colposcopy appointment within the recommended time. One RCT and one ITS showed no effect of distant consultancy (instant photography for dermatological conditions and telemedicine for ear nose throat (ENT) conditions) on waiting times; another ITS study showed no effect of a pooled waiting list on the number of participants waiting for uncomplicated spinal surgery.Overall quality of the evidence for all outcomes, assessed using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) tool, ranged from low to very low.We found no studies evaluating interventions to increase capacity or to ration demand. AUTHORS' CONCLUSIONS: As only a handful of low-quality studies are presently available, we cannot draw any firm conclusions about the effectiveness of the evaluated interventions in reducing waiting times. However, interventions involving the provision of more accessible services (open access or direct booking/referral) show some promise.

Get the content right: following reporting guidelines will make your research paper more complete, transparent and usable.

Substantial evidence demonstrates widespread shortcomings in the reporting of health research publications. Reporting guidelines represent an effective tool to help improve the completeness and transparency of published papers that are much needed for their future use. Examples of key reporting guidelines (CONSORT, STROBE, COREQ, ENTREQ, PRISMA, STARD, and SQUIRE) are introduced here together with other resources supporting the writing of high quality research publications that are provided by the EQUATOR Network (www.equator-network.org).

Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals.

The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and CONSORT guidance was mentioned. Information regarding endorsement of the ICMJE, trial registration and other reporting guidelines was extracted from the online instructions for authors of the journals included in the study. The search identified 477 references. We assessed a random sample of 240 titles of which 101 were randomized clinical trials published in 56 journals. Trial registration was reported in 19.8% of the randomized clinical trials, 6.9% were prospectively registered and 3% mentioned CONSORT. The ICMJE was mentioned by 68% of the journals and 36% of journals required trial registration. Fewer journals provided advice on reporting guidelines: CONSORT (13%), PRISMA (1.8%), STROBE (1.8%), and the EQUATOR network (3.6%). Wider endorsement of trial registration and adherence to reporting guidelines is necessary in clinical trials conducted in Latin America and the Caribbean.

Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals / Adherencia a las iniciativas de registro de ensayos clínicos y guías de reporte por revistas de América Latina y Caribe / Adesão às iniciativas de registro de ensaios clínicos e normas de notificação por periódicos da América Latina e do Caribe

The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and CONSORT guidance was mentioned. Information regarding endorsement of the ICMJE, trial registration and other reporting guidelines was extracted from the online instructions for authors of the journals included in the study. The search identified 477 references. We assessed a random sample of 240 titles of which 101 were randomized clinical trials published in 56 journals. Trial registration was reported in 19.8% of the randomized clinical trials, 6.9% were prospectively registered and 3% mentioned CONSORT. The ICMJE was mentioned by 68% of the journals and 36% of journals required trial registration. Fewer journals provided advice on reporting guidelines: CONSORT (13%), PRISMA (1.8%), STROBE (1.8%), and the EQUATOR network (3.6%). Wider endorsement of trial registration and adherence to reporting guidelines is necessary in clinical trials conducted in Latin America and the Caribbean.

Se evaluó el nivel de apoyo y cumplimiento a las iniciativas de registro de ensayos clínicos y de guías de reporte de revistas biomédicas de América Latina y Caribe. Se realizó una búsqueda de ensayos clínicos aleatoria en LILACS. Los ensayos clínicos aleatorios fueron evaluados para determinar si los autores informaron del registro de ensayos clínicos y mencionaron la guía CONSORT. Se evaluaron las instrucciones para los autores de las revistas que publicaron los ensayos clínicos aleatorios con el fin de determinar las indicaciones, en relación al registro de ensayos clínicos, las guías de reporte y el ICMJE. Se identificaron 477 citas; una muestra aleatoria de 240 de ellas detectó 101 ensayos clínicos aleatorios. Un 19,8% de los ensayos clínicos aleatorios informaron del registro de ensayos clínicos y un 6,9% fueron registrados prospectivamente; un 3% de los ensayos clínicos aleatorios aludieron a CONSORT. Un 68% de las 56 revistas mencionaron a ICMJE y un 36% requiere el registro de ensayos clínicos. La indicación acerca de otras guías de reporte fue infrecuente: CONSORT 13%, PRISMA 1,8% y STROBE 1,8% y la red EQUATOR 3,6%. Es necesario un mayor apoyo a las iniciativas de registro de ensayos clínicos y guías de reporte en América Latina y Caribe.

Avaliou-se o nível de apoio e cumprimento às iniciativas de registro de ensaios clínicos e aos guias de notificação de periódicos científicos biomédicos da América Latina e do Caribe. Realizou-se uma busca de ensaios clínicos randomizados no LILACS. Esses ensaios foram avaliados para determinar se os autores notificaram o registro de ensaios clínicos e mencionaram as normas do CONSORT. Avaliou-se as instruções para os autores dos periódicos que publicaram ensaios clínicos randomizados a fim de determinar as normas em relação ao registro de ensaios clínicos, os guias de notificação e ao ICMJE. Identificou-se 477 citações; uma amostra aleatória de 240 delas detectou 101 ensaios clínicos randomizados. Dezenove vírgula oito por cento dos ensaios clínicos randomizados reportaram o registro de ensaios clínicos e 6,9% foram registrados antecipadamente; 3% destes ensaios clínicos aludiram ao CONSORT. Sessenta e oito por cento das 56 revistas mencionaram o ICMJE e 36% requerem o registro de ensaios clínicos. Indicação acerca de outros guias de notificação não foi frequente: CONSORT 13%, PRISMA 1,8%, STROBE 1,8% e a rede EQUATOR 3,6%. É necessário um maior apoio às iniciativas de registro de ensaios clínicos e de guias de notificação na América Latina e no Caribe.

Does journal endorsement of reporting guidelines influence the completeness of reporting of health research? A systematic review protocol.

BACKGROUND: Reporting of health research is often inadequate and incomplete. Complete and transparent reporting is imperative to enable readers to assess the validity of research findings for use in healthcare and policy decision-making. To this end, many guidelines, aimed at improving the quality of health research reports, have been developed for reporting a variety of research types. Despite efforts, many reporting guidelines are underused. In order to increase their uptake, evidence of their effectiveness is important and will provide authors, peer reviewers and editors with an important resource for use and implementation of pertinent guidance. The objective of this study was to assess whether endorsement of reporting guidelines by journals influences the completeness of reporting of health studies. METHODS: Guidelines providing a minimum set of items to guide authors in reporting a specific type of research, developed with explicit methodology, and using a consensus process will be identified from an earlier systematic review and from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network's reporting guidelines library. MEDLINE, EMBASE, the Cochrane Methodology Register and Scopus will be searched for evaluations of those reporting guidelines; relevant evaluations from the recently conducted CONSORT systematic review will also be included. Single data extraction with 10% verification of study characteristics, 20% of outcomes and complete verification of aspects of study validity will be carried out. We will include evaluations of reporting guidelines that assess the completeness of reporting: (1) before and after journal endorsement, and/or (2) between endorsing and non-endorsing journals. For a given guideline, analyses will be conducted for individual and the total sum of items. When possible, standard, pooled effects with 99% confidence intervals using random effects models will be calculated. DISCUSSION: Evidence on which guidelines have been evaluated and which are associated with improved completeness of reporting is important for various stakeholders, including editors who consider which guidelines to endorse in their journal editorial policies.

Reporting clinical research: guidance to encourage accurate and transparent research reporting.

To encourage accurate, complete, and transparent reporting of research studies we provide a brief overview of generic guidelines for reporting the main types of clinical research: randomised trials, observational studies in epidemiology, and systematic reviews. These and many other guidelines developed to help authors to achieve the highest standards in their research publications are available on the EQUATOR (Enhancing the Quality and Transparency of Health Research) Network website (www.equator-network.org).

Nueva alianza entre la Organización Panamericana de la Salud y la Red EQUATOR para mejorar la escritura y publicación de estudios de investigación de salud / New alliance between the Panamerican Health Organization and the EQUATOR Network to improve writing and publication of articles on health outcomes research

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Describing reporting guidelines for health research: a systematic review.

OBJECTIVE: To describe the process of development, content, and methods of implementation of reporting guidelines for health research. STUDY DESIGN AND SETTING: A systematic review of publications describing health research reporting guidelines developed using consensus. RESULTS: Eighty-one reporting guidelines for health research were included in the review. The largest number of guidelines do not focus on a specific study type (n=35; 43%), whereas those that do primarily refer to reporting of randomized controlled trials (n=16; 35%). Most of the guidelines (n=76; 94%) include a checklist of recommended reporting items, with a median of 21 checklist items (range: 5-64 items). Forty-seven (58%) reporting guidelines were classified as new guidance. Explanation documents were developed for 11 (14%) reporting guidelines. Reporting-guideline developers provided little information about the guideline development process. Developers of 50 (62%) reporting guidelines encouraged endorsement, most commonly by including guidelines in journal instructions to authors (n=18; 36%). CONCLUSIONS: Reporting-guideline developers need to endeavor to maximize the quality of their product. Recently developed guidance is likely to facilitate more robust guideline development. Journal editors can be more confident in endorsing reporting guidelines that have followed these approaches.

Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network.

Although current electronic methods of scientific publishing offer increased opportunities for publishing all research studies and describing them in sufficient detail, health research literature still suffers from many shortcomings. These shortcomings seriously undermine the value and utility of the literature and waste scarce resources invested in the research. In recent years there have been several positive steps aimed at improving this situation, such as a strengthening of journals' policies on research publication and the wide requirement to register clinical trials.The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative set up to advance high quality reporting of health research studies; it promotes good reporting practices including the wider implementation of reporting guidelines. EQUATOR provides free online resources http://www.equator-network.org supported by education and training activities and assists in the development of robust reporting guidelines. This paper outlines EQUATOR's goals and activities and offers suggestions for organizations and individuals involved in health research on how to strengthen research reporting.

Tamoxifen for relapse of ovarian cancer.

BACKGROUND: Tamoxifen is an important drug for treating breast cancer. Ovarian cancer cells are known to possess receptors for hormones and may thus also respond to tamoxifen. OBJECTIVES: Tamoxifen is used to treat breast cancer in women whose tumours have oestrogen receptors. Since ovarian cancers also commonly have oestrogen receptors, it has been suggested that tamoxifen may be of some benefit. The objective of this review was to assess the effects of tamoxifen in women with relapsed ovarian cancer. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 1, 2009. Cochrane Gynaecological Cancer Group Trials Register, MEDLINE from 2002 to April 2009, EMBASE from 2002 to April 2009. We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of review articles and contacted experts in the field, as well as drugs companies. SELECTION CRITERIA: Randomised and non-randomised studies of tamoxifen in women with ovarian cancer who have not responded to conventional chemotherapy. Only trials involving 10 or more patients were included. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. No trials were found and therefore no data were analysed. MAIN RESULTS: The search strategy identified 1392 unique references of which 1360 were excluded on the basis of title and abstract. The remaining 32 articles were retrieved in full, but none satisfied the inclusion criteria. Only observational data from single arm studies of women treated with tamoxifen were reported. AUTHORS' CONCLUSIONS: We are unable to make any evidence-based recommendations as we found no comparative studies assessing the effectiveness of tamoxifen in women with recurrent ovarian cancer. There is limited evidence on anti-tumour activity from phase 2 studies, but these contain no data on the effect of tamoxifen on symptom control, QOL or the prolongation of life.

Guidance for developers of health research reporting guidelines.

David Moher and colleagues from the EQUATOR network offer guidance and recommended steps for developing health research reporting guidelines.