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1.
PLoS Biol ; 21(10): e3002255, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37792683

RESUMEN

Open Peer Review is gaining prominence in attention and use, but to responsibly open up peer review, there is an urgent need for additional evidence. Here, we propose a preliminary research agenda and issue a call to action.

2.
PLoS Biol ; 20(8): e3001773, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-35984842

RESUMEN

Various stakeholders in science have put research integrity high on their agenda. Among them, research funders are prominently placed to foster research integrity by requiring that the organizations and individual researchers they support make an explicit commitment to research integrity. Moreover, funders need to adopt appropriate research integrity practices themselves. To facilitate this, we recommend that funders develop and implement a Research Integrity Promotion Plan (RIPP). This Consensus View offers a range of examples of how funders are already promoting research integrity, distills 6 core topics that funders should cover in a RIPP, and provides guidelines on how to develop and implement a RIPP. We believe that the 6 core topics we put forward will guide funders towards strengthening research integrity policy in their organization and guide the researchers and research organizations they fund.


Asunto(s)
Proyectos de Investigación , Investigadores , Humanos , Políticas
4.
Sci Eng Ethics ; 26(6): 3053-3067, 2020 12.
Artículo en Inglés | MEDLINE | ID: mdl-32789752

RESUMEN

Citing of previous publications is an important factor in knowledge development. Because of the great amount of publications available, only a selection of studies gets cited, for varying reasons. If the selection of citations is associated with study outcome this is called citation bias. We will study determinants of citation in a broader sense, including e.g. study design, journal impact factor or the funding source of the publication. As a case study we assess which factors drive citation in the human literature on phthalates, specifically the metabolite mono(2-ethylhexyl) phthalate (MEHP). A systematic literature search identified all relevant publications on human health effect of MEHP. Data on potential determinants of citation were extracted in duplo. Specialized software was used to create a citation network, including all potential citation pathways. Random effect logistic regression was used to assess whether these determinants influence the likelihood of citation. 112 Publications on MEHP were identified, with 5684 potential citation pathways of which 551 were actual citations. Reporting of a harmful point estimate, journal impact factor, authority of the author, a male corresponding author, research performed in North America and self-citation were positively associated with the likelihood of being cited. In the literature on MEHP, citation is mostly driven by a number of factors that are not related to study outcome. Although the identified determinants do not necessarily give strong indications of bias, it shows selective use of published literature for a variety of reasons.


Asunto(s)
Factor de Impacto de la Revista , Ácidos Ftálicos , Sesgo , Estudios Epidemiológicos , Humanos , Masculino
5.
BMC Med Ethics ; 20(1): 64, 2019 09 18.
Artículo en Inglés | MEDLINE | ID: mdl-31533704

RESUMEN

BACKGROUND: Most studies are inclined to report positive rather than negative or inconclusive results. It is currently unknown how clinicians appraise the results of a randomized clinical trial. For example, how does the study funding source influence the appraisal of an RCT, and do positive findings influence perceived credibility and clinical relevance? This study investigates whether psychiatrists' appraisal of a scientific abstract is influenced by industry funding disclosures and a positive outcome. METHODS: Dutch psychiatrists were randomized to evaluate a scientific abstract describing a fictitious RCT for a novel antipsychotic drug. Four different abstracts were created reporting either absence or presence of industry funding disclosure as well as a positive or a negative outcome. Primary outcomes were the perceived credibility and clinical relevance of the study results (10-point Likert scale). Secondary outcomes were the assessment of methodological quality and interest in reading the full article. RESULTS: Three hundred ninety-five psychiatrists completed the survey (completion rate 45%). Industry funding disclosure was found not to influence perceived credibility (Mean Difference MD 0.12; 95% CI - 0.28 to 0.47, p?) nor interpretation of its clinical relevance (MD 0.14; 95% CI - 0.54 to 0.27, p?). A negative outcome was perceived as more credible than a positive outcome (MD 0.81 points; 95% Confidence Interval (CI) 0.43 to 1.18, p?), but did not affect clinical relevance scores (MD -0.14; 95% CI - 0.54 to 0.27). CONCLUSIONS: In this study, industry funding disclosure was not associated with the perceived credibility nor judgement of clinical relevance of a fictional RCT by psychiatrists. Positive study outcomes were found to be less credible compared to negative outcomes, but industry funding had no significant effects. Psychiatrists may underestimate the influence of funding sources on research results. The fact that physicians indicated negative outcomes to be more credible may point to more awareness of existing publication bias in the scientific literature.


Asunto(s)
Ensayos Clínicos como Asunto/economía , Ensayos Clínicos como Asunto/ética , Conflicto de Intereses , Industria Farmacéutica/economía , Industria Farmacéutica/ética , Psiquiatría/economía , Psiquiatría/ética , Apoyo a la Investigación como Asunto/ética , Humanos , Países Bajos
8.
J Clin Epidemiol ; 166: 111229, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38052277

RESUMEN

OBJECTIVES: To determine the reproducibility of biomedical systematic review search strategies. STUDY DESIGN AND SETTING: A cross-sectional reproducibility study was conducted on a random sample of 100 systematic reviews indexed in MEDLINE in November 2021. The primary outcome measure is the percentage of systematic reviews for which all database searches can be reproduced, operationalized as fulfilling six key Preferred Reporting Items for Systematic reviews and Meta-Analyses literature search extension (PRISMA-S) reporting guideline items and having all database searches reproduced within 10% of the number of original results. Key reporting guideline items included database name, multi-database searching, full search strategies, limits and restrictions, date(s) of searches, and total records. RESULTS: The 100 systematic review articles contained 453 database searches. Only 22 (4.9%) database searches reported all six PRISMA-S items. Forty-seven (10.4%) database searches could be reproduced within 10% of the number of results from the original search; six searches differed by more than 1,000% between the originally reported number of results and the reproduction. Only one systematic review article provided the necessary search details to be fully reproducible. CONCLUSION: Systematic review search reporting is poor. To correct this will require a multifaceted response from authors, peer reviewers, journal editors, and database providers.


Asunto(s)
Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Estudios Transversales , Bases de Datos Factuales , MEDLINE , Reproducibilidad de los Resultados
9.
Cochrane Database Syst Rev ; (8): CD003010, 2013 Aug 19.
Artículo en Inglés | MEDLINE | ID: mdl-23959683

RESUMEN

BACKGROUND: Traction has been used to treat low-back pain (LBP), often in combination with other treatments. We included both manual and machine-delivered traction in this review. This is an update of a Cochrane review first published in 1995, and previously updated in 2006. OBJECTIVES: To assess the effects of traction compared to placebo, sham traction, reference treatments and no treatment in people with LBP. SEARCH METHODS: We searched the Cochrane Back Review Group Specialized Register, the Cochrane Central Register of Controlled Trials (2012, Issue 8), MEDLINE (January 2006 to August 2012), EMBASE (January 2006 to August 2012), CINAHL (January 2006 to August 2012), and reference lists of articles and personal files. The review authors are not aware of any important new randomized controlled trial (RCTs) on this topic since the date of the last search. SELECTION CRITERIA: RCTs involving traction to treat acute (less than four weeks' duration), subacute (four to 12 weeks' duration) or chronic (more than 12 weeks' duration) non-specific LBP with or without sciatica. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. As there were insufficient data for statistical pooling, we performed a descriptive analysis. We did not find any case series that identified adverse effects, therefore we evaluated adverse effects that were reported in the included studies. MAIN RESULTS: We included 32 RCTs involving 2762 participants in this review. We considered 16 trials, representing 57% of all participants, to have a low risk of bias based on the Cochrane Back Review Group's 'Risk of bias' tool.For people with mixed symptom patterns (acute, subacute and chronic LBP with and without sciatica), there was low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status, global improvement or return to work when compared to placebo, sham traction or no treatment. Similarly, when comparing the combination of physiotherapy plus traction with physiotherapy alone or when comparing traction with other treatments, there was very-low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status or global improvement.For people with LBP with sciatica and acute, subacute or chronic pain, there was low- to moderate-quality evidence that traction probably has no impact on pain intensity, functional status or global improvement. This was true when traction was compared with controls and other treatments, as well as when the combination of traction plus physiotherapy was compared with physiotherapy alone. No studies reported the effect of traction on return to work.For chronic LBP without sciatica, there was moderate-quality evidence that traction probably makes little or no difference in pain intensity when compared with sham treatment. No studies reported on the effect of traction on functional status, global improvement or return to work.Adverse effects were reported in seven of the 32 studies. These included increased pain, aggravation of neurological signs and subsequent surgery. Four studies reported that there were no adverse effects. The remaining studies did not mention adverse effects. AUTHORS' CONCLUSIONS: These findings indicate that traction, either alone or in combination with other treatments, has little or no impact on pain intensity, functional status, global improvement and return to work among people with LBP. There is only limited-quality evidence from studies with small sample sizes and moderate to high risk of bias. The effects shown by these studies are small and are not clinically relevant. Implications for practice To date, the use of traction as treatment for non-specific LBP cannot be motivated by the best available evidence. These conclusions are applicable to both manual and mechanical traction. Implications for research Only new, large, high-quality studies may change the point estimate and its accuracy, but it should be noted that such change may not necessarily favour traction. Therefore, little priority should be given to new studies on the effect of traction treatment alone or as part of a package.


Asunto(s)
Dolor de la Región Lumbar/terapia , Ciática/terapia , Tracción , Dolor Agudo/terapia , Dolor Crónico/terapia , Humanos , Dolor de la Región Lumbar/complicaciones , Dimensión del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto , Ciática/complicaciones , Tracción/efectos adversos
10.
Qual Life Res ; 21(4): 651-7, 2012 May.
Artículo en Inglés | MEDLINE | ID: mdl-21732199

RESUMEN

BACKGROUND: The COSMIN checklist is a standardized tool for assessing the methodological quality of studies on measurement properties. It contains 9 boxes, each dealing with one measurement property, with 5-18 items per box about design aspects and statistical methods. Our aim was to develop a scoring system for the COSMIN checklist to calculate quality scores per measurement property when using the checklist in systematic reviews of measurement properties. METHODS: The scoring system was developed based on discussions among experts and testing of the scoring system on 46 articles from a systematic review. Four response options were defined for each COSMIN item (excellent, good, fair, and poor). A quality score per measurement property is obtained by taking the lowest rating of any item in a box ("worst score counts"). RESULTS: Specific criteria for excellent, good, fair, and poor quality for each COSMIN item are described. In defining the criteria, the "worst score counts" algorithm was taken into consideration. This means that only fatal flaws were defined as poor quality. The scores of the 46 articles show how the scoring system can be used to provide an overview of the methodological quality of studies included in a systematic review of measurement properties. CONCLUSIONS: Based on experience in testing this scoring system on 46 articles, the COSMIN checklist with the proposed scoring system seems to be a useful tool for assessing the methodological quality of studies included in systematic reviews of measurement properties.


Asunto(s)
Lista de Verificación/normas , Control de Calidad , Calidad de Vida , Literatura de Revisión como Asunto , Humanos , Psicometría , Reproducibilidad de los Resultados , Encuestas y Cuestionarios
11.
PLoS One ; 17(2): e0263023, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35171921

RESUMEN

Prevalence of research misconduct, questionable research practices (QRPs) and their associations with a range of explanatory factors has not been studied sufficiently among academic researchers. The National Survey on Research Integrity targeted all disciplinary fields and academic ranks in the Netherlands. It included questions about engagement in fabrication, falsification and 11 QRPs over the previous three years, and 12 explanatory factor scales. We ensured strict identity protection and used the randomized response method for questions on research misconduct. 6,813 respondents completed the survey. Prevalence of fabrication was 4.3% (95% CI: 2.9, 5.7) and of falsification 4.2% (95% CI: 2.8, 5.6). Prevalence of QRPs ranged from 0.6% (95% CI: 0.5, 0.9) to 17.5% (95% CI: 16.4, 18.7) with 51.3% (95% CI: 50.1, 52.5) of respondents engaging frequently in at least one QRP. Being a PhD candidate or junior researcher increased the odds of frequently engaging in at least one QRP, as did being male. Scientific norm subscription (odds ratio (OR) 0.79; 95% CI: 0.63, 1.00) and perceived likelihood of detection by reviewers (OR 0.62, 95% CI: 0.44, 0.88) were associated with engaging in less research misconduct. Publication pressure was associated with more often engaging in one or more QRPs frequently (OR 1.22, 95% CI: 1.14, 1.30). We found higher prevalence of misconduct than earlier surveys. Our results suggest that greater emphasis on scientific norm subscription, strengthening reviewers in their role as gatekeepers of research quality and curbing the "publish or perish" incentive system promotes research integrity.


Asunto(s)
Investigación Biomédica/ética , Ética en Investigación , Proyectos de Investigación/normas , Investigadores/ética , Mala Conducta Científica/ética , Mala Conducta Científica/estadística & datos numéricos , Estudios Transversales , Femenino , Humanos , Masculino , Prevalencia , Encuestas y Cuestionarios
12.
F1000Res ; 11: 471, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36128558

RESUMEN

Background: Traditionally, research integrity studies have focused on research misbehaviors and their explanations. Over time, attention has shifted towards preventing questionable research practices and promoting responsible ones. However, data on the prevalence of responsible research practices, especially open methods, open codes and open data and their underlying associative factors, remains scarce. Methods: We conducted a web-based anonymized questionnaire, targeting all academic researchers working at or affiliated to a university or university medical center in The Netherlands, to investigate the prevalence and potential explanatory factors of 11 responsible research practices. Results: A total of 6,813 academics completed the survey, the results of which show that prevalence of responsible practices differs substantially across disciplines and ranks, with 99 percent avoiding plagiarism in their work but less than 50 percent pre-registering a research protocol. Arts and humanities scholars as well as PhD candidates and junior researchers engaged less often in responsible research practices. Publication pressure negatively affected responsible practices, while mentoring, scientific norms subscription and funding pressure stimulated them. Conclusions: Understanding the prevalence of responsible research practices across disciplines and ranks, as well as their associated explanatory factors, can help to systematically address disciplinary- and academic rank-specific obstacles, and thereby facilitate responsible conduct of research.


Asunto(s)
Humanidades , Investigadores , Humanos , Países Bajos , Prevalencia , Universidades
13.
Cochrane Database Syst Rev ; (6): CD001250, 2011 Jun 15.
Artículo en Inglés | MEDLINE | ID: mdl-21678332

RESUMEN

BACKGROUND: Ultrasound is used in the treatment of a wide variety of musculoskeletal disorders, which include acute ankle sprains. This is an update of a Cochrane review first published in 1999, and previously updated in 2004. OBJECTIVES: To evaluate the effects of ultrasound therapy in the treatment of acute ankle sprains. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 3), MEDLINE (1966 to September 2010), EMBASE (1983 to September 2010), CINAHL (1982 to 2004), and PEDro - the Physiotherapy Evidence Database (accessed 01/06/09). We also searched the Cochrane Rehabilitation and Related Therapies Field database, reference lists of articles, and contacted colleagues.The WHO International Clinical Trials Registry Platform was searched for ongoing trials. SELECTION CRITERIA: Randomised or quasi-randomised trials were included if the following conditions were met: at least one study group was treated with therapeutic ultrasound; participants had acute lateral ankle sprains; and outcome measures included general improvement, pain, swelling, functional disability, or range of motion. DATA COLLECTION AND ANALYSIS: Two authors independently performed study selection, and assessed the risk of bias and extracted data. Risk ratios and risk differences together with 95% confidence intervals were calculated for dichotomous outcomes and mean differences together with 95% confidence intervals for continuous outcome measures. Limited pooling of data was undertaken where there was clinical homogeneity in terms of participants, treatments, outcomes, and follow-up time points. MAIN RESULTS: Six trials were included, involving 606 participants. Five trials included comparisons of ultrasound therapy with sham ultrasound; and three trials included single comparisons of ultrasound with three other treatments. The assessment of risk of bias was hampered by poor reporting of trial methods and results. None of the five placebo-controlled trials (sham ultrasound) demonstrated statistically significant differences between true and sham ultrasound therapy for any outcome measure at one to four weeks of follow-up. The pooled risk ratio for general improvement at one week was 1.04 (random-effects model, 95% confidence interval 0.92 to 1.17) for active versus sham ultrasound. The differences between intervention groups were generally small, between zero and six per cent, for most dichotomous outcomes. AUTHORS' CONCLUSIONS: The evidence from the five small placebo-controlled trials included in this review does not support the use of ultrasound in the treatment of acute ankle sprains. The potential treatment effects of ultrasound appear to be generally small and of probably of limited clinical importance, especially in the context of the usually short-term recovery period for these injuries. However, the available evidence is insufficient to rule out the possibility that there is an optimal dosage schedule for ultrasound therapy that may be of benefit.


Asunto(s)
Traumatismos del Tobillo/terapia , Esguinces y Distensiones/terapia , Terapia por Ultrasonido , Enfermedad Aguda , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto
14.
Res Integr Peer Rev ; 6(1): 5, 2021 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-33648609

RESUMEN

BACKGROUND: A proposal to encourage the preregistration of research on research integrity was developed and adopted as the Amsterdam Agenda at the 5th World Conference on Research Integrity (Amsterdam, 2017). This paper reports on the degree to which abstracts of the 6th World Conference in Research Integrity (Hong Kong, 2019) reported on preregistered research. METHODS: Conference registration data on participants presenting a paper or a poster at 6th WCRI were made available to the research team. Because the data set was too small for inferential statistics this report is limited to a basic description of results and some recommendations that should be considered when taking further steps to improve preregistration. RESULTS: 19% of the 308 presenters preregistered their research. Of the 56 usable cases, less than half provided information on the six key elements of the Amsterdam Agenda. Others provided information that invalidated their data, such as an uninformative URL. There was no discernable difference between qualitative and quantitative research. CONCLUSIONS: Some presenters at the WCRI have preregistered their research on research integrity, but further steps are needed to increase frequency and completeness of preregistration. One approach to increase preregistration would be to make it a requirement for research presented at the World Conferences on Research Integrity.

15.
Trials ; 22(1): 791, 2021 Nov 11.
Artículo en Inglés | MEDLINE | ID: mdl-34763714

RESUMEN

BACKGROUND: Problems continue to exist with the reporting quality and risk of bias in search methods and strategies in systematic reviews and related review types. Peer reviewers who are not familiar with what is required to transparently and fully report a search may not be prepared to review the search components of systematic reviews, nor may they know what is likely to introduce bias into a search. Librarians and information specialists, who have expertise in searching, may offer specialized knowledge that would help improve systematic review search reporting and lessen risk of bias, but they are underutilized as methodological peer reviewers. METHODS: This study will evaluate the effect of adding librarians and information specialists as methodological peer reviewers on the quality of search reporting and risk of bias in systematic review searches. The study will be a pragmatic randomized controlled trial using 150 systematic review manuscripts submitted to BMJ and BMJ Open as the unit of randomization. Manuscripts that report on completed systematic reviews and related review types and have been sent for peer review are eligible. For each manuscript randomized to the intervention, a librarian/information specialist will be invited as an additional peer reviewer using standard practices for each journal. First revision manuscripts will be assessed in duplicate for reporting quality and risk of bias, using adherence to 4 items from PRISMA-S and assessors' judgements on 4 signaling questions from ROBIS Domain 2, respectively. Identifying information from the manuscripts will be removed prior to assessment. DISCUSSION: The primary outcomes for this study are quality of reporting as indicated by differences in the proportion of adequately reported searches in first revision manuscripts between intervention and control groups and risk of bias as indicated by differences in the proportions of first revision manuscripts with high, low, and unclear bias. If the intervention demonstrates an effect on search reporting or bias, this may indicate a need for journal editors to work with librarians and information specialists as methodological peer reviewers. TRIAL REGISTRATION: Open Science Framework. Registered on June 17, 2021, at https://doi.org/10.17605/OSF.IO/W4CK2 .


Asunto(s)
Bibliotecólogos , Humanos , Servicios de Información , Revisión por Pares , Ensayos Clínicos Controlados Aleatorios como Asunto , Informe de Investigación
16.
J Clin Epidemiol ; 132: 71-78, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33278612

RESUMEN

OBJECTIVES: When the probability of being cited depends on the outcome of that study, this is called citation bias. The aim of this study is to assess the determinants of citation and how these compare across six different biomedical research fields. STUDY DESIGN AND SETTING: Citation network analyses were performed for six biomedical research questions. After identifying all relevant publications, all potential citations were mapped together with the actually performed citations in each network. As determinants of citation we assessed the following: study outcome, study design, sample size, journal impact factor, gender, affiliation, authority and continent of the corresponding author, funding source, title of the publication, number of references, and self-citation. Random effect logistic regression analysis was used to assess these factors. RESULTS: Four out of six networks showed evidence for citation bias. Self-citation, authority of the author, and journal impact factor were also positively associated with the probability of citation in all networks. CONCLUSION: The probability of being cited seems associated with positive study outcomes, the authority of its authors, and the journal in which that article is published. In addition, each network showed specific characteristics that impact the citation dynamics and that need to be considered when performing and interpreting citation analyses.


Asunto(s)
Bibliometría , Investigación Biomédica/métodos , Sesgo de Publicación/estadística & datos numéricos , Proyectos de Investigación , Humanos
17.
BMC Med Res Methodol ; 10: 22, 2010 Mar 18.
Artículo en Inglés | MEDLINE | ID: mdl-20298572

RESUMEN

BACKGROUND: The COSMIN checklist (COnsensus-based Standards for the selection of health status Measurement INstruments) was developed in an international Delphi study to evaluate the methodological quality of studies on measurement properties of health-related patient reported outcomes (HR-PROs). In this paper, we explain our choices for the design requirements and preferred statistical methods for which no evidence is available in the literature or on which the Delphi panel members had substantial discussion. METHODS: The issues described in this paper are a reflection of the Delphi process in which 43 panel members participated. RESULTS: The topics discussed are internal consistency (relevance for reflective and formative models, and distinction with unidimensionality), content validity (judging relevance and comprehensiveness), hypotheses testing as an aspect of construct validity (specificity of hypotheses), criterion validity (relevance for PROs), and responsiveness (concept and relation to validity, and (in) appropriate measures). CONCLUSIONS: We expect that this paper will contribute to a better understanding of the rationale behind the items, thereby enhancing the acceptance and use of the COSMIN checklist.


Asunto(s)
Lista de Verificación , Técnica Delphi , Indicadores de Salud , Humanos , Investigación Cualitativa , Resultado del Tratamiento
18.
BMC Med Res Methodol ; 10: 82, 2010 Sep 22.
Artículo en Inglés | MEDLINE | ID: mdl-20860789

RESUMEN

BACKGROUND: The COSMIN checklist is a tool for evaluating the methodological quality of studies on measurement properties of health-related patient-reported outcomes. The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist (n = 114). METHODS: 75 articles evaluating measurement properties were randomly selected from the bibliographic database compiled by the Patient-Reported Outcome Measurement Group, Oxford, UK. Raters were asked to assess the methodological quality of three articles, using the COSMIN checklist. In a one-way design, percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item. RESULTS: 88 raters participated. Of the 75 selected articles, 26 articles were rated by four to six participants, and 49 by two or three participants. Overall, percentage agreement was appropriate (68% was above 80% agreement), and the kappa coefficients for the COSMIN items were low (61% was below 0.40, 6% was above 0.75). Reasons for low inter-rater agreement were need for subjective judgement, and accustom to different standards, terminology and definitions. CONCLUSIONS: Results indicated that raters often choose the same response option, but that it is difficult on item level to distinguish between articles. When using the COSMIN checklist in a systematic review, we recommend getting some training and experience, completing it by two independent raters, and reaching consensus on one final rating. Instructions for using the checklist are improved.


Asunto(s)
Lista de Verificación , Indicadores de Salud , Evaluación de Resultado en la Atención de Salud/normas , Publicaciones Periódicas como Asunto/normas , Lista de Verificación/métodos , Interpretación Estadística de Datos , Variaciones Dependientes del Observador , Investigación Cualitativa , Reproducibilidad de los Resultados
19.
Qual Life Res ; 19(4): 539-49, 2010 May.
Artículo en Inglés | MEDLINE | ID: mdl-20169472

RESUMEN

BACKGROUND: Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist. METHODS: A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated 'agree' or 'strongly agree'. RESULTS: Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed. CONCLUSIONS: The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.


Asunto(s)
Técnica Delphi , Indicadores de Salud , Internacionalidad , Evaluación de Resultado en la Atención de Salud/métodos , Proyectos de Investigación , Humanos , Psicometría , Calidad de Vida , Reproducibilidad de los Resultados , Perfil de Impacto de Enfermedad , Estadística como Asunto , Encuestas y Cuestionarios
20.
Cochrane Database Syst Rev ; (2): CD007431, 2010 Feb 17.
Artículo en Inglés | MEDLINE | ID: mdl-20166095

RESUMEN

BACKGROUND: Low-back pain with leg pain (sciatica) may be caused by a herniated intervertebral disc exerting pressure on the nerve root. Most patients will respond to conservative treatment, but in carefully selected patients, surgical discectomy may provide faster relief of symptoms. Primary care clinicians use patient history and physical examination to evaluate the likelihood of disc herniation and select patients for further imaging and possible surgery. OBJECTIVES: (1) To assess the performance of tests performed during physical examination (alone or in combination) to identify radiculopathy due to lower lumbar disc herniation in patients with low-back pain and sciatica;(2) To assess the influence of sources of heterogeneity on diagnostic performance. SEARCH STRATEGY: We searched electronic databases for primary studies: PubMed (includes MEDLINE), EMBASE, and CINAHL, and (systematic) reviews: PubMed and Medion (all from earliest until 30 April 2008), and checked references of retrieved articles. SELECTION CRITERIA: We considered studies if they compared the results of tests performed during physical examination on patients with back pain with those of diagnostic imaging (MRI, CT, myelography) or findings at surgery. DATA COLLECTION AND ANALYSIS: Two review authors assessed the quality of each publication with the QUADAS tool, and extracted details on patient and study design characteristics, index tests and reference standard, and the diagnostic two-by-two table. We presented information on sensitivities and specificities with 95% confidence intervals (95% CI) for all aspects of physical examination. Pooled estimates of sensitivity and specificity were computed for subsets of studies showing sufficient clinical and statistical homogeneity. MAIN RESULTS: We included 16 cohort studies (median N = 126, range 71 to 2504) and three case control studies (38 to100 cases). Only one study was carried out in a primary care population. When used in isolation, diagnostic performance of most physical tests (scoliosis, paresis or muscle weakness, muscle wasting, impaired reflexes, sensory deficits) was poor. Some tests (forward flexion, hyper-extension test, and slump test) performed slightly better, but the number of studies was small. In the one primary care study, most tests showed higher specificity and lower sensitivity compared to other settings.Most studies assessed the Straight Leg Raising (SLR) test. In surgical populations, characterized by a high prevalence of disc herniation (58% to 98%), the SLR showed high sensitivity (pooled estimate 0.92, 95% CI: 0.87 to 0.95) with widely varying specificity (0.10 to 1.00, pooled estimate 0.28, 95% CI: 0.18 to 0.40). Results of studies using imaging showed more heterogeneity and poorer sensitivity. The crossed SLR showed high specificity (pooled estimate 0.90, 95% CI: 0.85 to 0.94) with consistently low sensitivity (pooled estimate 0.28, 95% CI: 0.22 to 0.35).Combining positive test results increased the specificity of physical tests, but few studies presented data on test combinations. AUTHORS' CONCLUSIONS: When used in isolation, current evidence indicates poor diagnostic performance of most physical tests used to identify lumbar disc herniation. However, most findings arise from surgical populations and may not apply to primary care or non-selected populations. Better performance may be obtained when tests are combined.


Asunto(s)
Desplazamiento del Disco Intervertebral/diagnóstico , Dolor de la Región Lumbar/etiología , Examen Físico/métodos , Radiculopatía/etiología , Humanos , Desplazamiento del Disco Intervertebral/complicaciones , Región Lumbosacra , Examen Físico/normas , Ciática/etiología
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