Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2021-057555 on 20 June 2022. Downloaded from http://bmjopen.bmj.com/ on July 14, 2023 at Sant Paul Hospital Consortia. Protected by Mapping Chilean clinical research: a protocol for a scoping review and multiple evidence gap maps Javier Bracchiglione ‍ ‍,1 Nicolás Meza ‍ ‍,1 Juan Victor Ariel Franco,2 Camila Micaela Escobar Liquitay ‍ ‍,3 Sergio R Munoz ‍ ‍,4 Gerard Urrutia,5 Eva Madrid ‍ ‍1 To cite: Bracchiglione J, ABSTRACT Meza N, Franco JVA, et al. Introduction Clinical research broadly aims to influence STRENGTHS AND LIMITATIONS OF THIS STUDY Mapping Chilean clinical decision-­making in order to promote appropriate ⇒ The protocol for this scoping review includes a com- research: a protocol for a prehensive electronic and hand search strategy. healthcare. Funding agencies should prioritise scoping review and multiple ⇒ We will be able to accurately elucidate local evi- research projects according to needed research topics, evidence gap maps. BMJ Open methodological and cost-­effectiveness considerations, and dence gaps by first constructing evidence grids and 2022;12:e057555. doi:10.1136/ bmjopen-2021-057555 expected social value. In Chile, there is no local diagnosis then populating them with the results of our search. regarding recent clinical research that might inform ⇒ Considering that we used the estimations from the ► Prepublication history and Global Burden of Disease 2019 for prioritising the prioritisation for future research funding. This research additional supplemental material most important diseases in Chile, we might be ne- aims to comprehensively identify and classify Chilean for this paper are available glecting some important clinical entities, such as health research studies, elaborating evidence gap maps online. To view these files, for the most burdensome local conditions. multicomponent diseases. please visit the journal online Methods and analysis We will search in electronic ⇒ We will develop gap maps only for the 20 conditions (http://dx.doi.org/10.1136/​ bmjopen-2021-057555). databases (MEDLINE, Embase, PsycINFO, CINAHL, LILACS with the highest burden in Chile. and WoS) and perform hand searches to retrieve, identify copyright. Received 20 September 2021 and classify health research studies conducted in Chile Accepted 01 June 2022 or by authors whose affiliations are based in Chile, from translation, decision support and imple- 2000 onwards. We will elaborate evidence matrices mentation in clinical settings, which should for the 20 conditions with the highest burden in Chile ultimately guide the generation of primary (according to the Global Burden of Disease 2019) selected research (on prevention, aetiology, diagnosis, from those defined under the General Regime of the treatment and prognosis of any health condi- Health Guarantees Act. To elaborate the evidence gap tion or disease).1 2 © Author(s) (or their maps, we will consider prioritised interventions and core employer(s)) 2022. Re-­use Good quality clinical research, which must outcome sets. To identify knowledge gaps and estimate permitted under CC BY. redundant research, we will contrast these gap maps with be set on priority questions,3 4 is essential for Published by BMJ. elucidating the best approaches to solve health the available international evidence of high or moderate 1 Interdisciplinary Centre for certainty of evidence, for each specific clinical question. challenges;5 aiming at informing decision-­ Health Studies (CIESAL), making to make healthcare more effective, For this purpose, we will search systematic reviews Universidad de Valparaíso, Valparaiso, Chile using the Grading of Recommendations, Assessment, less harmful and less expensive.6 However, 2 Institute of General Practice, Development and Evaluation (GRADE) approach. much concern exists about poor design and Heinrich-­Heine-­University Ethics and dissemination No ethical approval is required deficient conduction and reporting,7 not Düsseldorf, Düsseldorf, Germany to conduct this project. We will submit our results in both only because of methodological issues or its 3 Research Department, Instituto peer-­reviewed journals and scientific conferences. We effects on scientific advancement but by its Universitario Hospital Italiano will aim to disseminate our findings through different practical implications, at either individual or de Buenos Aires, Buenos Aires, academic platforms, social media, local press, among Argentina population level.8 Glasziou and Chalmers8 others. The final results will be communicated to local 4 Department of Public Health– funding agencies and government stakeholders. estimated that 85% of the investments for CIGES, Universidad de La Discussion We aim to provide an accurate and up-­to-­ clinical research end up being avoidable Frontera, Temuco, Chile research waste, which may be derived from 5 Biomedical Research Institute date picture of the research gaps—to be filled by new Sant Pau (IIB Sant Pau), CIBER future findings—and the identification of redundant any step along the research process and its Epidemiología y Salud Pública research, which will constitute relevant information for application (ie, disregarding regulation, (CIBERESP), Iberoamerican local decision-­makers. governance and management over clinical Cochrane Centre, Barcelona, research development).3 9–12 Stakeholders Spain should have accurate and up-­to-­date pictures Correspondence to INTRODUCTION of evidence so that resources are used in the Dr Nicolás Meza; Primary clinical research and synthe- best possible way.13 Nevertheless, the use of ​nicolas.​meza@u​ v.​cl sised evidence are the basis for knowledge rigorous evidence for both clinical practice Bracchiglione J, et al. BMJ Open 2022;12:e057555. doi:10.1136/bmjopen-2021-057555 1 Open access BMJ Open: first published as 10.1136/bmjopen-2021-057555 on 20 June 2022. Downloaded from http://bmjopen.bmj.com/ on July 14, 2023 at Sant Paul Hospital Consortia. Protected by and health policy-­making is still limited.14–16 The limited Eligibility criteria budgets make prioritisation a mandatory step for funding We will consider any clinical study design, either agencies; which should be done mainly considering the conducted in Chile or at least one affiliation based in needed research topics, cost-­effectiveness and expected Chile. We define clinical studies as those focused on a social value.17 18 clinical health topic describing, measuring or exploring Although some frameworks have been proposed to a health-­related outcome in humans. Considering that evaluate research applications,19 the focus on academic our focus in the following objectives will be the highest background and scientific productivity during the project priority conditions of the last Chilean health reform, we assessment seem to be predominant.20 In practice, organ- will consider studies published from 2000 onwards.28 isations summon expert panels to judge according to the We will consider any descriptive, observational or exper- afore-­mentioned technical and academic merit measures, imental primary study designs, including case reports, with heterogeneous considerations about cost, research case series, cross-­sectional studies, case–control studies, gaps, social value or local impact.20 cohort studies, quasiexperimental studies, diagnostic or The lack of a prioritised agenda in developing coun- prognostic studies, mixed methods studies, and clinical trials. We will also include different formats of evidence tries may generate a source of inequity, by letting third-­ synthesis, including systematic reviews, scoping reviews, party interests (ie, global research funding, or the evidence maps and overviews.29 We will exclude narrative pharmaceutical industry from high-­income countries) reviews, editorials, correspondence, letters to the editor, inhabit regional research planning,21–23 in a context of opinion articles, conference proceedings, study protocols poor governance in this matter.12 24 The strategic plan- and preprint reports without peer review. We will also ning of state funding allocation in most countries can exclude studies whose observation units are biological still improve the identification of local evidence gaps to samples, economic evaluations, modelling studies, valida- be filled by new research, avoiding (and not funding) tion of instruments and ecological studies. redundant research. In Chile, clinical research is funded through different government grants, in addition to other types of funding (private agencies, competitive Search methods funding, pharmaceutical or medical device industry Electronic search strategy sponsoring, international grants, etc),25 but there is We will perform a comprehensive search in electronic copyright. no comprehensive local diagnosis of recent clinical databases, without restriction of language or publication research that could inform prioritisation for future status. research funding. We will search the following databases: This is a protocol for a government-­funded project with 1. MEDLINE via Ovid SP. the following objectives: 2. Embase via Elsevier. 1. To identify and classify health research studies con- 3. PsycINFO via ProQuest SP. ducted in Chile or by authors whose affiliations are 4. Cumulative Index to Nursing and Allied Health Litera- ture (CINAHL) via EBSCOhost. based in Chile. 5. Latin American and Caribbean Literature in Health 2. To elaborate evidence maps for relevant health con- Sciences (LILACS). ditions in Chile, considering prioritised interventions 6. Web of Science (WoS) via Clarivate. and core outcome sets. Online supplemental appendix A provides details of 3. To populate the maps with the primary and secondary the electronic search strategy for MEDLINE via Ovid. For evidence and their risk of bias and to identify knowl- our MEDLINE search, we added a highly sensitive filter edge gaps and redundant research incorporating in- to identify randomised trials developed by the Cochrane ternational evidence. Collaboration30 and a validated search filter to retrieve systematic reviews developed by the Scottish Intercolle- giate Guidelines Network.31 The strategy proposed was METHODS AND ANALYSIS peer-­reviewed by another information specialist prior This section describes the methods for each of the to implementation using the Peer Review of Electronic objectives. Search Strategies (PRESS) checklist.32 Hand search strategy Objective 1: identification and classification of Chilean clinical We will conduct complimentary hand searches with research the same criteria reported in the electronic search. We will conduct a scoping review that will be reported We identified seven information resources considered following the Preferred Reporting Items for Systematic relevant to identify all the evidence that has not been Reviews and Meta-­Analyses extension for scoping reviews indexed in the databases described in the electronic (PRISMA-­ScR).26 For this protocol, we followed the guid- search and additional four information resources neces- ance from the PRISMA-­P extension for protocols.27 sary to retrieve trials, reviews or other types of evidence, 2 Bracchiglione J, et al. BMJ Open 2022;12:e057555. doi:10.1136/bmjopen-2021-057555 Open access BMJ Open: first published as 10.1136/bmjopen-2021-057555 on 20 June 2022. Downloaded from http://bmjopen.bmj.com/ on July 14, 2023 at Sant Paul Hospital Consortia. Protected by published peer reviewed research, that meet the eligi- Objective 2: elaboration of evidence matrices for relevant bility criteria (see online supplemental appendix B for health conditions in Chile, considering prioritised further details). interventions and core outcome sets We will elaborate evidence matrices for prioritised Study selection health conditions selected from those defined under the Two reviewers will independently perform a title and General Regime of the Health Guarantees Act (Garantías abstract screening. A third reviewer will solve any discrep- Explícitas en Salud (GES)) that was stated in 2004 in ancies. We will retrieve the full text of each study applying Chile. This Regime commanded public and private health our selection criteria to determine its final inclusion. providers to guarantee access, opportunity, quality and Afterwards, two reviewers will screen references by full financial protection for the most relevant programmes, text, solving discrepancies by a third reviewer. For this diseases or conditions.37 This Regime contemplates 85 process, we will use the Covidence platform.33 We will programmes, diseases and conditions that have been present a PRISMA 2020 flow diagram showing the process selected considering the health situation of the popula- of study selection.34 tion, the effectiveness of the interventions, their contribu- tion to the extension or quality of life and, when possible, their cost-­effectiveness.38 Data extraction We extracted the list of health conditions and excluded Two reviewers will extract the following data from the those defined as programmes (eg, ‘orthosis (or technical included studies: help) for people aged 65 years and older’ which aims ► Bibliographic data: full citation including the list of to improve independence in the elderly). These condi- authors, journal and date of publication. tions were initially prioritised by the Chilean government ► Type of evidence: primary studies or secondary based on a local study of the GBD in 2007.39 In consulta- studies. tion with the health ministry, we decided to prioritise the ► Study design: case reports, case series, cross-­sectional conditions based on the 2019 report by the GBD initiative studies, case–control studies, cohorts, quasiexperi- as it is a more up-­to-­date resource for decision-­making.40 mental studies, diagnostic studies, prognostic studies, GBD is a consortium of more than 3600 researchers randomised trials, systematic reviews and other forms who collect, analyse data and provide a tool to visualise of synthesised evidence. the burden and health loss of people due to hundreds copyright. ► Area of study: we will characterise the retrieved arti- of health conditions.40 We filtered the GBD database by cles by discipline and area of study used by the Organ- year (2019), location (Chile), context (cause), measure isation for Economic Co-­operation and Development (disability-­adjusted life years) and metric (number). We in their category scheme.35 distinguished causes by age groups, and used data from ► Location of the study: Chile, other country, multicen- all causes and both sexes. We excluded GES conditions tric study. that did not match precisely enough with a GBD cause, ► Authors and authorships: affiliation (based in Chilean according to the consensus of the authors. We provide institution or not), gender and type of authorship the details and judgements regarding the reasons for (main author, last author, corresponding author, exclusions for each GES problem in online supplemental working groups authorships, among others). appendix C. Then, we selected the 20 conditions with the ► Diseases or health conditions addressed by each study highest burden in Chile, among those included in GES. according to the taxonomy developed by the Global This selection closely matched the local study on burden Burden of Disease.36 of disease conducted in 2007, which informed decision-­ ► Funding: we will classify the type of funding of each making during the constitution of GES.39 See table 1 for article, public or private, competitive funding, phar- the list of the top 20 conditions identified in this process. maceutical or medical device industry sponsoring, or We will then conduct the following steps to complete international grants. the matrices that will be populated with evidence in the ► Conflicts of interest: we will extract the authors’ state- following objective. ments from each report, considering descriptions for each author if available. Step 1: identifying the main outcomes We will enter the data into a data extraction form The definition of main outcomes for each health condi- (based in Google Sheets, Google). tion is a complex and difficult task, considering that reported outcomes are prone to bias, and that many Summary of data studies tend to report outcomes with positive or statisti- We do not intend to perform a risk-­of-­bias assessment at cally significant findings.41 this stage (see Objective 3). We will summarise the find- For that reason, we will consider agreed standardised ings of each category (ie, proportion of clinical trials, sets of outcomes, known as core outcome sets (COS) for proportion of studies for each condition). Moreover, we identifying the main outcomes. The COS represents a will illustrate the trends for each study design and disease non-­restrictive minimum set of outcomes to be assessed category. and reported in studies for every health condition, and Bracchiglione J, et al. BMJ Open 2022;12:e057555. doi:10.1136/bmjopen-2021-057555 3 Open access BMJ Open: first published as 10.1136/bmjopen-2021-057555 on 20 June 2022. Downloaded from http://bmjopen.bmj.com/ on July 14, 2023 at Sant Paul Hospital Consortia. Protected by Table 1 Prioritised conditions from the General Regime of the Health Guarantees Act (Garantías Explícitas en Salud (GES)) according to the Global Burden of Disease (GBD) 2019 in Chile, in decreasing order by disability-­adjusted life years (DALYs) Matching GBD cause GBD 2019 DALYs, number GES condition (age group) (95% CI, upper to lower) Myocardial infarction Ischaemic heart disease (all ages) 214 819.57 (227 068.32 to 0) Type 2 diabetes Diabetes mellitus type 2 (all ages) 170 569.88 (213 283.00 to 0.19) Depression in people aged 15 years and over Depressive disorders (20 plus) 121 414.38 (169 061.49 to 2.23E−06) Chronic kidney disease stage 4 and 6 Chronic kidney disease (all ages) 101 733.72 (110 880.12 to 208.53) Ischaemic stroke in people aged 15 years Ischaemic stroke (20 plus) 100 161.76 and over (109 460.56 to 94.57) Stomach cancer Stomach cancer (all ages) 85 929.07 (91 647.46 to 1.26) Lung cancer Tracheal, bronchus and lung cancer (all ages) 83 674.49 (88 943.91 to 0.0002) Chronic obstructive pulmonary disease Chronic obstructive pulmonary disease (all 83 190.76 (outpatient management) ages) (96 438.34 to 0.0002) Alzheimer’s disease and other dementias Alzheimer’s disease and other dementias (all 72 825.97 ages) (154 958.48 to 4.11) Colorectal cancer in people aged 15 years Colon and rectum cancer (20 plus) 70 756.65 and over (75 584.77 to 1.66) Hip and/or knee osteoarthritis, mild or Osteoarthritis (55 plus) 55 576.88 moderate, in people aged 55 years and over (112 169.90 to 1.85) (medical management) copyright. Prevention of preterm birth Neonatal preterm birth (all ages) 51 479.73 (63 435.89 to 0.16) Chronic hepatitis C Cirrhosis and other chronic liver diseases due 50 969.21 to hepatitis C (all ages) (65 323.67 to 0.0005) Breast cancer in people aged 15 years and Breast cancer (20 plus) 47 006.54 over (51 554.51 to 16.13) Prostate cancer in people aged 15 years and Prostate cancer (20 plus) 45 854.87 over (54 664.48 to 2.60) Schizophrenia Schizophrenia (all ages) 42 501.32 (56 297.82 to 0.24) Bipolar disorder in people aged 15 years and Bipolar disorder (20 plus) 38 096.12 over (58 487.76 to 8.43E−06) Community-­acquired pneumonia in Lower respiratory infections (65–89 years) 34 844.45 people aged 65 years and over (outpatient (38 946.70 to 1.10) management) Asthma in people aged 15 years and over Asthma (20 plus) 32 694.24 (45 713.86 to 0.12) Secondary subarachnoid haemorrhage to Subarachnoid haemorrhage (all ages) 28 635.44 rupture of brain aneurysms (31 612.39 to 1089.41) they are permanently updated and revised by the Core outcomes embedded in current GES clinical practice Outcome Measures in Effectiveness Trials (COMET) guidelines. initiative (http://www.comet-initiative.org/). The COS includes outcomes that are most relevant to clinicians, Step 2: identifying the interventions decision-­makers, patients and carers. If COS are not We will define the interventions for the rows of the matrix available for an individual condition, we will build a set for each health condition considering: of outcomes based on consensus with the input of multi- ► Local Clinical Practice Guidelines: we will extract the disciplinary experts and patients, considering the existing main interventions from the clinical recommendations 4 Bracchiglione J, et al. BMJ Open 2022;12:e057555. doi:10.1136/bmjopen-2021-057555 Open access BMJ Open: first published as 10.1136/bmjopen-2021-057555 on 20 June 2022. Downloaded from http://bmjopen.bmj.com/ on July 14, 2023 at Sant Paul Hospital Consortia. Protected by in existing guidelines conducted by the Chilean (1) Cochrane Risk-­of-­Bias tool for randomised clinical Health Ministry. trials,44 (2) Risk Of Bias In Non-­randomised Studies - of ► Those prioritised by Cochrane Review Groups and Interventions (ROBINS-­I) for non-­randomised primary Networks: we will contact Cochrane Groups and studies45 and (3) Risk of Bias Assessment Tool for System- Networks’ authors in order to gather a list of priority atic Reviews (ROBIS) for systematic reviews.46 We will skip interventions for each health condition, according to this step in the case of overviews, since currently there is their consideration. no validated tool for assessing risk of bias in this specific ► Those identified by the regulatory agency: we will methodological design. review the authorisations of the Institute of Public Health in Chile as the main regulatory agency in Step 3: populating evidence gap maps charge of the permits for clinical trials, in order to We will populate each node of the previously elaborated classify the authorised pharmacological interventions grids or matrices with the selected studies, considering the for each health condition. intervention and outcome on that node. We will represent the populated nodes with visual symbols (bubbles), with Step 3: building up the matrices different colours according to the type of study and risk We will create evidence gap maps for each included condi- of bias, and different sizes according to the number of tion. These evidence gap maps will be framed on grids studies available. Once a matrix is populated with Chilean or matrices that will consider the relevant interventions studies, we will refer to it as a ‘local evidence map’. (defined in Step 3) in the rows, and the main outcomes (defined in Step 2) in the columns. These grids will be Step 4: developing global certainty of the evidence gap maps populated in each intersection with the included studies, We will develop a second map for each prioritised condi- as we detail in Objective 3 (see Objective 3 below). We tion populated with rigorous international research will use evimappr,42 an R43 package for producing bubble (defined as the availability of high or moderate certainty plots, which provides an interactive display for visualising of evidence), for each specific clinical question, according the evidence gap maps. to the Grading of Recommendations, Assessment, Devel- opment and Evaluation (GRADE) approach,47 that we will Objective 3: to populate the maps with local primary and refer to as a ‘global evidence map’. For this purpose, we secondary evidence and their risk of bias and to identify will conduct a new search aimed at identifying systematic knowledge gaps and redundant research incorporating copyright. reviews using the GRADE approach, using appropriate international evidence filters.32 We will populate these maps with the degree of After the completion of the tasks proposed in Objective 1, certainty of evidence, so each node will be classified as ‘high we will select all the studies that might provide evidence certainty’ or ‘moderate certainty’ (reflecting that mostly for decision-­making regarding interventions, to populate there is enough evidence); and ‘low certainty’, ‘very low each of the matrices elaborated as described in Objective certainty’, or ‘no evidence’ (reflecting that more evidence 2. Whenever an evidence matrix is populated with studies is needed). for a certain outcome and intervention, we will refer to it as an evidence map. Step 5: contrasting global certainty of the evidence maps with Step 1: identifying the main study designs local maps From the complete set of research articles included in Once Step 4 is concluded, we will have two maps for each Objective 1, we will separate all those studies with a design condition: (1) a local evidence map (populated with local relevant for decision-­making regarding interventions: Chilean research) and 2) a global certainty of the evidence 1. Randomised controlled trials. map (populated with certainties of evidence from inter- 2. Non-­randomised primary studies, including controlled national synthesised evidence). In order to identify clinical trials, quasiexperimental designs (eg, inter- knowledge gaps and estimate redundant research, we will rupted time series, controlled before–after studies) contrast these two maps. Once we cross these two maps, and observational studies (cohort studies, case–control we will classify each populated node of the local map as studies, analytical cross-­sectional studies). ‘adequate research’ or ‘redundant research’, while each 3. Synthesised evidence relevant to interventions (system- empty node will be classified as ‘evidence gap’, according atic reviews, overviews). to the criteria defined in table 2. Descriptive studies, qualitative or mixed methods We will consider the absence of local evidence as a gap. studies, diagnostic accuracy studies, narrative reviews, If this gap is established in the context of low or very low scoping reviews and evidence maps will not be consid- certainty of evidence in the global map, or if there is no ered for this objective as they do not provide evidence global evidence, we will consider it as a true gap. If the supporting the efficacy or effectiveness of interventions. gap is established in the context of high or moderate certainty of evidence in the global gap, we will consider it Step 2: risk-of-bias assessment in general as a false evidence gap. To assess risk of bias of the included studies, we will If there is local research in the context of a low, very use standardised tools for each methodological design: low certainty or no evidence in the global map, we will Bracchiglione J, et al. BMJ Open 2022;12:e057555. doi:10.1136/bmjopen-2021-057555 5 Open access BMJ Open: first published as 10.1136/bmjopen-2021-057555 on 20 June 2022. Downloaded from http://bmjopen.bmj.com/ on July 14, 2023 at Sant Paul Hospital Consortia. Protected by Table 2 Possible scenarios in the evidence gap maps Global evidence map: very low to low certainty of the evidence (or no evidence) Global evidence map: moderate to high certainty of the evidence Local evidence map True evidence gap False evidence gap (unless local conditions require context-­specific No local evidence research) Local evidence map Adequate research Adequate research (if local evidence was published before the review) Available local evidence Redundant research (if local evidence was published after the review) consider the local research as adequate. If there is local descriptive studies, qualitative or mixed methods studies and research in the context of a high or moderate certainty diagnostic accuracy studies, among others. Furthermore, we of evidence in the global map, we will consider the will limit the evidence maps only to health interventions in research as adequate if it was published before the review prioritised outcomes, and then, by focusing on the 20 condi- that informed the certainty of evidence, or as redundant tions with the highest burden in Chile, we will not address research if it was published after this review. the whole extent of the research in locally prioritised health conditions. Patient and public involvement A main strength of our protocol is the comprehensiveness No patients were involved in the development of this of our search strategy. The development of a peer-­reviewed protocol. search strategy in major electronic databases complemented with an exhaustive hand search will allow us to probably iden- Ethics and dissemination tify the whole body of clinical evidence conducted locally. No ethical approval is required to conduct this project. The hand search is crucial and constitutes an important Our findings will be submitted to peer-­reviewed journals source of information, considering that research in the and scientific conferences. To amplify the impact of our Latin American Region might not be adequately indexed work and to accomplish knowledge translation objectives, in the electronic databases. The process of development we will disseminate the results through different platforms, of evidence maps constitute another major strength of our including academic social media, blogs, local press, among proposed research. We will first develop the evidence grids others. At the same time, we will aim to communicate the copyright. identifying main outcomes and interventions independently final results to local funding agencies and government of the results of our search and screening process (Objec- stakeholders, in order to inform the elaboration of future tive 2), and we will populate those grids afterwards with national research agendas. the results of our selection process (Objective 3). Besides identifying the research being conducted in Chile, with this DISCUSSION approach, we will be able to accurately elucidate the evidence After the completion of this proposed study, we will deliver gaps, since it is possible that particular interventions in the an overall picture of the clinical research conducted in Chile grid remain unpopulated, as the construction of the grid will since 2000, and we will elaborate evidence gap maps for the not be guided by the results of our search. main health conditions guaranteed in Chile, with a detailed This accurate and up-­to-­date picture of the research gaps— description of the most relevant interventions and outcomes to be filled by new future findings—and the identification of and the type of clinical research in each node. redundant research will constitute relevant information for We will also study the evidence gaps for the 10 health local decision-­makers and, at the same time, an interesting conditions with the highest burden in Chile and compare methodological proposal to visualise clinical research trends them with the available research globally; as a way to estab- and gaps in other countries or regions. lish the true gaps of clinical research, and the amount of Twitter Nicolás Meza @nicolasmezac and Eva Madrid @eva_madrid_aris redundant findings addressed in Chile or by authors affili- ated to Chilean institutions. Acknowledgements We thank Ivan Solà from the Iberoamerican Cochrane Centre—Sant Pau Biomedical Research Institute (IIB Sant Pau)—CIBERESP A limitation of our protocol might be the use of the GBD (Barcelona, Spain) for his valuable support in drafting and refining our search 2019 estimations to prioritise the most important diseases strategy. or conditions in Chile, according to GES. As GES is based Contributors The study concept was developed by JB, NM, JVAF and EM. The on policy and local definitions, and not totally on an epide- manuscript of the protocol was drafted by JB, NM, JVAF, CMEL and EM. SRM and miological rationale, our conceptualisation may neglect GU developed and provided feedback for all sections of the review protocol and some important clinical entities (mainly multicomponent approved the final manuscript. The search strategy was developed by CMEL and JB. Study selection, data extraction, quality assessment and gap maps elaboration diseases). Nevertheless, we have added online supplemental will be performed by all the authors. All authors reviewed and approved the final appendices with the detailed pairing process, the burden of version of the manuscript. disease and the excluded health topics (and reason of exclu- Funding FONDECYT Grant 1212037 from the Chilean National Agency of Research sion). To operationalise our procedures, we also narrowed and Development (ANID). the scope of the gap maps development (Objective 3) to clin- Disclaimer The funding agency had no involvement in the conception, ical research centred on efficacy or effectiveness, excluding development, drafting or approval of this manuscript. 6 Bracchiglione J, et al. BMJ Open 2022;12:e057555. doi:10.1136/bmjopen-2021-057555 Open access BMJ Open: first published as 10.1136/bmjopen-2021-057555 on 20 June 2022. Downloaded from http://bmjopen.bmj.com/ on July 14, 2023 at Sant Paul Hospital Consortia. Protected by Competing interests All the authors have conducted clinical research in Chile or 15 Lester L, Haby MM, Chapman E, et al. Evaluation of the performance associated with Chilean researchers or institutions. Nevertheless, decisions about and achievements of the WHO evidence-­informed policy network inclusion, data extraction and quality assessment of these studies will be conducted (EVIPNet) Europe. Health Res Policy Sys 2020;18. 16 van de Goor I, Hämäläinen R-­M, Syed A, et al. Determinants of by independent researchers within our team. We declare no other conflict of evidence use in public health policy making: results from a study interests. across six EU countries. Health Policy 2017;121:273–81. Patient and public involvement Patients and/or the public were not involved in 17 Ciarli T, Ràfols I, fols R I. The relation between research priorities and the design, or conduct, or reporting, or dissemination plans of this research. societal demands: the case of rice. Res Policy 2019;48:949–67. 18 Mutapi F. Africa should set its own health-­research agenda. Nature Patient consent for publication Not applicable. 2019;575:567. 19 Tuffaha HW, Aitken J, Chambers S, et al. A framework to Prioritise Provenance and peer review Not commissioned; externally peer reviewed. health research proposals for funding: integrating value for money. Supplemental material This content has been supplied by the author(s). It has Appl Health Econ Health Policy 2019;17:761–70. not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been 20 Cassi L, Lahatte A, Rafols I, et al. Improving fitness: mapping peer-­reviewed. Any opinions or recommendations discussed are solely those research priorities against societal needs on obesity. J Informetr 2017;11:1095–113. of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and 21 Aguilera B. Trends in clinical trials performed in Chile. Rev. méd. responsibility arising from any reliance placed on the content. Where the content Chile 2021;149:110–8. includes any translated material, BMJ does not warrant the accuracy and reliability 22 Atal I, Trinquart L, Porcher R, et al. Differential globalization of of the translations (including but not limited to local regulations, clinical guidelines, Industry- and Non-­Industry-­Sponsored clinical trials. PLoS One terminology, drug names and drug dosages), and is not responsible for any error 2015;10:e0145122. and/or omissions arising from translation and adaptation or otherwise. 23 Hoffman SJ, Gunn E, Rogers Van Katwyk S, et al. Systematic analysis of global health research funding in Canada, 2000-­2016. Open access This is an open access article distributed in accordance with the Can J Public Health 2020;111:80–95. Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits 24 Smits P, Champagne F. 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