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Annotated Bibliography of Published Studies Addressing Searching for Unpublished Studies and Obtaining Access to Unpublished Data

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Annotated Bibliography of Published Studies Addressing Searching for Unpublished Studies and Obtaining Access to Unpublished Data Providing consultancy and research in health economics for the NHS, pharmaceutical and health care industries since 1986 Annotated bibliography of published studies addressing searching for unpublished studies and obtaining access to unpublished data MICK ARBER, Information Specialist MARIA CIKALO, Associate JULIE GLANVILLE, Associate Director CAROL LEFEBVRE, Associate DANIELLE VARLEY, Research Assistant HANNAH WOOD, Information Specialist JUNE 2013 Contents Page No. Acknowledgements Section 1: Introduction 1 1.1 Introduction 1 1.2 Objectives 1 Section 2: Methods 2 2.1 Criteria for considering studies for this Annotated Bibliography 2 2.2 Search methods for identification of studies 3 Section 3: Results 5 3.1 Search results 5 3.2 Structured abstracts 6 Appendices: Appendix A: Search Strategies Appendix B: Papers which we have not been able to obtain and / or assess for relevance All reasonable precautions have been taken by YHEC to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall YHEC be liable for damages arising from its use. Acknowledgements We are grateful to the following individuals and their colleagues, who supplied copies of their publications or information about their publications: Iain Chalmers Kay Dickersin Jini Hetherington Sally Hopewell Chris Hyde Tom Jefferson John Kirwan Steve McDonald David Moher Lorenzo Moja Helen Worthington How to cite this document: Arber M, Cikalo M, Glanville J, Lefebvre C, Varley D, Wood H. Annotated bibliography of published studies addressing searching for unpublished studies and obtaining access to unpublished data. York: York Health Economics Consortium; 2013. York Health Economics Consortium Ltd Level 2 Market Square University of York York YO10 5NH Tel: 44-1904-323620 Email: [email protected] http://www.yhec.co.uk/ Section 1: Introduction 1.1 INTRODUCTION This work is a sub-project of a larger project entitled “Searching for unpublished trials using trials registers and trials web sites and obtaining unpublished trial data and corresponding trial protocols from regulatory agencies”. Other outputs of this project include reviews conducted by Wolfe1 and Bennekou Schroll2. The project is a collaboration between the San Francisco Branch of the United States Cochrane Center, Nordic Cochrane Centre, Cochrane Acute Respiratory Infections Group, York Health Economics Consortium and the Cochrane Information Retrieval Methods Group. This sub-project has been undertaken by staff of York Health Economics Consortium and Carol Lefebvre of Lefebvre Associates Ltd, for which some funding was provided by the Cochrane Collaboration under the Methods Innovation Funding initiative. 1.2 OBJECTIVES To prepare an annotated bibliography of published studies addressing searching for and obtaining access to unpublished studies. 1 Wolfe N, Gotzsche PC, Bero L. Strategies for obtaining unpublished drug trial data: a qualitative interview study. Systematic Reviews. 2013;2:31. 2 Bennekou Schroll J, Bero L, Gotzsche PC. Searching for unpublished data for Cochrane reviews: cross sectional study. BMJ. 2013;346:f2231. Section 1 1 Section 2: Methods 2.1 CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW The following types of study were eligible for inclusion: Studies assessing methods of searching for / accessing unpublished trial information in healthcare settings; Reports discussing methods of searching for / accessing unpublished trial information in healthcare settings, even if no assessment of the methods’ utility was made. No date, language or study design restrictions were applied. Unpublished studies were defined as those not published in any of the following: The ‘mainstream’ (e.g. journal) literature Conference abstracts Bibliographic databases recording journal publications. Examples of methods of interest included: Use of regulatory agencies (for example for access to regulatory information such as trial protocols, clinical study reports, reviewers’ comments, correspondence and individual patient data); Use of trials registers; trials results registers; trials databases; trials web sites; Use of web sites of manufacturers; funders / sponsors; Contact with investigators; funders / sponsors. Documents reporting the following issues were not eligible for inclusion: Reports of initiatives around trial registration and progress in trial registration; Reports of details of individual trial registries; Reports on methods of searching bibliographic databases of journal articles; Reports on methods such as citation searching / pearl growing; Reports of the results of a systematic review on healthcare interventions; Reports of single trials; Reports of the development, population and results of cohort studies/registers of patients with a specific condition (patient registries); Reports of trial methods and conduct which do not relate to prospective registration or reporting of the trial; Reports of clinical trial legislation unrelated to registration; Reports of trial recruitment activity/methods; Section 2 2 Reports on hand-searching the journal literature; Reports on publication rate of conference abstracts; News stories; Animal studies, animal trials. 2.2 SEARCH METHODS FOR IDENTIFICATION OF STUDIES The search strategy shown in Figure 2.1 shows the MEDLINE strategy used to identify studies. The other strategies are provided in Appendix A. Figure 2 1: MEDLINE strategy to identify studies 1 ((request$ or obtain$ or identify$ or locat$ or find$ or detect$ or search$ or ask$ or access$) adj3 (unpublished or "un published" or "not published") adj3 (data or information or evidence or study or studies or trial$1 or paper$1 or article$1 or report$1 or literature or work)).ti,ab. 2 (Randomized Controlled Trials as Topic/ or Clinical Trials as Topic/) and Registries/ 3 ((search or identify$ or retriev$ or locat$ or find$ or detect$ or access) adj6 (trial$1 register or trial$1 registers or trial$1 registry or trial$1 registries)).ti,ab. 4 clinicaltrial$.ti,ab. not (clinicaltrial$ or ISRCTN).si. 5 current controlled trials.ti,ab. 6 (ictrp or mrct).ti,ab. 7 WHO portal.ti,ab. 8 or/1-7 Key: $ Truncation symbol; words beginning with the specified stem adj Proximity operator: words must appear together, within a specified number of words ti,ab. Search terms in the title or abstract si. Search terms in the Secondary Source ID field / Subject heading MEDLINE and MEDLINE in process, Embase and the Cochrane Methodology Register were searched for relevant studies (Table 2.1). Table 2 1: Databases searched to identify studies Database / information source Interface / URL MEDLINE and MEDLINE In-Process OvidSP Embase OvidSP Cochrane Methodology Register Cochrane Library/Wiley Interscience The search approach was limited by the funding available for this part of the project. This meant that no attempts were made to check the references listed in the included studies. Features such as ‘related articles’ were not used and no citation searching to identify references citing the included studies was undertaken. A number of the studies we abstracted provided limited data and would benefit from being followed up with the authors / investigators. This is particularly the case with studies reported in conference abstracts, letters or other brief communications. No systematic approach was made to link references Section 2 3 reporting the same study. Where related references were identified by the abstractor or the reviewer / editor, links were made to other relevant citations. Searching a number of databases produces a degree of duplication in the results. To manage this issue, the titles and abstracts of bibliographic records were downloaded and imported into EndNote bibliographic management software. Duplicate records were removed using several algorithms. Results in the EndNote library were then exported into the Mendeley reference management software, where further de-duplication and selection of studies took place. 2.2.1 Selection of studies Two of three reviewers (MA, HW, JG) independently assessed each of the titles and abstracts (where available) of records to identify and exclude clearly irrelevant studies. Where there was disagreement between reviewers, the records were passed to the second stage of assessment. The full text of documents was retrieved where possible for the remaining records. The full-text reports were examined by a single reviewer for compliance of the studies with eligibility criteria. Where inclusion was not clear-cut the document was classed as a query. Inclusion decisions and queries were checked by a second reviewer (JG). Where appropriate, authors were contacted to clarify study eligibility and to provide papers which we were unable to source elsewhere. 2.2.2 Study abstraction A structured abstract was completed for each included study. The abstract content was structured as follows: Study reference; Study objectives; Study methods; Study results; Study limitations as noted by study authors; Study limitations noted by abstractor; Key messages. MC and JG wrote the structured abstracts which comprise the Annotated Bibliography. CL reviewed and edited the structured abstracts. The documents which could not be obtained and/or assessed for relevance within the resources of the project are listed in Appendix B. Section 2 4 Section 3: Results 3.1 SEARCH RESULTS
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