Searching Strategy and Applied Methods

SEARCHING STRATEGY AND APPLIED METHODS

Search strategy

In this review, two evaluating models that have been suggested in the literature were taken into account and assess healthcare provision via RCTs and via information systems and technologies respectively. These are the PRISMA 2009 Checklist and the CONSORT-EHEALTH Checklist. Furthermore, for considering a study in this review, the review authors have a two-fold eligibility criterion. It should firstly meet the demanding requirements of randomized clinical trials in the medical or health domain, and secondly incorporate modern information technologies and computer-based equipment throughout its implementation. Fundamentally, a systematic review in the domain of medicine and health care is performed on a set of clinical trials. Then, the collection is being restricted according to directives and specific eligibility criteria. In most of the cases, it is sufficient to collect the trials data from searchable registries and/or databases of clinical trials. However, in this work, the data were selected from many sources and do not include any detailed material about information technology infrastructures applied in the trials, while in some of them it was hard to find the corresponding clinical trials through specific search keywords. The authors followed two parallel methodologies of a search strategy for finding the appropriate studies to include. More specifically: 1. We included in the initial stage articles for consideration for inclusion in our review these that we had full access either via the VPN Library's Remote Access System of the Univesity of Thessaly either through access to digital resources provided by the Technological Educational Institute of Peloponnese. 2. Searches were further limited as we accepted only the articles that were written in English. 3. We checked the results with specific terms. More specigically, were identified some papers specific to the searching terms “wireless sensor network” or bluetooth or zigbee or RFID. Also we used the searching terms “ontology” and “portal” but they had different meaning in the articles from this of our purpose. Then we cheched in these results and were no papers that also were randomized clinical trials. Therefore searches were repeated whithout these search terms. 4. More specifically, we applied a twofold searching method to cover two key issues:

Search methodology 1: Initially, the authors explored all the available resources they had from searchable registries and databases of clinical trials that contained specific keywords and methods (Additional file 1). The results (Additional compressed files 2) were stored in a repository for further study. Secondly, the authors made a survey for any related published article(s). The main keyword the authors used was their registration number. If any article was published, the review authors included it in the next step. Implementation of the search methodology 1: We searched for clinical studies (trials) in the following registry and/or results databases: -The Cochrane Central Register of Controlled Trials (CENTRAL), -World Health Organization (WHO) library databases (WHOLIS), -The ClinicalTrials.gov Register (NCT), -The ISRCTN Register, -The European Clinical Trials Database (EudraCT) -The Linked Clinical Trials (LinkedCT), -The Australian and New Zealand Clinical Trials Registry (ACTRN), -The Chinese Clinical Trial Registry (CCTR), -The Clinical Trials Registry – India (CTR-I), -The Deutsches Register Klinischer Studien (DRKS) (or German Clinical Trials Register), -The WHO International Clinical Trials Registry Platform (ICTRP), -The Iranian Registry of Clinical Trials (IRCT), -The Pan African Clinical Trials Registry (PACTR).

Therefore, we selected the randomized trials (when this was feasible) as resulting via selection criteria with a corresponding adjustment of the following search to each of the registry and/or results databases: ((“computer- interpretable” OR “computer-based”) AND (measurement OR assessment OR evaluation OR scale OR rating OR inventory OR monitoring) AND tool) OR ((ehealth) AND (measurement OR assessment OR evaluation OR scale OR rating OR inventory OR monitoring) AND tool) OR ((“computer-interpretable” or “computer-based” OR ehealth OR e_health OR e-health) AND (“Care plan” OR “Clinical guideline” OR tool)). Search methodology 2 : In parallel, the inverse method was used. Namely, the review authors searched in several academic digital libraries and search engines to find the appropriate articles containing specific keywords (Additional file 1). As in methodology 1, the results (Additional compressed files 2) were stored for further study. Subsequently, the authors parsed them to trace any registration number. If they had any, the authors included them in the repository. The next step was to gather only those trials, which had at least one journal publication. Similarly, the review authors selected only those studies of the initial collection phases (search methodology 1 and 2) that were implemented as clinical trials and they were also published in a journal (Additional file 3). The above technique was adopted in both search methodologies that the review authors followed in order to identify the records, which were screened for eligibility. These strategies are described in detail according to a PRISMA 2009 flow diagram (Fig. 1). In one hand, according to the first search methodology, the review authors examined the most common clinical trial registries and databases. Some search efforts returned poor or no results, either because the relevant databases were unable to provide criteria-based searching mechanisms or due to incomplete information provided about the clinical trials. Additionally, in cases where the registration number of a clinical trial was available by its related published article, the review authors used the registries to gather metadata elements of the relevant study. More specifically, the review authors performed an online search for completed studies over a multitude of registries and databases that are depicted in Additional file 3 (Tables 1 and 2). The basic criterion for the selection of an article is to be related to technological issues. This criterion is satisfied by applying specific keywords within the request. Therefore, the review authors adapted the search strategy to be appropriate to every electronic database as they used the keywords in varying combinations. Additional file 1 shows detailed information on the search strategy applied.

Implementation of the search methodology 2: An online search conducted on finding articles in scientific journals and carried out these that having related clinical studies (trials) finding them in registries and/or results databases of clinical trials. We searched for articles in the following in: - IEEE Xplore - PubMed -Scopus -Wiley Online Library -Scholar Google (the most recent and popular ) Therefore, the specific articles collected from the journals by applying the appropriate search keys and then C. S. review author chose those corresponding to a clinical trial, through a registration number. Furthermore, C. S. selected only the trials that have relevant publications in scientific journals. Thus the final collection for our research includes both the articles (reference lists of the abstracts of the articles) and the related registered clinical trials. Basically, the mapping between them is one to one. But in some special cases either an article references more than one clinical trials or a clinical trial is referenced by more than one publications. In some search engines we noted that we were able to set some additional and more specific search criteria while such a choice (e.g. to meet the criterion that the article has a relevant registered trial, to be a randomized trial etc.) in some others was not feasible. Subsequently, the differences in the submission criteria forced us to filter the results again in order the criteria to be fully met. 5. Afterwards search results were reviewd and non relevant results excluded. Further papers were identified by hand, searching reference lists in papers. Additional supporting references were identidied using Scholar Google.

The search strategy initially yielded 7750 articles or trials. Among them, 825 studies were retrieved and reviewed through their titles and some basic characteristics. 684 studies were further excluded, as they did not meet most of the substantial inclusion criteria set (Fig. 1). Consequently, the abstracts of 141 studied were retrieved and reviewed, while the full text of 60 studies was assessed for eligibility. Finally 48 full text articles were included in the final review. Eligibility criteria for research articles selection In this study, the review authors included only clinical trials that fulfilled the following eligibility criteria: 1. RCT studies. 2. RCTs must be recruited and completed. Thus protocols studies and unfinished studies were not included. 3. The publication period of the studies is between 01/01/2008 – 29/06/2014. The time limitation does not apply in medical research but may be used in systematic reviews related to IT and HIT due to the rapid evolution of technology. 4. Trials are allocated an official registration number. This is a fundamental requirement as in 2004 the International Committee of Medical Journal Editors indicated a change in their policy for publishing RCTs, stating that they would consider trials for publication only if they had been registered before the enrolment of the first patient. 5. Results are published in at least one article. Therefore every article is related with one or more trials and vise-versa. 6. Publication language is English. Methods for data collection and analysis The review authors created and adapted a two-dimensional classification list with recommended elements of 9 healthcare subjects (hi, i=1,..,9) and 7 technological aspects (tj, j=1,..,7). Consequently, each trial is classified into one healthcare subject and one or more technological aspects. Table 1 depicts the classification of the trials per Health Care Domain and Technological field. The horizontal axis corresponds to the technological (Tech) features of the trials, namely the following 7 aspects: 1. Internet 2. Mobile 3. Social support 4. Computer-based; Computer- assisted decision support 5. Tele-health 6. Virtual advisor and 7. Electronic health record–based. The vertical axis represents the Health Care (HC) features of the trials. The review authors adapted the healthcare elements of this classification list to a broader classification scheme by unifying many medical/health areas in one unified category. Accordingly it contains the following 8 healthcare subjects: 1. Cancer 2. Cardiovascular; Hypertension 3. Diabetes; Dyslipidemia 4. Diet and Nutrition; Exercise; Activities of Daily Living; Health Behavior, Lifestyle; Public Health and other Healthy subjects 5. Infections 6. Mental health; Depression; Addictions 7. Respiratory and 8. Other subjects with the following sub-categories i.e., Older adults, Reproductive Health and Childbirth, Screening for Partner Violence and Stroke. Consequently, according to the PRISMA 2009 study flow diagram (Fig. 1) C.S review author conducted the initial survey for the collection of the clinical trials from the registry databases and the articles from electronic databases. After a short survey on the respective sources, many of the studies were excluded either because they did not meet basic inclusion criteria or for other reasons (i.e. because the articles did not have a corresponding RCT, the RCTs did not have a corresponding article, observed as double-displayed records, were out of scope or were published as plain abstracts). The abstracts of the articles were subsequently studied by K.T. review author who removed those which did not thematically fit, while the review authors compiled a final set of articles and imported them in a reference management system (Qiqqa). Then, the review authors attempted to find the appropriate records that do not meet certain additional criteria for being considered in the study (e.g. to identify double records, to exclude articles that they do not include a refereed registration number, to remove articles that are published prior to 2008). In order to do that, the review authors searched within each article for the existence of the terms ‘trial’, ‘registration number’, or through the abbreviations that characterize a registration number (e.g. ACTRN, DRKS, IRCT, NCT00, PACTR, ANZCTR, ChiCTR, CTR-I, ICTRP, ISRCTN etc.). Subsequently, this list was imported in RevMan 5.3 for further study, editing and full text analysis. Curation methods were employed to correct failures or errors met in previous steps (duplicate articles, articles published before 2008, not interventional and RCT studies, articles without registration number etc.). In order to finalize the report and the relevant summary in section 3.3.1: i. Specific sections (i.e. the results and conclusions of the trials) were inserted in MS Excel 2010 and MS Access 2010. ii. Relevant queries were created in order to select the most accurate and effective clinical studies by health domain. iii. Parametric SQL queries were used in order to find the records that contain specific words in the outcomes and/or conclusion fields. These words are the following: “effective” or “efficient” or “ increase” or “improve” or “significant” (Description in the SQL command: the review authors put the term “Like '*effective*' Or Like '*efficient*' Or Like '*increase*' Or Like '*improve*' Or Like '*significant*'” in the outcomes and conclusion fields)..

Author contributions C.S. launched and formed the main objectives of this study and formulated the initial research questions. All the review authors have contributed to the conceptualization and formulated the final form of the research questions and design of the study, analyzing and interpreting outcomes, drafting and revising the content and the structure of the article. C.S. developed the literature search strategy, conducted the search and screened titles and abstracts. C.S. and K.T. assessed. C.S., K.T. and A.I. independently reviewed the included full-text articles and their related registered trials and extracted data (e.g. assessed the risk of bias in the trials, undertook data extraction, assessed eligibility and classified them into the tables completing them with the appropriate information). Also, all authors contributed to the analysis and interpretation of data and approved the final version of the manuscript. Any critical or doubtful judgment at any stage of this study was discussed and in case of disagreement it was recorded for further consideration by all review authors. Final decisions are consensus.