REporting Of Studies Conducted Using Observational Routinely-collected Health Data Research Articles

Appraising the Quality of Reporting of Vascular Surgery Studies That Use the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) Database.

The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) is an important data source for observational studies. While there are guides to ensure appropriate study reporting, there has been no evaluation of NSQIP studies in vascular surgery. We sought to evaluate the adherence of vascular-surgery related NSQIP studies to best reporting practices. In January 2022, we queried PubMed for all vascular surgery NSQIP studies. We used the REporting of studies Conducted using Observational Routinely-collected Health Data (RECORD) statement and the JAMA Surgery (JAMA-Surgery) checklist to assess reporting methodology. We also extracted the Journal Impact Factor (IF) of each article. One hundred and fifty-nine studies published between 2002 and 2022 were identified and analyzed. The median score on the RECORD statement was 6 out of 8. The most commonly missed RECORD statement items were describing any validation of codes and providing data cleaning information. The median score on the JAMA-Surgery checklist was 2 out of 7. The most commonly missed JAMA-Surgery checklist items were identifying competing risks, using flow charts to help visualize study populations, having a solid research question and hypothesis, identifying confounders, and discussing the implications of missing data. We found no difference in the reporting methodology of studies published in high vs low IF journals. Vascular surgery studies using NSQIP data demonstrate poor adherence to research reporting standards. Critical areas for improvement include identifying competing risks, including a solid research question and hypothesis, and describing any validation of codes. Journals should consider requiring authors use reporting guides to ensure their articles have stringent reporting methodology.

Evaluation of reporting quality of cohort studies using real-world data based on RECORD: systematic review

ObjectiveReal-world data (RWD) and real-world evidence (RWE) have been paid more and more attention in recent years. We aimed to evaluate the reporting quality of cohort studies using real-world data (RWD) published between 2013 and 2021 and analyze the possible factors.MethodsWe conducted a comprehensive search in Medline and Embase through the OVID interface for cohort studies published from 2013 to 2021 on April 29, 2022. Studies aimed at comparing the effectiveness or safety of exposure factors in the real-world setting were included. The evaluation was based on the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. Agreement for inclusion and evaluation was calculated using Cohen’s kappa. Pearson chi-square test or Fisher’s exact test and Mann-Whitney U test were used to analyze the possible factors, including the release of RECORD, journal IFs, and article citations. Bonferroni’s correction was conducted for multiple comparisons. Interrupted time series analysis was performed to display the changes in report quality over time.Results187 articles were finally included. The mean ± SD of the percentage of adequately reported items in the 187 articles was 44.7 ± 14.3 with a range of 11.1–87%. Of 23 items, the adequate reporting rate of 10 items reached 50%, and the reporting rate of some vital items was inadequate. After Bonferroni’s correction, the reporting of only one item significantly improved after the release of RECORD and there was no significant improvement in the overall report quality. For interrupted time series analysis, there were no significant changes in the slope (p = 0.42) and level (p = 0.12) of adequate reporting rate. The journal IFs and citations were respectively related to 2 areas and the former significantly higher in high-reporting quality articles.ConclusionThe endorsement of the RECORD cheklist was generally inadequate in cohort studies using RWD and has not improved in recent years. We encourage researchers to endorse relevant guidelines when utilizing RWD for research.

Assessing the quality of reporting of studies using Vascular Quality Initiative (VQI) data.

The Society for Vascular Surgery Vascular Quality Initiative (VQI) has become an increasingly popular data source for retrospective observational vascular surgery studies. There are published guidelines on the reporting of data in such studies to promote transparency and rigor, but these have not been used to evaluate studies using VQI data. Our objective was to appraise the methodological reporting quality of studies using VQI data by evaluating their adherence to these guidelines. The Society for Vascular Surgery VQI publication repository was queried for all articles published in 2020. The REporting of studies Conducted using Observational Routinely-collected Health Data (RECORD) statement and the Journal of American Medical Association-Surgical Section (JAMA-Surgery) checklist were utilized to assess the quality of each article's reporting. Five and three items from the RECORD statement and JAMA-Surgery checklist were excluded, respectively, because they were either inapplicable or nonassessable. Journal impact factor (IF) was queried for each article to elucidate any difference in reporting standards between high and low IF journals. Ninety studies were identified and analyzed. The median score on the RECORD checklist was 6 (of 8). The most commonly missed item was discussing data cleaning methods (93% missed). The median score on the JAMA-Surgery checklist was 3 (of 7). The most commonly missed items were the identification of competing risks (98% missed), the use of a flow chart to clearly define sample exclusion and inclusion criteria (84% missed), and the inclusion of a solid research question and hypothesis (81% missed). There were no differences in JAMA-Surgery checklist or RECORD statement median scores among studies published in low vs high IF journals. Studies using VQI data demonstrate a poor to moderate adherence to reporting standards. Key areas for improvement in research reporting include articulating a clear hypothesis, using flow charts to clearly define inclusion and exclusion criteria, identifying competing risks, and discussing data cleaning methods. Additionally, future efforts should center on creating tailored instruments to better guide reporting in studies using VQI data.

The impact of social capital on successful ageing of empty nesters: A cross-sectional study.

To explore the impact of social capital on successful ageing among empty nesters in China. A cross-sectional study. The data for this study came from the survey of the China Health and Retirement Longitudinal Study (CHARLS) in 2018. Overall, 6098 empty nesters aged 60 years and over were included. Successful ageing was defined according to Rowe and Kahn's model. Social capital includes social trust, social support, reciprocity and social networks. Multivariable logistic regression and a classification and regression tree model were applied to estimate the impact of social capital on successful ageing. For this study, we followed the Reporting of Studies Conducted Using Observational Routinely Collected Health Data (RECORD) reporting guidelines, an extension of Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. The successful ageing rate of empty nesters in China was 9.2%. Empty nesters who had a higher level of reciprocal behaviour and caregiving support in several dimensions of social capital and who were members of organizations in their social networks have had higher odds of achieving successful ageing. We also observed interactions with social capital associated with successful ageing, suggesting that special attention should be given to empty nesters who are less educated, have no caregiving support, live in rural areas, have worse self-rated health, are older, do not have reciprocal behaviours and are unmarried. The results of this study show that social capital, especially in terms of reciprocity, caregiving support and organizational membership in a social network, can contribute to the achievement of successful ageing among empty nesters. This study confirms the impact of social capital on the successful ageing of empty nesters for the first time and provides new ideas for state, community and health care workers to address ageing issues. Because of the public database data used in this study, all data were collected by survey agency personnel, so this section is not applicable to this study.

Critical Appraisal of the Quality of Publications in Hepatobiliary and Pancreatic Surgery Research Using the American College of Surgeons NSQIP Database.

The use of the American College of Surgeons (ACS) NSQIP has increased in hepatobiliary and pancreatic surgery (HPB) research as it provides access to high-quality surgical outcome data on a national scale. Using the ACS NSQIP database, this study examined the methodologic reporting of HPB publications. Web of Science core collection (all editions) was queried for all HPB studies using the ACS NSQIP database published between 2004 and 2022. In addition, a critical appraisal was performed using the JAMA Surgery checklist, Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement, and Reporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) statement. In total, 276 studies were included in the analysis. The median scores for the JAMA Surgery checklist, RECORD statement, and STROBE statement were 4 of 7 (interquartile range [IQR] 3 to 5), 3 of 10 (IQR 2 to 4), and 15 of 21 (IQR 13 to 17), respectively. The criteria with the highest rates of nonadherence were discussing competing risks, clear definitions of inclusion and exclusion criteria, unadjusted and adjusted outcomes, provision of supplementary data, and performing subgroup analyses. Additionally, when examining checklist fulfillment of hepatobiliary studies and pancreatic studies separately, pancreatic studies demonstrated significantly greater fulfillment of the STROBE statement checklist items. Satisfactory reporting of methodology is present among HPB studies utilizing the ACS NSQIP database, with multiple opportunities for improvement. Areas for improved adherence include discussing competing risks, providing supplementary information, and performing appropriate subgroup analysis. Given the increasing role of large-scale databases in surgical research, enhanced commitment to reporting guidelines may advance HPB research and ensure quality reporting.

Perceived Family Functioning Profile in Adolescents at Clinical High Risk for Psychosis: Rigidity as a Possible Preventive Target.

The presence of a positive family relationship has been suggested as a protective factor from parental stress and from the development of full-blown psychosis. However, to date, there is limited research on family functioning in adolescents with psychosis and at clinical high risk for psychosis (CHR-P). This study is aimed at comparing family functioning and perceived stress in parents of adolescents with either CHR-P, early onset psychosis (EOP), or other psychiatric disorders (no CHR-P). As a secondary aim, it will correlate family functioning with parental perceived stress in order to find critical targets of intervention. We conducted a Reporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD)—compliant, real-world, cross-sectional study. One-hundred and eleven adolescents aged 12–17 who access the institute of hospitalization and care with scientific character (IRCCS) Mondino Foundation Neuropsychiatric services (Pavia, Italy) between 2017 and 2020 and their parents (n = 222) were included. Sociodemographic characteristics of adolescents and their parents were collected. Family functioning was evaluated through the Family Adaptability and Cohesion Evaluation Scale-IV (FACES-IV) and the level of stress through the Perceived Stress Scale (PSS). Twenty adolescents had EOP, 38 had CHR-P, and 59 had no CHR-P. In total, 2.6% of CHR-P adolescents were adopted, 76.3% had separated-divorced parents, and 34.2% of parents had a depressive disorder. Among the FACES-IV sub-scale, maternal rigidity was progressively increased from no-CHR-P to CHR-P to EOP group, with statistical differences between EOP and the other two groups (p = 0.01). CHR-P mothers and fathers showed a high level of PSS values, without group difference. Lastly, PSS values correlated positively with the Rigidity, Disengagement, and Chaos scale of FACES-IV and negatively with the Communication scale (p < 0.05). Our results suggest that family functioning has a central role and could represent a worthwhile target of intervention for adolescents at CHR-P, leading the way to new preventive approaches.

Retraction of COVID-19 Pharmacoepidemiology Research Could Have Been Avoided by Effective Use of Reporting Guidelines.

IntroductionTwo recent high-profile publications (and subsequent retractions) of pharmacoepidemiology studies reporting the effectiveness and risk of hydroxychloroquine in COVID-19 patients received international media attention. Transparent and complete reporting of these studies could have provided peer reviewers and editors with sufficient information to question the methods used and the validity of results. Since these studies used routinely collected health data, the guidelines for the REporting of studies Conducted using Observational Routinely collected health Data (RECORD) should have been applied to ensure complete reporting of the research.MethodsWe evaluated the two retracted articles for completeness of reporting using the RECORD for Pharmacoepidemiology (RECORD-PE) checklist, which includes the checklists for the STengthening the Reporting of OBservational studies in Epidemiology (STROBE) and RECORD. We compared the proportion of STROBE, RECORD and RECORD-PE items adequately reported using Chi-squared statistics.ResultsIn the article published by The Lancet, 29 of 34 STROBE items (85.3%) were adequately reported, compared with 3.5 of 13 RECORD items (26.9%) and 9.5 of 15 RECORD-PE items (63.3%)(χ2 = 14.839, P <0.001). Similarly, the article published in NEJM reported 24 of 34 STROBE items (70.6%), two of 13 RECORD items (15.4%), and 7.5 of 15 RECORD-PE items (50.0%) (χ2 = 11.668, P = 0.003). Important aspects of the methods unique to research using routinely collected health data were not reported, including variables used to identify exposure, outcome and confounders, validation of the coding or algorithms, a description of the underlying database population and the accuracy of data linkage methods.DiscussionWhile STROBE items were generally adequately reported, RECORD and RECORD-PE items were not. Reporting guidelines should be effectively implemented in order for transparency and completeness of research manuscripts, allowing for adequate evaluation by editors and peer reviewers.

Reporting Methodology of Neurosurgical Studies Utilizing the American College of Surgeons-National Surgical Quality Improvement Program Database: A Systematic Review and Critical Appraisal.

Use of large databases such as the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) has become increasingly common in neurosurgical research. To perform a critical appraisal and evaluation of the methodological reporting for studies in neurosurgical literature that utilize the ACS-NSQIP database. We queried Ovid MEDLINE, EMBASE, and PubMed databases for all neurosurgical studies utilizing the ACS-NSQIP. We assessed each study according to number of criteria fulfilled with respect to Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement, REporting of studies Conducted using Observational Routinely-collected Health Data (RECORD) Statement, and Journal of American Medical Association-Surgical Section (JAMA-Surgery) Checklist. A separate analysis was conducted among papers published in core and noncore journals in neurosurgery according to Bradford's law. A total of 117 studies were included. Median (interquartile range [IQR]) scores for number of fulfilled criteria for STROBE Statement, RECORD Statement, and JAMA-Surgery Checklist were 20 (IQR:19-21), 9 (IQR:8-9), and 6 (IQR:5-6), respectively. For STROBE Statement, RECORD Statement, and JAMA-Surgery Checklist, item 9 (potential sources of bias), item 13 (supplemental information), and item 9 (missing data/sensitivity analysis) had the highest number of studies with no fulfillment among all studies (56, 68, 50%), respectively. When comparing core journals vs noncore journals, no significant difference was found (STROBE, P=.94; RECORD, P=.24; JAMA-Surgery checklist, P=.60). While we observed an overall satisfactory reporting of methodology, most studies lacked mention of potential sources of bias, data cleaning methods, supplemental information, and external validity. Given the pervasive role of national databases and registries for research and health care policy, the surgical community needs to ensure the credibility and quality of such studies that ultimately aim to improve the value of surgical care delivery to patients.

Protocol for the Data-Linkage Alcohol Cohort Study (DACS): investigating mortality, morbidity and offending among people with an alcohol-related problem using linked administrative data

IntroductionThe aims of this program of research are to use linked health and law enforcement data to describe individuals presenting to emergency and inpatient healthcare services with an acute alcohol...

A New Surgical Site Infection Risk Score: Infection Risk Index in Cardiac Surgery.

Various scoring systems attempt to predict the risk of surgical site infection (SSI) after cardiac surgery, but their discrimination is limited. Our aim was to analyze all SSI risk factors in both coronary artery bypass graft (CABG) and valve replacement patients in order to create a new SSI risk score for such individuals. A priori prospective collected data on patients that underwent cardiac surgery (n = 2020) were analyzed following recommendations from the Reporting of studies Conducted using Observational Routinely collected health Data (RECORD) group. Study participants were divided into two periods: the training sample for defining the new tool (2010–2014, n = 1298), and the test sample for its validation (2015–2017, n = 722). In logistic regression, two preoperative variables were significantly associated with SSI (odds ratio (OR) and 95% confidence interval (CI)): diabetes, 3.3/2–5.7; and obesity, 4.5/2.2–9.3. The new score was constructed using a summation system for punctuation using integer numbers, that is, by assigning one point to the presence of either diabetes or obesity. The tool performed better in terms of assessing SSI risk in the test sample (area under the Receiver-Operating Characteristic curve (aROC) and 95% CI, 0.67/055–0.76) compared to the National Nosocomial Infections Surveillance (NNIS) risk index (0.61/0.50–0.71) and the Australian Clinical Risk Index (ACRI) (0.61/0.50–0.72). A new two-variable score to preoperative SSI risk stratification of cardiac surgery patients, named Infection Risk Index in Cardiac surgery (IRIC), which outperforms other classical scores, is now available to surgeons. Personalization of treatment for cardiac surgery patients is needed.

Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.

Should the 6-Minute Walk Test Be Stopped If Oxyhemoglobin Saturation Falls Below 80%?

ObjectiveTo examine the occurrence of adverse events in patients undergoing assessment for pulmonary rehabilitation when a 6-minute walk test (6MWT) continues despite desaturation below 80%. DesignRetrospective audit following REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement. SettingLarge teaching hospital. ParticipantsAll patients (N=549) (55% men, mean age 69±11y) assessed for pulmonary rehabilitation (September 2005 to January 2016). InterventionsThe standardized tests were conducted by experienced cardiorespiratory physiotherapists. Oxyhemoglobin saturation was monitored continuously using a pulse oximeter (lowest value used for analysis). Medical records were reviewed, and adverse events defined as tachycardia, bradycardia, chest pain, or other sign/symptom necessitating cessation. Main Outcome Measure6MWT. ResultsData from 672 walk tests were included with mean distance 369 (124) meters. The main diagnoses were chronic obstructive pulmonary disease (70%), interstitial lung disease (14%), and bronchiectasis (8%). Sixty individuals (11%) recorded desaturation below 80% without adverse events. Two adverse events were recorded during tests without desaturation; in 1 instance, chest pain with no evidence of cardiorespiratory compromise and in another, the patient stopped due to concern regarding blood sugar levels (11.5 mmol/L when tested). Independent predictors of desaturation to less than 80% were resting oxyhemoglobin saturation <95% (odds ratio [OR] 3.82, 95% confidence interval [CI] 2.06-7.08) and a diagnosis of interstitial lung disease or pulmonary arterial hypertension (OR 5.24, 95% CI 2.59-10.58). ConclusionsThis study found that desaturation to less than 80% during a 6MWT was not associated with adverse events in a large cohort of patients referred to pulmonary rehabilitation and assessed by experienced physiotherapists, suggesting that test cessation due to desaturation in stable patients may be unwarranted.

Evaluation of reporting quality for observational studies using routinely collected health data in pharmacovigilance

ABSTRACTObjectives: To appraise the reporting quality of studies which concerned linezolid-related thrombocytopenia referring to REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement.Methods: Medline, Embase, Cochrane library and clinicaltrial.gov were searched for observational studies concerning linezolid-related thrombocytopenia using routinely collected health data from 2000 to 2017. Two reviewers screened potential eligible articles and extracted data independently. Finally, reporting quality assessment was performed by two senior researchers using RECORD statement.Results: Of 25 included studies, 11 (44.0%) mentioned the type of data in the title and/or abstract. In 38 items derived from RECORD statement, the median number of items reported in the included studies was 22 (inter-quartile range 18–27). Inadequate reporting issues were discovered in the following aspects: validation studies of the codes or algorithms, study size estimation, quantitative variables, subgroup statistical methods, missing data, follow-up/matching or sampling strategy, sensitivity analysis and cleaning methods, funding and role of funders and accessibility of protocol, raw data.Conclusion: This study provides the evidence that the reporting quality of post-marketing safety evaluation studies conducted using routinely collected health data was often insufficient. Future stakeholders are encouraged to endorse the RECORD guidelines in pharmacovigilance.

Variation in Access to Kidney Transplantation Across Renal Programs in Ontario, Canada.

In the United States, kidney transplant rates vary significantly across end-stage renal disease (ESRD) networks. We conducted a population-based cohort study to determine whether there was variability in kidney transplant rates across renal programs in a health care system distinct from the United States. We included incident chronic dialysis patients in Ontario, Canada, from 2003 to 2013 and determined the 1-, 5-, and 10-year cumulative incidence of kidney transplantation in 27 regional renal programs (similar to U.S. ESRD networks). We also assessed the cumulative incidence of kidney transplant for "healthy" dialysis patients (aged 18-50 years without diabetes, coronary disease, or malignancy). We calculated standardized transplant ratios (STRs) using a Cox proportional hazards model, adjusting for patient characteristics (maximum possible follow-up of 11 years). Among 23 022 chronic dialysis patients, the 10-year cumulative incidence of kidney transplantation ranged from 7.4% (95% confidence interval [CI] 4.8-10.7%) to 31.4% (95% CI 16.5-47.5%) across renal programs. Similar variability was observed in our healthy cohort. STRs ranged from 0.3 (95% CI 0.2-0.5) to 1.5 (95% CI 1.4-1.7) across renal programs. There was significant variation in kidney transplant rates across Ontario renal programs despite patients having access to the same publicly funded health care system.

Das RECORD-Statement zum Berichten von Beobachtungsstudien, die routinemäßig gesammelte Gesundheitsdaten verwenden

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps.RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist as well as explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included. This document, as well as the accompanying website and message board (http://www.record-statement.org), will improve the implementation and understanding of RECORD. By implementing RECORD, authors, journals editors, and peer reviewers can enhance transparency of research reporting.

The reporting of studies using routinely collected health data was often insufficient

ObjectivesTo assess reporting quality of studies using routinely collected health data (RCD) to inform the REporting of studies Conducted using Observational Routinely collected health Data (RECORD) guideline development. Study Design and SettingPubMed search for observational studies using RCD on any epidemiologic or clinical topic. Sample of studies published in 2012. Evaluation of five items based on the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guideline and eight newly developed items for RCD studies. ResultsOf 124 included studies, 39 (31.5%) clearly described its design in title or abstract. Complete information to frame a focused research question, that is, on the population, intervention/exposure, and outcome, was provided for 51 studies (41.1%). In 44 studies where definitions of codes or classification algorithms would be necessary to operationalize such a research question, only nine (20.5%) reported all items adequately. In 81 studies describing multivariable analyses, 54 (66.7%) reported all variables used for modeling and 34 (42.0%) reported basic details required for replication. Database linkage was reported adequately in 12 of 41 studies (29.3%). Statements about data sharing/availability were rare (5/124; 4%). ConclusionMost RCD studies are insufficiently reported. Specific reporting guidelines and more awareness and education on their use are urgently needed.

The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement.

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.

The REporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) Statement: Methods for Arriving at Consensus and Developing Reporting Guidelines.

ObjectiveRoutinely collected health data, collected for administrative and clinical purposes, without specific a priori research questions, are increasingly used for observational, comparative effectiveness, health services research, and clinical trials. The rapid evolution and availability of routinely collected data for research has brought to light specific issues not addressed by existing reporting guidelines. The aim of the present project was to determine the priorities of stakeholders in order to guide the development of the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement.MethodsTwo modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period.ResultsThe qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist.ConclusionsThe RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.