Development and validation of a patient-based measure of outcome for coronary revascularisation

Background: Disease-specific patient-based questionnaires are being used increasingly to evaluate treatment outcomes in coronary heart disease (CHD) from the patient's perspective. However, most have been developed to evaluate health-related quality of life (HRQoL) in medically rather than surgically treated patients and many have not been rigorously evaluated against required standards. There are currently no validated questionnaires to measure patient- based outcomes after coronary revascularisation, the surgical treatment for CHD. Objectives: To develop a new patient-based instrument, the Coronary Revascularisation Outcome Questionnaire (CROQ), to measure health outcomes and HRQoL before and after coronary artery bypass graft surgery (CABG) and percutaneous transluminal coronary angioplasty (PTCA). To evaluate the psychometric properties of the CROQ using classical psychometric methods. Design: Psychometric study. Subjects: A total of 725 (79% male) patients undergoing CABG and 643 (71% male) patients undergoing PTCA at three hospitals in the UK. Methods: Qualitative methods (literature review, review of existing instruments, patient interviews, and expert opinion) were used to develop two versions of the eROQ (CROQ-CABG and CROQ-PTCA). Two field tests were then conducted by postal survey to patients before and 3-months after revascularisation firstly, to identify possible items for elimination (item reduction) and secondly, to evaluate the psychometric properties (reliability, validity, responsiveness) of the item- reduced CROa in independent samples. Results: The CROQ was acceptable to patients, satisfied tests of scaling assumptions, showed good internal consistency, test-retest reliability, validity, and responsiveness. 4 Conclusions: The CROQ is a new l psychometrically rigorous patient-based measure of outcome for coronary revascularisation. The CROQ has many potential uses in evaluative research l such as in clinical trials of effectiveness I and as a routine clinical audit tool to assist providers of CABG and PTCA in monitoring the outcomes of car

Psychometric validation of the Coronary Revascularisation Outcome Questionnaire (CROQv2) in the context of the NHS Coronary Revascularisation PROMs Pilot.

OBJECTIVES: The Coronary Revascularisation Outcome Questionnaire (CROQ) is a patient-reported outcome measure (PROM) for coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI). We tested the psychometric properties of a modified version (CROQv2) when administered in a National Health Service (NHS)/Department of Health (DH) funded pilot of PROMs for coronary revascularisation. DESIGN: Psychometric validation study. SETTING: 11 English hospitals in the UK taking part in the NHS/DH funded pilot of PROMs for coronary revascularisation. PARTICIPANTS: Comprehensive analyses of acceptability, reliability, validity and responsiveness were conducted independently for each of the prerevascularisation (n=2685 and n=3711) and postrevascularisation (n=869 and n=837) versions of the CROQ-CABG and CROQ-PCI, respectively. RESULTS: All versions met prespecified stringent criteria for (1) acceptability of items (missing data) and scales (missing data, floor and ceiling effects, skewness); (2) tests of scaling assumptions; (3) reliability: internal consistency (Cronbach's α, item-total correlations); (4) construct validity based on within-scale analyses (internal consistency, intercorrelations between scales, factor analysis and hypothesis testing); (5) construct validity based on comparisons with external measures (convergent and discriminant validity and hypothesis testing) and (6) responsiveness. Results were also confirmed when tests were repeated on subsamples of CABG (n=639) and PCI (n=615) patients who reported receiving help completing prerevascularisation questionnaires. CONCLUSIONS: The availability of a psychometrically robust procedure-specific tool that could be used as part of a large-scale coronary revascularisation PROMs programme to capture the patients' perspective of coronary revascularisation will enable outcomes important to patients to be routinely collected alongside clinical outcomes. The CROQ is suitable for administration by postal survey or the prerevascularisation versions can be administered in the clinical setting as in the Coronary Revascularisation PROMs Pilot

Conflicts of interest in dermatology

Conflicts of interest exist in dermatology when professional judgement concerning a primary interest, such as research validity, may be influenced by a secondary interest, such as financial gain from a for-profit organization. Conflict of interest is a condition and not a behaviour, although there is clear evidence that gifts influence behaviour. Little has been written about conflicts of interest in dermatology. This series of papers raises awareness of the subject by exploring it in greater depth from the perspective of a dermatology researcher, an industry researcher, a dermatology journal editor, a health services researcher and a patient representative. Collectively, they illustrate the many ways in which conflicts can pervade the world of dermatology publications and patient support group activities

A survey exploring biomedical editors’ perceptions of editorial interventions to improve adherence to reporting guidelines

Background: Improving the completeness of reporting of biomedical research is essential for improving its usability. For this reason, hundreds of reporting guidelines have been created in the last few decades but adherence to these remains suboptimal. This survey aims to inform future evaluations of interventions to improve adherence to reporting guidelines. In particular, it gathers editors’ perceptions of a range of interventions at various stages in the editorial process. Methods: We surveyed biomedical journal editors that were knowledgeable about this topic. The questionnaire included open and closed questions that explored (i) the current practice of their journals, (ii) their perceptions of the ease of implementation and the potential effectiveness of different interventions, (iii) the barriers and facilitators associated with these interventions, and (iv) suggestions for future interventions and incentives. Results: Of the 99 editors invited, 24 (24%) completed the survey. Involving trained editors or administrative staff was deemed the potentially most effective intervention but, at the same time, it was considered moderately difficult to implement due to logistic and resource issues. Participants believed that checking adherence to guidelines goes beyond the role of peer reviewers and could decrease the overall quality of reviews. Journals incentivising adherence, and publishers and medical institutions encouraging journals to adopt strategies to boost adherence were two recurrent themesPostprint (author's final draft

Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.

OBJECTIVE: Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. DESIGN: Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. PARTICIPANTS: 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. RESULTS: Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. LIMITATIONS: This study was a non-randomised comparison cohort study. Some data were missing. CONCLUSIONS: An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision.The ethics officer pilot and the controlled evaluation was funded by the HRA. The process evaluation was conducted and funded separately by MD-W’s Wellcome Trust Investigator Award WT097899 with no HRA oversight or involvement beyond facilitating access to the database. MD-W’s contribution to this paper was also supported by University of Leicester study leave at the Dartmouth Institute for Health Policy and Clinical Practice. RA-SS was funded by a Medical Research Council senior clinical fellowship.This is the final version of the article. It first appeared from BMJ Group via http://dx.doi.org/10.1136/bmjopen-2016-01197

Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ

OBJECTIVES: Adding, omitting or changing prespecified outcomes can result in bias because it increases the potential for unacknowledged or post hoc revisions of the planned analyses. Journals have adopted initiatives such as requiring the prospective registration of trials and the submission of study protocols to promote the transparency of reporting in clinical trials. The main objective of this feasibility study was to document the frequency and types of outcome discrepancy between prespecified outcomes in the protocol and reported outcomes in trials submitted to The BMJ.METHODS: A review of all 3156 articles submitted to The BMJ between 1 September 2013 and 30 June 2014. Trial registry entries, protocols and trial reports of randomised controlled trials published by The BMJ and a random sample of those rejected were reviewed. Editorial, peer reviewer comments and author responses were also examined to ascertain any reasons for discrepancies.RESULTS: In the study period, The BMJ received 311 trial manuscripts, 21 of which were subsequently published by the journal. In trials published by The BMJ, 27% (89/333) of the prespecified outcomes in the protocol were not reported in the submitted paper and 11% (31/275) of reported outcomes were not prespecified. In the sample of 21 trials rejected by The BMJ, 19% (63/335) of prespecified outcomes went unreported and 14% (45/317) of reported outcomes were not prespecified. None of the reasons provided by published authors were suggestive of outcome reporting bias as the reasons were unrelated to the results.CONCLUSIONS: Mandating the prospective registration of a trial and requesting that a protocol be uploaded when submitting a trial article to a journal has the potential to promote transparency and safeguard the evidence base against outcome reporting biases as a result of outcome discrepancies. Further guidance is needed with regard to documenting reasons for outcome discrepancies.</p

Frequency of reporting on patient and public involvement (PPI) in research studies published in a general medical journal : a descriptive study

Objectives While documented plans for patient and public involvement (PPI) in research are required in many grant applications, little is known about how frequently PPI occurs in practice. Low levels of reported PPI may mask actual activity due to limited PPI reporting requirements. This research analysed the frequency and types of reported PPI in the presence and absence of a journal requirement to include this information. Design and setting A before and after comparison of PPI reported in research papers published in The BMJ before and 1 year after the introduction of a journal policy requiring authors to report if and how they involved patients and the public within their papers. Results Between 1 June 2013 and 31 May 2014, The BMJ published 189 research papers and 1 (0.5%) reported PPI activity. From 1 June 2015 to 31 May 2016, following the introduction of the policy, The BMJ published 152 research papers of which 16 (11%) reported PPI activity. Patients contributed to grant applications in addition to designing studies through to coauthorship and participation in study dissemination. Patient contributors were often not fully acknowledged; 6 of 17 (35%) papers acknowledged their contributions and 2 (12%) included them as coauthors. Conclusions Infrequent reporting of PPI activity does not appear to be purely due to a failure of documentation. Reporting of PPI activity increased after the introduction of The BMJ ’s policy, but activity both before and after was low and reporting was inconsistent in quality. Journals, funders and research institutions should collaborate to move us from the current situation where PPI is an optional extra to one where PPI is fully embedded in practice throughout the research process

Systematic review search strategies are poorly reported and not reproducible: a cross-sectional metaresearch study

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

Perspectives on involvement in the peer-review process : surveys of patient and public reviewers at two journals

Objective In 2014/2015, The BMJ and Research Involvement and Engagement (RIE) became the first journals to routinely include patients and the public in the peer review process of journal articles. This survey explores the perspectives and early experiences of these reviewers. Design A cross-sectional survey. Setting and participants Patient and public reviewers for The BMJ and RIE who have been invited to review. Results The response rate was 69% (157/227) for those who had previously reviewed and 31% (67/217) for those who had not yet reviewed. Reviewers described being motivated to review by the opportunity to include the patient voice in the research process, influence the quality of the biomedical literature and ensure it meets the needs of patients. Of the 157 who had reviewed, 127 (81%) would recommend being a reviewer to other patients and carers. 144 (92%) thought more journals should adopt patient and public review. Few reviewers (16/224, 7%) reported concerns about doing open review. Annual acknowledgement on the journals’ websites was welcomed as was free access to journal information. Participants were keen to have access to more online resources and training to improve their reviewing skills. Suggestions on how to improve the reviewing experience included: allowing more time to review; better and more frequent communication; a more user-friendly process; improving guidance on how to review including videos; improving the matching of papers to reviewers’ experience; providing more varied sample reviews and brief feedback on the usefulness of reviews; developing a sense of community among reviewers; and publicising of the contribution that patient and public review brings. Conclusions Patient and public reviewers shared practical ideas to improve the reviewing experience and these will be reviewed to enhance the guidance and support given to them