scholarly journals Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis

BMJ Open ◽  
2016 ◽  
Vol 6 (7) ◽  
pp. e011082 ◽  
Author(s):  
Meredith Hays ◽  
Mary Andrews ◽  
Ramey Wilson ◽  
David Callender ◽  
Patrick G O'Malley ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Reporting Quality ◽  
High Impact ◽  
Medical Journals ◽  
General Medical Journals ◽  
Randomised Controlled

scholarly journals Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038283
Author(s):  
Zet Wei Tan ◽  
Aidan Christopher Tan ◽  
Tom Li ◽  
Ian Harris ◽  
Justine M Naylor ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
English Language ◽  
Controlled Trial ◽  
Reporting Quality ◽  
Methodological Study ◽  
Eligibility Criteria ◽  
Significant Deterioration ◽  
Before And After ◽  
Randomised Controlled

ObjectivesTo determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors.DesignMethodological study.Data sourcesMEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies.Eligibility criteriaProtocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language.Main outcomePrimary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement.Results300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement (9 July 2012 to 28 December 2012) and 150 from a recent period after the SPIRIT statement (25 January 2019 to 20 March 2019). 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p<0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. While 40% of individual checklist items had a significant improvement in adequate reporting after the SPIRIT statement, 11.3% had a significant deterioration and there were no RCT protocols in which all individual checklist items were complete. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement.ConclusionThe overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial proportion of individual checklist items remain poorly reported. Continued and concerted efforts are required by journals, editors, reviewers and investigators to improve the completeness and transparency of RCT protocols.

scholarly journals 1379Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement?

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Aidan Tan ◽  
Zet Tan ◽  
Tom Li ◽  
Ian Harris ◽  
Justine Naylor ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
English Language ◽  
Controlled Trial ◽  
Reporting Quality ◽  
Recent Period ◽  
Before And After ◽  
Trial Protocols ◽  
Randomised Controlled ◽  
The Impact

Abstract Background The impact of the SPIRIT statement on the reporting quality of RCT protocols in health research is unknown. This methodological study aimed to determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the SPIRIT statement, and any association with author, trial or journal factors. Methods RCT protocols were identified by searching MEDLINE, Embase and CENTRAL, included if published in full-text, English language and a peer-reviewed journal, and assessed with the SPIRIT statement checklist items. Results 300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement and 150 from a recent period after the SPIRIT statement. 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p &lt; 0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement. Conclusions The overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial proportion of individual checklist items remain poorly reported. Key messages Continued, concerted and coordinated efforts are required by journals, editors, reviewers and investigators to improve the completeness and transparency of RCT protocols.

scholarly journals Reporting quality of randomised controlled trial abstracts presented at the SLEEP Annual Meetings: a cross-sectional study

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029270 ◽  
Author(s):  
Fang Hua ◽  
Qiao Sun ◽  
Tingting Zhao ◽  
Xiong Chen ◽  
Hong He
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Reporting Quality ◽  
Sleep Medicine ◽  
Reporting Rate ◽  
Secondary Outcome ◽  
Cross Sectional ◽  
Randomised Controlled ◽  
Consort For Abstracts

ObjectivesTo evaluate the reporting quality of randomised controlled trial (RCT) abstracts presented at a leading international conference in sleep medicine (the SLEEP Annual Meeting), and to investigate the association between potential predictors and the reporting quality of trial abstracts in this field.DesignCross-sectional, research on research study.MethodsA handsearch of the 2016–2018 SLEEP Annual Meeting abstract books was carried out to identify abstracts describing RCTs. Quality of reporting was assessed with the original 17-item CONSORT for Abstracts checklist. Univariable and multivariable linear regression analyses were performed to identify significant predictors of reporting quality. In addition, risk ratios were used to analyse the adequate reporting rate of each quality item by type of intervention and funding status.Primary and secondary outcome measuresThe overall quality score (OQS, range 0–17) in accordance with the CONSORT for Abstracts checklist (primary outcome), and the adequate reporting rate of each checklist item (secondary outcome).ResultsA total of 176 RCT abstracts were included and assessed. The mean OQS was 5.53 (95% CI 5.30 to 5.76). Only three quality items (objective,conclusionsandfunding) were adequately reported in most abstracts (>75%). None of the abstracts adequately reportedauthors,randomisationoroutcome in the results section. According to the multivariable analysis, pharmacological interventions (p=0.018) and funding from the industry (p=0.025) were significantly associated with better reporting quality.ConclusionsThe reporting quality of RCT abstracts presented at SLEEP Annual Meetings was suboptimal. Pharmacological intervention and funding from industry were significant predictors of better reporting quality. Joint efforts by authors and conference committees are needed to enhance the reporting quality of RCT abstracts presented at sleep medicine conferences, and thereby reduce relevant research waste in this field.

scholarly journals Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025692 ◽  
Author(s):  
Corita R Grudzen ◽  
Deborah J Shim ◽  
Abigail M Schmucker ◽  
Jeanne Cho ◽  
Keith S Goldfeld
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Randomised Controlled ◽  
End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

scholarly journals Comparison of the effects of intravenous propofol and inhalational desflurane on the quality of early recovery after hand-assisted laparoscopic donor nephrectomy: a prospective, randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e039881
Author(s):  
Jaesik Park ◽  
Minhee Kim ◽  
Yong Hyun Park ◽  
Jung-Woo Shim ◽  
Hyung Mook Lee ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Early Recovery ◽  
Total Hospital ◽  
Kidney Donors ◽  
Living Kidney Donors ◽  
Total Hospital Stay ◽  
Randomised Controlled

ObjectivesWe compared early recovery outcomes between living kidney donors who received total intravenous (IV) propofol versus inhalational desflurane during hand-assisted laparoscopic nephrectomy.DesignA single-centre, prospective randomised controlled trial.SettingUniversity hospital.ParticipantsStudy participants were enrolled between October 2019 and February 2020. A total of 80 living donors were randomly assigned to an intravenous propofol group (n=40) or a desflurane group (n=40).InterventionPropofol group received intravenous propofol and desflurane group received desflurane, as a maintenance anaesthetic.Primary and secondary outcome measuresThe quality of postoperative functional recovery was primarily assessed using the Korean version of the Quality of Recovery-40 (QoR-40K) questionnaire on postoperative day 1. Secondarily, ambulation, pain score, rescue analgesics, complications and total hospital stay were assessed postoperatively.ResultsOur study population included 35 males and 45 females. The mean age was 46±13 years. The global QoR-40K score (161 (154–173) vs 152 (136–161) points, respectively, p=0.001) and all five subdimension scores (physical comfort, 49 (45–53) vs 45 (42–48) points, respectively, p=0.003; emotional state, 39 (37–41) vs 37 (33–41) points, respectively, p=0.005; psychological support, 30 (26–34) vs 28 (26–32) points, respectively, p=0.04; physical independence, 16 (11–18) vs 12 (8-14) points, respectively, p=0.004; and pain, 31 (28–33) vs 29 (25-31) points, respectively, p=0.021) were significantly higher in the intravenous propofol group than the desflurane group. The early ambulation success rate and numbers of early and total steps were higher, but the incidence of nausea/vomiting was lower, in the intravenous propofol group than the desflurane group. The total hospital stay after surgery was shorter in the intravenous propofol group than the desflurane group.ConclusionsIntravenous propofol may enhance the quality of postoperative recovery in comparison to desflurane in living kidney donors.Trial registration numberKCT0004365.

scholarly journals Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046600
Author(s):  
Anne-Marie Hill ◽  
Rachael Moorin ◽  
Susan Slatyer ◽  
Christina Bryant ◽  
Keith Hill ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Care Recipient ◽  
Care At Home ◽  
Randomised Controlled

IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers’ health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers’ health-related quality of life (HRQOL) after care recipients’ hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient’s discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30–45 min telephone support sessions over 6 months. The primary outcome is caregivers’ HRQOL measured using the Assessment of Quality of Life—eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

scholarly journals E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e041548
Author(s):  
Cristian Ochoa-Arnedo ◽  
Joan Carles Medina ◽  
Aida Flix-Valle ◽  
Dimitra Anastasiadou
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Emotional Distress ◽  
Controlled Trial ◽  
Psychosocial Care ◽  
Cost Utility ◽  
Psychosocial Services ◽  
Randomised Controlled

IntroductionPsychosocial interventions for patients with breast cancer (BC) have demonstrated their effectiveness at reducing emotional distress and improving quality of life. The current digitisation of screening, monitoring and psychosocial treatment presents the opportunity for a revolution that could improve the quality of care and reduce its economic burden. The objectives of this study are, first, to assess the effectiveness of an e-health platform with integrated and stepped psychosocial services compared with usual psychosocial care, and second, to examine its cost–utility.Methods and analysisThis study is a multicentre randomised controlled trial with two parallel groups: E-health intervention with integrated and stepped psychosocial services vs usual psychosocial care. An estimated sample of 338 patients with BC in the acute survival phase will be recruited from three university hospitals in Catalonia (Spain) and will be randomly assigned to one of two groups. All participants will be evaluated at the beginning of the study (T1: recruitment), 3 months from T1 (T2), 6 months from T1 (T3) and 12 months from T1 (T4). Primary outcome measures will include number of clinical cases detected, waiting time from detection to psychosocial intervention and proportion of cases successfully treated in the different steps of the intervention, as well as outcomes related to emotional distress, quality of life, post-traumatic stress and growth, treatment adherence and therapeutic alliance. Secondary outcomes will include the acceptability of the platform, patients’ satisfaction and usability. For the cost–utility analysis, we will assess quality-adjusted life years and costs related to healthcare utilisation, medication use and adherence, work absenteeism and infrastructure-related and transport-related costs.Ethics and disseminationThis study was approved by the Ethics committee of the Institut Català d’Oncologia network in Hospitalet, Spain. Findings will be disseminated through peer-reviewed journals, reports to the funding body, conferences among the scientific community, workshops with patients and media press releases.Trial registration numberOnline Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors (ICOnnectat-B),NCT04372459.

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