Influence of overstated abstract conclusions on clinicians: a web-based randomised controlled trial

ObjectivesTo investigate whether overstatements in abstract conclusions influence primary care physicians’ evaluations when they read reports of randomised controlled trials (RCTs)DesignRCT setting: This study was a parallel-group randomised controlled survey, conducted online while masking the study hypothesis.ParticipantsVolunteers were recruited from members of the Japan Primary Care Association in January 2017. We sent email invitations to 7040 primary care physicians. Among the 787 individuals who accessed the website, 622 were eligible and automatically randomised into ‘without overstatement’ (n=307) and ‘with overstatement’ (n=315) groups.InterventionsWe selected five abstracts from published RCTs with at least one non-significant primary outcome and overstatement in the abstract conclusion. To construct a version without overstatement, we rewrote the conclusion sections. The methods and results sections were standardised to provide the necessary information of primary outcome information when it was missing in the original abstract. Participants were randomly assigned to read an abstract either with or without overstatements and asked to evaluate the benefit of the intervention.Outcome measuresThe primary outcome was the participants’ evaluation of the benefit of the intervention discussed in the abstract, on a scale from 0 to 10. A secondary outcome was the validity of the conclusion.ResultsThere was no significant difference between the groups with respect to their evaluation of the benefit of the intervention (mean difference: 0.07, 95% CI −0.28 to 0.42, p=0.69). Participants in the ‘without’ group considered the study conclusion to be more valid than those in the ‘with’ group (mean difference: 0.97, 95% CI 0.59 to 1.36, P<0.001).ConclusionThe overstatements in abstract conclusions did not significantly influence the primary care physicians’ evaluations of the intervention effect when necessary information about the primary outcomes was distinctly reported.Trial registration numberUMIN000025317; Pre-results.

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Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.2018.2 ◽

2018 ◽

Vol 213 (1) ◽

pp. 404-411 ◽

Cited By ~ 12

Author(s):

Ulrika Karlsson Stigsdotter ◽

Sus Sola Corazon ◽

Ulrik Sidenius ◽

Patrik Karlsson Nyed ◽

Helmer Bøving Larsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Well Being ◽

Behavioural Therapy ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Significant Difference ◽

Increasing Demand ◽

Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

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Triaging and Referring In Adjacent General and Emergency Departments (the TRIAGE trial): a cluster randomised controlled trial

10.1101/2021.08.16.21261782 ◽

2021 ◽

Author(s):

Stefan Morreel ◽

Hilde Philips ◽

Diana De Graeve ◽

Koenraad G Monsieurs ◽

Jarl Kampen ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Predictive Values ◽

Randomised Controlled

Objectives: To determine the effectiveness and safety of a tool diverting low urgency patients eligible for primary care from an emergency department (ED) to the adjacent general practitioner cooperative (GPC). Methods: Unblinded, randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was nurse-led triage using a new tool assigning patients to either ED or GPC. During intervention weekends, patients were encouraged to follow this assignment while it was not communicated to the patients during control weekends (they remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC during intervention and control weekends. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care eligible patients (with the opinion of the treating physician as the gold standard). Results: In the intervention group, 838/6374 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC (secondary outcome), in the control group 431/1744 (24.7%, 95% CI 22.7 to 26.8). In the intervention group, 599/6374 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the chosen MTS presentational flowchart, patient's age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) patients were referred back to the ED of which three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions: ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. ClinicalTrials.gov Identifier: NCT03793972 Funding: Research Foundation, Flanders (FWO)

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Triaging and referring in adjacent general and emergency departments (the TRIAGE trial): A cluster randomised controlled trial

PLoS ONE ◽

10.1371/journal.pone.0258561 ◽

2021 ◽

Vol 16 (11) ◽

pp. e0258561

Author(s):

Stefan Morreel ◽

Hilde Philips ◽

Diana De Graeve ◽

Koenraad G. Monsieurs ◽

Jarl K. Kampen ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Triage System ◽

Predictive Values ◽

Randomised Controlled

Objectives To determine whether a new triage system safely diverts a proportion of emergency department (ED) patients to a general practitioner cooperative (GPC). Methods Unblinded randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was triage by a nurse using a new extension to the Manchester Triage System assigning low-risk patients to the GPC. During intervention weekends, patients were encouraged to follow this assignment; it was not communicated during control weekends (all patients remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care patients (the opinion of the treating physician was the gold standard). Results In the intervention group, 838/6294 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC, in the control group this was 431/1744 (24.7%, 95% CI 22.7 to 26.8). In total, 599/6294 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the reason for encounter, age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) were referred back to the ED, three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. Trial registration ClinicalTrials.gov Identifier: NCT03793972

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Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial

Primary Health Care Research & Development ◽

10.1017/s1463423619000720 ◽

2019 ◽

Vol 20 ◽

Cited By ~ 1

Author(s):

Iñaki Aguirrezabal ◽

Maria Soledad Pérez de San Román ◽

Raquel Cobos-Campos ◽

Estibalitz Orruño ◽

Arturo Goicoechea ◽

...

Keyword(s):

Primary Care ◽

Educational Intervention ◽

Controlled Trial ◽

Basque Country ◽

Intervention Group ◽

Cost Effective ◽

Response To Treatment ◽

Secondary Outcome ◽

Control Group ◽

Randomised Controlled

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.

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Home initiation of chronic non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure: a randomised controlled trial

Thorax ◽

10.1136/thoraxjnl-2019-213303 ◽

2019 ◽

Vol 75 (3) ◽

pp. 244-252 ◽

Cited By ~ 20

Author(s):

Marieke L Duiverman ◽

Judith M Vonk ◽

Gerrie Bladder ◽

Joost P van Melle ◽

Jellie Nieuwenhuis ◽

...

Keyword(s):

Controlled Trial ◽

Mean Difference ◽

Invasive Ventilation ◽

Non Invasive ◽

Copd Patients ◽

Non Invasive Ventilation ◽

Number Of Patients ◽

Related Quality ◽

Registration Number ◽

Randomised Controlled

IntroductionChronic non-invasive ventilation (NIV) has become evidence-based care for stable hypercapnic COPD patients. While the number of patients increases, home initiation of NIV would greatly alleviate the healthcare burden. We hypothesise that home initiation of NIV with the use of telemedicine in stable hypercapnic COPD is non-inferior to in-hospital NIV initiation.MethodsSixty-seven stable hypercapnic COPD patients were randomised to initiation of NIV in the hospital or at home using telemedicine. Primary outcome was daytime arterial carbon dioxide pressure (PaCO2) reduction after 6 months NIV, with a non-inferiority margin of 0.4 kPa. Secondary outcomes were health-related quality of life (HRQoL) and costs.ResultsHome NIV initiation was non-inferior to in-hospital initiation (adjusted mean difference in PaCO2 change home vs in-hospital: 0.04 kPa (95% CI −0.31 to 0.38 kPa), with both groups showing a PaCO2 reduction at 6 months compared with baseline (home: from 7.3±0.9 to 6.4±0.8 kPa (p<0.001) and in-hospital: from 7.4±1.0 to 6.4±0.6 kPa (p<0.001)). In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI −0.4 to 0.5)). Furthermore, home NIV initiation was significantly cheaper (home: median €3768 (IQR €3546–€4163) vs in-hospital: median €8537 (IQR €7540–€9175); p<0.001).DiscussionThis is the first study showing that home initiation of chronic NIV in stable hypercapnic COPD patients, with the use of telemedicine, is non-inferior to in-hospital initiation, safe and reduces costs by over 50%.Trial registration numberNCT02652559.

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Impact of screening for risk of suicide: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.110.083592 ◽

2011 ◽

Vol 198 (5) ◽

pp. 379-384 ◽

Cited By ~ 42

Author(s):

Mike J. Crawford ◽

Lavanya Thana ◽

Caroline Methuen ◽

Pradip Ghosh ◽

Sian V. Stanley ◽

...

Keyword(s):

Primary Care ◽

Suicidal Ideation ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Secondary Outcome ◽

Worth Living ◽

Early Screening ◽

Care Services ◽

Randomised Controlled ◽

The Impact

BackgroundConcerns have been expressed about the impact that screening for risk of suicide may have on a person's mental health.AimsTo examine whether screening for suicidal ideation among people who attend primary care services and have signs of depression increases the short-term incidence of feeling that life is not worth living.MethodIn a multicentre, single-blind, randomised controlled trial, 443 patients in four general practices were randomised to screening for suicidal ideation or control questions on health and lifestyle (trial registration: ISRCTN84692657). The primary outcome was thinking that life is not worth living measured 10–14 days after randomisation. Secondary outcome measures comprised other aspects of suicidal ideation and behaviour.ResultsA total of 443 participants were randomised to early (n = 230) or delayed screening (n = 213). Their mean age was 48.5 years (s.d. = 18.4, range 16–92) and 137 (30.9%) were male. The adjusted odds of experiencing thoughts that life was not worth living at follow-up among those randomised to early compared with delayed screening was 0.88 (95% CI 0.66–1.18). Differences in secondary outcomes between the two groups were not seen. Among those randomised to early screening, 37 people (22.3%) reported thinking about taking their life at baseline and 24 (14.6%) that they had this thought 2 weeks later.ConclusionsScreening for suicidal ideation in primary care among people who have signs of depression does not appear to induce feelings that life is not worth living.

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Internet-based patient– primary care physician–cardiologist integrated management model of hypertension in China: study protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-039447 ◽

2020 ◽

Vol 10 (10) ◽

pp. e039447

Author(s):

Runyu Ye ◽

Rufeng Shi ◽

Kai Liu ◽

Xin Zhang ◽

Si Wang ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Primary Care Physicians ◽

Integrated Management ◽

Controlled Trial ◽

Care Physician ◽

Management Model ◽

Prevention And Treatment ◽

Treatment Of Hypertension ◽

Randomised Controlled

IntroductionThe control rate of hypertension is low in China, especially in rural, western and minority areas. This is related to poor medical skills among physicians in primary care institutions and low levels of trust among patients. However, primary healthcare institutions are the main battleground for the prevention and treatment of hypertension. It is worth exploring how to most effectively integrate patients, primary care physicians and cardiologists in tertiary hospitals, to build a long-term mechanism for the prevention and treatment of hypertension. In this study, we aim to evaluate the clinical effectiveness and conduct a health economic evaluation of an internet-based patient–primary care physician–cardiologist integrated management model of hypertension in areas of China with different socioeconomic levels.Methods and analysisThis is a 12-month, multicentre, randomised controlled trial involving patients with hypertension in urban communities and rural areas of Sichuan Province, China. Each primary healthcare institution will cooperate with their tertiary hospital through the Red Shine Chronic Disease Management System (RSCDMS). Patients will be randomly assigned 1:1 to two groups: (1) a traditional care group; (2) an intervention group in which primary care physicians and cardiologists can share patient data and manage patients together through the RSCDMS. Patients can upload their blood pressure (BP) values and communicate with physicians using the system. The primary outcome is the change in systolic BP over a 12-month period. Secondary outcomes are changes in diastolic BP, BP control rate, values of 24-hour ambulatory BP monitoring, difference in cost-effectiveness between the groups, patient satisfaction, medication adherence and home BP monitoring compliance. All data will be recorded and stored in the RSCDMS and analysed using IBM SPSS V.26.0.Ethics and disseminationThis study has been approved by the Biomedical Research Ethics Committee of the West China Hospital of Sichuan University in Sichuan, China (No. 2020-148). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration numberChiCTR2000030677.

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Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website

BMJ Open ◽

10.1136/bmjopen-2016-014576 ◽

2017 ◽

Vol 7 (11) ◽

pp. e014576 ◽

Cited By ~ 6

Author(s):

Paul Wallace ◽

Pierliugi Struzzo ◽

Roberto Della Vedova ◽

Francesca Scafuri ◽

Costanza Tersar ◽

...

Keyword(s):

Primary Care ◽

Computer Literacy ◽

Controlled Trial ◽

Relative Effectiveness ◽

Risky Drinking ◽

Face To Face ◽

Audit Score ◽

Registration Number ◽

Randomised Controlled ◽

Alcohol Reduction

BackgroundBrief interventions (BIs) delivered in primary care have been shown to be effective in reducing risky drinking, but implementation is limited. Facilitated access to a digital application offers a novel alternative to face-to-face intervention, but its relative effectiveness is unknown.MethodsPrimary care-based, non-inferiority, randomised controlled trial comparing general practitioner (GP) facilitated access to an interactive alcohol reduction website (FA) with face-to-face BI for risky drinking. Patients screening positive on the short Alcohol Use Disorders Identification Test (AUDIT-C) were invited to participate in the trial. Assessment at baseline, 3 months and 12 months was carried out using AUDIT and EQ-5D-5L questionnaires.Findings58 participating GPs approached 9080 patients of whom 4529 (49.9%) logged on, 3841 (84.8%) undertook screening, 822 (21.4%) screened positive and 763 (19·9%) were recruited. 347 (45.5%) were allocated to FA and 416 (54.5%) to BI. At 3 months, subjects in FA group with an AUDIT score of ≥8 reduced from 95 (27.5%) to 85 (26.8%) while those in BI group increased from 123 (20.6%) to 141 (37%). Differences between groups were principally due to responses to AUDIT question 10. Analysis of primary outcome indicated non-inferiority of FA compared with BI, and prespecified subgroup analysis indicated benefits for older patients and those with higher levels of computer literacy and lower baseline severity. Additional analyses undertaken to take account of bias in response to AUDIT question 10 failed to support non-inferiority within the prespecified 10% boundary.InterpretationPrespecified protocol-driven analyses of the trial indicate that FA is non-inferior to BI; however, identified bias in the outcome measure and further supportive analyses question the robustness of this finding. It is therefore not possible to draw firm conclusions from this trial, and further research is needed to determine whether the findings can be replicated using more robust outcome measures.Trial registration numberNCT01638338; Results.

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Effect of Recruitment Methods on Response Rate in a Web-Based Study for Primary Care Physicians: Factorial Randomized Controlled Trial (Preprint)

10.2196/preprints.8561 ◽

2017 ◽

Author(s):

Ryuhei So ◽

Kiyomi Shinohara ◽

Takuya Aoki ◽

Yasushi Tsujimoto ◽

Aya M Suganuma ◽

...

Keyword(s):

Primary Care ◽

Primary Care Physicians ◽

Response Rate ◽

Controlled Trial ◽

Response Rates ◽

Risk Difference ◽

Web Based ◽

Subject Line ◽

Significant Difference ◽

The Subject

BACKGROUND Low participation rates are one of the most serious disadvantages of Web-based studies. It is necessary to develop effective strategies to improve participation rates to obtain sufficient data. OBJECTIVE The objective of this trial was to investigate the effect of emphasizing the incentive in the subject line of the invitation email and the day of the week of sending the invitation email on the participation rate in a Web-based trial. METHODS We conducted a 2×2 factorial design randomized controlled trial. We contacted 2000 primary care physicians from members of the Japan Primary Care Association in January 2017 and randomly allocated them to 1 of 4 combinations of 2 subject lines (presence or absence of an emphasis on a lottery for an Amazon gift card worth 3000 yen or approximately US $30) and 2 delivery days (sending the invitation email on Tuesday or Friday). The primary outcome was the response rate defined as the number of participants answering the first page of the questionnaire divided by the number of invitation emails delivered. All outcomes were collected between January 17, 2017, and February 8, 2017. RESULTS We analyzed data from 1943 out of 2000 participants after excluding those whose email addresses were invalid. The overall response rate was 6.3% (123/1943). There was no significant difference in the response rates between the 2 groups regarding incentive in the subject line: the risk ratio was 1.12 (95% CI 0.80 to 1.58) and the risk difference was 0.7% (95% CI –1.5% to 2.9%). Similarly, there was no significant difference in the response rates between the 2 groups regarding sending the email on Tuesday or Friday: the risk ratio was 0.98 (95% CI 0.70 to 1.38) and the risk difference was –0.1% (95% CI –2.3% to 2.1%). CONCLUSIONS Neither emphasizing the incentive in the subject line of the invitation email nor varying the day of the week the invitation email was sent led to a meaningful increase in response rates in a Web-based trial with primary care physicians. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry UMIN000025317; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029121 (Archived by WebCite at http://www.webcitation. org/6wOo1jl9t)

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Side Effects of Intravenous Patient-Controlled Analgesia with Remifentanil Compared with Intermittent Epidural Bolus for Labour Analgesia – A Randomized Controlled Trial

PRILOZI ◽

10.2478/prilozi-2020-0009 ◽

2019 ◽

Vol 40 (3) ◽

pp. 99-108

Author(s):

Dafina Karadjova ◽

Mirjana Shosholcheva ◽

Еmilija Ivanov ◽

Аtanas Sivevski ◽

Ivo Kjaev ◽

...

Keyword(s):

Side Effects ◽

Epidural Analgesia ◽

Primary Outcome ◽

Controlled Trial ◽

Secondary Outcome ◽

Patient Controlled Analgesia ◽

Obstetric Anaesthesia ◽

Randomized Controlled ◽

Significant Difference ◽

Remifentanil Group

Abstract Introduction: Epidural analgesia is considered a gold standard in obstetric anaesthesia and analgesia. However, in situation when it is contraindicated, unwanted by the patient or simply unavailable, remifentanil can be an excellent alternative. The goal of our study is to analyse the side effects of intravenous patient-controlled analgesia (IV PCA) with remifentanil compared with epidural analgesia during delivery. Material and methods: This study included 155 pregnant women in term for birth, divided into 2 groups: a remifentanil group (RG), and an epidural group (EG). Patients in the RG received intravenous PCA with remifentanil, while patients in the ЕG received epidural analgesia with programmed intermittent bolus dosing. Our primary outcome was maternal safety; the secondary outcome was neonatal safety. Results: The results present a significantly lower SaO2 value of the parturients in the RG (96.95 ± 1.4 vs 98.22 ± 0.6), and a significantly higher respiratory rate per minute in the EG at all time points after the onset of analgesia (20.85 ± 1.4 vs 18.67 ± 0.9). There was more frequent sedation, nausea and vomiting in the RG, while in the EG there was a more elevated temperature, itching and irregularities in the CTG record. Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group. Conclusion: PCA with remifentanil is safe for the mother, foetus and the newborn, with minimal side effects. Continuous respiratory monitoring, oxygen supply and following of all consensus recommendations are mandatory.

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