Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated OA care model: Secondary analyses from a cluster-randomised stepped wedge trial

Abstract Background: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. Methods: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. Results: 284 intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (OR adjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. Conclusions: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers.

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Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated OA care model: Secondary analyses from a cluster-randomised stepped wedge trial

10.21203/rs.2.17081/v4 ◽

2020 ◽

Author(s):

Tuva Moseng ◽

Hanne Dagfinrud ◽

Leti van Bodegom-Vos ◽

Krysia Dziedzic ◽

Kåre Birger Hagen ◽

...

Keyword(s):

Usual Care ◽

Intervention Group ◽

Treatment Recommendations ◽

Control Group ◽

Stepped Wedge ◽

Care Model ◽

Structured Model ◽

Cluster Randomised ◽

Patient Reported ◽

And Control

Abstract Background: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. Methods: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. Results: 284 intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (OR adjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. Conclusions: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers.

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Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated OA care model: Secondary analyses from a cluster-randomised controlled trial

10.21203/rs.2.17081/v1 ◽

2019 ◽

Author(s):

Tuva Moseng ◽

Hanne Dagfinrud ◽

Leti van Bodegom-Vos ◽

Krysia Dziedzic ◽

Kåre Birger Hagen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Care Model ◽

Structured Model ◽

Cluster Randomised ◽

Randomised Controlled ◽

And Control

Abstract Background: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. Methods: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. Results: 284 intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (OR adjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. Conclusions: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers.

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OP0198-HPR A STRUCTURED MODEL FOR OA CARE IN PRIMARY HEALTHCARE IS A COST-EFFECTIVE ALTERNATIVE COMPARED TO USUAL CARE FOR PEOPLE WITH HIP AND KNEE OA

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.950 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 119-120

Author(s):

N. Østerås ◽

E. Aas ◽

T. Moseng ◽

L. Van Bodegom-Vos ◽

K. Dziedzic ◽

...

Keyword(s):

Usual Care ◽

Primary Healthcare ◽

Intervention Group ◽

Cost Effective ◽

Cost Utility ◽

Control Group ◽

Structured Model ◽

Knee Oa ◽

Cost Effective Alternative ◽

The Cost

Background:To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international treatment recommendations. A previous analysis of a cluster RCT (cRCT) showed that compared to usual care, the intervention group reported higher quality of care and greater satisfaction with care. Also, more patients were treated according to international guidelines and fulfilled recommendations for physical activity at the 6-month follow-up.Objectives:To assess the cost-utility of a structured model for hip or knee OA care.Methods:A cRCT with stepped-wedge cohort design was conducted in 6 Norwegian municipalities (clusters) in 2015-17. The OA care model was implemented in one cluster at the time by switching from “usual care” to the structured model. The implementation of the model was facilitated by interactive workshops for general practitioners (GPs) and physiotherapists (PTs) with an update on OA treatment recommendations. The GPs explained the OA diagnosis and treatment alternatives, provided pharmacological treatment when appropriate, and suggested referral to physiotherapy. The PT-led patient OA education programme was group-based and lasted 3 hours followed by an 8–12-week individually tailored resistance exercise programme with twice weekly 1-hour supervised group sessions (5–10 patients per PT). An optional 10-hours Healthy Eating Program was available. Participants were ≥45 years with symptomatic hip or knee OA.Costs were measured from the healthcare perspective and collected from several sources. Patients self-reported visits in primary healthcare at 3, 6, 9 and 12 months. Secondary healthcare visits and joint surgery data were extracted from the Norwegian Patient Register. The health outcome, quality-adjusted life-year (QALY), was estimated based on the EQ-5D-5L scores at baseline, 3, 6, 9 and 12 months. The result of the cost-utility analysis was reported using the incremental cost-effectiveness ratio (ICER), defined as the incremental costs relative to incremental QALYs (QALYs gained). Based on Norwegian guidelines, the threshold is €27500. Sensitivity analyses were performed using bootstrapping to assess the robustness of reported results and presented in a cost-effectiveness plane (Figure 1).Results:The 393 patients’ mean age was 63 years (SD 9.6) and 74% were women. 109 patients were recruited during control periods (control group), and 284 patients were recruited during interventions periods (intervention group). Only the intervention group had a significant increase in EQ-5D-5L utility scores from baseline to 12 months follow-up (mean change 0.03; 95% CI 0.01, 0.05) with QALYs gained: 0.02 (95% CI -0.08, 0.12). The structured OA model cost approx. €301 p.p. with an additional €50 for the Healthy Eating Program. Total 12 months healthcare cost p.p. was €1281 in the intervention and €3147 in the control group, resulting in an incremental cost of -€1866 (95% CI -3147, -584) p.p. Costs related to surgical procedures had the largest impact on total healthcare costs in both groups. During the 12-months follow-up period, 5% (n=14) in the intervention compared to 12% (n=13) in the control group underwent joint surgery; resulting in a mean surgical procedure cost of €553 p.p. in the intervention as compared to €1624 p.p. in the control group. The ICER was -€93300, indicating that the OA care model resulted in QALYs gained and cost-savings. At a threshold of €27500, it is 99% likely that the OA care model is a cost-effective alternative.Conclusion:The results of the cost-utility analysis show that implementing a structured model for OA care in primary healthcare based on international guidelines is highly likely a cost-effective alternative compared to usual care for people with hip and knee OA. More studies are needed to confirm this finding, but this study results indicate that implementing structured OA care models in primary healthcare may be beneficial for the individual as well as for the society.Disclosure of Interests:None declared

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Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.21.01344 ◽

2022 ◽

Author(s):

Wei Dai ◽

Wenhong Feng ◽

Yuanqiang Zhang ◽

Xin Shelley Wang ◽

Yangjun Liu ◽

...

Keyword(s):

Lung Cancer ◽

Usual Care ◽

Symptom Management ◽

Intervention Group ◽

Lung Cancer Surgery ◽

Patient Reported Outcome ◽

Cancer Surgery ◽

Interquartile Range ◽

Control Group ◽

Patient Reported

PURPOSE We aimed to evaluate the efficacy and feasibility of patient-reported outcome (PRO)-based symptom management in the early period after lung cancer surgery. METHODS Before surgery, patients with clinically diagnosed lung cancer were randomly assigned 1:1 to receive postoperative PRO-based symptom management or usual care. All patients reported symptoms on MD Anderson Symptom Inventory-Lung Cancer presurgery, daily postsurgery, and twice a week after discharge for up to 4 weeks via an electronic PRO system. In the intervention group, treating surgeons responded to overthreshold electronic alerts driven by any of the five target symptom scores (score ≥ 4 on a 0-10 scale for pain, fatigue, disturbed sleep, shortness of breath, and coughing). The control group patients received usual care and no alerts were generated. The primary outcome was the number of symptom threshold events (any target symptom with a score of ≥ 4) at discharge. Per-protocol analyses were conducted. RESULTS Of the 166 participants, 83 were randomly allocated to each group. At discharge, the intervention group reported fewer symptom threshold events than the control group (median [interquartile range], 0 [0-2] v 2 [0-3]; P = .007). At 4 weeks postdischarge, this difference was maintained between the intervention and control groups (median [interquartile range], 0 [0-0] v 0 [0-1]; P = .018). The intervention group had a lower complication rate than the control group (21.5% v 40.6%; P = .019). Surgeons spent a median of 3 minutes managing an alert. CONCLUSION PRO-based symptom management after lung cancer surgery showed lower symptom burden and fewer complications than usual care for up to 4 weeks postdischarge.

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Peer mentorship to improve self-management of hip and knee osteoarthritis: a randomised feasibility trial

BMJ Open ◽

10.1136/bmjopen-2020-045389 ◽

2021 ◽

Vol 11 (7) ◽

pp. e045389

Author(s):

Anna M Anderson ◽

Elizabeth C Lavender ◽

Esther Dusabe-Richards ◽

Teumzghi F Mebrahtu ◽

Linda McGowan ◽

...

Keyword(s):

Usual Care ◽

Sample Size ◽

Intervention Group ◽

Feasibility Trial ◽

Self Management ◽

Control Group ◽

Peer Mentor ◽

Peer Mentorship ◽

Knee Oa ◽

Patient Reported

ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).DesignSix-month parallel group non-blinded randomised feasibility trial.SettingOne secondary care and one primary care UK National Health Service Trust.ParticipantsFifty adults aged ≥55 years old with hip and/or knee OA.InterventionsParticipants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.Outcome measuresKey feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.ResultsNinety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.ConclusionsThe feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.Trial registration numberISRCTN:50675542.

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OP0279 THE IMPACT OF A REFERRAL STRATEGY FOR AXIAL SPONDYLOARTHRITIS: 12 MONTHS FOLLOW-UP OF PATIENT REPORTED OUTCOMES

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.6090 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 174.2-174

Author(s):

M. J. Abdelkadir ◽

M. Kuijper ◽

C. Appels ◽

A. Spoorenberg ◽

J. Hazes ◽

...

Keyword(s):

Primary Care ◽

Usual Care ◽

Axial Spondyloarthritis ◽

Control Group ◽

P Value ◽

Patient Reported ◽

Referral Strategy ◽

And Control ◽

The Impact ◽

Over Time

Background:Early recognition of axial spondyloarthritis (axSpA) patients is difficult for general practitioners within the large amount of chronic low back pain (CLBP) patients1. As a result, several referral strategies have been developed to help physicians identify patients at risk for axSpA. Most referral strategies were developed in secondary care patients with no available data on their impact. The only referral strategy that was developed and validated in primary CLBP patients is the Case Finding Axial Spondyloarthritis (CaFaSpA) strategy, but required an impact analysis before implementation in daily clinical practice2-3.Objectives:The purpose of this study was to assess the impact of using the CaFaSpA referral strategy on patient reported outcome outcomes (PROs) in primary care patients with CLBP at risk for axSpA.Methods:A clustered randomized controlled trial was performed in a primary care setting in the Netherlands. (ClinicalTrials.gov Identifier:NCT01944163). Each cluster contained the general practices from a single primary care practice and their included patients. Clusters were randomized to either the intervention (use of CaFaSpA referral strategy) or the control group (usual care). Primary outcome was disability after 12 months. Secondary outcome was quality of life, pain and fatigue after 12 months. A linear mixed-effects model was used to explore the effects over time according to intention to treat analysis.Results:In total 679 patients were included within 93 GP clusters. Sixty-four percent of our study population were female and mean age was 36 (7.5) years. Overall RMDQ reduced over time both in the intervention and control group (figure 1). The difference in decrease was not statically significant between the groups (p-value 0.81).Figure 1.Estimated mean RMDQ scores over time for the overall intervention and usual care group.EQ-5D increased by 0.03 after 12 months within the intervention group and 0.01 in the control group (not significant) (table 1). The decrease in pain and fatigue did not differ significantly between the intervention and control group.Table 1.Mean change in PROs after 12 months in the intervention and control groupPROsInterventionUsual careBaseline12 monthsp-valueBaseline12 monthsp-valueEQ-5D mean (SD)0.69 (0.26)0.72 (0.27)0.140.72 (0.24)0.73 (0.25)0.53VAS-pain mean (SD)5.03 (2.42)4.68 (2.69)0.074.96 (2.42)4.55 (2.69)0.02VAS-fatigue mean (SD)5.19 (2.50)5.01 (0.21)0.355.23 (2.45)4.86 (2.73)0.04Conclusion:Although the functional disability due to pain reduces over time, there was no positive effect by referring based on the CaFaSPA model. Further data on PROMs for the axSpA patients are under investigation.References:[1]Jois RN et al. Rheumatology (Oxford) 2008;47:1364-1366.[2]van Hoeven L et al. PLoS One 2015; 22;10(7):e0131963.[2]Moons KG et al. Heart 2012;98(9):691-8.Disclosure of Interests:None declared

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Fruit and vegetable intake among overweight and obese school children: A cluster randomised control trial

Malaysian Journal of Nutrition ◽

10.31246/mjn-2020-0023 ◽

2021 ◽

Vol 27 (1) ◽

pp. 067-079

Author(s):

Rusidah Selamat ◽

◽

Junidah Raib ◽

Nur Azlina Abdul Aziz ◽

Norlida Zulkafly ◽

...

Keyword(s):

Stages Of Change ◽

School Children ◽

Vegetable Intake ◽

Intervention Group ◽

Fruit And Vegetable Intake ◽

Control Group ◽

Fruit And Vegetable ◽

Cluster Randomised ◽

Maintenance Stage ◽

And Control

Introduction: Adequate daily intake of fruits and vegetables is crucial for the prevention of chronic diseases. This study aimed to determine the effects of My Body is Fit and Fabulous at School (MyBFF@school) with nutrition education intervention (NEI) on the stages of change for fruit and vegetable intake among overweight and obese secondary school children based on the trans-theoretical model (TTM). Methods: This was a cluster randomised controlled trial involving 15 out of 415 eligible government secondary schools in central Peninsular Malaysia, which were randomly assigned into intervention (six schools; 579 school children) and control (nine schools; 462 school children). The intervention group was given NEI for 24 weeks, while the control group followed the existing school programme by the Ministry of Education. Results: There was no significant difference between the intervention and control groups for the stages of change, with majority at the maintenance stage after six months (intervention: 34.9%; control: 39.0%). The within group analysis showed a significant reduction after six months for those at the action stage (action and maintenance stage) from 68.0% to 60.4% in the intervention group and from 71.4% to 65.6% in the control group. However, there was a significant increase among those with adequate fruit and vegetable intake in the intervention group and no significant increase in the control group. Conclusion: MyBFF@school with NEI based on TTM provided acceptable changes in fruit and vegetable intake among overweight and obese secondary school children.

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Effects of Continuous Care Model on Mental Health in Mothers of Children with Cerebral Palsy: A Randomized Clinical Trial

Shiraz E-Medical Journal ◽

10.5812/semj.108394 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Latif Panahi ◽

Abolfazl Etebarian Khorasgani ◽

Marzieh Amiri ◽

Somaye Pouy

Keyword(s):

Mental Health ◽

Cerebral Palsy ◽

Intervention Group ◽

Control Group ◽

Care Model ◽

Continuous Care ◽

Children With Cerebral Palsy ◽

The Mean ◽

And Control ◽

Positive Effect

Background: Cerebral palsy is a leading cause of disability among children, and most of these children depend on their care provider or parents all the time. Mothers of these children spend a great amount of time taking care of them, which could have adverse effects on their mental health. Objectives: The present study was conducted to investigate the impact of the continuous care model (CCM) on the mental health of mothers with children suffering from cerebral palsy. Methods: This randomized clinical trial was performed among 80 mothers of hospitalized children with cerebral palsy. Subjects were randomly divided into the two groups of intervention and control. In the intervention group, the CCM was administered to the mothers up to eight weeks after discharge, and for the control group, only routine nursing education was provided to the mothers at hospital discharge. Before and one and eight weeks after the intervention, in both groups, the mothers' mental health was assessed using the General Health Questionnaire. Data were analyzed using SPSS version 21 through descriptive and inferential statistics. Results: The mean age of the mothers was 33.2 ± 2.1 years and 34.3 ± 2.2 years in the intervention and control groups, respectively. In the intervention group, the CCM had a positive effect on the mental health of mothers one and two months after discharge from hospital compared to before the intervention (P = 0.04, P = 0.02, respectively); however, in the control group, the mean score of mothers' mental health was decreased over time. No significant relationship was found between mental health and the demographic characteristics of the mothers (i.e., age, education, participation in any child caring programs, having anxiety, having any other children with cerebral palsy, and experiencing depression due to having a child with cerebral palsy) (P > 0.05). Conclusions: The CCM had a positive effect on the mental health of mothers of children with cerebral palsy. Thus, this intervention might be useful, but further studies are needed about the cost effectiveness of this intervention and its long-term impact on a larger sample.

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Placental growth factor in assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a stepped wedge cluster randomised control trial (PARROT Ireland)

BMJ ◽

10.1136/bmj.n1857 ◽

2021 ◽

pp. n1857

Author(s):

D Hayes-Ryan ◽

A S Khashan ◽

K Hemming ◽

C Easter ◽

D Devane ◽

...

Keyword(s):

Usual Care ◽

Maternal Morbidity ◽

Point Of Care ◽

Intervention Group ◽

Group Versus ◽

Neonatal Morbidity ◽

Randomised Control Trial ◽

Control Group ◽

Stepped Wedge ◽

Cluster Randomised Control Trial

AbstractObjectiveTo determine whether the addition of placental growth factor (PlGF) measurement to current clinical assessment of women with suspected pre-eclampsia before 37 weeks' gestation would reduce maternal morbidity without increasing neonatal morbidity.DesignStepped wedge cluster randomised control trial from 29 June 2017 to 26 April 2019.SettingNational multisite trial in seven maternity hospitals throughout the island of IrelandParticipantsWomen with a singleton pregnancy between 20+0 to 36+6 weeks’ gestation, with signs or symptoms suggestive of evolving pre-eclampsia. Of the 5718 women screened, 2583 were eligible and 2313 elected to participate.InterventionParticipants were assigned randomly to either usual care or to usual care plus the addition of point-of-care PlGF testing based on the randomisation status of their maternity hospital at the time point of enrolment.Main outcomes measuresCo-primary outcomes of composite maternal morbidity and composite neonatal morbidity. Analysis was on an individual participant level using mixed-effects Poisson regression adjusted for time effects (with robust standard errors) by intention-to-treat.ResultsOf the 4000 anticipated recruitment target, 2313 eligible participants (57%) were enrolled, of whom 2219 (96%) were included in the primary analysis. Of these, 1202 (54%) participants were assigned to the usual care group, and 1017 (46%) were assigned the intervention of additional point-of-care PlGF testing. The results demonstrate that the integration of point-of-care PlGF testing resulted in no evidence of a difference in maternal morbidity—457/1202 (38%) of women in the control group versus 330/1017 (32%) of women in the intervention group (adjusted risk ratio (RR) 1.01 (95% CI 0.76 to 1.36), P=0.92)—or in neonatal morbidity—527/1202 (43%) of neonates in the control group versus 484/1017 (47%) in the intervention group (adjusted RR 1.03 (0.89 to 1.21), P=0.67).ConclusionsThis was a pragmatic evaluation of an interventional diagnostic test, conducted nationally across multiple sites. These results do not support the incorporation of PlGF testing into routine clinical investigations for women presenting with suspected preterm pre-eclampsia, but nor do they exclude its potential benefit.Trial registrationClinicalTrials.gov NCT02881073.

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