How and why a multifaceted intervention to improve adherence post-MI worked for some (and could work better for others): an outcome-driven qualitative process evaluation

ObjectivesTo explore (1) the extent to which a multicomponent intervention addressed determinants of the desired behaviours (ie, adherence to cardiac rehabilitation (CR) and cardiovascular medications), (2) the associated mechanism(s) of action and (3) how future interventions might be better designed to meet the needs of this patient population.DesignA qualitative evaluation embedded within a multicentre randomised trial, involving purposive semistructured interviews.SettingNine cardiac centres in Ontario, Canada.ParticipantsPotential participants were stratified according to the trial’s primary outcomes of engagement and adherence, resulting in three groups: (1) engaged, adherence outcome positive, (2) engaged, adherence outcome negative and (3) did not engage, adherence outcome negative. Participants who did not engage but had positive adherence outcomes were excluded. Individual domains of the Theoretical Domains Framework were applied as deductive codes and findings were analysed using a framework approach.ResultsThirty-one participants were interviewed. Participants who were engaged with positive adherence outcomes attributed their success to the intervention’s ability to activate determinants including behavioural regulation and knowledge, which encouraged an increase in self-monitoring behaviour and awareness of available supports, as well as reinforcement and social influences. The behaviour of those with negative adherence outcomes was driven by beliefs about consequences, emotions and identity. As currently designed, the intervention failed to target these determinants for this subset of participants, resulting in partial engagement and poor adherence outcomes.ConclusionThe intervention facilitated CR adherence through reinforcement, behavioural regulation, the provision of knowledge and social influence. To reach a broader and more diverse population, future iterations of the intervention should target aberrant beliefs about consequences, memory and decision-making and emotion.Trial registration numberClinicalTrials.gov registry; NCT02382731

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Hypotension in Preterm Infants (HIP) randomised trial

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2020-320241 ◽

2021 ◽

pp. fetalneonatal-2020-320241

Author(s):

Eugene M Dempsey ◽

Keith J Barrington ◽

Neil Marlow ◽

Colm Patrick Finbarr O'Donnell ◽

Jan Miletin ◽

...

Keyword(s):

Brain Injury ◽

Primary Outcome ◽

Randomised Trial ◽

Intraventricular Haemorrhage ◽

Standard Group ◽

Double Blind ◽

Group Assignment ◽

Standard Management ◽

Postmenstrual Age ◽

Registration Number

ObjectiveTo determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation.DesignDouble-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.Setting10 sites across Europe and Canada.ParticipantsInfants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage.InterventionParticipants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).Primary outcomeSurvival to 36 weeks of PMA without severe brain injury.ResultsThe trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038).ConclusionThough this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area.Trial registration numberNCT01482559, EudraCT 2010-023988-17.

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Exploring the potential for introducing home monitoring of blood pressure during pregnancy into maternity care: current views and experiences of staff—a qualitative study

BMJ Open ◽

10.1136/bmjopen-2020-037874 ◽

2020 ◽

Vol 10 (12) ◽

pp. e037874

Author(s):

Lisa Hinton ◽

James Hodgkinson ◽

Katherine L Tucker ◽

Linda Rozmovits ◽

Lucy Chappell ◽

...

Keyword(s):

Blood Pressure ◽

Maternity Care ◽

Healthcare Providers ◽

Home Monitoring ◽

Structured Interviews ◽

Group Discussions ◽

Self Monitoring ◽

Team Members ◽

Registration Number ◽

In Pregnancy

ObjectiveOne in 20 women are affected by pre-eclampsia, a major cause of maternal and perinatal morbidity, death and premature birth worldwide. Diagnosis is made from monitoring blood pressure (BP) and urine and symptoms at antenatal visits after 20 weeks of pregnancy. There are no randomised data from contemporary trials to guide the efficacy of self-monitoring of BP (SMBP) in pregnancy. We explored the perspectives of maternity staff to understand the context and health system challenges to introducing and implementing SMBP in maternity care, ahead of undertaking a trial.DesignExploratory study using a qualitative approach.SettingEight hospitals, English National Health Service.ParticipantsObstetricians, community and hospital midwives, pharmacists, trainee doctors (n=147).MethodsSemi-structured interviews with site research team members and clinicians, interviews and focus group discussions. Rapid content and thematic analysis undertaken.ResultsThe main themes to emerge around SMBP include (1) different BP changes in pregnancy, (2) reliability and accuracy of BP monitoring, (3) anticipated impact of SMBP on women, (4) anticipated impact of SMBP on the antenatal care system, (5) caution, uncertainty and evidence, (6) concerns over action/inaction and patient safety.ConclusionsThe potential impact of SMBP on maternity services is profound although nuanced. While introducing SMBP does not reduce the responsibility clinicians have for women’s health, it may enhance the responsibilities and agency of pregnant women, and introduces a new set of relationships into maternity care. This is a new space for reconfiguration of roles, mutual expectations and the relationships between and responsibilities of healthcare providers and women.Trial registration numberNCT03334149.

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Effectiveness and acceptability ofmyo-inositol nutritional supplement in the prevention of gestational diabetes (EMmY): a protocol for a randomised, placebo-controlled, double-blind pilot trial

BMJ Open ◽

10.1136/bmjopen-2018-022831 ◽

2018 ◽

Vol 8 (9) ◽

pp. e022831 ◽

Cited By ~ 3

Author(s):

Chiamaka Esther Amaefule ◽

Zoe Drymoussi ◽

Julie Dodds ◽

Lorna Sweeney ◽

Elena Pizzo ◽

...

Keyword(s):

Gestational Diabetes ◽

Plasma Glucose ◽

Healthcare Professionals ◽

Randomised Trial ◽

Pilot Trial ◽

Qualitative Evaluation ◽

Nutritional Supplement ◽

Cost Data ◽

Advisory Group ◽

Double Blind

IntroductionGestational diabetes increases maternal and offspring complications in pregnancy and cardiovascular complications in the long term. The nutritional supplementmyo-inositol may prevent gestational diabetes; however, further evaluation is required, especially in multiethnic high-risk mothers. Our pilot trial onmyo-inositol to prevent gestational diabetes will evaluate trial processes, assess acceptability to mothers and obtain preliminary estimates of effect and cost data prior to a large full-scale trial.Methods and analysisEMmY is a multicentre, placebo-controlled, double-blind, pilot, randomised trial, with qualitative evaluation. We will recruit pregnant women at 12–15+6weeks’ gestation, with gestational diabetes risk factors, from five maternity units in England between 2018 and 2019. We will randomise 200 women to take either 2 g ofmyo-inositol powder (intervention) or placebo, twice daily until delivery. We will assess rates of recruitment, randomisation, adherence to intervention and follow-up. Gestational diabetes will be diagnosed at 24–28 weeks as per the National Institute for Health and Care Excellence (NICE) criteria (fasting plasma glucose: ≥5.6 mmol/L and 2-hour plasma glucose: ≥7.8 mmol/L). We will assess the effects ofmyo-inositol on glycaemic indices at 28 weeks and on other maternal, fetal and neonatal outcomes at postnatal discharge. Qualitative evaluation will explore the acceptability of the trial and the intervention among women and healthcare professionals. Cost data and health-related quality of life measures will be captured. We will summarise feasibility outcomes using standard methods for proportions and other descriptive statistics, and where appropriate, report point estimates of effect sizes (eg, mean differences and relative risks) and associated 95% CIs.Ethics and disseminationEthical approval was obtained through the London Queen Square Research Ethics Committee (17/LO/1741). Study findings will be submitted for publication in peer-reviewed journals. Newsletters will be made available to participants, healthcare professionals and members of Katie’s Team (a patient and public advisory group) to disseminate.Trial registration numberISRCTN48872100.Protocol version and dateVersion 4.0, 15 January 2018.

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Perceived barriers & facilitators for bedtime routines in families with young children living in economically deprived areas

10.21203/rs.3.rs-20888/v1 ◽

2020 ◽

Author(s):

George Kitsaras ◽

Michaela Goodwin ◽

Julia Allan ◽

Michael P Kelly ◽

Iain A Pretty

Keyword(s):

Young Children ◽

Social Role ◽

Theoretical Domains Framework ◽

Structured Interview ◽

Role Identity ◽

Perceived Barriers ◽

Sources Of Information ◽

Self Monitoring ◽

Economically Deprived ◽

Past Experiences

Abstract Background: Bedtime routines are a highly recurrent family activity with important health, social and behavioural consequences. Despite their importance, information regarding formation, establishment and maintenance of bedtime routines remains limited. This study examined perceived barriers to, and facilitators of, formulating, establishing and maintaining optimal bedtime routines in families with young children from deprived socio-economic areas.Methods: A total of 12 parents participated in the study. Most participants (N=11) were females, had between 1 and 2 children (N=10), were white (N=9) and stay at home parents (N=6). They completed a semi-structured interview based on the Theoretical Domains Framework (TDF). Analysis followed a deductive, theory-informed mapping approach.Results: Key barriers included lack of appropriate knowledge and sources of information, problematic skills development, social influences, cognitive overload, lack of self-monitoring, lack of motivation and negative emotions. Facilitators included social role/identity, environment/access to resources, positive intentions, beliefs about consequences and reinforcement. In particular, optimal bedtime routines were less likely to be enacted when parents were tired/fatigued and there was a strong effect of habit, with suboptimal routines maintained over time due to past experiences and a lack of awareness about the contents and importance of a good bedtime routine. Conclusions: Several theory-based, and potentially modifiable, determinants of optimal bedtime routines were identified in this study, providing important information for future interventions. Several of the key determinants identified were transient (tiredness) and/or non-conscious (habit), suggesting that future interventions may need to be deployed in real time, and should extend beyond conventional techniques.

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A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol

BMJ Open ◽

10.1136/bmjopen-2017-017233 ◽

2017 ◽

Vol 7 (9) ◽

pp. e017233 ◽

Cited By ~ 15

Author(s):

Timme MAJ van Vuuren ◽

Jorinde H H van Laanen ◽

Maaike de Geus ◽

Patty J Nelemans ◽

Rick de Graaf ◽

...

Keyword(s):

Conservative Treatment ◽

Conventional Treatment ◽

Short Form ◽

Randomised Trial ◽

Case Series ◽

Interventional Treatment ◽

Venous Obstruction ◽

Venous Stenting ◽

Link Type ◽

Registration Number

IntroductionDeep venous obstruction (DVO) has a great impact on quality of life (QoL) comparable to angina pectoris or chronic pulmonary disease. Post-thrombotic scar formation and May-Thurner syndrome (MTS) are the most common causes of DVO. Conventional treatment of DVO focuses on reducing pain or leg swelling by use of (pain) medication and therapeutic elastic stockings. In the past, a venous bypass was offered in severe post-thrombotic cases, but this procedure showed bad clinical and patency outcomes. With the introduction of percutaneous angioplasty and dedicated venous stents new opportunities were created. Deep venous stenting has been shown to be effective in retrospective case series. However, there is no prior research in which QoL after interventional treatment is compared with QoL after conventional treatment. Currently, there is a debate about the true additional value of interventional treatment. We investigate whether those patients who are treated with stenting experience a change in short form 36 (SF-36) and the Veines-QoL/Sym questionnaires compared with conventionally treated patients.Methods and analysisThis is a randomised trial comparing conservative deep venous management to interventional treatment. A total of 130 patients with post-thrombotic syndrome (PTS) or MTS, eligible for interventional percutaneous treatment, who did not have previous deep venous intervention will be included. Patients will be randomised to conservative treatment or venous stenting and stratified for the PTS or MTS subgroup. Conservative treatment consists of either one or a combination of pain medications, manual lymphatic drainage, compression stockings and regular post-thrombotic anticoagulant therapy.The primary outcome is the QoL change after 12 months compared with baseline QoL. Secondary outcomes are QoL changes at 6 weeks, clinical assessment of DVO, recurrence rate of deep venous thrombosis at 6 weeks and 12 months, and the total amount of working days lost. Intervention-specific outcomes include complications and patency.Ethics and disseminationThe protocol is approved by the Medical Ethics Committee of Academisch ziekenhuis Maastricht/Universiteit Maastricht, The Netherlands (protocol number NLNL55641.068.15 / METC 161008).We aim to publish the results of this study in a peer reviewed journal and present our findings at national or international conferences.Trial registration numberThe study protocol was registered atwww.clinicaltrials.gov(registration number:NCT03026049) on 17 January 2017.

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Effectiveness of expanding annual mass azithromycin distribution treatment coverage for trachoma in Niger: a cluster randomised trial

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2017-310916 ◽

2017 ◽

Vol 102 (5) ◽

pp. 680-686 ◽

Cited By ~ 10

Author(s):

Abdou Amza ◽

Boubacar Kadri ◽

Beido Nassirou ◽

Sun Y Cotter ◽

Nicole E Stoller ◽

...

Keyword(s):

Repeated Measures ◽

Randomised Trial ◽

Chlamydia Infection ◽

Cluster Randomised Trial ◽

Active Trachoma ◽

Treatment Coverage ◽

Significant Difference ◽

Registration Number ◽

Rate Of Decline ◽

Antibiotic Coverage

Background/aimsThe WHO recommends 3–5 years of annual mass azithromycin distribution with at least 80% treatment coverage to districts with active trachoma prevalence over 10% among children. Here, we assess the efficacy of expanding the coverage target to at least 90% for trachoma control in a mesoendemic region of Niger.MethodsTwenty-four communities were randomised to a single day of azithromycin distribution with a coverage target of 80% of the community or up to 4 days of treatment, aiming for greater than 90% coverage. Distributions were annual and individuals above 6 months of age were treated. Children under 5 years of age were monitored for ocular chlamydia infection and active trachoma.ResultsAt baseline, ocular chlamydia prevalence was 20.5% (95% CI 9.8% to 31.2%) in the standard coverage arm and 21.9% (95% CI 11.3% to 32.5%) in the enhanced coverage arm, which reduced to 4.6% (95% CI 0% to 9.5%, p=0.008) and 7.1% (95% CI 2.7% to 11.4%, p<0.001) at 36 months, respectively. There was no significant difference in 36-month ocular chlamydia prevalence between the two arms (p=0.21). There was no difference in the rate of decline in ocular chlamydia between the two arms in a repeated measures model (p=0.80).ConclusionsFor annual mass azithromycin distribution programme to an entire community, there may be no additional benefit of increasing antibiotic coverage above the WHO’s 80% target.Trial registration numberNCT00792922, post-results.

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Explaining the mixed findings of a randomised trial of telehealth with centralised remote support for heart failure: qualitative evaluation

10.21203/rs.2.22388/v1 ◽

2020 ◽

Cited By ~ 1

Author(s):

Chrysanthi Papoutsi ◽

Christine A'Court ◽

Joseph Wherton ◽

Sara Shaw ◽

Trisha Greenhalgh

Keyword(s):

Heart Failure ◽

Randomised Trial ◽

Qualitative Evaluation ◽

Support Service ◽

Full Potential ◽

Variable Degree ◽

Care Model ◽

Illness Experiences ◽

Technological Intervention ◽

Technical Capacity

Abstract BackgroundCentralised specialist remote support, in which a clinician responds promptly to biomarker changes, could potentially improve outcomes in heart failure. The SUPPORT-HF2 trial compared telehealth technology alone with the same technology combined with centralised remote support. The intervention was implemented differently in different sites; no significant impact was found overall. We sought to explain these findings in a qualitative evaluation. Methods51 people (25 patients, 3 carers, 18 clinicians and 4 additional research staff) were interviewed and observed in 7 SUPPORT-HF sites across UK between 2016 and 2018. We also collected 110 pages of documents. Analysis was informed by sociotechnical theory. ResultsPatients’ experiences of the technology were largely positive; staff engaged with the intervention to a variable degree. Existing services, staffing levels, technical capacity and previous experience with telehealth all influenced how the complex intervention of ‘telehealth technology plus centralised specialist remote support’ was interpreted and the extent to which it was adopted and used to its full potential. In some settings, the intervention was quickly mobilised to fill significant gaps in service provision. In others, it was seen as usefully extending the existing care model for selected patients. However, in some settings, the new care model was actively resisted and the technology little used. In one setting, centralised provision of specialist advice aligned awkwardly with an existing community-based heart failure support service. ConclusionsThe introduction of a telehealth programme rests not only on the technological intervention but also on the individuals involved and numerous subtle aspects of local service design. An iterative approach that attends to patients’ illness experiences, clinicians’ professional values, work practices and care pathways could lead to more effective telehealth support for patients with heart failure.

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Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial

BMJ Open ◽

10.1136/bmjopen-2020-040110 ◽

2020 ◽

Vol 10 (11) ◽

pp. e040110

Author(s):

Mikaela Smit ◽

Annalisa Marinosci ◽

Giovanni Jacopo Nicoletti ◽

Thomas Perneger ◽

Silvio Ragozzino ◽

...

Keyword(s):

Randomised Trial ◽

Standard Of Care ◽

Cluster Randomised Trial ◽

Postexposure Prophylaxis ◽

Open Label ◽

Daily Monitoring ◽

Intention To Treat ◽

Cluster Randomised ◽

Registration Number ◽

Asymptomatic Individuals

IntroductionLopinavir/ritonavir (LPV/r) has been proposed as repurposed drugs for pre-exposure and postexposure prophylaxis as well as therapy of COVID-19. Coronavirus postexposure prophylaxis (COPEP) trial aims at assessing their efficacy as postexposure ring-prophylaxis among adults exposed to SARS-CoV-2.Methods and analysisCOPEP is a two-arm open-label cluster-randomised trial conducted in three cantons of Switzerland. Asymptomatic contacts (≥16 years) of individuals diagnosed with COVID-19 will be randomised (2:1) to either LPV/r (400 mg/100 mg two times per day) for 5 days, or a standard of care arm (no treatment). Asymptomatic individuals may be either SARS-CoV-2 positive or negative. Contacts living in the single household will form a cluster and will be randomised into the same arm. All participants will be followed-up for 21 days and undergo daily monitoring for COVID-19 symptoms. The primary endpoint is 21-day incidence of laboratory-confirmed COVID-19 with ≥1 compatible symptom, analysed in an intention-to-treat (ITT) analysis. The secondary endpoints include the 21-day incidence of COVID-19 as well as SARS-CoV-2 infection in a modified ITT analysis, excluding participants who had a positive SARS-CoV-2 RT-PCR from oropharyngeal swab and/or a positive SARS-CoV-2 IgG serology at baseline. Assuming a 21-day incidence for COVID-19 of 20% among contacts without postexposure chemoprophylaxis, to detect a relative risk reduction of 60% (ie, translating in an absolute reduction from 20% to 8%), with a power of 80%, an alpha of 5%. Accounting for design effect of cluster design of circa 1.1, we plan to enrol 200 participants to the LPV/r arm and 100 to the standard of care arm, 300 participants in total.Ethics and disseminationEthics approval has been granted by the Commission Cantonale d’Ethique de la Recherche, Ethikkommission Nordwest- und Zentralschweiz and Comitato Etico Cantonale (ref 2020-00864) and Swissmedic (2020DR3056). Results from this trial will be disseminated via journal articles and presentations at national and international conferences.Trial registration numberClinicaltrials.gov Registry (NCT04364022); Swiss National Clinical Trial Portal Registry (SNCTP 000003732).Registered report identifierCCER 2020-0864.

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Fidelity protocol for the Action Success Knowledge (ASK) trial: a psychosocial intervention administered by speech and language therapists to prevent depression in people with post-stroke aphasia

BMJ Open ◽

10.1136/bmjopen-2018-023560 ◽

2019 ◽

Vol 9 (5) ◽

pp. e023560

Author(s):

Marcella Carragher ◽

Brooke Ryan ◽

Linda Worrall ◽

Shirley Thomas ◽

Miranda Rose ◽

...

Keyword(s):

Health Behaviour ◽

Intervention Studies ◽

Language Disability ◽

Randomised Trial ◽

Experimental Treatment ◽

Cluster Randomised Trial ◽

Human Research ◽

Time Of Application ◽

Human Research Ethics ◽

Registration Number

IntroductionTreatment fidelity is a complex, multifaceted evaluative process which refers to whether a studied intervention was delivered as intended. Monitoring and enhancing fidelity is one recommendation of the TiDIER (Template for Intervention Description and Replication) checklist, as fidelity can inform interpretation and conclusions drawn about treatment effects. Despite the methodological and translational benefits, fidelity strategies have been used inconsistently within health behaviour intervention studies; in particular, within aphasia intervention studies, reporting of fidelity remains relatively rare. This paper describes the development of a fidelity protocol for the Action Success Knowledge (ASK) study, a current cluster randomised trial investigating an early mood intervention for people with aphasia (a language disability caused by stroke).Methods and analysisA novel fidelity protocol and tool was developed to monitor and enhance fidelity within the two arms (experimental treatment and attention control) of the ASK study. The ASK fidelity protocol was developed based on the National Institutes of Health Behaviour Change Consortium fidelity framework.Ethics and disseminationThe study protocol was approved by the Darling Downs Hospital and Health Service Human Research Ethics Committee in Queensland, Australia under the National Mutual Acceptance scheme of multicentre human research projects. Specific ethics approval was obtained for those participating sites who were not under the National Mutual Agreement at the time of application. The monitoring and ongoing conduct of the research project is in line with requirements under the National Mutual Acceptance. On completion of the trial, findings from the fidelity reviews will be disseminated via publications and conference presentations.Trial registration numberACTRN12614000979651.

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Efficacy of platinum-based chemotherapy and prognosis of patients with pancreatic cancer with homologous recombination deficiency: comparative analysis of published clinical studies

ESMO Open ◽

10.1136/esmoopen-2019-000578 ◽

2020 ◽

Vol 5 (1) ◽

pp. e000578 ◽

Cited By ~ 2

Author(s):

Ilya Pokataev ◽

Mikhail Fedyanin ◽

Elizaveta Polyanskaya ◽

Anna Popova ◽

Julia Agafonova ◽

...

Keyword(s):

Systematic Review ◽

Pancreatic Cancer ◽

Homologous Recombination ◽

Meta Analysis ◽

Randomised Trial ◽

Systematic Analysis ◽

Homologous Recombination Deficiency ◽

Platinum Based Chemotherapy ◽

Registration Number ◽

Weighted Median

The aim of our study was to determine the effect of homologous recombination deficiency (HRD) on prognosis and efficacy of platinum-based chemotherapy in patients with pancreatic cancer (PC). We performed PubMed and Embase database queries. We included 4 studies into the meta-analysis and 16 studies in the systematic review. Our systematic analysis showed that the average weighted median overall survival (OS) in patients with HRD with advanced PC was 19.8 and 15.6 months in patients without HRD. With platinum-based chemotherapy, the average weighted median OS in patients with HRD was 23.8 and 17.1 months in patients without HRD. Without platinum-based chemotherapy, the average weighted median OS in patients with HRD was 8.3 and 12.0 months in patients without HRD. For resected PC, our meta-analysis demonstrated that HRD status did not affect the prognosis (HR 1.03, 95% CI 0.46 to 2.33), but results were rather heterogeneous (I2=83%, p=0.003). Our systematic analysis showed that the average weighted median OS in patients with HRD was 34.6 and 27.0 months in patients without HRD. With platinum-based chemotherapy, the average weighted median OS in patients with HRD was 46.1 and 36.3 months in patients without HRD. Without platinum-based chemotherapy, the average weighted median OS in patients with HRD was 24.2 and 42.9 months in patients without HRD. Results of our meta-analysis and systematic review support the idea of platinum use in patients with HRD both in resected and metastatic PCs, although a randomised trial is warranted to make a more reliable conclusion.PROSPERO registration numberCRD42019121914.

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