scholarly journals Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis

BMJ ◽  
2018 ◽  
pp. k4738 ◽  
Author(s):  
Joanna C Crocker ◽  
Ignacio Ricci-Cabello ◽  
Adwoa Parker ◽  
Jennifer A Hirst ◽  
Alan Chant ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Lived Experience ◽  
Odds Ratio ◽  
Public Involvement ◽  
Meta Analysis ◽  
Patient And Public Involvement ◽  
Retention Rates ◽  
The Impact

AbstractObjectiveTo investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.DesignSystematic review and meta-analysis.Data sourcesTen electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteriaExperimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysisTwo independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14v1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).ConclusionsThese findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registrationPROSPERO CRD42016043808.

scholarly journals The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Derek G. Kyte ◽  
Olalekan Lee Aiyegbusi ◽  
Anita L. Slade ◽  
Christel McMullan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Case Studies ◽  
Real World ◽  
Clinical Trial Data ◽  
Research Impact ◽  
Trial Data ◽  
Patient Reported ◽  
The Impact

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.

Hepatitis B reactivation in patients with solid tumors: A systematic review and meta-analysis.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 138-138 ◽  
Author(s):  
Lisa K. Hicks ◽  
Jordan J. Feld ◽  
Ronak Saluja ◽  
Judy Truong ◽  
Adam E. Haynes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Hepatitis B ◽  
Solid Tumors ◽  
Solid Tumor ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Hbv Reactivation ◽  
Antiviral Prophylaxis ◽  
Chronic Hbv ◽  
The Impact

138 Background: Hepatitis B virus (HBV) affects over 250 million people worldwide. Most people with chronic HBV (HBsAg positive) have no signs or symptoms of infection. However, when exposed to immunosuppression they are at risk of HBV reactivation which can cause hepatitis, liver failure and death. The risk of HBV reactivation in patients receiving chemotherapy for solid tumors, the efficacy of antiviral prophylaxis, and the clinical impact of HBV reactivation in this setting are uncertain. Primary Aim: To estimate the risk of clinical HBV reactivation (increased HBV DNA + transaminitis) among HBsAg-positive patients administered chemotherapy for a solid tumor. Secondary Aims: To estimate the efficacy of anti-viral prophylaxis and the risk of death from HBV reactivation in patients receiving chemotherapy for solid tumors. Methods: A systematic review and meta-analysis of the English language literature on HBV reactivation was completed (OVID Medline, 1946 to Aug 2013). All citations were reviewed by two or more authors. Data from patients with hematologic malignancies were excluded. Pooled probabilities of HBV reactivation risk, death from HBV reactivation, and odds ratio for the impact of anti-viral prophylaxis were estimated with a random effects model. Results: 2,667 citations were identified; 19 were eligible for inclusion. The pooled estimate for clinical HBV reactivation in HBsAg-positive patients receiving chemotherapy for a solid tumor was 21.9% (95% CI; 16.5% to 27.3%) in those not receiving anti-viral prophylaxis, and 2.4% (95% CI 0.7% to 4.2%) in those receiving anti-viral prophylaxis. The odds ratio for clinical HBV reactivation with antiviral prophylaxis compared to no prophylaxis was 0.12 (95% CI 0.06 to 0.25). In the absence of viral prophylaxis, the risk of dying from HBV reactivation in HBsAg-positive solid tumor patients was estimated at 1.3% with a 95% CI of 0.3% to 2.3%. Conclusions: Patients with chronic HBV who are administered chemotherapy for a solid tumor appear to be at substantial risk of clinical HBV reactivation; this risk may be mitigated by anti-viral prophylaxis. In the absence of anti-viral therapy, patients may experience a small but important risk of dying from HBV reactivation.

scholarly journals Mapping the impact of patient and public involvement on health and social care research: a systematic review

2012 ◽  
Vol 17 (5) ◽  
pp. 637-650 ◽  
Author(s):  
Jo Brett ◽  
Sophie Staniszewska ◽  
Carole Mockford ◽  
Sandra Herron-Marx ◽  
John Hughes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Public Involvement ◽  
Social Care ◽  
Patient And Public Involvement ◽  
Care Research ◽  
Health And Social Care ◽  
The Impact

scholarly journals A living systematic review protocol for COVID-19 clinical trial registrations

2020 ◽  
Vol 5 ◽  
pp. 60 ◽  
Author(s):  
Brittany J. Maguire ◽  
Philippe J. Guérin
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Geographic Location ◽  
Diagnostic Methods ◽  
Future Research ◽  
Strong Response ◽  
Level Of Evidence

Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website (COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.

scholarly journals Achieving effective patient and public involvement in international clinical trials in neurology

2019 ◽  
Vol 10 (3) ◽  
pp. 265-272 ◽  
Author(s):  
Emma C. Tallantyre ◽  
Nikos Evangelou ◽  
Clare Bale ◽  
Burhan Z. Chaudhry ◽  
Emma H. Gray ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Research Team ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Controlled Trials ◽  
Framework Analysis ◽  
Randomized Controlled ◽  
Structured Approach

There is a growing need for patient and public involvement (PPI) to inform the way that research is developed and performed. International randomized controlled trials are particularly likely to benefit from PPI, but guidance is lacking on how or when it should be incorporated. In this article, we describe the PPI process that occurred during the design and initiation of an international treatment clinical trial in MS. PPI was incorporated using a structured approach, aiming to minimize bias and achieve equivalence in study design, implementation, and interpretation. Methods included PPI representation within the study research team, and the use of focus groups, analyzed using thematic framework analysis. We report the outcomes of PPI and make recommendations on its use in other neurology clinical trials. By sharing our model for PPI, we aim to maximize effectiveness of future public involvement and to allow its effect to be better evaluated.

Heparin Does Not Increase Live Births in Pregnant Women with Previous Unexplained Recurrent Miscarriages: A Systematic Review and Meta-Analysis

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 504-504
Author(s):  
Murtadha K. Al-Khabori ◽  
Zainab S. Al-Hosni ◽  
Hajer M. Al Ghaithi ◽  
Altaf M. Al Maamari ◽  
Wafa S. Bessiso ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Pregnant Women ◽  
Antiphospholipid Antibodies ◽  
Odds Ratio ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Inherited Thrombophilia ◽  
Recurrent Miscarriages ◽  
Live Births

Abstract Abstract 504 Background: The impact of heparin in pregnant women with previous unexplained recurrent miscarriages remains uncertain. The use of heparin in this patient population has been increasing with the hope of improving the rate of live births. We performed a systematic review of the randomized clinical trials addressing this question. Methods: We searched MEDLINE (searched July 1st 2012), CENTRAL (Issue 7 of 12, July 2012), American Society of Hematology (searched July 1st 2012), clinical trials registries (http://clinicaltrials.gov/, searched July 1st 2012), and bibliographies of relevant studies for randomized clinical trials comparing heparin (unfractionated or low molecular weight) to other best care approaches. Use of aspirin was allowed in either study arms. Included patients were pregnant women over 18 years of age with previous recurrent unexplained miscarriages (at least two at any trimester). We performed a meta-analysis using random effects models to estimate the pooled odds ratio. Statistical heterogeneity was calculated by using the I2 statistic. Results: Eight trials proved eligible, five of which provided data from 1141 patients that could be included in the meta-analysis and three of which remain unpublished. Only the subgroup of patients with no antiphospholipid antibodies or inherited thrombophilia was included. There was a total of 839 live births observed. Enoxaparin was used in four trials and nadroparin was used in one trial. All trials randomized patients before the 8th week of gestation. There were 430 live births (among a total of 561 pregnancies) and 409 live births (among a total of 580 pregnancies) in the heparin and other best care treatment arms respectively. The difference between the two treatment arms was not statistically significant with a pooled odds ratio of 1.49 (95% confidence interval: 0.84, 2.66; P = 0.17). There was a substantial heterogeneity among the results of different trials (Chi2 = 14.91, P = 0.005; I2 = 73%). Conclusions: Available evidence suggests that heparin does not increase live births in pregnant women with previous unexplained recurrent miscarriages with no evidence of antiphospholipid antibodies or inherited thrombophilia. Future trials should explore new treatment strategies. Disclosures: No relevant conflicts of interest to declare.

scholarly journals An investigation into the impact and implications of published papers from retracted research: systematic search of affected literature

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031909 ◽  
Author(s):  
Alison Avenell ◽  
Fiona Stewart ◽  
Andrew Grey ◽  
Greg Gamble ◽  
Mark Bolland
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Research Misconduct ◽  
Evidence Base ◽  
Bibliographic Databases ◽  
Potential Influence ◽  
Relevant Research ◽  
Meta Analyses ◽  
The Impact

ObjectiveAnalyses of the impact of a body of clinical trial reports subject to research misconduct have been few. Our objective was to examine the impact on clinically relevant research of a group of researchers’ trial reports (‘affected trial reports’) affected by research misconduct, and whether identification of misconduct invoked a reappraisal.DesignIn 2016, we used five databases and search engines to identify ‘citing publications’, that is, guidelines, systematic and other reviews, and clinical trials citing any of 12 affected trial reports, published 1998–2011, eventually retracted for research misconduct. The affected trial reports were assessed more likely to have had impact because they had hip fracture outcomes and were in journals with impact factor >4. Two authors assessed whether findings of the citing publications would change if the affected trial reports were removed. In 2018, we searched for evidence that the citing publications had undertaken a reassessment as a result of the potential influence of the affected trial reports.ResultsBy 2016 the affected trial reports were cited in 1158 publications, including 68 systematic reviews, meta-analyses, narrative reviews, guidelines and clinical trials. We judged that 13 guidelines, systematic or other reviews would likely change their findings if the affected trial reports were removed, and in another eight it was unclear if findings would change. By 2018, only one of the 68 citing publications, a systematic review, appeared to have undertaken a reassessment, which led to a correction.ConclusionsWe found evidence that this group of affected trial reports distorted the evidence base. Correction of these distortions is slow, uncoordinated and inconsistent. Unless there is a rapid, systematic, coordinated approach by bibliographic databases, authors, journals and publishers to mitigate the impact of known cases of research misconduct, patients, other researchers and their funders may continue to be adversely affected.

Sign in / Sign up

Export Citation Format

Share Document