Clinical Trial Adherence to Focal Muscle Spasticity Guidelines: A Systematic Review

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.

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Strategi monitoring kepatuhan penggunaan antiretroviral pre-exposure prophilaxis pada pasangan serodiscordant

Berita Kedokteran Masyarakat ◽

10.22146/bkm.35359 ◽

2019 ◽

Vol 35 (1) ◽

pp. 29

Author(s):

Ni Kadek Diah Purnamayanti ◽

Nurma Yuni Pari Usemahu ◽

Fatih Haris M ◽

Marina Kristi Layun R

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Monitoring Strategy ◽

Inclusion Criteria ◽

Serodiscordant Couple ◽

Data Bases ◽

Social Commitment ◽

Homosexual Orientation ◽

Exposure Prophylaxis ◽

Level Monitoring

Monitoring strategy of antiretroviral pre-exposure prophylaxis adherence among serodiscordant couple Antiretroviral pre-exposure prophylaxis (PrEP) has been recommended as HIV prevention but poor medical adherence can cause suboptimal therapy. This study explored the strategies of monitoring PrEP adherence among the serodiscordant couples. This systematic review based on 4 data bases (Scopus, Pubmed, Ebsco and Sage Journal), included clinical trial studies articles between 2013-2018, in English, and available in full-text. Papers, which not met the inclusion criteria, will be excluded. Keywords used in this study are ‘serodiscordant couple’ AND ‘method’ OR ‘strategy’ OR ‘approach’ AND ‘pre-exposure prophylaxis intention’ OR ‘pre-exposure prophylaxis adherence’. This study discovered various strategies applied based on the type of delivering process, the variance of dose, and variance of preference of the couple. Preference of PrEP dose and type of application related to heterosexual or homosexual orientation and their social commitment. The paper explains the advantage of M-health and biomarker level monitoring.

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Placebo response in relation to clinical trial design: a systematic review and meta-analysis of randomized controlled trials for determining biologic efficacy in psoriasis treatment

Archives of Dermatological Research ◽

10.1007/s00403-012-1266-9 ◽

2012 ◽

Vol 304 (9) ◽

pp. 707-717 ◽

Cited By ~ 20

Author(s):

Sonia A. Lamel ◽

Kaley A. Myer ◽

Naji Younes ◽

James A. Zhou ◽

Hilda Maibach ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Randomized Controlled Trials ◽

Trial Design ◽

Meta Analysis ◽

Placebo Response ◽

Clinical Trial Design ◽

Controlled Trials ◽

Psoriasis Treatment ◽

Randomized Controlled

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Strategies to facilitate shared decision-making about pediatric oncology clinical trial enrollment: A systematic review

Patient Education and Counseling ◽

10.1016/j.pec.2018.02.001 ◽

2018 ◽

Vol 101 (7) ◽

pp. 1157-1174 ◽

Cited By ~ 10

Author(s):

Eden G. Robertson ◽

Claire E. Wakefield ◽

Christina Signorelli ◽

Richard J. Cohn ◽

Andrea Patenaude ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Decision Making ◽

Shared Decision Making ◽

Pediatric Oncology ◽

Shared Decision ◽

Oncology Clinical Trial ◽

Clinical Trial Enrollment

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Increasing underrepresented minority cancer patient enrollment into cancer clinical trials: A systematic review.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18574 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e18574-e18574

Author(s):

Rosa Nouvini ◽

Patricia A. Parker ◽

Charlotte Malling ◽

Kendra Godwin ◽

Rosario Costas-Muñiz

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Clinical Trials ◽

Minority Groups ◽

Relationship Building ◽

Institutional Research ◽

Underrepresented Minority ◽

Randomized Controlled ◽

Clinical Trial Enrollment ◽

Recruitment Model

e18574 Background: Minorities continue to be underrepresented in clinical trials despite the National Institute of Health’s Revitalization Act, passed in 1993, mandating the representation of women and underrepresented minority groups in clinical trials. Studies have shown that although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates in are disproportionately low at 4-6% and 3-6% respectively. We conducted a systematic review exploring interventions aimed at improving clinical trial enrollment for racial and ethnic minorities. Methods: A systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies of humans since 1993. Inclusion criteria included peer-reviewed, U.S.-based studies with interventions aimed to recruit underrepresented minority adult cancer patients into cancer clinical trials. We defined underrepresented minority groups as Black, Hispanic/Latino, Asian, American Indian/Alaska Native and Native Hawaiian/other Pacific Islander. Results: A total of 2471 titles and abstracts were identified and 2324 were excluded based on the eligibility criteria. A full text review was conducted of the remaining 147 articles, of which only 9 met criteria for our review. The interventions included patient navigation/coaching (n = 4), a clinical trial educational video (n = 2), institutional research infrastructure changes (n = 1), a relationship building and social marketing recruitment model (n = 1) and cultural competency training for providers (n = 1). Studies were conducted in a variety of practice settings including national cancer institutes and community practices. The quality of evidence was limited by the heterogeneity of study methods, patient representation and bias. Several studies had a homogeneous population of Black patients. Most studies (n = 7) were single arm trials that compared results to either historical controls or those cited in the existing literature; two studies were randomized controlled trials. A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos, the institutional research infrastructure change and the relationship building and social marketing recruitment model. The common threads to many of these successful interventions were support through the cancer care continuum, cultural congruency of research staff and culturally catered clinical trial educational materials. Conclusions: This systematic review illustrates several mechanisms by which to increase cancer clinical trial recruitment for cancer patients of underrepresented minority backgrounds in a variety of clinical settings. Randomized controlled trials with representation of multiple races/ethnicities are needed to further explore the benefits of these interventions.

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Guidance for reporting clinical trial registry records and published protocols use in systematic reviews of interventions

10.21203/rs.2.10624/v1 ◽

2019 ◽

Author(s):

Julia Bidonde ◽

Jose Francisco Meneses-Echavez ◽

Angela Jean Busch ◽

Catherine Boden

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Systematic Reviews ◽

Cochrane Collaboration ◽

Subject Area ◽

Selective Reporting ◽

Trial Registry ◽

Clinical Trial Registry ◽

Reporting Practices ◽

Starting Point

Abstract Background: Transparency is a tenet of systematic reviews. Searching for clinical trial registry records and published protocols has become a mandatory standard when conducting a systematic review of interventions. However, there is no comprehensive guidance for review authors on how to report the use of registry records and published protocols in their systematic review. The objective of this study was to generate initial guidance to assist authors of systematic reviews of interventions in the reporting of registry records and published protocols in systematic reviews of interventions. Methods: We used a compilation of the procedures recommended by expert organizations (e.g., Cochrane Collaboration) related to the reporting of use of registry records and published protocols in the conduct of systematic reviews. The compilation was developed by one of the authors in this study and served as a starting point in developing the algorithm. We extracted current practice data related to registry records and published protocols from a stratified random sample of Cochrane systematic reviews of interventions published between 2015 and 2016 (n=169). We identified examples that adhered to or extended the current guidance. Based on the on the elements above, we created the algorithm to bridge gaps and improve current reporting practices. Results: Trial protocols should be used to account for all evidence in a subject area, evaluate reporting bias (i.e. selective reporting and publication bias), and determine the nature and number of ongoing or unpublished studies for planning review updates. Review authors’ terminology (e.g., ongoing, terminated) and consequent reporting in the review should reflect the phase of the trial found. Protocols should be clearly and consistently reported throughout the review (e.g. abstract, methods, results) as is done with published articles. Conclusions: Our study expands on available guidance to describe in greater detail the reporting of registry records and published protocols for review authors. We believe this is a timely investigation that will increase transparency in the reporting of trial records in systematic reviews of interventions and bring clarification to current fuzziness in terminology. We invite researchers to provide feedback on our work for its improvement and dissemination. Trial Registration: not applicable

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Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review

Research Integrity and Peer Review ◽

10.1186/s41073-019-0073-7 ◽

2019 ◽

Vol 4 (1) ◽

Cited By ~ 1

Author(s):

Obaro Evuarherhe ◽

William Gattrell ◽

Richard White ◽

Christopher C. Winchester

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Medical Writing

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

Health and Quality of Life Outcomes ◽

10.1186/s12955-019-1220-z ◽

2019 ◽

Vol 17 (1) ◽

Cited By ~ 12

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.

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