Factors in Randomized Controlled Trials Reported to Impact the Implementation of Patient-Reported Outcome Measures Into Routine Care: Protocol for a Systematic Review (Preprint)

BACKGROUND Patient-reported outcome measures (PROMs) are tools that enable patients to directly report their own assessments of well-being, or symptoms, in a structured and consistent way. Despite the usefulness of PROMs in optimizing health outcomes, their use in clinical practice is not routine. PROMs are complex to integrate into the clinical setting, with many elements potentially impacting on the success of implementation. For this reason, a protocol has been developed to guide a systematic review to collate information on implementation as presented in the randomized controlled trials (RCTs) to date. OBJECTIVE The primary objective of this systematic review is to identify and synthesize factors available from RCT data about the fidelity of PROM interventions in clinical practice. The secondary objective will be an assessment of how implementation factors impact fidelity outcomes. METHODS Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting standards will be followed. MEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature via OvidSP will be accessed using a defined search strategy. Grey literature and ClinicalTrials.gov will be reviewed for unpublished studies. Data extraction will be done to identify fidelity and factors impacting implementation, summarized using a narrative synthesis. An evidence-based implementation science framework will assist in identifying potential elements of importance and their effect on the process and outcomes of implementation. A meta-analysis to assess the impact of implementation factors will be attempted. A Cochrane risk of bias tool will be used. RESULTS This protocol has received funding, and searches of databases will commence at the end of May 2019. It is planned that this systematic review will be finalized for publication in (December) 2019. CONCLUSIONS Applying an implementation science evidence-based framework to the published literature may identify factors present in the data that impact on the implementation of PROMs into routine clinical care. This systematic review aims to improve understanding of how these factors impact the fidelity of this intervention, so that PROMs can be more effectively used in the care of patients. This systematic review can also offer more detailed information about the process and outcomes of successful implementation of PROMs.

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Factors in Randomized Controlled Trials Reported to Impact the Implementation of Patient-Reported Outcome Measures Into Routine Care: Protocol for a Systematic Review

JMIR Research Protocols ◽

10.2196/14579 ◽

2019 ◽

Vol 8 (11) ◽

pp. e14579

Author(s):

Natasha Anne Roberts ◽

Kimberly Alexander ◽

David Wyld ◽

Monika Janda

Keyword(s):

Systematic Review ◽

Clinical Practice ◽

Randomized Controlled Trials ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Controlled Trials ◽

Evidence Based ◽

Randomized Controlled ◽

Patient Reported ◽

Implementation Factors

Background Patient-reported outcome measures (PROMs) are tools that enable patients to directly report their own assessments of well-being, or symptoms, in a structured and consistent way. Despite the usefulness of PROMs in optimizing health outcomes, their use in clinical practice is not routine. PROMs are complex to integrate into the clinical setting, with many elements potentially impacting on the success of implementation. For this reason, a protocol has been developed to guide a systematic review to collate information on implementation as presented in the randomized controlled trials (RCTs) to date. Objective The primary objective of this systematic review is to identify and synthesize factors available from RCT data about the fidelity of PROM interventions in clinical practice. The secondary objective will be an assessment of how implementation factors impact fidelity outcomes. Methods Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting standards will be followed. MEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature via OvidSP will be accessed using a defined search strategy. Grey literature and ClinicalTrials.gov will be reviewed for unpublished studies. Data extraction will be done to identify fidelity and factors impacting implementation, summarized using a narrative synthesis. An evidence-based implementation science framework will assist in identifying potential elements of importance and their effect on the process and outcomes of implementation. A meta-analysis to assess the impact of implementation factors will be attempted. A Cochrane risk of bias tool will be used. Results This protocol has received funding, and searches of databases will commence at the end of May 2019. It is planned that this systematic review will be finalized for publication in (December) 2019. Conclusions Applying an implementation science evidence-based framework to the published literature may identify factors present in the data that impact on the implementation of PROMs into routine clinical care. This systematic review aims to improve understanding of how these factors impact the fidelity of this intervention, so that PROMs can be more effectively used in the care of patients. This systematic review can also offer more detailed information about the process and outcomes of successful implementation of PROMs. International Registered Report Identifier (IRRID) PRR1-10.2196/14579

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Effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes: a systematic review protocol

BMJ Open ◽

10.1136/bmjopen-2020-044888 ◽

2021 ◽

Vol 11 (3) ◽

pp. e044888

Author(s):

Rita McMorrow ◽

Barbara Hunter ◽

Christel Hendrieckx ◽

Dominika Kwasnicka ◽

Leanne Cussen ◽

...

Keyword(s):

Systematic Review ◽

Type 2 Diabetes ◽

Outcome Measures ◽

Study Design ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Diabetes Distress ◽

Controlled Trials ◽

Patient Reported

IntroductionType 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes.Methods and analysisMEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case–control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate.Ethics and disseminationEthics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations.PROSPERO registration numberCRD42020200246.

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Trends in randomized controlled trials in ENT: a 30-year review

The Journal of Laryngology & Otology ◽

10.1017/s0022215100138101 ◽

1997 ◽

Vol 111 (7) ◽

pp. 611-613 ◽

Cited By ~ 9

Author(s):

K. W. Ah-See ◽

N. C. Molony ◽

A. G. D. Maran

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Randomized Controlled Trials ◽

Gold Standard ◽

Controlled Trials ◽

Evidence Based ◽

Controlled Clinical Trials ◽

Medline Search ◽

Randomized Controlled Clinical Trials ◽

Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

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Impact of Blinding on Patient-Reported Outcome Differences Between Treatment Arms in Cancer Randomized Controlled Trials

JNCI Journal of the National Cancer Institute ◽

10.1093/jnci/djab177 ◽

2021 ◽

Cited By ~ 1

Author(s):

Fabio Efficace ◽

David Cella ◽

Neil K Aaronson ◽

Melanie Calvert ◽

Francesco Cottone ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Experimental Treatment ◽

Patient Reported Outcome ◽

Controlled Trials ◽

Open Label ◽

Multivariable Logistic Regression Model ◽

Randomized Controlled ◽

Patient Reported ◽

Independent Variable ◽

Outcome Differences

Abstract Some concerns have been raised about potential bias in patient-reported outcome (PRO) results from open-label cancer randomized controlled trials (RCTs). We investigated if open-label trials favor the experimental treatment over the standard treatment more frequently than blinded trials. We also examined if the effect of blinding differs for distal vs more proximal PROs. We assessed 538 RCTs with a PRO endpoint conducted in the most prevalent cancers, of which 366 (68.0%) were open-label, 148 (27.5%) were blinded, and 24 (4.5%) were categorized as unclear. In our multivariable logistic regression model, we did not observe a statistically significant association of the independent variable treatment concealment (blinded vs open-label) on the dependent variable measuring the proportion of trials favoring the experimental treatment (adjusted odds ratio = 1.19, 95% confidence interval = 0.79 to 1.79; 2-sided P = .40). This was also the case when comparing distal and proximal PROs. Our findings provide novel evidence-based data that support the validity of PRO results from open-label cancer RCTs.

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Evidence-based Status of Pulsed Radiofrequency Treatment for Patients with Shoulder Pain: A Systematic Review of Randomized Controlled Trials

Pain Practice ◽

10.1111/papr.12310 ◽

2015 ◽

Vol 16 (4) ◽

pp. 518-525 ◽

Cited By ~ 9

Author(s):

An Liu ◽

Wei Zhang ◽

Miao Sun ◽

Chiyuan Ma ◽

Shigui Yan

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Shoulder Pain ◽

Controlled Trials ◽

Evidence Based ◽

Pulsed Radiofrequency ◽

Randomized Controlled ◽

Radiofrequency Treatment ◽

Pulsed Radiofrequency Treatment

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Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review

Clinical Gastroenterology and Hepatology ◽

10.1016/j.cgh.2017.10.019 ◽

2018 ◽

Vol 16 (5) ◽

pp. 648-663.e3 ◽

Cited By ~ 38

Author(s):

Marin J. de Jong ◽

Roxanne Huibregtse ◽

Ad A.M. Masclee ◽

Daisy M.A.E. Jonkers ◽

Marie J. Pierik

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Clinical Practice ◽

Outcome Measures ◽

Inflammatory Bowel Diseases ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Patient Reported ◽

Bowel Diseases ◽

Inflammatory Bowel

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Intranasal Azelastine and Fluticasone as Combination Therapy for Allergic Rhinitis: Systematic Review and Meta-analysis

Otolaryngology ◽

10.1177/0194599819841883 ◽

2019 ◽

Vol 161 (3) ◽

pp. 412-418

Author(s):

Peter M. Debbaneh ◽

Anna K. Bareiss ◽

Sarah K. Wise ◽

Edward D. McCoul

Keyword(s):

Systematic Review ◽

Allergic Rhinitis ◽

Combination Therapy ◽

Randomized Controlled Trials ◽

Nasal Spray ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

Patient Reported ◽

Symptom Scores

Objective Combination therapy with intranasal azelastine and fluticasone propionate is an option for treatment of allergic rhinitis. This systematic review and meta-analysis examines existing literature to determine efficacy in treating allergic rhinitis compared to monotherapy. Data Sources The PubMed, EMBASE, Cochrane, and MEDLINE databases were systematically searched for randomized controlled trials using AzeFlu nasal spray. Review Methods Randomized, controlled trials that reported symptom relief of allergic rhinitis in males and females of all ages were included. Results were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standard. Results Systematic review identified 8 articles suitable for review. The risk of bias was generally low. All studies exhibited a greater decrease in patient-reported symptom scores in patients treated with combination therapy compared to monotherapy or placebo. Meta-analysis revealed superiority of combination therapy in reducing Total Nasal Symptom Score compared to placebo (mean change from baseline: −2.41; 95% confidence interval [CI], −2.82 to −1.99; P < .001; I 2 = 60%), azelastine (mean change from baseline: −1.40; 95% CI, −1.82 to −0.98; P < .001; I 2 = 0%), and fluticasone (mean change from baseline: −0.74; 95% CI, −1.17 to −0.31; P < .001; I 2 = 12%). Conclusion Current evidence supports both efficacy and superiority of combination intranasal azelastine and fluticasone in reducing patient-reported symptom scores in patients with allergic rhinitis. Combination nasal spray should be considered as second-line therapy in patients with allergic rhinitis that is not controlled with monotherapy.

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The Quality of Randomized Controlled Trials in High-impact Rheumatology Journals, 1998–2018

The Journal of Rheumatology ◽

10.3899/jrheum.191306 ◽

2020 ◽

Vol 47 (9) ◽

pp. 1446-1449

Author(s):

Michael S. Putman ◽

Ashley Harrison Ragle ◽

Eric M. Ruderman

Keyword(s):

Randomized Controlled Trials ◽

Patient Reported Outcome Measures ◽

High Impact ◽

Controlled Trials ◽

Industry Funding ◽

Primary Analysis ◽

Randomized Controlled ◽

Patient Reported ◽

Over Time

Objective.Well-designed randomized controlled trials (RCT) mitigate bias and confounding, but previous evaluations of rheumatology trials found high rates of methodological flaws. Outside of rheumatoid arthritis, no studies in the modern era have assessed the quality of rheumatology RCT over time or regarding industry funding.Methods.We identified all RCT published in 3 high-impact rheumatology journals from 1998, 2008, and 2018. Quality metrics derived from a modified Jadad scale were analyzed by year of publication and by funding source.Results.Ninety-six publications met inclusion criteria; 82 of these described the primary analysis of an RCT. Over time (1998–2008–2018), trials were less likely to adequately report dropouts and withdrawals (100% vs 82% vs 60%; p < 0.01) or include an active comparator (44% vs 12% vs 13%; p = 0.01). Later trials were more likely to evaluate biologic therapy (11% vs 38% vs 83%; p < 0.01) and report adequate randomization procedures (39% vs 29% vs 60%; p = 0.04). Seventy-nine percent of trials received industry funding. Industry-funded trials were more likely to report double-blinding (86% vs 53%; p < 0.01), patient-reported outcome measures (77% vs 41%; p < 0.01), and intention-to-treat analyses (86% vs 65%; p = 0.04).Conclusion.Industry-funded trials comprise the majority of RCT published in high-impact rheumatology journals and more frequently report metrics associated with RCT quality. RCT assessing active comparators and nonbiologic therapies have become less common in high-impact rheumatology journals.

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