Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets

Abstract Introduction and hypothesis Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. Methods Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. Results Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). Conclusions Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.

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Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS)

International Urogynecology Journal ◽

10.1007/s00192-021-05040-1 ◽

2022 ◽

Author(s):

Reem Moussa ◽

Maria Patricia Rada ◽

Constantin Durnea ◽

Gabriele Falconi ◽

Cornelia Betschart ◽

...

Keyword(s):

Adverse Events ◽

Outcome Measures ◽

Methodological Quality ◽

Reporting Quality ◽

Adult Women ◽

Core Outcome ◽

Pharmacological Management ◽

Core Outcome Sets ◽

Outcome Reporting ◽

Management Interventions

Abstract Introduction and hypothesis Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). Methods RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. Results Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman’s rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. Conclusions Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.

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Quality of Split-Mouth Trials in Dentistry: 1998, 2008, and 2018

Journal of Dental Research ◽

10.1177/0022034520946025 ◽

2020 ◽

Vol 99 (13) ◽

pp. 1453-1460

Author(s):

D. Qin ◽

F. Hua ◽

H. He ◽

S. Liang ◽

H. Worthington ◽

...

Keyword(s):

Sample Size ◽

Methodological Quality ◽

Linear Models ◽

Sample Size Calculation ◽

Reporting Quality ◽

Treatment Groups ◽

Item Checklist ◽

The Mean ◽

Over Time

The objectives of this study were to assess the reporting quality and methodological quality of split-mouth trials (SMTs) published during the past 2 decades and to determine whether there has been an improvement in their quality over time. We searched the MEDLINE database via PubMed to identify SMTs published in 1998, 2008, and 2018. For each included SMT, we used the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 guideline, CONSORT for within-person trial (WPT) extension, and a new 3-item checklist to assess its trial reporting quality (TRQ), WPT-specific reporting quality (WRQ), and SMT-specific methodological quality (SMQ), respectively. Multivariable generalized linear models were performed to analyze the quality of SMTs over time, adjusting for potential confounding factors. A total of 119 SMTs were included. The mean overall score for the TRQ (score range, 0 to 32), WRQ (0 to 15), and SMQ (0 to 3) was 15.77 (SD 4.51), 6.06 (2.06), and 1.12 (0.70), respectively. The primary outcome was clearly defined in only 28 SMTs (23.5%), and only 27 (22.7%) presented a replicable sample size calculation. Only 45 SMTs (37.8%) provided the rationale for using a split-mouth design. The correlation between body sites was reported in only 5 studies (4.2%) for sample size calculation and 4 studies (3.4%) for statistical results. Only 2 studies (1.7%) performed an appropriate sample size calculation, and 46 (38.7%) chose appropriate statistical methods, both accounting for the correlation among treatment groups and the clustering/multiplicity of measurements within an individual. Results of regression analyses suggested that the TRQ of SMTs improved significantly with time ( P < 0.001), while there was no evidence of improvement in WRQ or SMQ. Both the reporting quality and methodological quality of SMTs still have much room for improvement. Concerted efforts are needed to improve the execution and reporting of SMTs.

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Reporting and methodological quality of meta-analyses in urological literature

PeerJ ◽

10.7717/peerj.3129 ◽

2017 ◽

Vol 5 ◽

pp. e3129 ◽

Cited By ~ 12

Author(s):

Leilei Xia ◽

Jing Xu ◽

Thomas J. Guzzo

Keyword(s):

Logistic Regression ◽

Predictive Factors ◽

Methodological Quality ◽

A Priori ◽

Reporting Quality ◽

Regression Analyses ◽

The Mean ◽

Funding Support ◽

Meta Analyses

Purpose To assess the overall quality of published urological meta-analyses and identify predictive factors for high quality. Materials and Methods We systematically searched PubMed to identify meta-analyses published from January 1st, 2011 to December 31st, 2015 in 10 predetermined major paper-based urology journals. The characteristics of the included meta-analyses were collected, and their reporting and methodological qualities were assessed by the PRISMA checklist (27 items) and AMSTAR tool (11 items), respectively. Descriptive statistics were used for individual items as a measure of overall compliance, and PRISMA and AMSTAR scores were calculated as the sum of adequately reported domains. Logistic regression was used to identify predictive factors for high qualities. Results A total of 183 meta-analyses were included. The mean PRISMA and AMSTAR scores were 22.74 ± 2.04 and 7.57 ± 1.41, respectively. PRISMA item 5, protocol and registration, items 15 and 22, risk of bias across studies, items 16 and 23, additional analysis had less than 50% adherence. AMSTAR item 1, “a priori” design, item 5, list of studies and item 10, publication bias had less than 50% adherence. Logistic regression analyses showed that funding support and “a priori” design were associated with superior reporting quality, following PRISMA guideline and “a priori” design were associated with superior methodological quality. Conclusions Reporting and methodological qualities of recently published meta-analyses in major paper-based urology journals are generally good. Further improvement could potentially be achieved by strictly adhering to PRISMA guideline and having “a priori” protocol.

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Quality Assessment of Prospective Cohort Studies Evaluating Arthroscopic Treatment for Femoroacetabular Impingement Syndrome: A Systematic Review

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119838533 ◽

2019 ◽

Vol 7 (5) ◽

pp. 232596711983853 ◽

Cited By ~ 3

Author(s):

Axel Öhlin ◽

Louise Karlsson ◽

Eric Hamrin Senorski ◽

Páll Jónasson ◽

Mattias Ahldén ◽

...

Keyword(s):

Cohort Studies ◽

Randomized Controlled Trials ◽

Prospective Cohort ◽

Methodological Quality ◽

Arthroscopic Surgery ◽

Controlled Trials ◽

Prospective Cohort Studies ◽

Randomized Controlled ◽

The Mean

Background: Femoroacetabular impingement (FAI) syndrome is a cause of pain and reduced range of motion in the hip joint. Given the limited number of randomized controlled trials, prospective cohort studies constitute the dominant part of the available prospective evidence evaluating relevant clinical outcomes after arthroscopic hip surgery for FAI. Purpose: To assess the methodological quality of prospective cohort studies evaluating arthroscopic surgery for FAI and to determine whether there has been an improvement in methodological quality over time. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic literature search was performed in PubMed, Embase (OvidSP), and the Cochrane Library. Included studies were clinical prospective cohort studies of primary arthroscopic surgery for cam and/or pincer morphology FAI. Methodological quality was assessed with the Methodological Index for Non-randomized Studies (MINORS). The mean MINORS score for studies published during the first 5 years of the period was compared with those published during the last 5 years to evaluate methodological improvement over time. The methodological quality of randomized controlled trials was also assessed with the Coleman Methodology Score. Results: The search yielded 53 studies. There were 34 noncomparative studies, 15 nonrandomized comparative studies, and 4 randomized controlled trials. The included studies were published between 2008 and 2017. The mean ± SD MINORS score for noncomparative and comparative studies was 10.4 ± 1.4 of 16 possible and 18.7 ± 2.0 of 24 possible, respectively. The mean Coleman Methodology Score for randomized controlled trials was 79.0 ± 7.0 of 100 possible. Conclusion: The methodological quality of prospective cohort studies evaluating arthroscopic surgery for FAI is moderate for comparative and noncomparative studies. Common areas for improvement include unbiased assessment of study endpoints and prospective sample-size calculations. Despite an increase in the number of published studies, an improvement in methodological quality over time was not observed.

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AB0584 THE QUALITY OF REPORTING IN RANDOMIZED CONTROLLED TRIALS OF HOME BASED REHABILITATION FOR KNEE OSTEOARTHRITIS: UTILIZING PEDRO SCORE AND CONSORT CRITERIA

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.476 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1329.2-1329

Author(s):

M. Meran ◽

B. Unver ◽

E. Çağlar

Keyword(s):

Knee Osteoarthritis ◽

Methodological Quality ◽

Reporting Quality ◽

Global Burden ◽

Controlled Trials ◽

High Quality ◽

Randomized Controlled ◽

Home Based ◽

High Level

Background:Osteoarthritis of the knee (KOA) is a very common rheumatic disease, and its global burden is gradually increasing (1). The benefits of exercise in patients with KOA are supported by high-level evidence and take their place in primary care therapy (2). Today, coronavirus disease 2019 has developed as a pandemic all over the world, creating difficulties in healthcare and highlighting home-based rehabilitation (HBR) (3). Randomized controlled trials (RCTs) are considered the gold standard for evaluating the effects of clinical interventions, but poorly reported results can have negative consequences. The Physiotherapy Evidence Database (PEDro) evaluates the methodological quality of RCTs (4). The CONSORT (Consolidated Standards of Reporting Trials) statement has been developed to improve the reporting quality of RCTs (5).There are no studies examining the quality of RCTs related to HBR in patients with KOA.Objectives:The aim of this study was to assess the reporting quality of HBR trials for KOA, and explore the factors associated with the reporting.Methods:Two independent researchers investigated HBR RCTs in patients with KOA published between 1999 and 2020 were sourced from PubMed, the Cochrane Reviews and Web of Science. Each researcher evaluated the methodological quality of the included studies using the PEDro scoring and reporting aspects using 9 items from CONSORT. The relationship between adherence to the CONSORT criteria and the PEDro score were evaluated.Results:Twenty-five RCTs met our eligibility criteria. The mean PEDro score of studies is 5.76 ± 1.48. Only one study found high quality (PEDro score: ≥ 9). The PEDro scores were: randomization type (96%, 24/25) and baseline comparability (92%, 23/25); all studies described group comparisons and variablity measures. In contrast, concealed allocation (18%, 7/25), blinding of participants (16%, 4/25) and therapists (0%) were not included in most studies. The CONSORT criteria were: flow diagram (92%, 23/25), sample size, subgroup analysis and sources of funding (56%, 11/25 for all three), while the majority of studies the trial registration number (16%, 4/25) was not available. A high level of correlation was found between meeting the CONSORT criteria and PEDro scores (r=0.820, p<0.001).Conclusion:The majority of RCTs based on HBR for KOA are low-to-modarate quality studies based on the PEDro score. Adherence to the CONSORT criteria is linked to high quality scores. If the studies are planned and written in accordance with the CONSORT criteria, we think that better quality studies will emerge.References:[1]Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, et al. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020;79(6):819-28.[2]Skou ST, Pedersen BK, Abbott JH, Patterson B, Barton C. Physical Activity and Exercise Therapy Benefit More Than Just Symptoms and Impairments in People With Hip and Knee Osteoarthritis. J Orthop Sport Phys. 2018;48(6):439-47.[3]Karasavvidis T, Hirschmann MT, Kort NP, Terzidis I, Totlis T. Home-based management of knee osteoarthritis during COVID-19 pandemic: literature review and evidence-based recommendations. J Exp Orthop. 2020;7(1):52.[4]Sherrington C, Herbert RD, Maher CG, Moseley AM. PEDro. A database of randomized trials and systematic reviews in physiotherapy. Man Ther. 2000;5(4):223-6.[5]Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55.Disclosure of Interests:None declared.

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Methodological Quality of Randomized Controlled Trials of Spinal Manipulation and Mobilization in Tension-Type Headache, Migraine, and Cervicogenic Headache

Journal of Orthopaedic and Sports Physical Therapy ◽

10.2519/jospt.2006.2126 ◽

2006 ◽

Cited By ~ 1

Author(s):

Juan C. Miangolarra-Page

Keyword(s):

Randomized Controlled Trials ◽

Methodological Quality ◽

Spinal Manipulation ◽

Cervicogenic Headache ◽

Tension Type Headache ◽

Controlled Trials ◽

Randomized Controlled ◽

Type Headache

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How Does Mindfulness Affect Cognition? A Reflection on Confounding Issues Surrounding Mindfulness-based Intervention Research Targeting Cognitive Outcomes

10.31231/osf.io/86hrv ◽

2018 ◽

Author(s):

David R Vago ◽

Resh Gupta ◽

Sara Lazar

Keyword(s):

Systematic Review ◽

Health Outcomes ◽

Cognitive Functioning ◽

Cognitive Processes ◽

Methodological Quality ◽

Cognitive Outcomes ◽

Controlled Trials ◽

Randomized Controlled ◽

Existing Data

One potential pathway by which mindfulness-based meditation improves health outcomes is through changes in cognitive functioning. A systematic review of randomized controlled trials of mindfulness-based interventions (MBIs) was conducted with a focus on assessing the state of the evidence for effects on cognitive processes and associated assays. Here, we comment on confounding issues surrounding the reporting of these and related findings, including 1) criteria that appropriately define an MBI; 2) limitations of assays used to measure cognition; and 3) methodological quality of MBI trials and reporting of findings. Because these issues contribute to potentially distorted interpretations of existing data, we offer constructive means for interpretation and recommendations for moving the field of mindfulness research forward regarding the effects on cognition.

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Reporting quality of randomized, controlled trials evaluating immunotherapy in lung cancer

Thoracic Cancer ◽

10.1111/1759-7714.14114 ◽

2021 ◽

Author(s):

Jun Du ◽

Yundi Zhang ◽

Yiting Dong ◽

Jianchun Duan ◽

Hua Bai ◽

...

Keyword(s):

Lung Cancer ◽

Randomized Controlled Trials ◽

Reporting Quality ◽

Controlled Trials ◽

Randomized Controlled

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EXPRESS: The benefit of exercise-based rehabilitation programmes in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials

Pulmonary Circulation ◽

10.1177/20458940211007810 ◽

2021 ◽

pp. 204589402110078

Author(s):

Lu Yan ◽

Wence Shi ◽

Zhi-hong Liu ◽

Qin Luo ◽

Zhihui Zhao ◽

...

Keyword(s):

Quality Of Life ◽

Pulmonary Hypertension ◽

Randomized Controlled Trials ◽

Exercise Capacity ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

The Mean ◽

Quality Evidence

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I Â² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peakÂ oxygen uptakeÂ Â was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control groupÂ . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.

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