The quality of reporting of phase II and III trials for new antipsychotics: a systematic review

BackgroundThe findings of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study and the Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS) called previous trials of antipsychotics into question, including pre-licensing trials. Concerns regarding methodological robustness and quality of reporting increased. This systematic review aimed to examine the quality of reporting of phase II and III trials for new antipsychotics in the aftermath of the CATIE and CUtLASS studies.MethodElectronic searches were conducted in EMBASE, Medline and Cochrane databases and also ClinicalTrials.gov for antipsychotic trials (published between January 2006 and February 2012). Phase II and III randomized controlled trials (RCTs) for iloperidone, asenapine, paliperidone, olanzapine, lurasidone and pomaglumetad methionil were selected for schizophrenia and schizoaffective disorder. The reporting of the methodology was evaluated in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines.ResultsThirty-one articles regarding 32 studies were included. There was insufficient reporting of design in 47% of studies and only 13% explicitly stated a primary hypothesis. Exclusion criteria were poorly reported for diagnosis in 22% of studies. Detail regarding comparators, particularly placebos, was suboptimal for 56% of studies, and permitted concomitant medication was often not reported (19%). Randomization methods were poorly described in 56% of studies and reporting on blinding was insufficient in 84% of studies. Sample size calculations were insufficiently reported in 59% of studies.ConclusionsThe quality of reporting of phase II and III trials for new antipsychotics does not reach the standards outlined in the CONSORT guidelines. Authors often fail to adequately report design and methodological processes, potentially impeding the progress of research on antipsychotic efficacy. Both policymakers and clinicians require high quality reporting before decisions are made regarding licensing and prescribing of new antipsychotics.

Download Full-text

Cost-effectiveness of treatment optimisation with biomarkers for immunotherapy in solid tumours: a systematic review protocol

BMJ Open ◽

10.1136/bmjopen-2020-048141 ◽

2021 ◽

Vol 11 (9) ◽

pp. e048141

Author(s):

Sara Mucherino ◽

Valentina Lorenzoni ◽

Valentina Orlando ◽

Isotta Triulzi ◽

Marzia Del Re ◽

...

Keyword(s):

Systematic Review ◽

Cost Effectiveness ◽

Immune Checkpoint ◽

Cost Utility ◽

Solid Tumours ◽

Economic Evaluations ◽

Monetary Benefit ◽

The Cost ◽

Net Monetary Benefit

IntroductionThe combination of biomarkers and drugs is the subject of growing interest both from regulators, physicians and companies. This study protocol of a systematic review is aimed to describe available literature evidences about the cost-effectiveness, cost-utility or net-monetary benefit of the use of biomarkers in solid tumour as tools for customising immunotherapy to identify what further research needs.Methods and analysisA systematic review of the literature will be carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed and Embase will be queried from June 2010 to June 2021. The PICOS model will be applied: target population (P) will be patients with solid tumours treated with immune checkpoint inhibitors (ICIs); the interventions (I) will be test of the immune checkpoint predictive biomarkers; the comparator (C) will be any other targeted or non-targeted therapy; outcomes (O) evaluated will be health economic and clinical implications assessed in terms of incremental cost-effectiveness ratio, net health benefit, net monetary benefit, life years gained, quality of life, etc; study (S) considered will be economic evaluations reporting cost-effectiveness analysis, cost-utility analysis, net-monetary benefit. The quality of the evidence will be graded according to Grading of Recommendations Assessment, Development and Evaluation.Ethics and disseminationThis systematic review will assess the cost-effectiveness implications of using biomarkers in the immunotherapy with ICIs, which may help to understand whether this approach is widespread in real clinical practice. This research is exempt from ethics approval because the work is carried out on published documents. We will disseminate this protocol in a related peer-reviewed journal.PROSPERO registration numberCRD42020201549.

Download Full-text

Cost-effectiveness of interventions to reduce the risk of healthcare-acquired infections in middle-income countries: A systematic review

Journal of Infection Prevention ◽

10.1177/1757177419852662 ◽

2019 ◽

Vol 20 (6) ◽

pp. 266-273

Author(s):

Pushpa Udayangani Gamalathge ◽

Sanjeewa Kularatna ◽

Hannah E Carter ◽

Sameera Senanayake ◽

Nicholous Graves

Keyword(s):

Systematic Review ◽

Cost Effectiveness ◽

Developed Countries ◽

Healthcare Systems ◽

Quality Of Reporting ◽

Middle Income ◽

Middle Income Countries ◽

Use Of Resources ◽

The Cost

Background: Hospital-acquired infections (HAI) contribute to prolonged hospital stays and account for a substantial economic burden to healthcare systems. Middle-income countries (MICs) experience a greater burden of HAI than developed countries. Evidence on the cost-effectiveness of interventions to reduce HAI is required to inform decision-making in these settings. Aim: To synthesise the evidence on cost-effectiveness as related to HAI interventions in MICs and to assess the quality of this evidence. Methods: A systematic review of published literature on the cost-effectiveness of interventions to reduce the incidence of HAI in MICs between 2000 and 2018 was conducted. Results: Six studies met the pre-determined inclusion criteria. The studies were from three countries: Thailand; India; and Vietnam. The evidence suggests that interventions to reduce HAI are cost-effective and, in most cases, cost-saving to healthcare systems. The quality of the reporting varied across studies. Conclusions: The implementation of HAI prevention interventions appears to be a high value use of resources in MICs. There is a need for further cost-effectiveness analyses in a wider range of MICs in order to confirm these findings. Improved standardisation and quality of reporting is required.

Download Full-text

A Systematic Review of the Cost-Effectiveness of Recombinant Factor VIIa (rFVIIa) and Activated Prothrombin Complex Concentrate (aPCC) in the Treatment of Mild to Moderate Bleeding Episodes for Haemophilia Patients with Inhibitors

Blood ◽

10.1182/blood.v112.11.4678.4678 ◽

2008 ◽

Vol 112 (11) ◽

pp. 4678-4678

Author(s):

Chris Knight ◽

Anne Møller Danø ◽

Tessa Kennedy-Martin

Keyword(s):

Systematic Review ◽

Cost Effectiveness ◽

Factor Viia ◽

Cost Effective ◽

Primary Treatment ◽

Cost Utility ◽

Economic Consequences ◽

Modelling Framework ◽

The Cost

Abstract Objectives: Although haemophilia patients with inhibitors are rare, the clinical, humanistic and economic consequences associated with this disorder are considerable. The primary treatment for such patients is either rFVIIa or aPCC. The aim of this study was to identify, review and evaluate the quality of the published literature on the relative cost-effectiveness of rFVIIa and aPCC in treating haemophilia patients with inhibitors. Methods: The review concentrates on the model type, the model design, model assumptions, and results. Results: The results of this study suggest that rFVIIa may be the cost-effective alternative to treatment with aPCC due to the superior efficacy of rFVIIa and hence the avoidance of subsequent lines of treatment. In 7 of the 9 studies, rFVIIa had the lower average treatment cost. The adapted modelling framework is similar in all the economic models reviewed, suggesting clinical acceptability of the approach used. The estimates of efficacy varied between the models, especially for aPCC. The efficacy for aPCC derived from retrospective studies was lower than reported in the literature. Sensitivity analysis had been undertaken in the majority of the economic analyses and the results were found to be robust to realistic parameter variations. Only one of the studies was a cost-utility study, showing the lack of measuring health status within this area. The results showed the large impact appropriate treatment can have on the quality of life for haemophilia patients with inhibitors. Conclusions: Ideally, there should be a systematic approach to identifying the relevant data and the lack of data from relevant randomized head-to-head trials is a contributing factor to the variation in efficacy rates and average dosages assumed. However, this systematic review has shown that despite differences in the estimates of efficacy, average dosage required, and unit costs the overall results are robust and appear to favour rFVIIa as the cost-effectiveness treatment for haemophilia patients with inhibitors.

Download Full-text

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review

PLoS ONE ◽

10.1371/journal.pone.0185536 ◽

2017 ◽

Vol 12 (12) ◽

pp. e0185536 ◽

Cited By ~ 5

Author(s):

Julien Langrand-Escure ◽

Romain Rivoirard ◽

Mathieu Oriol ◽

Fabien Tinquaut ◽

Chloé Rancoule ◽

...

Keyword(s):

Systematic Review ◽

Phase Ii ◽

Phase Ii Trials ◽

Quality Of Reporting

Download Full-text

Cost and cost-effectiveness of mHealth interventions for the prevention and control of type 2 diabetes mellitus: a protocol for a systematic review

BMJ Open ◽

10.1136/bmjopen-2018-027490 ◽

2019 ◽

Vol 9 (4) ◽

pp. e027490 ◽

Cited By ~ 2

Author(s):

Giulia Rinaldi ◽

Alexa Hijazi ◽

Hassan Haghparast-Bidgoli

Keyword(s):

Diabetes Mellitus ◽

Systematic Review ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Cost Effectiveness ◽

Economic Evaluations ◽

Quality Of Reporting ◽

The Cost

IntroductionType 2 diabetes mellitus (T2DM) remains one of the most common chronic diseases of adulthood which creates high degrees of morbidity and mortality worldwide. The incidence of T2DM continues to rise and recently, mHealth interventions have been increasingly used in the prevention, monitoring and management of T2DM. The aim of this study is to systematically review the published evidence on cost and cost-effectiveness of mHealth interventions for T2DM, as well as assess the quality of reporting of the evidence.Methods and analysisA comprehensive review of PubMed, EMBASE, Science Direct and Web of Science of articles published until January 2019 will be conducted. Included studies will be partial or full economic evaluations which provide cost or cost-effectiveness results for mHealth interventions targeting individuals diagnosed with, or at risk of, T2DM. The quality of reporting evidence will be assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Results will be presented using a flowchart following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Graphical and tabulated representations of the results will be created for both descriptive and numerical results. The cost and cost-effectiveness values will be presented as reported by the original studies as well as converted into international dollars to allow comparability. As we are predicting heterogenous results, we will conduct a narrative and interpretive analysis of the data.Ethics and disseminationNo formal approval or review of ethics is required for this systematic review as it will involve the collection and analysis of secondary data. This protocol follows the current PRISMA-P guidelines. The review will provide information on the cost and cost-effectiveness of mHealth interventions targeting T2DM. These results will be disseminated through publication and submission to conferences for presentations and posters.PROSPERO registration numberCRD42019123476

Download Full-text

The quality of intervention reporting in trials of therapeutic exercise for hip osteoarthritis: a secondary analysis of a systematic review

Trials ◽

10.1186/s13063-021-05342-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Louise C. Burgess ◽

Thomas W. Wainwright ◽

Khara A. James ◽

Johan von Heideken ◽

Maura D. Iversen

Keyword(s):

Systematic Review ◽

Secondary Analysis ◽

Internal Validity ◽

Hip Osteoarthritis ◽

Therapeutic Exercise ◽

Quality Of Reporting ◽

Effective Interventions ◽

Randomised Controlled ◽

Intervention Reporting

Abstract Background Therapeutic exercise is recommended as a core treatment for hip osteoarthritis (HOA). Whilst it is widely accepted that exercise can improve pain and disability, optimal type and dose of exercise are yet to be agreed upon. This may, in part, be attributed to the wide variation and inadequate reporting of interventions within the literature. This study evaluates the quality of intervention reporting among trials of therapeutic exercise in HOA. Methods Randomised controlled trials (RCTs) were sourced in a systematic review, completed in August 2020. Two raters independently used the Template for Intervention Description and Replication (TIDieR) and Consensus on Exercise Reporting Template (CERT) to evaluate intervention reporting. Correlations between quality assessment scores and CERT and TIDieR scores evaluated the relationship between internal validity and external applicability. The year of publication was compared to the quality of reporting scores. Results Fourteen RCTs were included in the analysis. On average, studies were awarded 9.43 ± 1.95 out of 12 points for the TIDieR checklist (range 4–12) and 13.57 ± 4.01 out of 19 points for the CERT (range 5–19). Pearson’s correlation coefficient suggested that the quality of reporting had improved over time and that there was a fair, positive relationship between internal validity and external applicability. Discussion Whilst the quality of intervention reporting is improving, many RCTs of therapeutic exercise in HOA lack the detail necessary to allow accurate evaluation and replication. Researchers are encouraged to utilise the standardised reporting guidelines to increase the translation of effective interventions into clinical practice.

Download Full-text

A Systematic Review of the Cost-Effectiveness of Nurse Practitioners and Clinical Nurse Specialists: What Is the Quality of the Evidence?

Nursing Research and Practice ◽

10.1155/2014/896587 ◽

2014 ◽

Vol 2014 ◽

pp. 1-28 ◽

Cited By ~ 19

Author(s):

Faith Donald ◽

Kelley Kilpatrick ◽

Kim Reid ◽

Nancy Carter ◽

Ruth Martin-Misener ◽

...

Keyword(s):

Systematic Review ◽

Cost Effectiveness ◽

Nurse Practitioners ◽

Internal Validity ◽

Risk Of Bias ◽

Nurse Specialist ◽

Clinical Nurse ◽

Education Experience ◽

The Cost

Background. Improved quality of care and control of healthcare costs are important factors influencing decisions to implement nurse practitioner (NP) and clinical nurse specialist (CNS) roles.Objective. To assess the quality of randomized controlled trials (RCTs) evaluating NP and CNS cost-effectiveness (defined broadly to also include studies measuring health resource utilization).Design. Systematic review of RCTs of NP and CNS cost-effectiveness reported between 1980 and July 2012.Results. 4,397 unique records were reviewed. We included 43 RCTs in six groupings, NP-outpatient (n=11), NP-transition (n=5), NP-inpatient (n=2), CNS-outpatient (n=11), CNS-transition (n=13), and CNS-inpatient (n=1). Internal validity was assessed using the Cochrane risk of bias tool; 18 (42%) studies were at low, 17 (39%) were at moderate, and eight (19%) at high risk of bias. Few studies included detailed descriptions of the education, experience, or role of the NPs or CNSs, affecting external validity.Conclusions. We identified 43 RCTs evaluating the cost-effectiveness of NPs and CNSs using criteria that meet current definitions of the roles. Almost half the RCTs were at low risk of bias. Incomplete reporting of study methods and lack of details about NP or CNS education, experience, and role create challenges in consolidating the evidence of the cost-effectiveness of these roles.

Download Full-text

Cost-Effectiveness of Hip Arthroscopy for Treatment of Femoroacetabular Impingement Syndrome and Labral Tears: A Systematic Review

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120987538 ◽

2021 ◽

Vol 9 (3) ◽

pp. 232596712098753

Author(s):

Cammille C. Go ◽

Cynthia Kyin ◽

Jeffrey W. Chen ◽

Benjamin G. Domb ◽

David R. Maldonado

Keyword(s):

Systematic Review ◽

Cost Effectiveness ◽

Femoroacetabular Impingement ◽

Hip Arthroscopy ◽

Nonoperative Treatment ◽

Cochrane Library ◽

System Perspective ◽

Labral Tears ◽

The Cost

Background: Hip arthroscopy has frequently been shown to produce successful outcomes as a treatment for femoroacetabular impingement (FAI) and labral tears. However, there is less literature on whether the favorable results of hip arthroscopy can justify the costs, especially when compared with a nonoperative treatment. Purpose: To systematically review the cost-effectiveness of hip arthroscopy for treating FAI and labral tears. Study Design: Systematic review; Level of evidence, 3. Methods: PubMed/MEDLINE, Embase, and Cochrane Library databases, and the Tufts University Cost-Effectiveness Analysis Registry were searched to identify articles that reported the cost per quality-adjusted life-year (QALY) generated by hip arthroscopy. The key terms used were “hip arthroscopy,” “cost,” “utility,” and “economic evaluation.” The threshold for cost-effectiveness was set at $50,000/QALY. The Methodological Index for Non-Randomized Studies instrument and Quality of Health Economic Studies (QHES) score were used to determine the quality of the studies. This study was prospectively registered on PROSPERO (CRD42020172991). Results: Six studies that reported the cost-effectiveness of hip arthroscopy were identified, and 5 of these studies compared hip arthroscopy to a nonoperative comparator. These studies were found to have a mean QHES score of 85.2 and a mean cohort age that ranged from 33-37 years. From both a health care system perspective and a societal perspective, 4 studies reported that hip arthroscopy was more costly but resulted in far greater gains than did nonoperative treatment. The preferred treatment strategy was most sensitive to duration of benefit, preoperative osteoarthritis, cost of the arthroscopy, and the improvement in QALYs with hip arthroscopy. Conclusion: In the majority of the studies, hip arthroscopy had a higher initial cost but provided greater gain in QALYs than did a nonoperative treatment. In certain cases, hip arthroscopy can be cost-effective given a long enough duration of benefit and appropriate patient selection. However, there is further need for literature to analyze willingness-to-pay thresholds.

Download Full-text

PP048 Quality Of Health Care Through Integration: Experience Of Cochlear Implantation

International Journal of Technology Assessment in Health Care ◽

10.1017/s026646231700232x ◽

2017 ◽

Vol 33 (S1) ◽

pp. 93-94

Author(s):

Lyazzat Kosherbayeva ◽

Aigul Medeulova ◽

Abdulla Alzhanov

Keyword(s):

Health Care ◽

Healthcare System ◽

Cochlear Implantation ◽

Cost Utility ◽

Economic Research ◽

Rehabilitation Programs ◽

Life Years ◽

The Republic ◽

The Cost

INTRODUCTION:The State Program for Health Development of the Republic of Kazakhstan (RK) “Densaulyk” for 2016–2019 initiated the modernization of primary health care with the introduction of family practice in order to ensure the availability, completeness and quality of health services on the basis of an integrated healthcare system focused on the needs of the population. The aim of this study was to determine the effectiveness of the cochlear implantation (CI) programs.METHODS:A literature search was conducted for all clinical trials, randomized controlled trials, and reviews in the PubMed, Cochrane, and Center for Reviews and Dissemination databases. Two reviewers independently evaluated all publications for selection. The analysis included the cost-effectiveness and benefit from the CI program.RESULTS:We analyzed the effectiveness of the services for CI in the RK and other countries (1). In our analysis, we identified that there is no research on Quality-adjusted Life Years (QALYs) and Cost-Utility Analysis (CUA) in RK. We found that, in general, the cost of CI and pre-surgical procedures are comparable with other countries. The length of stay in Kazakhstan was much higher (an average of 8 days) compared with other countries (3 days). Also in RK, there were significantly lower prices per hospital day and cost of various consultations. Postoperative costs of other countries consisted of one-third to two-thirds of the total costs for preoperative and implantation stages (2, 3). There was a little information on the effectiveness of rehabilitation programs in RK.CONCLUSIONS:Economic research like QALYs and CUA are new directions in the healthcare system in the RK. Lack of integration between primary care, rehabilitation and other services leads to difficulties in assessing the effectiveness of CI programs (for example, in our case, there was the restriction of assessment in only postoperative costs).

Download Full-text