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A patient-level data meta-analysis of standard-of-care treatments from eight prostate cancer clinical trials.

ABSTRACT: Open clinical trial data offer many opportunities for the scientific community to independently verify published results, evaluate new hypotheses and conduct meta-analyses. These data provide valuable opportunities for scientific advances in medical research. Herein we present the comparative meta-analysis of different standard of care treatments from newly available comparator arm data from several prostate cancer clinical trials. Comparison of survival rates following treatment with mitoxantrone or docetaxel in combination with prednisone as well as prednisone alone, validated the previously demonstrated superiority of treatment with docetaxel. Additionally, comparison of four testosterone suppression treatments in hormone-refractory prostate cancer revealed that subjects who had undergone surgical castration had significantly lower survival rates than those treated with LHRH, anti-androgen or LHRH plus anti-androgen, suggesting that this treatment option is less optimal. This study illustrates how the use of patient-level clinical trial data enables meta-analyses that can provide new insights into clinical outcomes of standard of care treatments and thus, once validated, has the potential to help optimize healthcare delivery.

SUBMITTER: Geifman N

PROVIDER: S-EPMC4862324 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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A patient-level data meta-analysis of standard-of-care treatments from eight prostate cancer clinical trials.

Geifman N N Butte A J AJ

Scientific data 20160510

Open clinical trial data offer many opportunities for the scientific community to independently verify published results, evaluate new hypotheses and conduct meta-analyses. These data provide valuable opportunities for scientific advances in medical research. Herein we present the comparative meta-analysis of different standard of care treatments from newly available comparator arm data from several prostate cancer clinical trials. Comparison of survival rates following treatment with mitoxantro ...[more]

PMID: 27163794

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Project description:Needle acupuncture in small children has gained some acceptance in Western medicine. It is controversial, as infants and toddlers are unable to consent to treatment. We aimed to assess its efficacy for treating infantile colic.A systematic review and a blinding-test validation based on individual patient data from randomised controlled trials. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson's chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents]. Eligibility criteria and data sources: We included randomised controlled trials of acupuncture treatments of infantile colic. Systematic searches were conducted in Cochrane CENTRAL, MEDLINE, EMBASE, CINAHL and AMED, and in the Chinese language databases CNKI, VIP, Wang fang, SinoMed and Chinese Clinical Trial Registry.We included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was -24.9?min [95% confidence interval, CI -46.2 to -3.6; three trials] at mid-treatment, -11.4?min [95% CI -31.8 to 9.0; three trials] at the end of treatment and -11.8?min [95% CI -62.9 to 39.2; one trial] at the 4-week follow-up. The corresponding standardised mean differences [SMDs] were -0.23 [95% CI -0.42 to -0.06], -0.10 [95% CI -0.29 to 0.08] and -0.09 [95% CI -0.48 to 0.30]. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD -13.8?min [95%CI -37.5 to 9.9] and SMD -0.13 [95%CI -0.35 to 0.09]. The registration of crying during treatment suggested more crying during acupuncture [odds ratio 7.7; 95% CI 2.7-20.6; one trial]. GRADE-Moderate quality evidence.Percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis. Systematic review registration: PROSPERO 2015:CRD42015023253 Key points The role of acupuncture in the treatment of infantile colic is controversial. Available trials are small and present conflicting results. There were no clinically important differences between infants receiving acupuncture and no acupuncture control in this IPD meta-analysis of randomised controlled trials. The data indicate that acupuncture induces some treatment pain in many of the children. The study results indicate that percutaneous needle acupuncture should not be recommended for treatment of infantile colic on a general basis.

Project description:BackgroundThe importance of local failure (LF) after treatment of high-grade prostate cancer (PCa) with definitive radiotherapy (RT) remains unknown.ObjectiveTo evaluate the clinical implications of LF after definitive RT.Design, setting, and participantsIndividual patient data meta-analysis of 992 patients (593 Gleason grade group [GG] 4 and 399 GG 5) enrolled in six randomized clinical trials.Outcome measurements and statistical analysisMultivariable Cox proportional hazard models were developed to evaluate the relationship between overall survival (OS), PCa-specific survival (PCSS), and distant metastasis (DM)-free survival (DMFS) and LF as a time-dependent covariate. Markov proportional hazard models were developed to evaluate the impact of specific transitions between disease states on these endpoints.Results and limitationsMedian follow-up was 6.4 yr overall and 7.2 yr for surviving patients. LF was significantly associated with OS (hazard ratio [HR] 1.70 [95% confidence interval {CI} 1.37-2.10]), PCSS (3.10 [95% CI 2.33-4.12]), and DMFS (HR 1.92 [95% CI 1.54-2.39]), p < 0.001 for all). Patients who had not transitioned to the LF state had a significantly lower hazard of transitioning to a PCa-specific death state than those who transitioned to the LF state (HR 0.13 [95% CI 0.04-0.41], p < 0.001). Additionally, patients who transitioned to the LF state had a greater hazard of DM or death (HR 2.46 [95% CI 1.22-4.93], p = 0.01) than those who did not.ConclusionsLF is an independent prognosticator of OS, PCSS, and DMFS in high-grade localized PCa and a subset of DM events that are anteceded by LF events. LF events warrant consideration for intervention, potentially suggesting a rationale for upfront treatment intensification. However, whether these findings apply to all men or just those without significant comorbidity remains to be determined.Patient summaryMen who experience a local recurrence of high-grade prostate cancer after receiving upfront radiation therapy are at significantly increased risks of developing metastases and dying of prostate cancer.

Project description:ObjectiveThe aim of the present study was to assess the degree and impact of patient selection of patients with intermittent claudication undergoing supervised exercise therapy in Randomized Controlled Trials (RCTs) by describing commonly used exclusion criteria, and by comparing baseline characteristics and treatment response measured as improvement in maximum walking distance of patients included in RCTs and patients treated in standard care.MethodsWe compared data from RCTs with unselected standard care data. First, we systematically reviewed RCTs that investigated the effect of supervised exercise therapy in patients with intermittent claudication. For each of the RCTs, we extracted and categorized the eligibility criteria and their justifications. To assess whether people in RCTs (n = 1,440) differed from patients treated in daily practice (n = 3,513), in terms of demographics, comorbidity and walking capacity, we assessed between group-differences using t-tests. To assess differences in treatment response, we compared walking distances at three and six months between groups using t-tests. Differences of ≥15% were set as a marker for a clinically relevant difference.ResultsAll 20 included RCTs excluded large segments of patients with intermittent claudication. One-third of the RCTs eligibility criteria were justified. Despite, the numerous eligibility criteria, we found that baseline characteristics were largely comparable. A statistically significant and (borderline) clinically relevant difference in treatment response after three and six months between trial participants and standard care patients was found. Improvements in maximum walking distance after three and six months were significantly and clinically less in trial participants.ConclusionsThe finding that baseline characteristics of patients included in RCTs and patients treated in standard care were comparable, may indicate that RCT eligibility criteria are used implicitly by professionals when referring patients to standard physiotherapy care. The larger treatment response reported in standard physiotherapy care compared to clinical trials, might suggest that scientific studies underestimate the benefits of supervised exercise therapy in patients with intermittent claudication.

Project description:AimsThere is a need of more quantitative standardised data to compare local Mental Health Systems (MHSs) across international jurisdictions. Problems related to terminological variability and commensurability in the evaluation of services hamper like-with-like comparisons and hinder the development of work in this area. This study was aimed to provide standard assessment and comparison of MHS in selected local areas in Europe, contributing to a better understanding of MHS and related allocation of resources at local level and to lessen the scarcity in standard service comparison in Europe. This study is part of the Seventh Framework programme REFINEMENT (Research on Financing Systems' Effect on the Quality of Mental Health Care in Europe) project.MethodsA total of eight study areas from European countries with different systems of care (Austria, England, Finland, France, Italy, Norway, Romania, Spain) were analysed using a standard open-access classification system (Description and Evaluation of Services for Long Term Care in Europe, DESDE-LTC). All publicly funded services universally accessible to adults (≥18 years) with a psychiatric disorder were coded. Care availability, diversity and capacity were compared across these eight local MHS.ResultsThe comparison of MHS revealed more community-oriented delivery systems in the areas of England (Hampshire) and Southern European countries (Verona - Italy and Girona - Spain). Community-oriented systems with a higher proportion of hospital care were identified in Austria (Industrieviertel) and Scandinavian countries (Sør-Trøndelag in Norway and Helsinki-Uusimaa in Finland), while Loiret (France) was considered as a predominantly hospital-based system. The MHS in Suceava (Romania) was still in transition to community care.ConclusionsThere is a significant variation in care availability and capacity across MHS of local areas in Europe. This information is relevant for understanding the process of implementation of community-oriented mental health care in local areas. Standard comparison of care provision in local areas is important for context analysis and policy planning.

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A patient-level data meta-analysis of standard-of-care treatments from eight prostate cancer clinical trials.

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A patient-level data meta-analysis of standard-of-care treatments from eight prostate cancer clinical trials.

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