Extensive selective reporting of quality of life in clinical study reports and publications of placebo-controlled trials of antidepressants

2020 ◽  
pp. 1-13
Author(s):  
Asger Sand Paludan-Müller ◽  
Tarang Sharma ◽  
Kristine Rasmussen ◽  
Peter C. Gøtzsche
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Case Report ◽  
Clinical Study ◽  
Regulatory Agencies ◽  
Selective Reporting ◽  
Controlled Trials ◽  
Sf 36 ◽  
Clinical Study Reports

BACKGROUND: Selective reporting of trial results is common. OBJECTIVE: To study selective reporting in clinical study reports, company trial registers and publications of quality of life in placebo-controlled trials of antidepressants. METHODS: We compared clinical study reports of four antidepressants (fluoxetine, duloxetine, paroxetine and sertraline) obtained from two European drug regulators, data from online company registers, and publications received or retrieved from Eli Lilly and GlaxoSmithKline. Pfizer was also contacted but did not provide any publications. RESULTS: We included 15 trials (19,015 pages) and 4717 patients. Six trials had used SF-36, seven EQ-5D and two both instruments. Nine of the 15 CSRs (60%) displayed selective reporting. In the companies’ online registers, there was selective reporting for all 15 trials (100%). We received 20 publications from Eli Lilly and retrieved six from the GlaxoSmithKline register. There was selective reporting in 24 of the 26 publications (92%). Despite extensive selective reporting, we found only small differences between placebo and active drugs. CONCLUSIONS: Access to the full raw data from clinical trials and to case report forms for all patients are needed to evaluate the effect of antidepressants on quality of life. Regulatory agencies should refuse to approve drugs or new indications based on incomplete reporting.

scholarly journals Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ismail Zul Khairul Azwadi ◽  
Mohd Noor Norhayati ◽  
Mohd Shafie Abdullah
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Obstructive Uropathy ◽  
Meta Analysis ◽  
Percutaneous Nephrostomy ◽  
Procedural Pain ◽  
Controlled Trials ◽  
Failure Rates ◽  
Ureteral Stenting

AbstractAcute obstructive uropathy is associated with significant morbidity among patients with any condition that leads to urinary tract obstruction. Immediate urinary diversion is necessary to prevent further damage to the kidneys. In many centres, the two main treatment options include percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS). The purpose of this study if to compare the efficacy and safety of PCN and RUS for the treatment of acute obstructive uropathy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov. We also searched the reference lists of included studies to identify any additional trials. We included randomised controlled trials and controlled clinical trials comparing the outcomes of clinical improvement (septic parameters), hospitalisation duration, quality of life, urinary-related symptoms, failure rates, post-procedural pain [measured using a visual analogue scale (VAS)] and analgesics use. We conducted statistical analyses using random effects models and expressed the results as risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). Seven trials were identified that included 667 patients. Meta-analysis of the data revealed no difference in the two methods in improvement of septic parameters, quality of life, failure rates, post-procedural pain (VAS), or analgesics use. Patients receiving PCN had lower rates of haematuria and dysuria post-operatively and longer hospitalisation duration than those receiving RUS. PCN and RUS are effective for the decompression of an obstructed urinary system, with no significant difference in most outcomes. However, PCN is preferable to RUS because of its reduced impact on the patient’s post-operative quality of life due to haematuria and dysuria, although it is associated with slightly longer hospitalisation duration.

scholarly journals Four-rod Technique Stabilization after Pedicle Subtraction Osteotomy (PSO) for the Treatment of Thoracolumbar Hyperkyphosis Secondary to Pott Disease: A Two-Year Follow-Up Case Report

2019 ◽  
Vol 38 (03) ◽  
pp. 219-226
Author(s):  
Alecio Cristino Evangelista Santos Barcelos ◽  
Sterphany Ohana Soares Azevedo Pinto ◽  
Thaise Ellen de Moura Agra Teixeira ◽  
Rayana Ellen Fernandes Nicolau
Keyword(s):  
Quality Of Life ◽  
Case Report ◽  
Short Form ◽  
Spinal Tuberculosis ◽  
Pedicle Subtraction Osteotomy ◽  
High Rate ◽  
Hardware Failure ◽  
Sf 36

AbstractPedicle subtraction osteotomy (PSO) is a powerful tool for the management of sagittal misalignment. However, this procedure has a high rate of implant failure, particularly rod breakages. The four-rod technique diminishes this complication in the lumbar spine. The aim of the present study is to provide a case report regarding PSO and four-rod technique stabilization in the treatment of short-angle hyperkyphosis in the thoracolumbar (TL) junction. The authors describe the case of a patient with TL hyperkyphosis secondary to spinal tuberculosis treated with L1 PSO and fixation with a four-rod technique. There were no major surgical complications. The self-reported quality of life questionnaires (the Short-Form Health Survey 36 [SF-36] and the Oswestry disability index) and radiological parameters were assessed preoperatively, as well as 6, 12 and 24 months after surgery, and they showed considerable and sustained improvements in pain control and quality of life. No hardware failure was observed at the two-year follow-up.

scholarly journals Efficacy and safety of guselkumab for the treatment of patients with moderate-to-severe plaque psoriasis: A metaanalysis of randomized clinical trials

2020 ◽  
Vol 19 (2) ◽  
pp. 433-440
Author(s):  
Xing-Bao Tao ◽  
Yin-Qiu Huang ◽  
Yi-Hong Zhou ◽  
Lv-Lang Zhang ◽  
Yao-Kai Chen
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Adverse Events ◽  
Plaque Psoriasis ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Double Blind ◽  
Severe Plaque Psoriasis ◽  
Central Registry

Purpose: To conduct a systematic analysis on data from randomized controlled trials (RCTs) on different doses of guselkumab, and provide high-quality evidence for its use in the treatment of patients with moderate-to-severe plaque psoriasis (PsO). Methods: Related studies were searched using online search engines including MEDLINE, PubMed, and central registry of Cochrane controlled trials from January 2001 to October 2017. Only randomized, placebo-controlled, double-blind clinical trials involving guselkumab- and placebo-treated PsO subjects were included. Results: Five eligible double-blind, randomized, and placebo-controlled trials involving patients with moderate-to-severe PsO subjects treated with guselkumab were included. Compared with the placebo groups, the proportion of patients with improvements in Psoriasis Area and Severity Index (PASI) 75 (RR= 12.14; 95% CI= 9.11-16.16; p < 0.001); PASI 90 (RR= 23.26; 95% CI =14.57-37.13; p < 0.001), and PASI 100 (RR = 37.66; 95% CI = 15.81-89.69; p < 0.001) were significantly higher than those in guselkumab-treated groups. Furthermore, the guselkumab-treated groups showed significant decreases in Physician’s Global Assessment (PGA) score (RR = 10.46; 95% CI = 7.96-13.83; p < 0.001) and the Dermatology Life Quality Index (DLQI) score (SMD = -1.3; 95% CL = -1.4 to -1.19; p < 0.001), when compared with the placebo groups. However, there were no significant differences in adverse events (AEs) (RR = 1.01; 95% CL = 0.93-1.11; p > 0.05); severe adverse events (SAEs) (RR = 1.32; 95% CI =0.69-2.54; p > 0.05) and study discontinuations (RR = 0.79; 95% CI = 0.42-1.48; p > 0.05) between the two groups. Conclusion: This meta-analysis summarizes available evidence for the use of guselkumab in psoriasis. The results suggest that guselkumab is superior to placebo in moderate-to-severe psoriasis, and is welltolerated, effective, and safe in improving the severity of disease and quality of life. Keywords: Guselkumab, Effectiveness, Safety, Plaque psoriasis, Meta-analysis, Quality of life

Evidence-based measurement in multiple sclerosis: the psychometric properties of the physical and psychological dimensions of three quality of life rating scales

2003 ◽  
Vol 9 (4) ◽  
pp. 411-419 ◽  
Author(s):  
A Riazi ◽  
J C Hobart ◽  
D L Lamping ◽  
R Fitzpatrick ◽  
A J Thompson
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Psychometric Properties ◽  
Effect Size ◽  
Evidence Based ◽  
Sf 36 ◽  
Psychological Dimensions ◽  
Selection Of

The selection of measures of quality of life used in clinical trials of multiple sclerosis (MS) should be evidence-based. Head-to -head comparison of measures facilitates the selection of measures. The aim of the study was to compare the psychometric properties of the physical and psychological dimensions in three measures of quality of life to aid choice of the most appropriate scale for use in clinical trials of MS. O ne hundred and twenty-one people with MS (rehabilitation =57; steroids =64) completed a selection of health measures before and after treatment. The psychometric properties of three measures of physical function (MSIS-29 physical, SF-36 physical functioning, FA MS mobility) and three measures of psychological function (MSIS-29 psychological, SF-36 mental health, FA MS emotional well-being) were compared by examining data quality, scaling assumptions, acceptability, reliability, validity and responsiveness. Physical (0.63- 0.71) and psychological (0.70-0.75) scales were substantially correlated indicating they measure related constructs. The MSIS-29 physical and psychological scales satisfied all criteria for internal consistency reliability (physical =0.91; psychological =0.89) and validity. The SF-36 physical scale had a notable floor effect (20%). The FA MS mobility scale had lower reliability (a=0.78) compared to other measures. The MSIS-29 physical (effect size=0.91) and psychological (effect size =0.62) scales were the most responsive. In these three samples, the MSIS-29 had better measurement properties for combined physical and psychological health than the SF-36 and the FA MS.

scholarly journals Percutaneous Nephrostomy Versus Retrograde Ureteral Stenting for Acute Obstructive Uropathy: A Systematic Review and Meta-Analysis

2020 ◽  
Author(s):  
ZUL KHAIRUL AZWADI ISMAIL ◽  
NORHAYATI MOHD NOOR ◽  
MOHD SHAFIE ABDULLAH
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Obstructive Uropathy ◽  
Meta Analysis ◽  
Percutaneous Nephrostomy ◽  
Procedural Pain ◽  
Controlled Trials ◽  
Failure Rates ◽  
Ureteral Stenting

Abstract Acute obstructive uropathy is associated with significant morbidity among patients with any condition that leads to urinary tract obstruction. Immediate urinary diversion is necessary to prevent further damage to the kidneys. In many centres, the two main treatment options include percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS). The purpose of this study if to compare the efficacy and safety of PCN and RUS for the treatment of acute obstructive uropathy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov. We also searched the reference lists of included studies to identify any additional trials. We included randomised controlled trials and controlled clinical trials comparing the outcomes of clinical improvement (septic parameters and hospitalisation duration), quality of life, urinary-related symptoms, failure rates, post-procedural pain [measured using a visual analogue scale (VAS)] and analgesics use. We conducted statistical analyses using random effects models and expressed the results as risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). Seven trials were identified that included 667 patients. Meta-analysis of the data revealed no difference in the two methods in improvement of septic parameters, quality of life, failure rates, post-procedural pain (VAS), or analgesics use. Patients receiving PCN had lower rates of haematuria and dysuria post-operatively and longer hospitalisation duration than those receiving RUS. PCN and RUS are effective for the decompression of an obstructed urinary system, with no significant difference in most outcomes. However, PCN is preferable to RUS because of its reduced impact on the patient’s post-operative quality of life due to haematuria and dysuria, although it is associated with slightly longer hospitalisation duration.

scholarly journals AB0766 ACCURACY OF PATIENT REPORTED OUTCOME REPORTING IN RANDOMIZED CONTROLLED TRIALS IN PSORIATIC ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1681.2-1681
Author(s):  
B. Frade-Sosa ◽  
A. Kerschbaumer ◽  
P. Studenic ◽  
E. Chwala ◽  
J. S. Smolen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Randomized Controlled Trials ◽  
Well Being ◽  
Controlled Trials ◽  
Research Support ◽  
Randomized Controlled ◽  
Patient Reported

Background:Patient-reported outcomes (PROs) allow incorporating the patient’s perspective and health related quality of life (HRQoL) into shared decision making when choosing the optimal treatment strategy in patients suffering from psoriatic arthritis (PsA). PsA is a chronic inflammatory disease with heterogeneous manifestations with a range of symptoms, co-morbidities and reduced quality of life. International working groups (1) emphasized to integrate these outcomes as endpoints in clinical trials and as part of the core set of measures.Objectives:To evaluate the quality of PRO reporting in randomized clinical trials in PsA.Methods:We conducted a systematic literature review (PROSPERO ID 160930) searching PUBMED, MEDLINE and the Cochrane Library for publications (in English language) on randomized controlled trials investigating biological or targeted synthetic disease modifying drugs in adult PsA patients that included some PROs to evaluate the response to treatment. Two of the authors (BFS, AK) screened, selected and extracted the data of the trials that fulfilled inclusion criteria. Statistics were descriptive.Results:Of 1392 articles in total 880 were screened (512 duplicates); 92 were selected for detailed analysis with 48 finally analysed. 87% were primary publications were some patient-outcome measure were reported. The Health Assessment Questionnaire Disability Index (HAQ-DI) was reported in all RCTs (100%), while 70% of trials reported on the Short Form (36) Health Survey (SF36). Fatigue (FACIT-F) was reported in 29% of trials with different rates of articles published before and after the OMERACT working group recommendations (27% vs 50%) (1). Data on burden of psoriasis through the Dermatology Life Quality Index in 45%. Other PRO measurements to assess potentially affected health domains such as sleep disturbance, psychological disorders or well-being at work were reported only rarely.Conclusion:Our SLR shows that all trials report data on HAQ-DI. However, important domains as also emphasized by the OMERACT working group (1) are not routinely reported. Especially fatigue, included in 2016 as part of the OMERACT “Inner core” of the PsA Core Domain Set is only reported in about one quarter of studies, although 50% of studies published after 2016 report on fatigue. Data on emotional well-being, psychological status, productivity losses, and sleep disturbance remain rarely reported in PsA randomized controlled trials.References:[1]Orbai A, de Wit M, Mease P, et al International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Annals of the Rheumatic Diseases 2017;76:673-680.Acknowledgments:Acknowledgements: The author BFS had received an economic grant from the Spanish Society of Rheumatology (FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research) and the Catalan Society of Rheumatology (BequesNovartis de formació per estades a l’estranger) for the research stay in Vienna (Austria).Disclosure of Interests:Beatriz Frade-Sosa Grant/research support from: FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research. BequesNovartis de formació per estades a l’estranger, Andreas Kerschbaumer Paid instructor for: Celgene, Speakers bureau: Andreas Kerschbaumer has received lecture fees from Bristol-Myers Squibb, Gilead, Merck Sharp and Dohme and Pfizer., Paul Studenic Grant/research support from: Abbvie, Eva Chwala: None declared, Josef S. Smolen Grant/research support from: AbbVie, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, Roche – grant/research support, Consultant of: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – consultant, Speakers bureau: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – speaker, Daniel Aletaha Grant/research support from: AbbVie, Novartis, Roche, Consultant of: AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme, Speakers bureau: AbbVie, Celgene, Lilly, Merck, Novartis, Pfizer, Sanofi Genzyme, UCB

scholarly journals Clinical Trial the Efficacy of Boiled Hypertension Herbs Compared with Steeped Hypertension Herbs

2018 ◽  
Vol 16 (1) ◽  
pp. 78
Author(s):  
Agus Triyono ◽  
Peristiwan Ridha ◽  
Danang Ardianto
Keyword(s):  
Quality Of Life ◽  
Blood Pressure ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Herbal Medicine ◽  
Randomized Clinical Trials ◽  
Clinical Symptoms ◽  
Short Form ◽  
Sf 36

To search for scientific evidence the efficacy of herbal medicine, has conducted clinical trial the efficacy of  hypertension herbs compared with hydrochlorotiazide. Efficacy of clinical trials were conducted with the design open-label, randomized clinical trials and parallel design. It was involving 80 subjects who have met the inclusion and exclusion criteria. Subjects randomized study that is divided into two groups, a herbs group  and hydrochlorotiazide group. Subjects performed once a week to check the complaint history, the development of clinical symptoms, the possibility of side effects and diagnostic physical examination. Assessment score of quality of life by questionnaires Short Form 36 (SF-36) every four weeks. Results showed that administration of herbal medicine for 56 days hypertension, lower blood pressure (systolic and diastolikic) is equivalent to hydrochlorotiazide (HCT). Lowering blood pressure to normal (normotensive) 62.7% of the subjects. Eliminating the clinical symptoms of hypertension (dizziness / headache, stiff neck / whiny and myalgia) herbs group subjects at almost the same time with the  hidrochlorthiazide group. Raising the quality of life scores (SF-36) subjects herbs group equivalent to the increase in quality of life scores (SF-36)  hydrochlorotiazide group.

scholarly journals Measurement properties of selected patient-reported outcome measures for use in randomised controlled trials in patients with systemic lupus erythematosus: a systematic review

2020 ◽  
Vol 7 (1) ◽  
pp. e000373 ◽  
Author(s):  
Vibeke Strand ◽  
Lee S Simon ◽  
Alexa Simon Meara ◽  
Zahi Touma
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trials ◽  
Measurement Properties ◽  
Controlled Trials ◽  
Sf 36 ◽  
Patient Reported ◽  
Randomised Controlled ◽  
Test Retest Reliability ◽  
Pro Instruments

ObjectiveThe heterogeneous multisystem manifestations of SLE include fatigue, pain, depression, sleep disturbance and cognitive dysfunction, and underscore the importance of a multidimensional approach when assessing health-related quality of life. The US Food and Drug Administration has emphasised the importance of patient-reported outcomes (PROs) for approval of new medications and Outcome Measures in Rheumatology has mandated demonstration of appropriate measurement properties of selected PRO instruments.MethodsPublished information regarding psychometric properties of the Medical Outcomes Survey Short Form 36 (SF-36), Lupus Quality of Life Questionnaire (LupusQoL) and Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), and their suitability as end points in randomised controlled trials (RCTs) and longitudinal observational studies (LOS) were assessed. A search of English-language literature using MEDLINE and EMBASE identified studies related to development and validation of these instruments. Evidence addressed content validity, reliability (internal consistency and test-retest reliability), construct validity (convergent and divergent) and longitudinal responsiveness, including thresholds of meaning and discrimination.ResultsAll instruments demonstrated strong internal consistency, reliability and appropriate face/content validity, indicating items within each instrument that measure the intended concept. SF-36 and LupusQoL demonstrated test-retest reliability; although not published with FACIT-F in SLE supported by evidence from other rheumatic diseases. All instruments demonstrated convergent validity with other comparable PROs and responsivity to treatment.ConclusionThe measurement properties of PRO instruments with published data from RCTs including: SF-36, LupusQoL and FACIT-F indicate their value as secondary end points to support labelling claims in RCTs and LOS evaluating the efficacy of SLE treatments.

Psychosocial Interventions to Improve the Quality of Life for Men with Prostate Cancer: A Network Meta-analysis of 31 Randomized Controlled Trials

2017 ◽  
Vol 41 (S1) ◽  
pp. S252-S253
Author(s):  
S. Qiu ◽  
D. Linghui
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Behavioral Therapy ◽  
Meta Analysis ◽  
Psychosocial Interventions ◽  
Controlled Trials ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

BackgroundThe treatment of prostate cancer (PCa) can trigger a sequence of life-altering decisions that can induce depression and effects on health-related quality of life. We aimed to simultaneously compare all available psychosocial interventions using both direct and indirect data.MethodsIn this systematic review and network meta-analysis, we searched the Embase, Medline, PsycINFO, and the Cochrane central register of controlled trials for randomized controlled trials (RCT) published before Oct, 2016, that compared active treatments dealing with psychosocial problems in PCa patients after treatment. The primary outcome was health-related quality of life improvement as measured by the 36-Item Short-Form Health Survey (SF-36). Psychological morbidity was assessed with the Hospital Anxiety and Depression Scale (HADS). This study is registered with PROSPERO, number CRD42016049621.ResultsWe screened 113 potentially eligible studies and identified 31 RCTs, that examined 7 psychosocial interventions in 3643 PCa participants. In terms of SF-36, cognitive behavioral therapy [standard mean difference (SMD) 2·48, credible interval [CrI] 0.23 to 4.46], group based counseling (SMD 1·36, CrI 0·40 to 3·17) had significantly greater effects than usual care. Participants assigned to all assessed interventions had a significantly improvement in depression compared with usual care, except for those assigned to psychoeducational therapy (SMD 0.02, 95% CrI -0.11 to 0.15).ConclusionThis review shows that cognitive behavioral therapy, group based counseling and exercise may have significant beneficial effects considering SF-36 and HADS when compared with usual care. However, additional well-done research studies are necessary to establish the role of psychosocial interventions in men with PCa.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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