Abstract
Objectives:
Assess the extent to which the clinical trial registration and reporting policies of 25 of the world’s largest public and philanthropic medical research funders meet best ...practice benchmarks as stipulated by the 2017 WHO Joint Statement, and document changes in the policies and monitoring systems of 19 European funders over the past year.
Design, Setting, Participants:
Cross-sectional study, based on assessments of each funder’s publicly available documentation plus validation of results by funders. Our cohort includes 25 of the largest medical research funders in Europe, Oceania, South Asia, and Canada.
Interventions:
Scoring all 25 funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into three primary categories: trial registries, academic publication, and monitoring, plus validation of results by funders.
Main outcome measures:
How many of the 11 WHO best practice items each of the 25 funders has put into place, and changes in the performance of 19 previously assessed funders over the preceding year.
Results:
The 25 funders we assessed had put into place an average of 5/11 (49%) WHO best practices. Only 6/25 funders (24%) took the PI’s past reporting record into account during grant application reviews. Funders’ performance varied widely from 0/11 to 11/11 WHO best practices adopted. Of the 19 funders for which 2021(2) baseline data was available, 10/19 (53%) had strengthened their policies over the preceding year.
Conclusions:
Most medical research funders need to do more to curb research waste and publication bias by strengthening their clinical trial policies.
Background Non-publication, incomplete publication and excessively slow publication of clinical trial outcomes contribute to research waste and can harm patients. While research waste in German ...academic trials is well documented, research waste in Germany related to a specific disease area across non-commercial and commercial sponsors has not previously been assessed. Methods In this cohort study, we used public records from three clinical trial registries to identify 70 completed or terminated clinical trials involving women with metastatic breast cancer with trial sites in Germany. We then searched registries and the literature for trial outcomes and contacted sponsors about unreported studies. Results We found that 66/70 trials (94.3%) had made their results public. Only 13/70 (18.6%) trials had reported results within one year of completion as recommended by the World Health Organisation (WHO). The outcomes of 4/70 trials (5.7%) had not been made public at all, but only one of those trials had recruited a significant number of patients. Conclusions Discussions about research waste in clinical trials commonly focus on weakly designed or unreported trials. We believe that late reporting of results is another important form of research waste. In addition, a discussion regarding the appropriate ethical and legal rules for reporting the results of terminated trials might add value. German legislation now requires sponsors to upload the results of some clinical trials onto a trial registry within one year of trial completion, but these laws only cover around half of all trials. Our findings highlight the potential benefits of extending the scope of national legislation to cover all interventional clinical trials involving German patients.
Epilepsy is a disease that affects more than 50 million people worldwide. This most common chronic neurological disorder, which actually represents impairment of some brain structures, makes the ...patients suffering from epilepsy victims of environmental stigma, which, due to ignorance, is considered them to be mentally ill.
The aim of the study was to examine the demographic data of epilepsy patients, disease duration, frequency of seizures and type of therapy (mono/polytherapy), determine the existence of depressive symptomatology in patients with epilepsy and to examine predictive gender significance, degree of education, employment status, type of epileptic seizure on the presence of stigma.
The sample consisted of 100 respondents, both sexes, treated in the Epilepsy Outpatient Clinic of the Clinic for Neurology of the Clinical Center of the University of Sarajevo, selected randomly. All respondents fulfilled the Mini Mental Status Test. Patients who met the required score (27 and more of a total of 30) performed a test to evaluate the possible presence of depressive affective disorder with Back's Depression Scale. They also responded to the questionnaire of the revised version of Epilepsy Stigma Scale.
The mean age of the respondents was 37.46±11.9 years. Men are on average older 40.84±11.9 years, than women 34.69±11.2 in the tested sample, and the difference shown is statistically significant, p=0.009. The difference in the frequency of respondents by status of employment is statistically significant, χc
=50.4; p=0.0001. According to Beck's Depression Scale, a total of 15 respondents were without a stigma, a total of 51 respondents felt mild stigma, and 34 respondents felt high level of stigma, 18 of which (52.9%) with score ≤9, 2 (5.9%) score 10-15, 4 (11.8%) had a score of 16-19, 4 (11.8%) score of 20-29, while 6 (17.6%) had a score of ≥30. The degree of depression and the degree of stigma are in correlation, p=0.011. The time without epileptic seizures was approximately 6 (3-8) months for respondents without stigma, in respondents with mild stigma 4 (3-6) months and respondents with high stigma 6 (4-9) months. The mean time without epileptic seizures is statistically significantly different in relation to the degree of stigma, p=0.026.
The results of this study showed that poor control of epileptic seizures and the presence of depression had a significant predictive value for the development of the stigma. Therefore, in addition to establishing good control over epileptic manifestations, it is extremely important to pay attention to psychological changes, to raise awareness in the community, to continuously carry out education, in order to have the best outcomes in treatment of a patient with epilepsy.
The purpose of this study was to validate Bosnian translation of disease specific quality of life measure MSQoL-54 which is widely used in practice.
Previously translated and culturally adopted ...MSQoL-54 questionnaire used in this study has been provided and licensed by Optum Inc. The questionnaire was validated in 62 MS patients seen at Neurology clinic at University Clinical Center Sarajevo, during April 2016 until May 2016. Internal reliabilities of Bosnian version MSQoL-54 were assessed for multiple item scales by using Cronbach's alpha coefficient. Clinical validity was assessed comparing means of the two summary MSQoL-54 scores by the EDSS score. Pearson's (r) correlation coefficient was used to investigate the relationship between the composite scores and the main clinical and demographic variables.
Patients' participation was satisfactory and all scales fulfilled the usual psychometric standards. Highly significant inverse relationship was found between both composite scores and clinical characteristics of the disease and the EDSS. The lowest internal consistency reliability is found on social function scale (0.743), overall quality of life (0.782) and pain (0.833). The highest internal consistency reliability is found on role limitations due to physical problems (0.959), physical health (0.962) and role limitations due to emotional problems (0.966). The mean value of MSQoL-54 PHC (Physical Health Composite) and MHC (Mental Health Composite) were 49.82±18.90 (36.05-61.38) 51.84±22.22 (34.93-70.20) respectively. Our study has shown that the Bosnian version of MSQoL-54 is easy to administer and well accepted by patients and may be useful as clinical outcome measures in patients with MS.
This cost-of-illness (COI) study provides deep insight in direct and indirect costs of multiple sclerosis (MS) in Bosnia and Herzegovina (BH).
Objective of this study was to analyze the costs and ...quality of life (QoL) of patients with MS in BH.
We applied the same methodology already used in study conducted across nine European countries. Sixty-two patients participated with EDSS score not higher than 6.5. Costs are collected using a questionnaire quality of life was measured by EQ-5D and MSQOL-54 questionnaires.
Mean age of respondents was 39.8 The mean utility measured by EQ-5D-3L was 0.68 at the beginning and 0.63 at the end of the study. QoL measured by MSQoL-54 showed improvement at the end of the trial. Costs are presented from the societal and payer perspective. Cost of MS in Bosnia and Herzegovina annually amount 124.8 million BAM. Cost driver where indirect and DMDs costs, with significant differences among subgroups.
This study provides an in-depth analysis of MS costs in BH providing data for health policies development and information for future cost-effectiveness evaluations of new therapeutic options as well as for comparison of MS costs with other countries.
Multiple sclerosis (MS) as chronic neurodegenerative disease significantly impact patients' quality of life (QoL). QoL instruments can be generic (EQ-5D, SF-36) and disease-specific like MSQoL-54. ...Use of disease-specific instruments is preferred since it captures broader symptoms related to MS than generic instruments. Mental health is impacted by MS and different psychiatric conditions significantly impact QoL. We have conducted prospective non-interventional study among MS patients. Aim was to measure and compare MS patients QoL by generic and disease-specific instrument at baseline and after one year and to identify potential correlation between these two types of measurements and to assess mental health scores among MS patients in Bosnia and Herzegovina (B&H) and other countries.
Study included 62 patients diagnosed with MS and treated at Neurology clinic in Sarajevo from April 2016 to May 2017. Study was approved by Ethical Committee. QoL has been measured by EQ-5D and MSQoL-54. Measurement has been performed at baseline and after 12 months.
Average utility score measured by EQ-5D at the baseline and end of the study were 0.688 and 0.639 respectively with no significant difference (p=0.850). EQ-5D utility and MSQoL-54 score showed high correlation at baseline; rho=0.873 p=0.0001 for physical health and rho=0.711 p=0.0001 for mental health. At the end of the study no significant correlations have been found (p>0.05). High negative correlation found between EDSS and scores measured by EQ-5D and MSQoL-54; at baseline (rho=-0.744 p=0.0001) and at the end of the study (rho=-0.832 p=0.0001). Similar MS impact and loss of QoL found in B&H and other countries.
Both instruments can be used in measuring QoL but disease-specific are preferred since they capture broader symptoms impacting MS patient QoL. Using QoL instruments could drive clinician decision and patient-centric care as well as reimbursement and policy decision by recording treatment outcomes.
Veza između epilepsije i moždanog udara poznata je još od 1864. godine. Patofiziološka osnova epileptičnih napadaja tijekom i nakon moždanog udara su molekularne promjene koje u ishemiji nastaju ...primarno, a u hemoragiji sekundarno. Cilj ovoga rada bio je utvrditi incidenciju epileptičnih napadaja tijekom i nakon moždanog udara u desetgodišnjem razdoblju na Neurološkoj klinici Kliničkoga centra Univerziteta u Sarajevu. Obuhvaćeno je razdoblje od 1. siječnja 1989. do 31. prosinca 1998. godine, tijekom kojega je na Klinici liječen 7001 bolesnik. Najviše je bilo cerebralnih tromboza (53,65), potom cerebralnih embolija(17,25%), intracerebralnih hemoragija (21,96%) i subarahnoidnih hemoragija (7,17%). Incidencija simptomatskih epileptičnih napadaja u pojedinim godinama kretala se za ukupan uzorak od 0,75% do 6,67%. Prema tipovima inzulta incidencija je bila kako slijedi: za cerebralnu trombozu 1,0%-3,375%; za cerebralnu emboliju 1,22%-6,67%; za intracerebralnu hemoragiju 0,65%-4,05%; i za subarahnoidnu hemoragiju 1,34%-4,34%. U studiju nisu bili uključeni asocirani epileptični napadaji (napadaji kojima je započinjao moždani udar). Na temelju ispitivanja zaključeno je da je u desetgodišnjem razdoblju na Klinici bilo 75 bolesnika sa simptomatskim epileptičnim napadajima (47 bolesnika s kasnim napadajima i 28 bolesnika s ranim napadajima ili 1,998% od ukupnog uzorka naših bolesnika tijekom promatranog razdoblja). Bio je 36 bolesnika s cerebralnom embolijom (23 u skupini s kasnim napadajima i 13 u skupini s ranim napadajima; 2,980%), 30 bolesnika s intracerebralnom hemoragijom (23 u skupini s kasnim napadajima i 7 u skupini s ranim napadajima; 1,951%) i sedmoro bolesnika sa subarahnoidnim krvarenjem (4 u skupini s kasnim napadajima i 3 u skupini s ranim napadajima; 1,394%). Prema tipovima i podtipovima moždanog udara utvrđeno je daje hemoragijski moždani udar u našem kliničkom materijalu bio češći etiološki čimbenik za nastanak simptomatskih ranih i kasnih epileptičnih napadaja, dok se cerebralna embolija u ishemijskim inzultima i na našem materijalu pokazala kao češći razlog pojave simptomatskih epileptičnih napadaja u odnosu na cerebralnu trombozu. Tijekom promatranoga razdoblja mali je broj bolesnika sa simptomatskim ranim i kasnim epileptičnim napadajima (ukupno 9) zabilježen u godinama 1993., 1994. i 1995. Na temelju rezultata ovoga ispitivanja zaključeno je da se je incidencija epileptičnih napadaja u ukupnom uzorku bolesnika s moždanim udarom u desetgodišnjem razdoblju kretala od 1,394% do 2,980%.
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