Methodological issues raised by clinical trials on dysthymia: assessment instruments and response criteria

1997 ◽  
Vol 12 (4) ◽  
pp. 183-189 ◽  
Author(s):  
J.D. Guelfi ◽  
E Corruble

SummaryDysthymia clinical trials raise several methodological issues. The validity of the concept remains a matter of concern, as does the need for specific instruments, the difficulties in assessment of change and long-term assessments. Diagnostic criteria for inclusion should be used in a polydiagnostic approach. This paper summarises the main assessment tools and diagnostic criteria used in clinical trials on dysthymia. Severity criterion for inclusion could be a Hamilton Depression Rating Scale score (HAMD-17) between 13 and 17. The main response criteria should be a decrease of at least 50% of the total score on this scale and a final score under a predetermined limit. However, other response criteria may be useful: depression self-ratings, global assessments, general psychopathology assessments, personality and defense mechanisms, quality of life, psychosocial and functional impairment, diagnostic criteria (presence or absence) and side-effect assessment.

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 168 ◽  
Author(s):  
Cen Zhang ◽  
Scott Kasner

Despite many advances in our understanding of ischemic stroke, cryptogenic strokes (those that do not have a determined etiology) remain a diagnostic and therapeutic challenge. Previous classification approaches to cryptogenic stroke have led to inconsistent definitions, and evidence to determine optimal treatment is scarce. These limitations have prompted international efforts to redefine cryptogenic strokes, leading to more rigorous diagnostic criteria, outcome studies, and new clinical trials. Improvement in our ability to detect paroxysmal atrial fibrillation in patients with cryptogenic stroke has strengthened the idea that these strokes are embolic in nature. Further, better understanding of acute biomarkers has helped to identify otherwise occult mechanisms. Together, these strategies will inform long-term outcomes and shape management.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Lelde Ģiga ◽  
Anete Pētersone ◽  
Silva Čakstiņa ◽  
Guna Bērziņa

Abstract Aims To determine the most frequently utilized functional status assessment instruments for patients with brain tumors, compare their contents, using the International Classification of Functioning, Disability and Health (ICF), and their psychometric properties. Methods A scoping review was conducted to explore possible assessment instruments and summarize the evidence. A systematic literature search was performed for identification of the frequently used functional assessment tool in clinical trials in PubMed, ScienceDirect, and ProQuest databases. The content of most used instruments was linked to the ICF categories. The psychometric qualities of these assessment tools were systematically searched and analyzed. Results Nine most used assessment tools in clinical trials were identified. The most frequently used assessment instrument is the Karnofsky Performance Scale, which is developed for a general assessment of oncological patients. Out of four self-assessment tools, two were disease-specific (EORTC QLQ-BN20 and FACT-Br), EORTC QLQ-C30 has been shown good psychometric properties in patients with brain tumors as well as in patients with various oncological diseases, similar to the SF-36, it is used in patients with brain tumors as well as in patients with various diseases. The Functional Independence Measure and the Barthel Index were two objective assessment tools that described functioning, but two were neuropsychological tests (MMSE and Trial Making Test). Two hundred eighty-three meaningful concepts were identified and linked to 102 most relevant second-level categories covering all components of the ICF. Forty-nine studies reporting psychometric properties of those nine assessment tools were identified, indicating good reliability and validity for all the instruments. Conclusion Nine most frequently utilized functional status assessment instruments for patients with brain tumors represent all components of the ICF and have good psychometric properties. However, the choice of the tool depends on the clinical question posed and the aim of its use.


2021 ◽  
pp. 1-18
Author(s):  
DANIEL DICKSON ◽  
PATRIK MARIER ◽  
ANNE-SOPHIE DUBÉ

Abstract The concept of autonomy is essential in the practice and study of gerontology and in long-term care policies. For older adults with expanding care needs, scores from tightly specified assessment instruments, which aim to measure the autonomy of service users, usually determine access to social services. These instruments emphasise functional independence in the performance of activities of daily living. In an effort to broaden the understanding of autonomy into needs assessment practice, the province of Québec (Canada) added social and relational elements into the assessment tool. In the wake of these changes, this article studies the interaction between the use of assessment instruments and the extent to which they alter how older adults define their autonomy as service users. This matters since the conceptualisation of autonomy shapes the formulation of long-term care policy problems, influencing both the demand and supply of services and the types of services that ought to be prioritised by governments. Relying on focus groups, this study shows that the functional autonomy frame dominates problem definitions, while social/relational framings are marginal. This reflects the more authoritative weight of functional autonomy within the assessment tool and contributes to the biomedicalisation of aging.


2020 ◽  
Author(s):  
Lelde Ģiga ◽  
Anete Pētersone ◽  
Silva Čakstiņa ◽  
Guna Bērziņa

Abstract Aims: To determine the most frequently utilized functional status assessment instruments for patients with brain tumors, compare their contents, using the International Classification of Functioning, Disability and Health (ICF), and their psychometric properties.Methods: a systematic literature search was performed for identification of the frequently used functional assessment tool in clinical trials in PubMed, ScienceDirect and ProQuest databases. The content of most used instruments was linked to the ICF categories. Psychometric qualities of these assessment tools were systematically searched and analyzed.Results: Nine most used assessment tools in clinical trials were identified. The Karnofsky Performance Scale was the only generic tool for oncologic patients. Out of four self-assessment tools, three were disease-specific (EORTC QLQ-C30, EORTC QLQ-BN20 and FACT-Br) and one used for different diagnosis (SF-36). The Functional Independence Measure and the Barthel Index were two objective assessment tools that described functioning, but two were neuropsychological tests (MMSE and Trial Making Test). Two hundred eighty-three meaningful concepts were identified and linked to 102 most relevant second-level categories covering all components of the ICF. Forty-nine studies reporting psychometric properties of those nine assessment tools were identified, indicating good reliability and validity for all the instruments.Conclusion: Nine most frequently utilized functional status assessment instruments for patients with brain tumors represent all components of the ICF and have good psychometric properties. However, the choice of the tool depends on the clinical question posed and the aim of its use.


2019 ◽  
Vol 7 (3_suppl) ◽  
pp. 2325967119S0003 ◽  
Author(s):  
Meagan J. Sabatino ◽  
Chan-Hee Jo ◽  
Philip L. Wilson ◽  
Henry B. Ellis

Background: Pain is the most common symptom for presentation to an orthopaedic practice and orthopedists rank 4th among top prescribers of opiates. Pain acuity, etiology and severity have been published as guiding factors for pain assessment and management. In an attempt to address the underassessment and undertreatment of pain, pain was even considered the 5th vital sign for a period of time. Assessment of pain using validated severity assessment instruments including the Visual Analogue Scale and the Wong-Baker FACES® Scale, is common in orthopaedic practices. The purpose of this study is to evaluate the validity and sensitivity of self-reported pain assessment tools administered to pediatric and adolescent patients presenting with a primary complaint of knee pain. Methods: A retrospective review of 211 patients with a primary complaint of knee pain in a single practice over a nine-month period was completed. Medical records were reviewed for demographics, sport, laterality, symptoms, and factors described as influencing the pain. Prior to orthopaedic evaluation, patients were given an electronic tablet to complete patient reported outcomes measures and the visual analog scale (VAS). Patients were asked, electronically, “Do you have pain today?” and to verbally rate the pain using a Wong-Baker FACES® Pain Rating Scale (FACES). The FACES scale, typically a 0-5 rating, was normalized to a 0-10 scale for comparison to both the VAS and the pain component of the pedi-IKDC (Pain-pIKDC). A Pearson’s correlation was used to compare the VAS and the Pain-pIKDC with the FACES scores to determine validity. A paired t-test was used to identify differences between the three measures. Results: Of the 211 subjects, 112 were females and 99 were males, with a mean age of 13.9 years (range 7-18). 82% of patients reported presenting for pain due to a specific injury and not of spontaneous origin. The mean FACES score was 1.26 (normalized to 2.52) with a median score of 0. Compared to the FACES, the mean VAS was 4.22 (p<0.001) and Pain-pIKDC was 3.66 (p<0.001) noted to be both a statistically and clinically significant difference. When comparing the FACES to VAS, a weak correlation was noted (0.360, p<0.001). A stronger correlation was noted between the VAS and the Pain-pIKDC (0.752, p<0.001). 66.4% of patients reported no pain on the FACES but reported pain >1 on the Pedi-IKDC. 80.5% of patients reported no pain on FACES but pain of >1 on the VAS. Only 12.2% on VAS and 16.2% on Pain-pIKDC reported no pain . For both the VAS and Pain-pIKDC, the sensitivity of detecting “no pain” is low at 19.2% and 30.2% respectively. Conclusion: Though pain is widely accepted as an important factor for patient care management, clinicians should be aware that self-reported pain assessment tools in pediatrics and adolescents, without verbal confirmation, may inflate reported pain intensity and lead to possible overtreatment.


2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.


2019 ◽  
Vol 85 (9) ◽  
pp. 61-65
Author(s):  
N. A. Makhutov

We consider and analyze general methodological issues regarding the strength and endurance (life-time) of the materials and structure elements under a combined effect of various force, deformation and temperature factors. The Journal "Zavodskaya laboratoriya. Diagnostika materialov" (Industrial laboratory. Diagnostics of materials) has launched systematic publications on this problematic since 2018. For many decades, domestic and foreign laboratory studies have gleaned to a traditional methodology for obtaining initial curves of the long-term and cyclic strength that related the breaking stresses with time or number of cycles. These curves, with the characteristic sections and break points, separating the areas of elastic and inelastic (plastic strain or creep strain) strain, are used in analysis of long-term and cyclic damage. Using the elementary linear law of damage summation, it is possible to calculate at a first approximation the strength and endurance under varying conditions of loading. Stepping up the requirements to the accuracy of calculations necessitates a transition from force fracture criteria (at stresses a) to deformation criteria (in elastic and inelastic deformations e). Thus, it becomes possible to construct and use a unified expression for the curve of the long-term cyclic fracture (taking into account the temporal x and cyclic N factors) and a long-term cyclic damage. With such approach it is possible to remain the linear law of damage summation though those damages are obviously nonlinear. The goal of the study is to continue and support the discussion of the most complex problems of a comprehensive assessment of the strength, resource, survivability and safety of high-risk engineering equipment within the journal pages.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 805.2-805
Author(s):  
D. A. J. M. Latijnhouwers ◽  
C. H. Martini ◽  
R. G. H. H. Nelissen ◽  
H. M. J. Van der Linden ◽  
T. P. M. Vliet Vlieland ◽  
...  

Background:Chronic pain is a frequently reported unfavourable outcome of total hip and knee arthroplasties (THA/TKA) (7-23% and 10-34%, respectively) in osteoarthritis (OA) patients (1), which is difficult to treat as underlying mechanisms are not fully understood. Acute postoperative pain has been identified as risk factor for development of long-term pain in other surgical procedures, such as mastectomy and thoracotomy (2). However, the effect of acute postoperative pain on development of long-term pain in THA and TKA patients is unknown.Objectives:To investigate if acute pain following THA/TKA in OA patients is associated with long-term pain and if acute pain affects the course of pain up to 1-year postoperatively.Methods:From a longitudinal multicenter study, OA patients scheduled for primary THA or TKA were included. Acute pain scores, using Numeric Rating Scale (NRS), were routinely collected as part of standard care (≤72 hours after surgery). In case of ≥2 NRS scores the two highest scores were averaged (n=160), else the single score was taken. Pain was dichotomized into severe (NRS≥5) and mild (NRS<5). Pain was assessed preoperatively, at 3 (only THA), 6 and 12 months postoperatively using HOOS/KOOS subscale pain. Separate mixed-effect models for THA and TKA patients were used, with dichotomized acute pain as fixed-effect and long-term pain as outcome, while adjusting for confounders (age, sex, BMI, preoperative pain, mental component scale of the SF12 (MCS-12), and duration of the surgery and hospitalization). We included an interaction between time of measurement and acute postoperative pain to analyse whether effect modification was present. Missing values in preoperative pain and MCS-12 were imputed using multiple imputation methods.Results:81 THA and 87 TKA patients were included, of whom 32.1% and 56.3% reported severe acute pain. The results did not show an associated between severe acute pain and long term pain (THA: β=2.0, 95%-CI:-10.9-7.0; TKA: β=3.8, 95%-CI:-10.6-2.9). Furthermore, It seems that there is no effect present of difference in severity of acute pain and the course of pain over time (THA 6-months: β=6.4, 95%-CI:1.9-10.9 and 12-months: β=0.2, 95%-CI:-4.4-4.8; TKA 12-months: β=3.2, 95%-CI:-0.5-6.8).Conclusion:We did not find an association between acute pain and the development of long-term pain nor that severity of acute pain affects the course of postoperative pain in THA and TKA patients. The fact that THA and TKA patients often experience chronic preoperative pain might be a possible explanation for this finding. Nonetheless, future studies including additional measures of acute pain and pain sensitization in patients with chronic preoperative pain are necessary to draw stronger conclusions.References:[1]Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ open. 2012;2(1):e000435.[2]Katz J, Seltzer Ze. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert review of neurotherapeutics. 2009;9(5):723-44.Acknowledgments:We would like to thank the study group that consists of: B.L. Kaptein, Leiden University Medical Center, Leiden; S.B.W Vehmeijer, Reinier de Graaf Hospital, Delft; R. Onstenk, Groene Hart Hospital, Gouda; S.H.M. Verdegaal, Alrijne Hospital, Leiderdorp; H.H. Kaptijn, LangeLand Hospital, Zoetermeer; W.C.M. Marijnissen, Albert Schweitzer Hospital, Dordrecht; P.J. Damen, Waterland Hospital, Hoorn; the NetherlandsDisclosure of Interests:None declared


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