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Journal of Lower Genital Tract Disease Jul 2018To systematically evaluate the literature regarding vulvodynia treatment outcome measures. (Review)
Review
OBJECTIVES OF THE STUDY
To systematically evaluate the literature regarding vulvodynia treatment outcome measures.
METHODS
A systematic literature search on OVID, PubMed, and PsycINFO databases was conducted from inception until May 2016. Studies were included/excluded based on prespecified criteria. Reported outcome measures were organized into 6 core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain; physical functioning, emotional functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition.
RESULTS
Of the 206 articles identified for full-text screening, 33 met our criteria. One study adhered to all IMMPACT recommendations. The number of outcomes measured per study ranged from 1 to greater than 20. Patient-reported pain outcomes were found in the majority (27/33; 82%) of studies. Pain severity with intercourse was reported by 24 (73%) of 33 studies-9 different scales were used to measure this outcome. Clinician-reported outcomes were present in 14 (42%) of 33 studies. Methods of measuring vestibular sensitivity by "cotton swab" test were different in 8 of 10 studies. Other domains reported included; physical function (8/33 studies; 24%), sexual function (23/33 studies; 70%), and emotional function (13/33 studies; 39%). Symptoms and adverse events were reported by 15 (45%) of 33 studies. One study formally reported participant disposition using all the information recommended by CONSORT.
CONCLUSIONS
Comparison of clinical trial results in vulvodynia is not possible because of a lack of standard treatment outcome measures. Vulvodynia researchers should apply the IMMPACT criteria to guide the development of a minimum core set of standard outcome measures that measure holistic health.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Clinical Trials as Topic; Female; Humans; Middle Aged; Treatment Outcome; Vulvodynia; Young Adult
PubMed: 29933290
DOI: 10.1097/LGT.0000000000000406 -
Child: Care, Health and Development Nov 2016Sleep disturbances in adolescents have received significant attention because of their high prevalence and the negative health outcomes. Relative to objective measures,... (Review)
Review
BACKGROUND
Sleep disturbances in adolescents have received significant attention because of their high prevalence and the negative health outcomes. Relative to objective measures, subjective sleep instruments have been the most practical tools used to identify sleep problems and assess responses to interventions in research and clinical settings. This systematic review aims to examine the psychometric properties of subjective measures that are used to assess sleep quality and disturbances among adolescents, identify the strength and limitation of each measurement and inform recommendations for practice.
METHODS
PubMed, Embase and PsycInfo were searched from 2000 through May 2016. The reference lists of important articles were included if they met the inclusion criteria. The available measures were evaluated and classified as positive, intermediate or poor according to the quality criteria for health status questionnaires.
RESULTS
Thirteen self-reported or parent-reported sleep measures met the inclusion criteria. Of the measurements reviewed, six were generic instruments assessing overall sleep quality and disturbances; five were dimension-specific instruments measuring daytime sleepiness, sleep insufficiency and sleep hygiene; and two were condition-specific instruments for insomnia. None of the subjective sleep measures for adolescents has a psychometric profile with all essential measurement properties. Specifically, the generic sleep measurements capture multiple dimensions but face issues of participant burden and compatibility. Among the domain-specific tools, the Cleveland Adolescent Sleepiness Questionnaire and the Chronic Sleep Reduction Questionnaire have achieved good psychometric merits but need further evaluation for responsiveness. Likewise, essential measurement properties of condition-specific tools for insomnia have yet to be established.
CONCLUSIONS
Because of the limited evidence, no definite recommendations can be made at this point. However, each available measurement has its own uniqueness and strength despite the limitations. Future research on measurement development and evaluation for adolescent sleep is needed to ensure the relevance and suitability to different stages of adolescence and social contexts.
Topics: Adolescent; Humans; Psychometrics; Reproducibility of Results; Severity of Illness Index; Sleep Hygiene; Sleep Wake Disorders; Surveys and Questionnaires
PubMed: 27495828
DOI: 10.1111/cch.12376 -
JAMA Psychiatry Feb 2017Increased activity and energy alongside mood change are identified in the DSM-5 as cardinal symptoms of mania and hypomania. A wide range of existing research suggests... (Review)
Review
IMPORTANCE
Increased activity and energy alongside mood change are identified in the DSM-5 as cardinal symptoms of mania and hypomania. A wide range of existing research suggests that this revision may be valid, but systematic integration of the evidence has not been reported. The term activation is understood as emerging from underlying physiological change and having objective (observable motor activity) and related subjective (energy) levels.
OBJECTIVES
To systematically review studies of the clinical phenomenon of activation in bipolar disorder, to determine whether activation is statistically abnormal in bipolar disorder and demonstrably distinct from mood, and to identify any significant between- and within-individual differences in the dynamics of activation.
EVIDENCE REVIEW
This systematic review of MEDLINE, PsycINFO, EMBASE, CINAHL, and PubMed databases from January 1, 1970, until September 30, 2016, identified 56 of a possible 3284 citations for (1) data-driven analyses of the dimensions and factor structure of mania and bipolar depression and (2) longitudinal studies reporting real-time objective monitoring or momentary assessment of daytime activity in individuals with bipolar disorder compared with other clinical or healthy control samples. Hand search of reference lists, specialty journals, websites, published conference proceedings, and dissertation abstracts and contact with other researchers ensured inclusion of gray literature and additional analyses as well as raw data if appropriate. Quality assessment was perfomed using the National Institutes of Health quality assessment tool.
FINDINGS
A total of 56 studies met eligibility criteria for inclusion in the review including 29 analyses of the factor structure of bipolar disorder, 3 of activity data from experimental sampling or ecological momentary assessment, and 20 actigraphy and 4 laboratory-based studies. Synthesizing findings across the studies revealed that the most robust finding was that mean levels of activity are lower during euthymia and depression in patients with bipolar disorder compared with healthy controls and other comparison groups (11 studies). The 7 ecological and laboratory studies show less organized or predictable patterns of behavior and a relative lack of habituation among patients with bipolar disorders compared with others. Factor analytic studies provide fairly consistent evidence that mood and activation represent distinct dimensions of bipolar disorder. Ten studies that examined interindividual and intraindividual patterns of activity suggest that mania may be better characterized by differences in robustness, variability, predictability, or complexity of activation rather than mean levels of activity.
CONCLUSIONS AND RELEVANCE
Within the limitations of the data, this synthesis of available evidence broadly supports the elevation of activation as a criterion A symptom for bipolar disorder in DSM-5. Although the importance of activation in bipolar disorders has been acknowledged for more than a century, this review suggests that this critical construct is understudied and should be the topic of more systematic high-quality research.
Topics: Arousal; Bipolar Disorder; Diagnostic and Statistical Manual of Mental Disorders; Humans; Motor Activity; Reference Values
PubMed: 28002572
DOI: 10.1001/jamapsychiatry.2016.3459 -
Physical Therapy Feb 2021Hand swelling may result from injury or trauma. Various physical assessment tools and measurement methods can be used to quantify the volume or size of the hand or...
OBJECTIVE
Hand swelling may result from injury or trauma. Various physical assessment tools and measurement methods can be used to quantify the volume or size of the hand or fingers; however, the reliability and validity of each tool and measurement method have not been evaluated. The purpose of this study was to evaluate the reliability and validity of physical assessment tools and methods used to quantify hand and finger volume orsize.
METHODS
MEDLINE, CINAHL, EMBASE, Web of Science, and Scopus were searched using key terms related to swelling, edema, volume, size, hand, measures, reliability, and validity. Cross-sectional or longitudinal studies that assessed reliability and/or validity of physical assessment tools or measurement methods to quantify hand swelling were included. Two examiners independently extracted data from the included articles and appraised the articles' quality using the Consensus-Based Standards for the Selection of Health Measurement Instruments methodology. Data extracted from studies analyzing reliability and validity were grouped by type of assessment tool and measurement method.
RESULTS
Five physical assessment tools used for quantification of hand swelling were evaluated, including tape measure, water volumeter, bioimpedance spectroscopy, ring gauge, 3-dimensional techniques. All assessment tools had good to excellent reliability (ICC = 0.74 - 0.99), and moderate to high validity (Pearson coefficient = 0.58 - 0.99), for quantification of the volume or size of the hand or fingers.
CONCLUSION
All measurement methods with these tools had good to excellent reliability and moderate to high validity. The evidence underpinning the figure-of-eight technique, which uses a tape measure, was the highest. Because these physical assessment tools and measurement methods assess different aspects and regions of the hand, which one is selected depends on the region of interest for assessment and the availability of tools.
IMPACT
Reliable tools and measurement methods are available to measure the size or volume of the hand and fingers, either together or separately. The best tool will depend on the aim of assessment and tool availability.
LAY SUMMARY
Hand swelling can occur with injuries, burns, or lymphedema. This review shows that tools are available to accurately measure swelling in any part of thehand.
Topics: Body Weights and Measures; Edema; Hand; Humans; Reproducibility of Results
PubMed: 33313914
DOI: 10.1093/ptj/pzaa206 -
Documenta Ophthalmologica. Advances in... Dec 2017The aim of the meta-analysis was to derive a range of mean normal clinical electrooculogram (EOG) values from a systematic review of published EOG studies that followed... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The aim of the meta-analysis was to derive a range of mean normal clinical electrooculogram (EOG) values from a systematic review of published EOG studies that followed the guidelines of the ISCEV standard for clinical electro-oculography.
METHODS
A systematic literature review was performed using four relevant databases limited to peer-reviewed articles in English between 1967 and February 2017. Studies reporting clinical EOG or FO normal values were included when the report used a standard 30° horizontal saccade, a retinal luminance of between 100 and 250 cd m, and had > 10 subjects in their normative values. The search identified 1145 articles after duplicates were removed with subsequent screening of the abstracts excluding a further 1098, resulting in 47 full-text articles that were then assessed by the author (PC) with a final nine articles meeting the inclusion criteria. An overall effect estimate using inverse variance-weighted meta-analysis was performed to estimate the mean values for the light peak/dark trough ratio (LP:DT ratio) (dilated and undilated), the time to the LP, the amplitude of the LP, dark trough (DT) and the fast oscillation (FO) peak-to-trough ratio from the included studies.
RESULTS
The mean dilated LP:DT ratio was 2.35 (95% CI 2.28-2.42); undilated LP:DT ratio was 2.37 (95% CI 2.28-2.45); LP amplitude was 835 (95% CI 631-1039) µV and the mean time to the LP being 8.2 (95% CI 7.7-8.7) min. The mean DT amplitude was 358 (95% CI 292-424) µV, and the mean FO peak-to-trough ratio was 1.13 (95% CI 1.11-1.16). The results of the LP/DT ratio are drawn from studies with a mean ± standard deviation (SD) age of 34.08 ± 12.93 years for dilated and 33.65 ± 12.28 years for undilated LP/DT ratios.
CONCLUSIONS
The meta-analysis of EOG studies has generated a reference range of normal mean values for clinicians to refer to when using the ISCEV clinical EOG. It provides a potential method to generate similar data sets from published normal values in related visual electrophysiology tests.
Topics: Electrooculography; Humans; Reference Values; Retina; Retinal Pigment Epithelium; Vision Tests; Vision, Ocular
PubMed: 29019002
DOI: 10.1007/s10633-017-9616-8 -
Expert Review of Gastroenterology &... Aug 2018The pancreas plays a central role in metabolism and is involved in the pathogenesis of several diseases. Pancreas volume is a holistic quantitative measure of pancreas... (Meta-Analysis)
Meta-Analysis Review
The pancreas plays a central role in metabolism and is involved in the pathogenesis of several diseases. Pancreas volume is a holistic quantitative measure of pancreas size but the clinical relevance of pancreas volumetry is poorly understood. Areas covered: The aim was to systematically review studies in adults that used computed tomography or magnetic resonance imaging to measure pancreas volume in health and disease, to determine normal pancreas volume range, and to quantify changes in pancreas volume that are associated with disease. Expert commentary: The normal pancreas volume range in adults is 71-83 cm, with no statistically significant difference between men and women. Type 2 diabetes and type 1 diabetes are associated with a progressively reduced pancreas volume. Overweight and obesity are associated with a progressively increased pancreas volume. There is a paucity of studies on pancreas volume in the setting of diseases of the exocrine pancreas, which should become a research priority in the future.
Topics: Diabetes Complications; Healthy Volunteers; Humans; Magnetic Resonance Imaging; Organ Size; Overweight; Pancreas; Pancreatic Diseases; Reference Values; Tomography, X-Ray Computed
PubMed: 29972077
DOI: 10.1080/17474124.2018.1496015 -
Psychopharmacology Nov 2022While one of the basic axioms of pharmacology postulates that there is a relationship between the concentration and effects of a drug, the value of measuring blood... (Meta-Analysis)
Meta-Analysis Review
RATIONALE
While one of the basic axioms of pharmacology postulates that there is a relationship between the concentration and effects of a drug, the value of measuring blood levels is questioned by many clinicians. This is due to the often-missing validation of therapeutic reference ranges.
OBJECTIVES
Here, we present a prototypical meta-analysis of the relationships between blood levels of aripiprazole, its target engagement in the human brain, and clinical effects and side effects in patients with schizophrenia and related disorders.
METHODS
The relevant literature was systematically searched and reviewed for aripiprazole oral and injectable formulations. Population-based concentration ranges were computed (N = 3,373) and pharmacokinetic influences investigated.
RESULTS
Fifty-three study cohorts met the eligibility criteria. Twenty-nine studies report blood level after oral, 15 after injectable formulations, and nine were positron emission tomography studies. Conflicting evidence for a relationship between concentration, efficacy, and side effects exists (assigned level of evidence low, C; and absent, D). Population-based reference ranges are well in-line with findings from neuroimaging data and individual efficacy studies. We suggest a therapeutic reference range of 120-270 ng/ml and 180-380 ng/ml, respectively, for aripiprazole and its active moiety for the treatment of schizophrenia and related disorders.
CONCLUSIONS
High interindividual variability and the influence of CYP2D6 genotypes gives a special indication for Therapeutic Drug Monitoring of oral and long-acting aripiprazole. A starting dose of 10 mg will in most patients result in effective concentrations in blood and brain. 5 mg will be sufficient for known poor metabolizers.
Topics: Humans; Aripiprazole; Schizophrenia; Reference Values; Antipsychotic Agents; Cytochrome P-450 CYP2D6
PubMed: 36195732
DOI: 10.1007/s00213-022-06233-2 -
Sleep & Breathing = Schlaf & Atmung Mar 2024Snoring is the most common symptom of obstructive sleep apnea. Various objective methods of measuring snoring are available, and even if the measurement is performed the... (Review)
Review
PURPOSE
Snoring is the most common symptom of obstructive sleep apnea. Various objective methods of measuring snoring are available, and even if the measurement is performed the same way, communication is difficult because there are no common reference values between the researcher and clinician with regard to intensity and frequency, among other variables. In other words, no consensus regarding objective measurement has been reached. This study aimed to review the literature related to the objective measurement of snoring, such as measurement devices, definitions, and device locations.
METHODS
A literature search based on the PubMed, Cochrane, and Embase databases was conducted from the date of inception to April 5, 2023. Twenty-nine articles were included in this study. Articles that mentioned only the equipment used for measurement and did not include individual details were excluded from the study.
RESULTS
Three representative methods for measuring snoring emerged. These include (1) a microphone, which measures snoring sound; (2) piezoelectric sensor, which measures snoring vibration; and (3) nasal transducer, which measures airflow. In addition, recent attempts have been made to measure snoring using smartphones and applications.
CONCLUSION
Numerous studies have investigated both obstructive sleep apnea and snoring. However, the objective methods of measuring snoring and snoring-related concepts vary across studies. Consensus in the academic and clinical communities on how to measure and define snoring is required.
Topics: Humans; Snoring; Polysomnography; Sleep Apnea, Obstructive; Sound; Vibration
PubMed: 37421520
DOI: 10.1007/s11325-023-02865-6 -
Surgical Oncology Mar 2018The methodological rigour of original studies on a diagnostic or prognostic research topic, and systematic reviews of these primary studies, varies; improving overall... (Review)
Review
The methodological rigour of original studies on a diagnostic or prognostic research topic, and systematic reviews of these primary studies, varies; improving overall quality is warranted. This paper, the second of the series, outlines key concepts and essential steps required to conduct a high-quality systematic review on diagnostic topics. It is comprised of six aspects: clarifying the project objectives; generating an appropriate research question; searching the literature and selecting study criteria; assessing risk of bias of eligible studies, reporting and analyzing data, and interpreting data and making conclusions. This review emphasizes clarifying the role of the index test(s), including the "PIRO" components in a diagnostic research question, setting a hypothesis and threshold for an accurate test if needed, searching for existing systematic reviews, assessing the risk of bias for individual studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool, considering methodological heterogeneity before performing a meta-analysis, managing uninterpretable or inconclusive data, and assessing the overall quality of the aggregate evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. We believe clinicians and health researchers would benefit from this methodological training.
Topics: Biomedical Research; Diagnostic Techniques and Procedures; Evidence-Based Medicine; Humans; Patient Selection; Reference Standards; Research Design
PubMed: 29549907
DOI: 10.1016/j.suronc.2017.11.010 -
Strabismus Jun 2019: Fusional amplitudes are important for clinical practice in diagnosing and managing binocular vision anomalies. Several measurement methods can be used to assess... (Comparative Study)
Comparative Study
: Fusional amplitudes are important for clinical practice in diagnosing and managing binocular vision anomalies. Several measurement methods can be used to assess fusional amplitudes. However, those methods are not interchangeable, and measurement repeatability has been questioned. : To compare the normative values of tests for the measurement of fusional vergence and to investigate sources of heterogeneity of diagnostic accuracy including: age, variation in method of assessment, study design and size, type (convergent, divergent, vertical, cyclo) and severity of strabismus (constant/intermittent/latent). : Bibliographic databases were searched up to March 2018, including Cochrane registers, PubMed, Web of Science, Google Scholar and Science Citation Index. Trial registers and conference proceedings were hand searched. : The review observed and reported according to the PRISMA guidelines and was registered with PROSPERO. The I was used to show the percentage of observed total variation across studies that is due to real heterogeneity rather than chance. The results of the different studies and the overall effect (meta-analysis under the random effects model) are shown. : Eighty-one studies were included in the review. Heterogenous information about break vergence amplitudes is reported for the step vergence method (I > 50%; p < 0.05) in children. Four parameters were reported consistently to affect measurements; age, method of assessment, order of testing and target size. For the smooth vergence technique break vergence values heterogeneity was not present in children and adults (I = 0%; p > 0.05). : The results are based on cross-sectional studies that were performed independently of each other, with different examiners, methods of examination and different populations. : The source of heterogeneity between studies for vergence break points measured with the step vergence method seems to be linked with age. Normal vergences reported in children had considerable heterogeneity compared with adults. In clinical practice, the population-based vergence ranges measured with the step vergence method in children should not be used as one single criterion. For the smooth vergence technique, normative population data can be used.
Topics: Adult; Child; Convergence, Ocular; Cross-Sectional Studies; Databases, Factual; Humans; Observer Variation; Reference Values; Reproducibility of Results; Research Design; Strabismus; Vision, Binocular
PubMed: 30821611
DOI: 10.1080/09273972.2019.1583675