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At least 19 recordsLinked to original sources

Review of regulatory requirements for benefit-risk assessment for medical devices: uncovering existing methodologies.

INTRODUCTION: A positive benefit-risk profile is a prerequisite for the market approval of medical devices. However, regulations are often criticized for providing limited information on benefit-risk assessment (BRA) despite growing expectations for quantitative methods. A clearer understanding of regulatory requirements, existing methodologies, and unresolved issues is needed. AREAS COVERED: Relevant regulatory documents referencing BRA for medical devices were systematically identified, with a primary focus on the European regulation followed by screening to extract BRA‑related requirements and any explicitly or implicitly described methods. The findings were analyzed and consolidated by BRA context, type, objective, methodological description, and implementation, thereby establishing a basis for the BRA methodological landscape. EXPERT OPINION: BRA is not a single concept, but a set of context‑dependent assessments across lifecycle of a medical device. BRA within clinical evaluation framed into BRAs of risk management holds a pivotal role and is supported by the most detailed methodological guidance, although BRAs in other contexts are important. A structured overview of existing BRA requirements clarifies their treatment across regulatory documents. By differentiating BRA contexts, types, objectives, and required methodological detail, the analysis supports a more transparent understanding of BRA and helps identify priorities for methodological refinement and interface clarification.

Risk Assessment

Mixed Methods Research on Family Caregiving for Stroke Survivors: A Methodological Systematic Review.

AIM: To examine how mixed methods research has been applied in studies of family caregiving for stroke survivors, focusing on key methodological components (rationale, design types, integration strategies, and use of joint displays). DESIGN: Methodological systematic review. METHODS: A systematic search of five databases yielded 17 studies. The extraction focused on mixed methods features (rationale, design, integration, joint displays), and quality was appraised using the Mixed Methods Appraisal Tool. DATA SOURCES: PubMed, CINAHL, Scopus, Web of Science, and PsycINFO were searched for relevant studies published from 2010 to 2025. RESULTS: The included studies addressed topics such as caregiver burden, coping, resilience, and intervention outcomes. Convergent and explanatory sequential designs predominated. Complementarity was the most frequent rationale for mixing methods. Integration occurred mainly through merging, with fewer instances of connecting or building. Three studies included joint displays to integrate the results. CONCLUSION: Mixed methods research is increasingly applied in family caregiving. To advance the field, researchers should strengthen integration during analysis and results and improve transparency in reporting key design features. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Strengthening methodological rigour in mixed methods studies on stroke caregiving will improve the evidence base for nursing practice. Intentional and meaningful integration of qualitative and quantitative evidence can better inform effective interventions and support programs, ultimately enhancing care for stroke survivors and their families. IMPACT: This review evaluates how mixed methods research is applied in family caregiving studies. It identifies significant methodological gaps, including unclear reporting of design and limited use of advanced integration techniques. The recommendations provide practical guidance for researchers to improve reporting and integration, yielding richer evidence to inform interventions and policies that support family caregivers. REPORTING METHOD: The review followed the PRISMA 2021 guidelines for transparent reporting of systematic reviews. PATIENT OR PUBLIC CONTRIBUTION: No patient or public involvement.

Humans

Darwinism and positivism as methodological influences on the development of psychology.

The methodological significance of evolutionary theory for psychology may be distinguished from its substantive or theoretical significance. The methodological significance was that evolutionay theory broadened the current conceptors of scientific method and rendered them relatively independent of physics. It thereby made the application of the "scientific method" to psychology much more feasible than it had been previously, and thus established the possibility of a wide-ranging scientific psychology for the first time. The methodological eclecticism that made scientific psychology possible did not, however, remain a feature of psychology for very long. Psychology's methodology rapidly became restricted and codified through the influence of, and in imitation of, the rigorously positivistic orientation of physics around the turn of the twentieth century.

Biological Evolution

Psychological skills training for sport-related outcomes: An umbrella review of evidence credibility and methodological quality.

Psychological skills training (PST) is widely used in sport, but review-level evidence remains fragmented across interventions, populations, outcomes, and methodological standards. This umbrella review synthesized evidence on PST-related interventions for sport-related outcomes, including athletic performance, psychological outcomes, cognitive performance, and sports injury, and evaluated evidence credibility, certainty, and methodological quality. A systematic literature search was conducted on 21 May 2025 in MEDLINE, PsycInfo, PubMed, Scopus, SportDiscus, Web of Science, and CINAHL Complete. Overall, 61 reviews involving 42,106 participants were included; 35 meta-analyses involving 28,076 participants were eligible for quantitative synthesis, and 26 reviews or meta-analyses involving 14,030 participants were summarized qualitatively. Quantitative findings showed generally positive point estimates for mindfulness-based interventions, imagery practice, music-based interventions, neurofeedback, perceptual-cognitive training, and multiple PST interventions, but most findings were weak or non-significant and certainty was generally very low. Qualitative evidence suggested potential benefits, but conclusions varied according to intervention definition, delivery, outcome measurement, and methodological quality. Evidence was more developed for athletic performance and psychological outcomes than for cognitive performance and sports injury. Overall, PST-related interventions may benefit sport-related outcomes, but conclusions should remain cautious because of low certainty, methodological heterogeneity, and limited evidence credibility.

Humans

Planning serials cancellations and cooperative collection development in the health sciences: methodology and background information.

In an era of steady-state budgets many research and academic libraries must cancel a significant number of current serials to maintain acquisitions of monographs. Thus paper reviews several techniques that have been used or that are of potential use in a rational selection of titles for cancellation. The context of the proposed methodology involves a network of libraries rather than an individual library. The methodology was tested with specific health sciences serial titles held by University of California libraries and resource libraries in NLM Region XI. As a test for the proposed methodology, background data were collected on 600 current foreign language serial titles included in SERLINE and held by at least one of the libraries in the networks of interest. Price, major secondary service coverage with productivity/impact factors, extent of holdings, and average number of recorded circulations per year in several of the libraries were recorded for each title. With the use of several different rules, estimates were made of the subscription savings that might be realized. It seems feasible to extend the same methodology to other groups of serial titles.

Abstracting and Indexing

Methodological issues in alpha biofeedback training.

Current controversies concerning outcomes of EEG alpha feedback training are at least in part due to methodological differences among different studies. The aim of this paper is to provide future and present researchers in this field with an analysis of methods used in most of the studies published from 1968 to 1976, and to comment on those methodological issues we think most important. These include alpha assessment, training schedules, and uni- versus bidirectional training. This analysis is accomplished in part by a series of tables listing 45 studies and the detailed methodologies used. It is believed that the probabilities of successful feedback enhancement of alpha can be substantially improved by incorporating the following suggestions: (a) employing at least four training sessions, (b) the use of continuous rather than dichotomous feedback, supplemented by periodic quantitative scores of progress, and (c) using training trials of at least 10 minutes' duration.

Alpha Rhythm

Adult-child interaction analysis: methodology and case application.

A revised methodology for analyzing adult-child interactions incorporating the use of videotape is presented. Results obtained from the application of this methodology to a successfully treated case of prolonged subsistence on pureed foods demonstrate that it is valid and useful. Objective confirmation of previous subjective clinical impressions and judgments was provided, and previously unnoted behavioral characteristics of mother, child and therapist were revealed. The clinical, research, and training potential of this comprehensive yet unobtrusive methodology is discussed.

Behavior Therapy

Assessment of Methodological Bias in Studies Reporting Racial Differences in Retinopathy of Prematurity in the United States.

PURPOSE: To assess methodological biases in studies reporting racial and ethnic differences in retinopathy of prematurity (ROP). METHODS: Systematic review of peer-reviewed studies published between 2014 and 2024 that reported on ROP outcome measures by race, ethnicity, or social determinants of health (SDOH). Three reviewers independently assessed each observation for selection and collider bias using definitions derived from perinatal epidemiology literature. Findings were also compared using a structured comparative synthesis between studies with and without identified methodological bias. RESULTS: A structured PubMed search identified 78 articles; 13 met inclusion criteria, with one study contributing two distinct analytical approaches, yielding 14 total observations. Survivorship bias was identified in 6 of 14 observations (42.9%), primarily due to the exclusion of infants who died prior to ROP screening. Potential collider bias was most common, found in 9 of 14 observations (64.3%), and was introduced through adjustment or stratification by gestational age and/or birthweight. Three studies did not exhibit either assessed biases. Among studies with identified bias, 8 of 10 observations reported lower ROP risk among Black versus White infants, whereas 3 of 4 observations without identified bias reported higher ROP risk or incidence among Black infants. CONCLUSION: Methodological biases in ROP studies investigating race or ethnicity are prevalent. Adjustment for gestational age or birthweight may introduce spurious race-ROP associations and contribute to paradoxical findings. Further exploration of the impact of SDOH on disease outcomes may reduce the misattribution of race as a biological risk factor and improve the interpretation of ROP disparities.

Collider bias

Standardization Challenges in Glycated Albumin Measurement: Methodological Heterogeneity and Quantification Discrepancies.

BACKGROUND: Glycated albumin (GA) is a valuable biomarker for monitoring glycemic status. However, measurement standardization is challenged by methodological heterogeneity, where different analytical principles and target measurands cause quantification discrepancies. This study systematically compared prevailing methodologies to identify a robust reference measurement procedure for widespread standardization. METHODS: We compared a targeted bottom-up proteomics method (ID-LC-MS/MS) with an enzymatic assay and the Japan Society of Clinical Chemistry (JSCC) reference method. A cohort of 129 donor serum specimens and certified reference materials (JCCRM-611) were analyzed to assess methodological comparability. Furthermore, GA concentration-dependent glycation kinetics at the Lys-525 site of albumin was examined. RESULTS: The optimized targeted bottom-up proteomics method showed a strong correlation (r = 0.986) with both the enzymatic assay and JSCC reference method. However, a progressively increasing negative systematic bias was observed at higher GA levels, confirming that Lys-525 underestimates GA at higher levels. In addition, with increasing overall GA concentration, the glycation ratio at the Lys-525 site consistently declined compared to the total glycated lysine residues. CONCLUSIONS: The standardization of GA measurements requires a precise, universally accepted definition to address analytical discrepancies. The present results indicate that quantification targeting all glycated lysine residues (as in the JSCC method) aligns more closely with biologically relevant GA values than site-specific measurement at Lys-525, which shows greater bias at higher concentrations. Therefore, further GA standardization would focus on adopting total glycated lysine residues on albumin as the preferred measurand definition, to improve detection accuracy and clinical comparability.

Serum Albumin

A new planning methodology to assess the impact of the health care system on health status.

This article summarizes a new methodology recently developed by the Rand Corporation which permits health planners to assess the impact of the local health care system on the health status of the population. The methodology, in algorithm form, should assist health planners in developing objectives and actions related to the occurrence of selected health status indicators and should be amenable to health care interventions. Emphasis has been placed on developing a simplified, approximate analysis that health planners will find both feasible and effective. No detailed mathematic analyses are called for. The data required are, in most instances, readily obtainable. The algorithm is a methodology by which HSAs can investigate determinants of health status, identify breakdowns in the health care system, and specify needed improvements in the system. The goal of these algorithms is to assist HSAs to obtain valid and sufficiently detailed data that will provide a basis for monitoring breakdowns in the health care system and to improve planning decisions aimed at preventing such breakdowns. This should, in turn, affect population health status in the planning area.

Breast Neoplasms

Comparison of miniaturized multitest systems with conventional methodology for identification of Enterobacteriaceae from foods.

Four miniaturized multiple test systems were compared with tube methodology used to identify Enterobacteriaceae encountered in foods. Identification aids supplied with each system were used to assign names to isolates at the species level. For the 129 strains tested, the Minitek system demonstrated a 96.9 percent agreement with reactions in tubed media. The Inolex, Analytab, and PathoTec test systems exhibited 94.3, 93.8, and 92.7 percent agreement, respectively. Analytab identified 96.1 percent of the isolates to the species level, whereas the Minitek, PathoTec, and Inolex systems were able to identify 78.3, 32.6, and 27.1 percent, respectively. The results indicate that the Analytab and Minitek systems are acceptable substitutes for the tube methodology routinely employed in identifying enterics from foods. Although the PathoTec system might be used to screen isolates for their identity, neither the presently available PathoTec nor the Inolex systems should be substituted for current methodology when definitive identification of foodborne organisms is required.

Bacteriological Techniques

The potential of phosphorescence spectrometry in clinical chemistry--the new generation of instrumentation and methodology.

We review recent advances in instrumentation and methodology in phosphorimetry that should facilitate the use of phosphorimetry for clinical analyses and recent phosphorescence studies of interest to the clinical chemist. We indicate recent advances, particularly improvements in instrumentation, novel methodologies, and new chemical processes that result in either an increase in sensitivity or selectivity (or both) of measurement of compounds of clinical importance. The greatest use of phosphorimetry in the clinical laboratory will not be for the analysis of very large numbers of samples for one species via automatic instrumentation, but rather will be for the analysis of those molecular species difficult or impossible to measure by conventional methods (colorimetry, fluorometry, etc.). Although various instrumental and methodological advances are discussed separately here, the most important use of these advances in clinical chemistry will undoubtedly be when two or more of them are combined, for example, in the use of time- or frequency-resolved phosphorimetry for the selective measurement of the phosphorescence resulting with inorganic probes and the appropriate choice of solvent and pH (of course, the instrument could contain an image vidicon detector for rapid determination of the spectrum, the decay curve, or both).

Antimetabolites

[The application of methodological aspects of the social sciences to psychoanalytic research--impressions from Tutzing, 1976].

Discussing problems in the application of methodological aspects of social sciences to psychoanalytic research the question was asked whether statistical methodology can be adapted to the multidimensional communicative process of psychoanalysis. Referring to the fact that experimentally and methodologically confirmed research usually demands a reduction of the process to be examined it was pointed out that the results of these studies might undergo a reduction in statement value and practicable clinical relevance accordingly.

Humans

[Clinical trials in psychiatry. Recent evolution of the methodology in France (author's transl)].

The comparison, with the help of a check list of criteria, of psychotropic clinical trials published in France, with an interval of five years, covered 80 trials in 1970 and 75 trials in 1975. The differences found between these two years all indicate a stricter methodological approach in 1975. Certain gaps persist however, such as the extreme rarity of codified pretherapeutic evaluation, preliminary wash out periods, references to an official nosography and a sufficient homogeneity of treatment groups. On the other hand, in the majority of trials, the exclusion criteria are not given and a global clinical assessment is the only criterium of change used. Finally the conclusions proposed coincide with the data in only two thirds of the publications. The comparative revue of 120 controlled psychotropic trials so far published in French show above all the extreme variability of the type of control utilized. Only 58 trials out of 120 have been randomized and a minority of these were carried out according to a strict methodology, with quantitative evaluation of the results and an appropriate statistical analysis. The most frequent methodological insufficiences are the obvious heterogeneity of the treatment groups, the insufficient use of standardized evaluation instruments and the inadapted ness of certain experimental protocols to the goals being pursued. The points most frequently omitted in the presentation of the results are the drop-outs of treatment, information relating to associated and previous treatment, the dates of evaluation of the therapeutic effects as well as the approach used to established side effects. The recent application of the 1975 French Law has deeply changed the habits of French experimentators and it is necessary to correctly interpret the term of "control". The control of non-specific variables intervening in the therapeutical results is the only means of identifying the pharmacological effects of drugs. The best control of these variables is the randomized comparative trial of simultaneous treatment groups using double-blind prescriptions. In order to further comparisons of trials from different sources, it is absolutely necesary that evaluation studies in French be carried out and transmitted according to internationally recognized recommendations based on general rules of protocols and on standardized evaluation instruments.

Anti-Anxiety Agents

Communications: Should mechanisms be established for sharing among clinical trial investigators experiences in handling problems in design, execution, and analysis? Methodology: the case for improved communications.

Despite their long history, the number that are in operation now, and the current level of expenditures on them, clinical trials have not been the focus of sufficient methodologic research. The paucity of metholologic explorations is further aggravated by the constraints on communications regarding methodology. Those individuals working in the area of clinical trials need to establish some professional identity with the field. Methodology in the areas of design and management of clinical trials needs to be stimulated, perhaps through special requests for applications (RFAs) and requests for proposals (RFPs). Communications could be improved by the establishments of a professional society, the development of an appropriate journal, and establishment of national training and information centers for clinical trials.

Clinical Trials as Topic

Psychoanalytic methodology in Helene Deutsch's the psychology of women.

Although Helen Deutsch's The Psychology of Women contains a wealth of descriptive material about women's problems, the methodology employed by Deutsch in reaching her conclusions about femininity is marred in several ways. Her evolutionary-adaptational bias and natural science approach led to the attribution of questionable biological bases to behavior and to the neglect of social factors and learning. Her concepts and language reveal an unquestioning adoption of Freud's metapsychology and lead to a perception and interpretation of psychological events according to the specific cast of that approach. She confuses her values with definition and observation. A re-examination of the thought of Deutsch seems fitting in these days of ever more extensive reconsideration of the views of Freud and other major psychoanalytic thinkers on the psychology of women. In addition to furthering our understanding of her insights, the study of Deutsch's methodology and its pitfalls contributes to a more critical understanding of the values and preconceptions that influence popular thinking about women and to a deeper grasp of problems inherent in psychoanalytic methodology.

Adaptation, Psychological