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PubMed1999

Clusters and clustering of childhood cancer: a review.

Methodological considerations in the study of clusters and clustering of childhood cancer are reviewed briefly. A selection of 11 studies of individual clusters of childhood leukaemia which are either particularly notable or recent and have been reported in peer review journals is then considered. Focus is placed on sources of alerts, descriptive studies, field-work studies, conclusions and communication management. Some of these studies are probably essential but they are unlikely to yield firm conclusions; studies of large data sets are recommended. No causal factor has been identified which can explain a single cluster of childhood leukaemia.

Adolescent↗

PubMed2002

The use of dedicated methodology and statistical reviewers for peer review: a content analysis of comments to authors made by methodology and regular reviewers.

STUDY OBJECTIVES: In 1997, Annals of Emergency Medicine initiated a protocol by which every original research article, in addition to each regular review, was concurrently evaluated by 1 of 2 methodology and statistical reviewers. We characterized and contrasted comments made by the methodology and regular peer reviewers. METHODS: After pilot testing, interrater reliability assessment, and revision, we finalized a 99-item taxonomy of reviewer comments organized in 8 categories. Two authors, uninvolved in the writing of reviews, classified each comment from a random sample of methodology reviews from 1999. For 30 of these reviews (15 for each methodology reviewer), the 2 authors also scored all (range 2 to 5) regular reviews. RESULTS: Sixty-five reviews by methodologist A, 60 by methodologist B, and 68 by regular reviewers were analyzed. Comments by methodologist A most frequently concerned the presentation of results (33% of all comments) and methods (17%). Methodologist B commented most frequently on presentation of results (28%) and statistical methods (16%). Regular reviewers most frequently made non-methodology/statistical comments (45%) and comments on presentation of results (18%). Of note, comments made by methodology and regular reviewers about methods issues were often contradictory. CONCLUSION: The distributions of comments made by the 2 methodology and statistical reviewers were similar, although reviewer A emphasized presentation and reviewer B stressed statistical issues. The regular reviewers (most of whom were unaware that a dedicated methodology and statistical reviewer would be reviewing the article) paid much less attention to methodology issues. The 2 dedicated methodology and statistical reviewers created reviews that were similarly focused and emphasized methodology issues that were distinct from the issues raised by regular reviewers.

Peer Review, Research↗

PubMed2000

Peripheral retinal ablation for threshold retinopathy of prematurity in preterm infants.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: In premature infants with threshold retinopathy of prematurity (ROP) does peripheral retinal ablation, by any means, reduce the incidence of adverse ophthalmic outcome? SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group was used. This included a search of the Cochrane Neonatal Group Register of Clinical Trials, MEDLINE, EMBASE, previous reviews including cross references, abstracts from pediatric and ophthalmologic meetings, letters and expert informants. Search terms included "Retinopathy of Prematurity" [MeSH Terms], "Retrolental Fibroplasia" [All Fields] and "Lightcoagulation" [All Fields] or "Cryosurgery" [All Fields]. In addition, a personal bibliographic database was used as a cross-reference. SELECTION CRITERIA: All trials in human premature infants with threshold ROP utilizing random or quasi random allocation to either peripheral retinal ablation of the avascular retina, by any means, or concurrent control group with independent outcome assessment were initially selected for review. Following methodologic review, only studies using random allocation were selected for data extraction. DATA COLLECTION AND ANALYSIS: Relevance and validity were assessed by the two authors and consensus reached. Each author extracted clinical outcomes from valid reports independently. Data analysis was conducted according to the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Two randomised trials were identified. Data from these studies show that peripheral retinal ablation reduces the risk of (1) early unfavorable retinal structure from 47. 9% to 28.1% (absolute risk reduction 19.8% [95% CI 27.9 - 11.8%]), (2) unfavorable retinal structure in early childhood from 44.3% to 26.3% (absolute risk reduction 18% [95% CI 27.0 - 9.1%]) and (3) unfavorable visual acuity in early childhood from 63% to 50.6% (absolute risk reduction 12.2% [95% CI 21.2 - 3.1]). In addition, visual fields in sighted eyes were slightly smaller in the treated (51.3 degrees +/- 11.8 degrees ) group as compared to the control (58.2 degrees +/- 14.5 degrees ) group. REVIEWER'S CONCLUSIONS: Peripheral retinal ablation reduces the incidence of adverse ophthalmic outcome in premature infants with threshold ROP. In sighted eyes, peripheral retinal ablation may reduce the size of the visual field. At this stage, long term outcomes remain unknown.

Cryosurgery↗

PubMed2004

Rates and external causes of blunt head trauma in Ontario: analysis and review of Ontario Trauma Registry datasets.

Contemporary studies of blunt head trauma and its determinants are important for prevention. It is also important to understand the strengths and limitations of the common sources of data used for the ongoing study of these injuries. Using the Ontario Trauma Registry, we described frequent patterns of blunt head trauma and identified priorities for prevention and research. A review of methodological issues that arose during the analysis of these trauma registry data is also provided. Blunt head trauma cases were identified within two data sets of the Ontario Trauma Registry. The Minimal Data Set is population-based and contains acute care injury hospitalizations, and the Comprehensive Data Set contains "major injuries" treated at a lead trauma hospital. Injury control priorities varied by age group, sex and data set and these are profiled in the manuscript. The results indicate the importance of examining multiple sources of surveillance data in establishing injury control priorities. The methodological review demonstrated the need to critically examine the completeness and accuracy of trauma registry data in arriving at decisions about priorities.

Adolescent↗

PubMed2003

A review and methodologic critique of the literature supporting 'chronic whiplash injury'. Part II. Reviews, editorials, and letters.

In an earlier publication (part I) we conducted a critique of the literature supporting whiplash as a 'chronic injury', specifically examining original research which contradicts scientific measures and efforts showing that the highly prevalent problem of chronic whiplash is a cultural and psychosocially determined phenomenon. We reviewed the biomedical and engineering literature relating to whiplash syndrome, searching for articles that supported the construct of 'chronic whiplash injuries' and found that all of the articles contained significant methodologic errors relative to their respective authors' statements regarding chronic whiplash. The most frequent concerns reside with sampling, experimental design and interpretation of data. In Part II of this critique we examine other article types (reviews, editorials, letters). The authors of the current critique found that these articles also contained significant errors or biases relative to their respective authors' statements regarding chronic whiplash. The most frequent concerns reside with terminology, citation methods, scientific reasoning, and lack of address of contrary evidence.

Bias↗

PubMed2005

The integrative review: updated methodology.

AIM: The aim of this paper is to distinguish the integrative review method from other review methods and to propose methodological strategies specific to the integrative review method to enhance the rigour of the process. BACKGROUND: Recent evidence-based practice initiatives have increased the need for and the production of all types of reviews of the literature (integrative reviews, systematic reviews, meta-analyses, and qualitative reviews). The integrative review method is the only approach that allows for the combination of diverse methodologies (for example, experimental and non-experimental research), and has the potential to play a greater role in evidence-based practice for nursing. With respect to the integrative review method, strategies to enhance data collection and extraction have been developed; however, methods of analysis, synthesis, and conclusion drawing remain poorly formulated. DISCUSSION: A modified framework for research reviews is presented to address issues specific to the integrative review method. Issues related to specifying the review purpose, searching the literature, evaluating data from primary sources, analysing data, and presenting the results are discussed. Data analysis methods of qualitative research are proposed as strategies that enhance the rigour of combining diverse methodologies as well as empirical and theoretical sources in an integrative review. CONCLUSION: An updated integrative review method has the potential to allow for diverse primary research methods to become a greater part of evidence-based practice initiatives.

Data Collection↗

PubMed2026

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↗

PubMed1999

Economic evaluation of diagnostic tests. A review of published studies.

OBJECTIVES: The purpose of this review was to examine whether studies from the medical literature focusing on efficiency of diagnostic facilities reported economic evaluation methods appropriately, following guidelines for conducting and reporting economic evaluations. METHODS: A Medline search was conducted, and studies that concerned a diagnostic technology and fulfilled the Drummond criteria were selected for methodological review. The reliability of selection and methodological review based on the abstracts was determined by scoring a random sample of both abstracts and full articles. Interrater reliability was determined by scoring a random sample of abstracts by both authors. Kappa values were calculated. Nine methodological aspects were reviewed: study design, the type of economic evaluation, the comparison made, the study's perspective, the cost-effectiveness ratio used, the definition of cost-effective, the types of costs analyzed, the cost calculation method, and the use of sensitivity analysis. RESULTS: Two hundred fifty studies published between 1992 and 1997 were found regarding efficiency of diagnostic facilities; 134 studies fulfilled the Drummond criteria and were selected for methodological review. Kappa values showed reliability of selection and methodological review and interrater reliability. The existing literature on the economic evaluation of diagnostic facilities does not adhere well to guidelines for economic evaluation. In 95%, no perspective was mentioned, in 50% of the cases no ratio was given, in 82% the cost calculation method was not mentioned, and in 66% no sensitivity analysis was reported. CONCLUSIONS: Our review suggests that to improve the quality of reporting economic evaluations, editorial boards could issue and enforce guidelines for standard reporting of such studies.

Cost-Benefit Analysis↗

PubMed1997

Alcohol misuse prevention for young people: a systematic review reveals methodological concerns and lack of reliable evidence of effectiveness.

In a systematic review we assessed the methodological quality of evaluations of alcohol misuse prevention programmes for young people, and recorded evidence of effectiveness. Studies were identified through systematic searches of electronic databases; hand searches of all obtained papers, existing reviews and several journals; and mailshots to key organizations, conferences and individuals. Relevant papers were checked and cross-checked by members of the review team, and only those studies with an experimental or quasi-experimental design and positive attributes on a number of other quality criteria were included in the review. After pre-screening over 500 papers which reported prevention programmes, information was systematically abstracted from 155 papers. Only 33 studies merited inclusion in the review, and most of these had some methodological shortcomings. Twenty-one studies reported some significant short- and medium-term reductions in drinking behaviour. Of two studies which carried out longer-term evaluations, only one reported a significant longer-term effect, with small effect sizes. No factors clearly distinguished partially effective from ineffective or harmful prevention programmes. In conclusion, the lack of reliable evidence means that no one type of prevention programme can be recommended. In particular there is a need to carry out well-designed scientific evaluations of the effectiveness of current or new prevention efforts which target young people's alcohol misuse.

Adolescent↗

PubMed2004

HealthGrades opening up methodology to review.

Workshop topics include risk-adjustment methodology and statistical models. The science behind this type of health care data still is in the nascent stage. Use by employers and consumers should drive quality improvement.

Health Facilities↗

PubMedDate not supplied

[Study of HIV-related neuropsychological impairment: a review of methodological aspects].

Research on the HIV-related neuropsychological impairment has been marked by the variety and discrepancy of results, mainly in regards to asymptomatic phases. These discrepancies have been associated with the different types of methodology used in these studies. In this article, we review the main methodological problems present in studies about HIV-related neuropsychological impairment. Our aim is to gather the suggestions contained in the literature, to help overcome these problems in future studies in the field. These suggestions consider the samples used, the way in which they are selected, their size, the sampling methods used, the risk group studied, the criteria for inclusion/exclusion applied, or the selection of the control group. References are also included for the measuring instruments or neuropsychological tests used, statistical methods and criteria for defining the presence of neuropsychological impairment, and for dealing with confounding factors. There can be no doubt that a precise and thorough examination of these issues will make it possible to achieve more conclusive results on the incidence and nature of HIV-related neuropsychological impairment, and the factors that are associated with it.

Cognition Disorders↗

PubMed1995

Primary care, avoidable hospitalization, and outcomes of care: a literature review and methodological approach.

The purpose of this article is to review the literature on the relationships between primary care, potentially avoidable hospitalizations, and outcomes of care and to develop a methodology to study these relationships. The methodological approach includes developing criteria to select medical conditions, aggregating patient claims files of both ambulatory and acute care records, and delineating episodes of care. A taxonomy of physician visits is proposed that classifies visits on the basis of type of care, type of illness, and linkage to hospital episodes. A structural model of use and outcomes is specified that includes hazard rate models to estimate the likelihood of a potentially avoidable hospitalization, primary care and ad hoc physician visits, and mortality; the latter suggests a modification of the Health Care Financing Administration methodology that includes physician visit variables.

Centers for Medicare and Medicaid Services, U.S.↗

PubMedDate not supplied

Self-management education programs in chronic disease: a systematic review and methodological critique of the literature.

BACKGROUND: Self-management programs have been widely reported to help patients manage symptoms and contain utilization of health care resources for several chronic conditions, but to date no systematic review across multiple chronic diseases has been reported. We evaluated the efficacy of patient self-management educational programs for chronic diseases and critically reviewed their methodology. METHODS: We searched MEDLINE and HealthSTAR for the period January 1, 1964, through January 31, 1999, then hand searched the reference section of each article for other relevant publications. We included studies if a self-management education intervention for a chronic disease was reported, a concurrent control group was included, and clinical outcomes were evaluated. Two authors reviewed each study and extracted the data on clinical outcomes. RESULTS: We included 71 trials of self-management education. Trial methods varied substantially and were suboptimal. Diabetic patients involved with self-management education programs demonstrated reductions in glycosylated hemoglobin levels (summary effect size, 0.45; 95% confidence interval [CI], 0.17-0.74); diabetic patients had improvement in systolic blood pressure (summary effect size, 0.20; 95% CI, 0.01-0.39); and asthmatic patients experienced fewer attacks (log rate ratio, 0.59; 95% CI, 0.35-0.83). Although we found a trend toward a small benefit, arthritis self-management education programs were not associated with statistically significant effects. Evidence of publication bias existed. CONCLUSIONS: Self-management education programs resulted in small to moderate effects for selected chronic diseases. In light of evidence of publication bias, further trials that adhere to a standard methodology would help clarify whether self-management education is worthwhile.

Arthritis↗

PubMedDate not supplied

[Ambulatory esophageal pH monitoring: critical review of methodology: (equipment, reproducibility, standards), clinical importance and personal experience].

The authors review the recent literature about the methodology of oesophageal pH monitoring, which has a high sensitivity and a high specificity for assessing gastro-oesophageal reflux. Combined electrodes offer most advantages. Ambulatory recording should be done in hospital under standard conditions (meals), particularly for clinical studies. The best clinical indication is to detect pathological reflux in case of atypical symptoms with negative oesophagoscopy. The authors give their normal values in a series of measurements with two systems as well as their results in a series of cases of oesophagitis of various grades.

Esophagitis↗

PubMed1999

A critical review of methodology and interpretation of mirror self-recognition research in nonhuman primates.

In this paper we critically review conceptual and methodological issues of mirror self-exploration research. We conclude that: (1) mirror self-exploration provides evidence for mirror self-recognition; (2) inter- and intraspecies differences in terms of presence or absence of mirror self-recognition are not yet sufficiently clear, that is, whether its absence in species and individuals is methodological (false negative with respect to trait) or ontological (true negative with respect to trait) in nature; and (3) proposals of hypotheses to account phylogenetically for the existence of inter- and intraspecies differences in mirror self-recognition are premature. Before hypotheses such as these are advanced, the impact of rearing conditions on mirror self-recognition should be examined further. Copyright 1999 The Association for the Study of Animal Behaviour.

Journal Article↗

PubMed1986

A review of methodological issues of the standardized mortality ratio (SMR) in occupational cohort studies.

This paper is a review and clarification of methodological issues related to the standardized mortality ratio (SMR), widely used in occupational epidemiology. Although the SMR seems to be a simple statistic, it can be misused and misinterpreted. The paper discusses SMRs in relation to age-specific mortality ratios, relative risk, life expectancy, and statistics derived from direct standardization. Inter-SMR comparisons and the effect of the choice of the comparison population on the SMR are also discussed. Mathematical and empirical review of SMR use has led to the development of a correction procedure which permits direct comparisons of two SMRs by adjusting for the age distributions of the two populations. The paper also proposes a method for testing the trend of age-specific mortality ratios (MRs). If MRs are homogeneous, this method can also be used to compare two SMRs. If MRs are not homogeneous, the relative risk between two sets of age-specific MRs can be tested for significance, but no summary index, including the SMR, can accurately describe the mortality experience over the entire age range. It is suggested that the summary statistics of a cohort mortality experience should include relative risk, attributable risk, and life expectancy. These statistics are complementary and can be derived or approximated from the data that generated the SMR. A valid risk assessment should weigh the evidence from all three summary statistics.

Adult↗

PubMedDate not supplied

[Clinical trials using medicinal plants: bibliographical review and methodological analysis].

BACKGROUND: The importance of traditional medicine, one of the fundamentals of the cultural heritage of African, Asian and South American peoples, is evident in that such medicine is practised by more than 80% of these populations. METHODS: To analyse the methodology of clinical trials using medicinal plants, we reviewed articles published on this topic between 1980 and 2000. RESULTS: Forty-eight clinical trials were identified. Most were carried out in developed countries. Standard methodological principles were applied in almost all the trials: randomisation (85.4%), comparison (87.5%) versus placebo (95.2%), and blinded design (81.3%). The duration of the studies was short. Sample sizes were generally small, ranging from 30 to 99 subjects; statistical tests were used in 90% of the trials. Adverse effects were infrequently collected. CONCLUSION: Most clinical trials included in this survey were conducted in accordance with WHO guidelines. Respect for methodological principles and the implementation of a legislative framework are important in obtaining credibility and international recognition of the traditional pharmacopoeia.

Clinical Trials as Topic↗

PubMedDate not supplied

Group training for parents of mentally retarded children: a review and methodological analysis of behavioural studies.

Behavioural group training studies with parents of mentally retarded children were reviewed, with a special emphasis on methodology. While all studies reported favourable training outcome, the lack of certain methodological controls demands that the results of these studies be interpreted with caution. Several methodological refinements are proposed in this paper and it is suggested that the group training modality offers a more economical and practical approach than individual parent training.

Adolescent↗