A modular approach to case report design.
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Clinical Trials as Topic↗
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A pressure-balanced radio-telemetry system for the measurement of intracranial pressure. A preliminary design report.
A fully implantable radio-telemetric differential intracranial pressure sensor is described with a zero-point calibration that can be confirmed repeatedly. Intracranial pressure (ICP) is measured with the device by the principle of applying a known external pressure to the scalp above the sensor and simultaneously detecting by radio-telemetry the zero-point of the sensor corresponding to a balance of pressures across it. The radio-telemetry is implemented by a resonant circuit in the sensor of which the resonant radiofrequency is detected outside the body. The sensor is passive, has built-in barametric compensation, negligible permeability of temperature drift, no calibration ambiguities, and fast dynamic response. The implanted sensor has been used successfully for short-term as well as long-term ICP monitoring. It has been implemented primarily for intermittent ICP measurements, but also adapted to continuous recording. Preliminary clinical experience with the system indicates that it is effective, safe, and simple to operate.
Electronics, Medical↗
Development and pilot testing of a prostate cancer polygenic risk report.
BACKGROUND: Polygenic risk scores (PRS) are increasingly being incorporated into clinical care, yet optimal strategies for communicating PRS results to patients and clinicians remain undefined. Effective report design is critical to ensure comprehension and appropriate use, particularly for complex conditions such as prostate cancer where screening decisions are nuanced. We developed and pilot tested patient-facing materials to communicate integrated polygenic and monogenic risk for prostate cancer in the context of a randomized clinical trial. METHODS: We designed a summary report and accompanying Frequently Asked Questions (FAQ) page to communicate prostate cancer genetic risk within the Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS). Materials were developed through an iterative, multidisciplinary process informed by existing literature on genomic risk communication. We conducted semi-structured interviews with a national sample of eight men eligible for prostate cancer screening to evaluate comprehension, interpretation of visual elements, perceived usefulness, and preferences for improvement. Interviews were transcribed and analyzed using reflexive thematic analysis. RESULTS: Participants generally found the summary report and FAQ page understandable and visually engaging. Graphical displays of absolute risk, particularly pictograph arrays, facilitated comprehension and helped contextualize risk. Visual cues such as color and bold formatting effectively directed attention to key information, with red coloring perceived as particularly salient for high-risk results. In contrast, more complex visualizations, including bell curves and incidence curves, were frequently misunderstood or not interpreted as intended. Participants expressed a desire for clearer guidance regarding next steps and additional accessible information, suggesting supplementary resources such as hyperlinks or QR codes. Concerns about readability included small font size and high text density. CONCLUSIONS: In this qualitative pilot study, patient-facing materials for communicating prostate cancer PRS were generally well received, with specific design features such as simple visualizations and clear formatting enhancing understanding. Findings highlight the importance of intuitive risk displays and actionable guidance in PRS reporting. These results provide practical insights to inform the design of genomic risk reports as PRS-based prostate cancer screening approaches move toward clinical implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05926102; date of registry: July 3, 2023.
Aged↗
A prospective, randomized study of oral contraceptives: the effect of study design on reported rates of symptoms.
A study was undertaken to assess the effects of the study design (frequency and method of inquiry about the side effects) on the reporting of oral contraceptive (OC)-associated side effects. The study found that the one-contact-per-cycle schedule yielded consistently lower rates of side effects than the two-contact-per-cycle schedule. Also, asking subjects about the occurrence of specific symptoms led to the reporting of higher rates of side effects than those obtained by general inquiry. The study suggests that differences in the reported rates of side effects may be due in part to the manner in which the data were collected.
Contraceptives, Oral↗
Content and design of laboratory report forms for human immunodeficiency virus type 1 antibody testing.
In a pilot study involving proficiency testing for human immunodeficiency virus, markedly diverse and potentially confusing test report forms were encountered among participating laboratories. Therefore, a comprehensive study of human immunodeficiency virus type 1 report forms was conducted from state-licensed testing laboratories in California. Participants analyzed three serum samples of known human immunodeficiency virus type 1 antibody reactivity and reported their results on forms that they would normally submit to clinicians. Report forms from 84 laboratories were evaluated for content, design, and clarity. Differences were found among commercial, hospital, and public health laboratories. The significance of these findings is discussed. This technique also may be applied to evaluate laboratory report form design and content for other diagnostic test results.
AIDS Serodiagnosis↗
Effects of chronic hypoxia on myocardial metabolism.
Chronic hypoxia had widespread effects on myocardial metabolism. In understanding these effects, it is necessary to take account of the indirect ways in which hypoxia may act on the heart. Two such important indirect actions are those which follow the development of pulmonary hypertension and anorexia. The experimental design reported here enables one largely to distinguish the effects of pulmonary hypertension and anorexia from the rest. Using such a design, we have presented a number of diverse aspects of myocardial metabolism under conditions of chronic alveolar hypoxia induced by a low atmospheric pressure.
Animals↗
IV free-flow--still a cause for alarm.
A nurse's aide, in transferring a mother in labor to the delivery room, turned off the infusion pump delivering Pitocin, a drug administered intravenously to accelerate contractions. The aide removed the infusion set from the pump without first closing the manual clamp on the line. A free-flow infusion occurred, and the mother received nearly 35 times the prescribed amount of drug. The infant suffered organ damage and pneumonia and died four days later. Free-flow infusions can have tragic consequences when a potent drug is involved. Although other causes of overinfusion and free-flow exist, such incidents are typically associated with removing a disposable intravenous (IV) infusion set from an infusion device without first closing the manual clamp. We first raised this issue in our 1982 Evaluation "Infusion Controllers" and have emphatically and repeatedly addressed it in Health Devices and other ECRI publications. Yet, hospitals continue to report free-flow infusions, a problem that can be addressed by both hospitals and device manufacturers. In this article, we describe the causes of free-flow--both user error and device design; report numerous incidents, some resulting in death; and provide recommendations for reducing the likelihood that such problems will continue to occur.
Equipment Design↗
QCatch: a framework for quality control assessment and analysis of single-cell sequencing data.
MOTIVATION: Single-cell sequencing data analysis requires robust quality control (QC) to mitigate technical artifacts and ensure reliable downstream results. While tools like alevin-fry and simpleaf (and augmented execution context for the alevin-fry), offer flexibility and computational efficiency to process single-cell data, this ecosystem will further benefit from a standardized QC reporting tailored for its outputs. RESULTS: We introduce QCatch, a Python-based command-line tool that generates comprehensive and interactive HTML QC reports designed specifically for single-cell quantification results. Taking the output directory of alevin-fry or simpleaf as the input, QCatch is able to perform essential processing steps, like cell calling, and generate detailed QC reports that contain informative visualizations and statistics, including unique molecular identifier (UMI) count distributions, sequencing saturation estimates, and splicing status information, for QC assurance. Built for seamless integration into downstream analysis workflows, QCatch exports the processed results in a richly-annotated H5AD format file, a widely used data format common among many downstream single-cell data analysis tools. AVAILABILITY AND IMPLEMENTATION: The source code and documentation of QCatch are available on GitHub at https://github.com/COMBINE-lab/QCatch. QCatch can be installed via both Bioconda and PyPI.
Single-Cell Analysis↗
Effects of anabolic-androgenic steroids on muscular strength.
OBJECTIVE: To assess the effects of anabolic-androgenic steroids on human muscle strength. DATA SOURCES: A MEDLINE search for the period from January 1966 to April 1990, supplemented by manual searches of previous reviews, produced 30 studies in which subjects received more than one dose of the study steroid and in which changes in muscular strength were measured. STUDY SELECTION: Of the 30 studies, 14 were not included in the detailed data summary because they did not use a placebo control, did not randomize subjects to groups, or did not make objective strength measurements, or because percent change in strength data could not be abstracted. DATA EXTRACTION: Details of study design, reporting of results, and the adequacy and correctness of statistical methods were tabulated. Percent improvement in strength for the largest muscle group studied was computed, using the difference between results for the placebo and for the steroid-treated groups. DATA SYNTHESIS: Previously trained athletes show slightly greater improvements in strength in the anabolic-androgenic steroid-treated group than in the placebo group, with a median difference of 5% across the nine studies (range, 1.2% to 18.7%). A meta-analysis of the three studies with enough information to compute effect size showed a mean difference of 1.0 standard deviations (95% CI, 0.49 to 1.5). However, the poor overall quality of the studies in terms of design, sample size, and analysis; the lack of a dose-response effect across the narrow range of dosages tested; and the tendency for differences to be smaller in the larger studies throw these results into question. No evidence was found to support enhanced muscle strength with steroid use in eight studies in untrained normal volunteers. CONCLUSIONS: Anabolic steroids may slightly enhance muscle strength in previously trained athletes. No firm conclusion is possible concerning the efficacy of anabolic steroids in enhancing overall athletic performance. Results for the low steroid dosages studied in the published reports cannot be generalized to steroid-using athletes taking megadose regimens.
Anabolic Agents↗
Occupational cancer in Canada: what do we know?
OBJECTIVE: To examine the reporting of cases of occupational cancer in Canada in order to determine reporting requirements, the availability of data, the characteristics of reported cancers and the completeness of reporting. DESIGN: Descriptive epidemiologic study based on data requested from workers' compensation boards (WCBs) and cancer registries in each province and territory from 1980 to 1989. OUTCOME MEASURES: The number of claims accepted and rejected by the WCBs; year of claim, cancer site, sex of claimant, age of claimant at diagnosis, occupation, industry, exposure agent and reasons for rejection of claims; and new primary cancers according to site, age and sex. RESULTS: Reporting of occupational cancer by physicians is required in Alberta, Saskatchewan and Newfoundland. Only British Columbia, Saskatchewan and Ontario were able to provide all the requested information about the claims. Of the 1026 claims in these three provinces almost all were by men, and about two-thirds were for cancers of the respiratory tract. Asbestos was listed as the etiologic agent in more than one-third of the cases. A comparison of the proportion of incident cancers accepted as occupational by the WCBs with the estimated proportion of cancers in the general population attributable to occupation (based on population-attributable risk percentages from epidemiologic data) suggests that less than 10% of occupational cancers [corrected] are compensated. The main source of the deficit is underreporting to WCBs rather than rejection of claims. CONCLUSIONS: The availability of data about occupational cancers in Canada is inconsistent from jurisdiction to jurisdiction, and reporting is incomplete. An active disease surveillance system and additional education of physicians and workers about work-related illnesses may be required to improve reporting.
Age Factors↗
A comparison of death certificates and autopsies in the Australian Capital Territory.
OBJECTIVE: To determine the accuracy of death certificates in the Australian Capital Territory (ACT) by comparison with autopsy reports. DESIGN: A retrospective study of 495 deaths occurring from 1979 to 1987, excluding coronial deaths and deaths of infants under one year of age. The main cause of death on the death certificate was compared with the main cause of death recorded on an autopsy-supported death certificate created for the study. SETTING: The deaths occurred in both major institutional hospitals in the ACT. These hospitals are government-funded and administered, catering for both private and public patients. PATIENTS: There were 495 autopsies recorded in the ACT over the study period. The age data were lost in two cases. MAIN OUTCOME MEASURES: To find a simple measure of death certificate accuracy and compare the results with previous work. RESULTS: The accuracy of death certificates was 77%. Age, sex and length of hospital stay made little difference to the accuracy. Neoplastic diseases were accurately reported in 90% of cases, digestive and cardiovascular diseases in 81%. CONCLUSIONS: There is a need for practical methods and standard criteria to evaluate accuracy of death certificates.
Adolescent↗
No association between an allele at the D2 dopamine receptor gene (DRD2) and alcoholism.
OBJECTIVE: --We attempted to replicate a positive allelic association between the A1 allele of DRD2 (the D2 dopamine receptor locus) and alcoholism that has been reported. DESIGN: --We compared allele frequencies at the previously described Taq I restriction fragment length polymorphism system of DRD2 in alcoholics and random population controls. SUBJECTS: --The alcoholic subjects were 44 unrelated white individuals, diagnosed by direct structured interview to have alcohol dependence (by the Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition, criteria). The subjects in our random population control group (N = 68) were also white. RESULTS: --For the control group, allele frequencies at DRD2 were 0.20 (A1) and 0.80 (A2). For the alcoholic group overall, allele frequencies were 0.23 (A1) and 0.77 (A2). There were no significant differences in allele frequencies at the DRD2 locus between alcoholics and controls. The allele frequencies in both groups agreed closely with those observed in most previously described control populations. Subtyping the alcoholic group according to presence or absence of family history of alcoholism, presence or absence of antisocial personality disorder, age of onset, presence or absence of physical withdrawal symptoms, or recent alcohol consumption (as a measure of severity) did not in any case reveal significant differences in allele frequencies. CONCLUSION: --We were not able to replicate the results previously reported. We conclude that our data do not support an allelic association between the A1 allele at DRD2 and alcoholism.
Adult↗
Value of mortality data and necropsy records in monitoring morbidity in a population.
STUDY OBJECTIVE: The aim was to compare the value of four sources of data in assessing morbidity in a population: (1) data from a screening programme including follow up records, (2) death certifications by attending physicians, (3) death certifications by doctor-coroners, and (4) necropsy reports. DESIGN: The study was a cohort analysis of health and mortality in a sample of agricultural workers first examined in 1964-66 when they were aged 60 years or older. Follow up examinations enabled morbidity assessment to be made and ICD diagnostic categories to be compared with data available on persons in the cohort who had died. SETTING: Hajdúszoboszló, a small town in eastern Hungary. PARTICIPANTS: 1412 persons (96.1% of those aged greater than or equal to 60 years) were examined in 1964-6. Those still alive and available in 1989 were examined again. Necropsy records were available for 144 persons from the cohort in 1989 and were extensively reviewed in comparison with data available from other sources. MEASUREMENTS AND MAIN RESULTS: Comparison of causes of death established at necropsy showed marked differences from those registered by attending physicians and doctor-coroners, deviations ranging from -91.6% to +74.8%; 19.4% of underlying causes of death occurred exclusively in the necropsy group. Major divergencies in diagnostic classification occurred in the three data sources, particularly for diseases of the circulatory system, where hypertensive renal disease, old myocardial infarction, acute cerebrovascular disease, and venous thrombosis were rarely documented by physicians/coroners. When necropsy data were used the number of diagnostic categories increased strikingly over the other sources of information. Necropsy records revealed quantitatively similar information on morbidity to follow up examination though there were qualitative differences, necropsy being less likely to document diagnoses of endocrine disorders, mental and neurological diseases, digestive disorders, and musculosketal disorders. CONCLUSIONS: Necropsy records contain much valuable material not available from other sources, exceeding by ninefold the amount of information reported at present. A way should be found to make use of this large data pool.
Aged↗
Safety and efficacy of immune checkpoint inhibitors as a bridge to allogeneic hematopoietic stem cell transplantation in classical Hodgkin lymphoma: A systematic review and meta-analysis.
Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for relapsed or refractory classical Hodgkin lymphoma (cHL); however, a substantial subset of patients ultimately requires allogeneic hematopoietic stem cell transplantation (allo-HCT) to achieve long-lasting disease control. The use of ICIs as a bridge to allo-HCT has therefore gained increasing clinical interest, though concerns persist regarding post-transplant complications and incompletely-defined safety profiles. Accordingly, this systematic review and meta-analysis was conducted to evaluate outcomes of ICIs administered prior to allo-HCT in cHL. Following PRISMA guidelines, a comprehensive literature search was conducted across online databases through January 2026. Eligible studies included observational designs reporting survival and transplant-related outcomes in cHL patients treated with ICIs followed by allo-HCT. Pooled proportions for overall survival, progression-free survival, non-relapse mortality, and graft-versus-host disease (GVHD) incidence were calculated using a random-effects model. Seven studies comprising 739 patients were included. Post-transplant survival outcomes were favorable, with high pooled estimates across timepoints. Transplant-related mortality remained low, with NRM rates consistently within an acceptable range through long-term follow-up. Acute GVHD was observed at a meaningful frequency, including a smaller subset of severe cases, while chronic GVHD occurred in approximately one-quarter of patients at follow-up. Overall, these findings suggest that ICI therapy prior to allo-HCT in cHL is associated with encouraging survival and disease control and does not appear to confer excessive non-relapse mortality, supporting its use as a feasible and effective bridging strategy, while underscoring the need for future prospective studies to clarify optimal timing, risk mitigation strategies, and patient selection.
Humans↗
Certification of cause of death in French diabetic patients.
STUDY OBJECTIVE: The aim was to assess the level of mortality related to diabetes in France. In other countries, an underrecording of diabetes on the death certificates of diabetic patients has been reported. DESIGN AND SETTING: Estimated death rate of diabetic patients was calculated using (a) the actual number of death certificates where diabetes was registered either as an underlying or as a contributory cause of death, and (b) estimates of the prevalence of diabetes in the population, by sex and age group, from which expected numbers of diabetic deaths were determined. Standardised mortality ratios were calculated using 1988 French mortality statistics as reference. MAIN RESULTS: The estimated standardised mortality ratio for diabetic subjects, with diabetes registered as the underlying cause, was 0.36. This standardised mortality ratio increased to 0.92 if both the underlying and contributory causes were considered. The estimated death rate, by sex and age group, implies that diabetes has a protective effect between the ages of 45 and 64 years, particularly in men. CONCLUSIONS: Evidence suggests that diabetes is completely omitted on the death certificates of many diabetic subjects, especially for those between the ages of 45 and 64 years. Using mortality statistics underestimates the prevalence of diabetes and its effects on public health. The difference in diabetes mortality between countries will not be reliable until there is a better registration of the causes of death in diabetic patients, and contributory as well as the underlying cause are coded and published.
Adult↗
Hospital discharge reports: content and design.
The information required by family doctors on initial and final discharge reports from hospitals was specified and 546 such reports from hospitals in Aylesbury, Amersham, Banbury, Oxford, and High Wycombe were reviewed for the availability and accessibility of important information. Several items could have been recorded better, including the name of the hospital, the specialty (or department) concerned, and the name of the consultant in charge of the case. Drug reactions seemed to be under-reported in the initial discharge reports and information about treatment on discharge was inadequate. The recording of the prognosis and information given to the patient was deficient and communication on follow-up needs to be improved. The use of obscure abbreviations was widespread. There is room for improvement in the ease of access to important information, especially the diagnostic assessment, and the time taken for final reports to reach the general practitioner.
England↗
New approaches in cancer pharmacology: drug design and development. Report of a European School of Oncology Task Force.
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Antineoplastic Agents↗
Diarrheal diseases of infancy in Cali, Colombia: study design and summary report on isolated disease agents.
For public health reasons, it is important that the etiologic agents of early childhood diarrhea be isolated and identified, and that their routes of transmission be defined. This is especially true in tropical and subtropical developing countries, where childhood patterns of exposure to diarrheal disease agents usually differ from those in developed countries, and where diarrheal illness is a frequent harbinger of death among children under five years of age. This artical describes a study designed to identify diarrheal disease agents and transmission patterns in Cali, a large city of western Colombia's fertile Cauca River Valley. The study area, composed of five working-class districts with a total population of some 40,000, appeared to provide an environment fairly similar to those of many other "average" working-class communities in Latin America. Beginning in July 1962, a cohort of 296 children being born in these districts was studied, the period of investigation starting with the date of birth and continuing until each child's second birthday or its premature withdrawal from the study. Weekly home visits were made to establish defecation patterns, feeding practices, and anthropometry. The resulting data were then analyzed in terms of defecation frequencies, occurrence of liquid stools, and the presence of blood, mucus, or pus in the stools. Differences were noted in male and female defecation patterns and in the defecation frequencies of different age groups. Stool specimens for bacteriologic, virologic, and parasitologic examination were collected monthly on a regular basis and weekly when diarrhea occurred. Numerically, viruses were isolated and identified more often than other agents. The most commonly isolated parasite species and viral and bacterial serotypes were G. lamblia (from 222 subjects), echovirus 11 (from 166 subjects), and enteropathogenic Escherichia coli 026:B6 (from 138 subjects). Compared with the findings of several studies in other countries, isolations of shigellae were relatively rare.
Age Factors↗