Recommendations for Designing, Conducting and Reporting Observational Studies in Homeopathy

Abstract Background Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades. Method We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide. Results Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails. Conclusions We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

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Adherence to the Strengthening the Reporting of Observational Studies in Epidemiology Statement in Observational Studies Published in Iranian Medical Journals

Iranian Journal of Public Health ◽

10.18502/ijph.v49i8.3896 ◽

2020 ◽

Author(s):

Soheila SHAGHAGHIAN ◽

Behrooz ASTANEH

Keyword(s):

Observational Studies ◽

Medical Knowledge ◽

Cross Sectional Study ◽

Observational Research ◽

Sectional Study ◽

Cross Sectional ◽

Medical Journals ◽

Multistage Sampling ◽

Different Characteristics ◽

Strobe Statement

Background: Although much medical knowledge comes from observational research, such studies are more prone to confounding and bias than others. This study was conducted to evaluate the adherence of the observational studies published in Iranian medical journals to the STROBE (strengthening the reporting of observational studies in epidemiology) statement. Methods: In this cross-sectional study, we selected 150 articles of Iranian medical journals, using multistage sampling from Aug 2016 to Jun 2017. The reported items of the STROBE statement in the articles was determined and considered as the adherence of the articles to the statement. The adherence of the articles with different characteristics was compared. Results: The adherence of the articles to the statement varied from 24% to 68% with a mean score of 48%±9%. The lowest mean scores were found in the Result (36%) and Method (49%) sections. The adherence was significantly better in the articles published in the journals indexed in PubMed or Web of Knowledge (ISI) databases (P<0.001) and those written by cooperation of the authors from other countries (P=0.044). Conclusion: The evaluated articles in our study had not adequately reported the items recommended by the STROBE statement. This indicates deficiency in key elements for readers to assess the validity and applicability of a study.

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Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. Translation to Russian

Digital Diagnostics ◽

10.17816/dd70821 ◽

2021 ◽

pp. 1-10

Author(s):

Jan P. Vandenbroucke ◽

Erik Von Elm ◽

Douglas G. Altman ◽

Peter C. Gotzsche ◽

Cynthia D. Mulrow ◽

...

Keyword(s):

Observational Studies ◽

Empirical Studies ◽

Observational Research ◽

Case Control Studies ◽

Quality Of Reporting ◽

Cross Sectional ◽

Useful Flow ◽

Study Designs ◽

Strobe Statement

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www. strobe-statement.org/) should be helpful resources to improve reporting of observational research. This article is the reprint with Russian translation of the original that can be observed here: Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. PLoS Med 2007;4(10):e297. doi:10.1371/journal.pmed.0040297

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External Validity Reconsidered

Population-Based Survey Experiments ◽

10.23943/princeton/9780691144511.003.0008 ◽

2011 ◽

Author(s):

Diana C. Mutz

Keyword(s):

Political Science ◽

Real World ◽

External Validity ◽

Observational Studies ◽

Internal Validity ◽

Conventional Wisdom ◽

Observational Research ◽

Convincing Case

This chapter talks about the significance of generalizability. Experimentalists often go to great lengths to argue that student or other convenience samples are not problematic in terms of external validity. Likewise, a convincing case for causality is often elusive with observational research, no matter how stridently one might argue to the contrary. The conventional wisdom is that experiments are widely valued for their internal validity, and experiments lack external validity. These assumptions are so widespread as to go without question in most disciplines, particularly those emphasizing external validity, such as political science and sociology. But observational studies, such as surveys, are still supposed to be better for purposes of maximizing external validity because this method allows studying people in real world settings.

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Quality of observational studies in prestigious journals of occupational medicine and health based on Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: a cross-sectional study

BMC Research Notes ◽

10.1186/s13104-018-3367-9 ◽

2018 ◽

Vol 11 (1) ◽

Cited By ~ 2

Author(s):

Javad Aghazadeh-Attari ◽

Kazhal Mobaraki ◽

Jamal Ahmadzadeh ◽

Behnam Mansorian ◽

Iraj Mohebbi

Keyword(s):

Occupational Medicine ◽

Observational Studies ◽

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional ◽

Strobe Statement

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Patient perceptions of the challenges of recruitment to a renal randomised trial registry: a pilot questionnaire-based study

Trials ◽

10.1186/s13063-021-05526-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Ellen Murphy ◽

Aoife O’Keeffe ◽

Niamh O Shea ◽

Eva Long ◽

Joseph A. Eustace ◽

...

Keyword(s):

External Validity ◽

Quantitative Data ◽

Observational Studies ◽

Randomised Trial ◽

Renal Dialysis ◽

Current Treatment ◽

Descriptive Statistics ◽

Trial Registry ◽

Cross Sectional ◽

Randomised Controlled

Abstract Background Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. However, issues of external validity often affect result application to real-world settings. Using registries to conduct RCTs is a reasonably new practice, but is appealing because it combines the benefits of both observational studies and RCTs. There is limited literature on patient motivators, barriers, and consent to registries for conducting RCTs. The purpose of our study was to establish the factors that motivate and/or inhibit patients from joining a registry for RCTs and to determine what information matters to patients when making an enrolment decision to participate in such a registry. Methods We conducted a cross-sectional questionnaire-based study at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. Results Eighty-seven patients completed the questionnaire. Reasons for participation in a registry included personal and altruistic benefits. Barriers to participation were time and travel requirements associated with registry participation, data safety concerns, risks, side effects, and concerns that registry participation would impact current treatment. Although 29.8% of patients expressed concern regarding their data being stored in a registry, 79.3% were still willing to consent to have their data uploaded and stored in a registry for conducting RCTs. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. Conclusion Challenges to recruitment to registries for RCTs exist, but addressing the identified concerns of potential participants may aid patients in making a more informed enrolment decision and may improve recruitment to registries, and by extension, to RCTs conducted using the registry.

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A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study

F1000Research ◽

10.12688/f1000research.12673.2 ◽

2017 ◽

Vol 6 ◽

pp. 1708 ◽

Cited By ~ 2

Author(s):

Laura McDonald ◽

Anna Schultze ◽

Alex Simpson ◽

Sophie Graham ◽

Radek Wasiak ◽

...

Keyword(s):

Medical Journal ◽

Data Sharing ◽

Exploratory Study ◽

Observational Studies ◽

Cross Sectional Study ◽

Research Data ◽

Observational Research ◽

Sectional Study ◽

Cross Sectional ◽

Current State

In order to understand the current state of data sharing in observational research studies, we reviewed data sharing statements of observational studies published in a general medical journal, the British Medical Journal. We found that the majority (63%) of observational studies published between 2015 and 2017 included a statement that implied that data used in the study could not be shared. If the findings of our exploratory study are confirmed, room for improvement in the sharing of real-world or observational research data exists.

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A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study

F1000Research ◽

10.12688/f1000research.12673.1 ◽

2017 ◽

Vol 6 ◽

pp. 1708 ◽

Cited By ~ 2

Author(s):

Laura McDonald ◽

Anna Schultze ◽

Alex Simpson ◽

Sophie Graham ◽

Radek Wasiak ◽

...

Keyword(s):

Medical Journal ◽

Data Sharing ◽

Exploratory Study ◽

Observational Studies ◽

Cross Sectional Study ◽

Research Data ◽

Observational Research ◽

Sectional Study ◽

Cross Sectional ◽

Current State

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Vitamin D and Hospital Admission in Older Adults: A Prospective Association

Nutrients ◽

10.3390/nu13020616 ◽

2021 ◽

Vol 13 (2) ◽

pp. 616

Author(s):

Avril Beirne ◽

Kevin McCarroll ◽

James Bernard Walsh ◽

Miriam Casey ◽

Eamon Laird ◽

...

Keyword(s):

Older Adults ◽

Vitamin D ◽

Hospital Admission ◽

Cross Sectional Study ◽

Vitamin D Supplementation ◽

Inverse Association ◽

Cross Sectional ◽

Prospective Association ◽

Randomised Controlled

The health effects of vitamin D are well documented, with increasing evidence of its roles beyond bone. There is, however, little evidence of the effects of vitamin D on hospitalisation among older adults. This study aimed to prospectively determine the relationship of vitamin D status in older adults with hospital admission and emergency department (ED) attendance. Trinity University of Ulster Department of Agriculture (TUDA) is a large cross-sectional study of older adults with a community population from three disease-defined cohorts (cognitive dysfunction, hypertension, and osteoporosis). Participants included in this analysis were recruited between 2008 and 2012. ED and hospital admission data were gathered from the date of TUDA participation until June 2013, with a mean follow up of 3.6 years. Of the 3093 participants, 1577 (50.9%) attended the ED during the period of follow-up. Attendees had lower mean serum 25(OH)D concentrations than non-attendees (59.1 vs. 70.6 nmol/L). Fully adjusted models showed an inverse association between vitamin D and ED attendance (Hazard Ratio (HR) 0.996; 95% Confidence Interval (CI) 0.995–0.998; p < 0.001). A total of 1269 participants (41%) were admitted to hospital during the follow-up. Those admitted had lower mean vitamin D concentrations (58.4 vs. 69.3 nmol/L, p < 0.001). In fully adjusted models, higher vitamin D was inversely associated with hospital admission (HR 0.996; 95% CI 0.994–0.998; p < 0.001) and length of stay (LOS) (β = −0.95, p = 0.006). This study showed independent prospective associations between vitamin D deficiency and increased hospitalisation by older adults. The need for further evaluation of current recommendations in relation to vitamin D supplementation, with consideration beyond bone health, is warranted and should focus on randomised controlled trials.

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Perception of Inpatient Oncologic Rehabilitation in Children, Adolescents and Young Adults Diagnosed with Cancer in Switzerland

Klinische Pädiatrie ◽

10.1055/a-1210-2599 ◽

2020 ◽

Vol 232 (06) ◽

pp. 294-299

Author(s):

Maria Otth ◽

Sibylle Denzler ◽

Sibylle Schmid ◽

Birgitta Setz ◽

Katrin Scheinemann

Keyword(s):

Young Adults ◽

Cancer Patients ◽

Peer Group ◽

Inpatient Rehabilitation ◽

Cross Sectional Study ◽

Adolescents And Young Adults ◽

Cross Sectional ◽

Rehabilitation Programs ◽

Specialized Institutions ◽

Strobe Statement

Abstract Background Inpatient rehabilitation improves physical and psychosocial performance in childhood cancer patients and their families. Two kinds of inpatient rehabilitation are available in specialized institutions in Germany: family-oriented rehabilitation or peer group-oriented rehabilitation for adolescents and young adults (AYA). Our study aimed to find out what Swiss childhood and AYA cancer patients and their families thought about the rehabilitation programs in which they had participated. Patients and methods We conducted a questionnaire-based, cross-sectional study of Swiss childhood and AYA cancer patients and their families whose inpatient rehabilitation stays were scheduled to take place in Germany between May 2012 and March 2019. We analyzed the data descriptively and present our findings in accordance with the STROBE statement. Results Of the 57 eligible families contacted, 38 (67%) responded. Most rated the rehabilitation stay as very good (68%) or good (26%). Nearly all participants emphasized that these programs should be available to all affected patients and their families. Most (80%) thought the program gave them enough valuable information to enable them to cope with daily life after the stay ended. Only one fifth (19%) of the rehabilitation stays were fully funded by the health or disability insurance. Conclusion Participants expressed an overwhelmingly positive opinion about the rehabilitation programs they attended. We are convinced that childhood and AYA cancer patients and their families in Switzerland benefit from these programs and encourage insurances to cover the costs.

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