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Checklist guideline outlining recommended items for transparent reporting in cohort, case-control, and cross-sectional study manuscripts.
Title:
STROBE Statement—Checklist of Items to Be Included in Reports of Observational Studies
Thematic area:
Epidemiology and reporting standards
Document type:
Reporting guideline checklist
Subject:
Transparent reporting of observational studies
Scope:
Cohort, case-control, and cross-sectional studies
Sections covered:
Title and abstract; Introduction; Methods; Results; Discussion; Other information
Key components:
Study design; Participants; Variables; Data sources and measurement; Bias; Study size; Statistical methods; Outcome data; Main results; Limitations; Interpretation; Generalisability; Funding
Related publication:
Explanation and Elaboration article
Associated initiative:
STROBE Initiative
Referenced journals:
PLoS Medicine; Annals of Internal Medicine; Epidemiology
Availability:
Publicly accessible via journal websites and www.strobe-statement.org
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Year:
2021
Region / city:
Global
Topic:
Reporting standards for cross-sectional studies
Document type:
Checklist
Author:
STROBE Initiative
Target audience:
Researchers, Medical professionals, Academics
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Title:
STROBE Statement—Checklist of Items to Be Included in Reports of Cohort Studies
Document type:
Reporting guideline checklist
Subject:
Reporting standards for cohort studies in epidemiology
Scope:
Structure and content of scientific reports of cohort studies
Sections:
Title and abstract; Introduction; Methods; Results; Discussion; Other information
Number of checklist items:
22
Target audience:
Authors of cohort study reports; researchers; journal editors; peer reviewers
Related initiative:
STROBE Initiative
Associated publication:
Explanation and Elaboration article
Referenced resources:
PLoS Medicine; Annals of Internal Medicine; Epidemiology
Title:
STROBE Statement—Checklist of Items to Be Included in Reports of Observational Studies
Document type:
Reporting guideline checklist
Subject:
Reporting standards for observational studies
Scope:
Cohort studies, case-control studies, and cross-sectional studies
Structure:
Title and abstract; Introduction; Methods; Results; Discussion; Other information
Issuing initiative:
STROBE Initiative
Related publications:
PLoS Medicine; Annals of Internal Medicine; Epidemiology
Availability:
Publicly available online
Year:
2021
Region / city:
Not specified
Theme:
Epidemiology, Public Health
Document type:
Checklist
Organization:
Not specified
Author:
Not specified
Target audience:
Researchers, Epidemiologists, Public Health professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Contextual description:
A checklist to guide the reporting of cross-sectional studies, ensuring key aspects of study design, methods, and results are clearly presented.
Year:
2007
Region / city:
Global
Topic:
Observational studies, Reporting guidelines
Document type:
Checklist
Organization / institution:
STROBE Initiative
Author:
STROBE Group
Target audience:
Researchers, scientists, medical professionals
Period of validity:
Ongoing
Approval date:
2007
Date of modifications:
Not specified
Year:
Not specified
Field:
Epidemiology
Topic:
Reporting standards for cross-sectional studies
Document type:
Checklist
Initiative:
STROBE Initiative
Full name of initiative:
Strengthening the Reporting of Observational Studies in Epidemiology
Purpose:
Transparent and complete reporting of cross-sectional research
Structure:
Numbered checklist items with recommendations and reporting locations
Sections:
Title and abstract; Introduction; Methods; Results; Discussion; Other information
Items count:
22 checklist items
Target audience:
Researchers and authors of observational studies
Related publications:
Explanation and Elaboration article
Associated journals:
PLoS Medicine; Annals of Internal Medicine; Epidemiology
Referenced resource:
www.strobe-statement.org
Year:
2016
Region / city:
Switzerland
Topic:
Nutritional Epidemiology
Document type:
Research article
Institution:
Plos Medicine
Author:
Lachat C et al.
Target audience:
Researchers, public health professionals, epidemiologists
Period of validity:
Not applicable
Date of approval:
2016
Date of changes:
Not applicable
Year:
2016
Region / city:
NA
Topic:
Nutritional Epidemiology
Document type:
Article
Organ / institution:
PLOS Medicine
Author:
Lachat C et al.
Target audience:
Researchers in epidemiology and nutrition
Period of validity:
NA
Approval date:
NA
Date of changes:
NA
Year:
2016
Authors:
Lachat C et al.
Journal:
PLoS Medicine
Volume and Issue:
13(6)
DOI:
10.1371/journal.pmed.1002036
Type of document:
Reporting guideline checklist
Field:
Nutritional epidemiology
Related guideline:
STROBE (Strengthening the Reporting of Observational Studies in Epidemiology)
Scope:
Observational studies in nutritional epidemiology
Sections covered:
Title and abstract; Introduction; Methods; Results; Discussion; Other information
Items included:
STROBE items with STROBE-nut extensions (nut-1 to nut-22.2)
Ethics:
Procedure for consent and ethics committee approval addressed (nut-22.1)
Supplementary material:
Data collection tools and data access addressed (nut-22.2)
Title:
STROBE Statement—Checklist of Items to Be Included in Reports of Cohort Studies
Document type:
Reporting guideline checklist
Subject:
Reporting standards for cohort studies in epidemiology
Scope:
Structure and content of scientific reports of cohort studies
Sections:
Title and abstract; Introduction; Methods; Results; Discussion; Other information
Number of checklist items:
22
Target audience:
Authors of cohort study reports; researchers; journal editors; peer reviewers
Related initiative:
STROBE Initiative
Associated publication:
Explanation and Elaboration article
Referenced resources:
PLoS Medicine; Annals of Internal Medicine; Epidemiology
Test SensitivityTP/TP+FN SpecificityTN/FP+TN PPVTP/TP+FP NPVTN/TN+FN Limitations USC pathway1 80.4% 47.2% 3.5% 99.0% low no’s of confirmed CRCAUC=0.65 Raman-CRC blood test* 85.7% 68% 14% 98.7:
//doi.org/10.1111/apt.13846
2. Lung PF, Burling D, Kallarackel L, et al. Implementation of a new CT colonography service:
5 year experience. Clin Radiol. 2014; 69(6): 597-605. doi: 10.1016/j.crad.2014.01.007.3. Bowles CJ, Leicester R, Romaya C, et al. A prospective study of colonoscopy practice in the UK today: are we adequately prepared for national colorectal cancer screening tomorrow? Gut 2004; 53: 277-283.1) Can you describe the current colorectal cancer USC referral pathway?What are your perceptions of it? (Prompt: memorised or need to refer to it, makes secondary care the gatekeeper for tests, NICE criteria, timeliness, capacity, reassurance to have a guideline to follow, ignores GP’s ‘instinct’)2) Experience of the timeframe from referral to colonoscopy/CTC? How do you manage patient’s expectation? Frequency of repeat consultations between referral and test being done?(Prompt: 37 days average)3) Do you consider your personal volume of USC pathway referrals to be just right, too few, or too many?(Prompt: how much does knowledge of waiting times and resource capacity affect your likelihood to refer a patient? 4). If resources weren’t a problem and if you could wave a magic wand tomorrow what do you think we should do about improving outcomes from CRC? What do you perceive are the barriers to early diagnosis of CRC?(Prompt: Wales is 22nd of 28 in the European league table of CRC survival, screening problems, resources, effective tests, patient choice, patient education). Perception of need for better access to diagnostics in primary care (invasive and non-invasive)5). Which situation would the Raman-CRC blood test be of most value to a GP:-non-specific symptoms? eg constipation, abdominal pain -younger age group below USC age? -all USC patients? What would a USC pathway look like with Raman-CRC embedded? -should it be a secondary care tool ie decision to perform colonoscopy or not: help with triage/prioritisation of referral in secondary care6). Given the Raman-CRC test performance described (on vignette sheet) would you have confidence to use it? If not, what sens/spec/PPV/NPV would it need to have?(Prompt: to seek to understand what is most important for a GP, ability to exclude (NPV) or to correctly identify cancer (PPV))7).What additional clinical trials would you like to see with the blood test before implementation?Further observational work with larger numbers/centres/situations?Release test for use and observe outcomes? RCT test v no test?Comparison with FIT?NICE guidance?1) Can you describe the current colorectal cancer USC referral pathway?What are your perceptions of it? (Prompt: memorised or need to refer to it, makes secondary care the gatekeeper for tests, NICE criteria, timeliness, capacity, reassurance to have a guideline to follow, ignores GP’s ‘instinct’)2) Experience of the timeframe from referral to colonoscopy/CTC? How do you manage patient’s expectation? Frequency of repeat consultations between referral and test being done?(Prompt: 37 days average)3) Do you consider your personal volume of USC pathway referrals to be just right, too few, or too many?(Prompt: how much does knowledge of waiting times and resource capacity affect your likelihood to refer a patient? 4). If resources weren’t a problem and if you could wave a magic wand tomorrow what do you think we should do about improving outcomes from CRC? What do you perceive are the barriers to early diagnosis of CRC?(Prompt: Wales is 22nd of 28 in the European league table of CRC survival, screening problems, resources, effective tests, patient choice, patient education). Perception of need for better access to diagnostics in primary care (invasive and non-invasive)5). Which situation would the Raman-CRC blood test be of most value to a GP:-non-specific symptoms? eg constipation, abdominal pain -younger age group below USC age? -all USC patients? What would a USC pathway look like with Raman-CRC embedded? -should it be a secondary care tool ie decision to perform colonoscopy or not: help with triage/prioritisation of referral in secondary care6). Given the Raman-CRC test performance described (on vignette sheet) would you have confidence to use it? If not, what sens/spec/PPV/NPV would it need to have?(Prompt: to seek to understand what is most important for a GP, ability to exclude (NPV) or to correctly identify cancer (PPV))7).What additional clinical trials would you like to see with the blood test before implementation?Further observational work with larger numbers/centres/situations?Release test for use and observe outcomes? RCT test v no test?Comparison with FIT?NICE guidance?Box S1. GP focus group questions.VIGNETTESAssumptions: Colonoscopy/CTC capacity is the same as present Raman-CRC blood test is routinely available under local guidelines.Raman-CRC test performance is 85.7% sensitivity, 68% specificity, 14% PPV, 98.7% NPV, based on interim analysis of 120 cases and controls.1. 60 y.o. male presents with tiredness. His wife (also in the practice) diagnosed with breast cancer a year ago and just completing adjuvant chemotherapy. He has had time off work himself when she has been ill with side effects. On deeper questioning he describes 6 weeks of increased stool frequency (usually once/day, now 3 times per day). No history of rectal bleeding or mucous, abdominal pain or weight loss. Doesn’t smoke. Abdominal and rectal examinations are normal. Simple diagnostics show he is not anaemic and a stool culture is negative.a) Refer to secondary care on USC pathway without further testingb) Request Raman-CRC blood test to risk stratifyc) Involve patient in decision making? Explore patient expectations/underlying concerns....d) Other?2. A 50 year old patient who is a frequent attender describes three or four episodes of rectal bleeding. This is fresh blood, noticed in the toilet water. No anal pain or itching. No change on bowel habit. Appetite and weight stable. On citalopram for anxiety. No relevant family history. Abdominal examination: appendicectomy scar, nil else. Rectal exam: small skin tags, no masses felt, no blood on glove, no proctoscope available. FBC normal. Action?3. 45 year old female patient, complains of tiredness and self limiting looser stools for 3 weeks, but does have a FH of bowel cancer. Examination normal.Decision made to perform a Raman-CRC blood test. The test returns positive 2 days later. How would you go about discussing this with the patient in the fol
Title:
STROBE Statement—Checklist of Items to Be Included in Reports of Observational Studies
Document type:
Reporting guideline checklist
Subject:
Reporting standards for observational studies
Scope:
Cohort studies, case-control studies, and cross-sectional studies
Structure:
Title and abstract; Introduction; Methods; Results; Discussion; Other information
Issuing initiative:
STROBE Initiative
Related publications:
PLoS Medicine; Annals of Internal Medicine; Epidemiology
Availability:
Publicly available online
Document type:
Reporting guideline checklist
Subject:
Epidemiology research reporting standards
Research design focus:
Cross-sectional studies
Organization:
STROBE Initiative
Field:
Epidemiology and public health research methodology
Content elements:
Title and abstract guidance, introduction, methods, results, discussion, funding disclosure
Included materials:
Reporting checklist, references to supplementary figures and flowchart of data collection
Referenced resources:
PLoS Medicine, Annals of Internal Medicine, Epidemiology journals
Purpose:
Standardized reporting of observational research studies
Supplementary figures:
Data collection flowchart; decision conflict score responses
Sample size referenced:
n=172 (decision conflict score responses)
Year:
2021
Region / city:
Not specified
Theme:
Epidemiology, Public Health
Document type:
Checklist
Organization:
Not specified
Author:
Not specified
Target audience:
Researchers, Epidemiologists, Public Health professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Contextual description:
A checklist to guide the reporting of cross-sectional studies, ensuring key aspects of study design, methods, and results are clearly presented.
Year:
2007
Region / city:
Global
Topic:
Observational studies, Reporting guidelines
Document type:
Checklist
Organization / institution:
STROBE Initiative
Author:
STROBE Group
Target audience:
Researchers, scientists, medical professionals
Period of validity:
Ongoing
Approval date:
2007
Date of modifications:
Not specified
Year:
Not specified
Field:
Epidemiology
Topic:
Reporting standards for cross-sectional studies
Document type:
Checklist
Initiative:
STROBE Initiative
Full name of initiative:
Strengthening the Reporting of Observational Studies in Epidemiology
Purpose:
Transparent and complete reporting of cross-sectional research
Structure:
Numbered checklist items with recommendations and reporting locations
Sections:
Title and abstract; Introduction; Methods; Results; Discussion; Other information
Items count:
22 checklist items
Target audience:
Researchers and authors of observational studies
Related publications:
Explanation and Elaboration article
Associated journals:
PLoS Medicine; Annals of Internal Medicine; Epidemiology
Referenced resource:
www.strobe-statement.org
Year:
2026
Region / City:
London
Subject:
Clinical Research Protocol
Document Type:
Template
Institution:
University College London Hospitals NHS Foundation Trust (UCLH)
Author:
UCLH Research Office
Target Audience:
UCLH Investigators, Clinical Researchers
Study Duration:
Ongoing
Approval Date:
Not specified
Date of Modification:
Not specified
Year:
2018
Region / city:
United States
Topic:
Clinical Research / Observational Studies
Document type:
Template
Organization:
National Institute for Dental and Craniofacial Research (NIDCR)
Author:
N/A
Target audience:
Principal Investigators and Study Staff
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2021
Region / City:
London
Subject:
Research Protocols
Document Type:
Template
Organization:
UCL/UCLH Joint Research Office
Author:
UCL/UCLH Research Office
Target Audience:
Chief Investigators, Researchers
Period of Validity:
N/A
Approval Date:
06/01/2021
Modification Date:
N/A