The STROCSS 2021 Guideline

Item Item description Page

no.
TITLE
1 Title
• The word cohort or cross-sectional or case-control is included*
• Temporal design of study is stated (e.g. retrospective or prospective)
• The focus of the research study is mentioned (e.g. population, setting,
disease, exposure/intervention, outcome etc.)

*STROCSS 2021 guidelines apply to cohort studies as well as other observational

studies (e.g. cross-sectional, case-control etc.)
ABSTRACT
2a Introduction – briefly describe:
• Background
• Scientific rationale for this study
• Aims and objectives
2b Methods - briefly describe:
• Type of study design (e.g. cohort, case-control, cross-sectional etc.)
• Other key elements of study design (e.g. retro-/prospective,
single/multicentred etc.)
• Patient populations and/or groups, including control group, if applicable
• Exposure/interventions (e.g. type, operators, recipients, timeframes etc.)
• Outcome measures – state primary and secondary outcome(s)
2c Results - briefly describe:
• Summary data with qualitative descriptions and statistical relevance,
where appropriate
2d Conclusion - briefly describe:
• Key conclusions
• Implications for clinical practice
• Need for and direction of future research
INTRODUCTION
3 Introduction – comprehensively describe:
• Relevant background and scientific rationale for study
with reference to key literature
• Research question and hypotheses, where appropriate •
Aims and objectives
METHODS
4a Registration
• In accordance with the Declaration of Helsinki*, state the research
registration number and where it was registered, with a hyperlink to the
registry entry (this can be obtained from ResearchRegistry.com,
ClinicalTrials.gov, ISRCTN etc.)
• All retrospective studies should be registered before submission; it should
be stated that the research was retrospectively registered

* “Every research study involving human subjects must be registered in a publicly

accessible database before recruitment of the first subject”
4b Ethical approval
• Reason(s) why ethical approval was needed
 • Name of body giving ethical approval and approval number
• Where ethical approval wasn’t necessary, reason(s) are provided
4c Protocol
• Give details of protocol (a priori or otherwise) including how to access it
(e.g. web address, protocol registration number etc.)
• If published in a journal, cite and provide full reference
4d Patient and public involvement in research
• Declare any patient and public involvement in research
• State the stages of the research process where patients and the public
were involved (e.g. patient recruitment, defining research outcomes,
dissemination of results etc.) and describe the extent to which they were
involved.
5a Study design
• State type of study design used (e.g. cohort, cross-sectional, case-control
etc.)
• Describe other key elements of study design (e.g. retro-/prospective,
single/multi-centred etc.)
5b Setting and timeframe of research – comprehensively describe:
• Geographical location
• Nature of institution (e.g. primary/secondary/tertiary care setting, district
general hospital/teaching hospital, public/private, low-resource setting
etc.)
• Dates (e.g. recruitment, exposure, follow-up, data collection etc.)
5c Study groups
• Total number of participants
• Number of groups
• Detail exposure/intervention allocated to each group
• Number of participants in each group
5d Subgroup analysis – comprehensively describe:
• Planned subgroup analyses
• Methods used to examine subgroups and their interactions
6a Participants – comprehensively describe:
• Inclusion and exclusion criteria with clear definitions
• Sources of recruitment (e.g. physician referral, study website, social
media, posters etc.)
• Length, frequency and methods of follow-up (e.g. mail, telephone etc.)
6b Recruitment – comprehensively describe:
• Methods of recruitment to each patient group (e.g. all at once, in batches,
continuously till desired sample size is reached etc.)
• Any monetary incentivisation of patients for recruitment and retention
should be declared; clarify the nature of any incentives provided
• Nature of informed consent (e.g. written, verbal etc.) • Period of
recruitment
6c Sample size – comprehensively describe:
• Analysis to determine optimal sample size for study accounting for
population/effect size
• Power calculations, where appropriate
• Margin of error calculation
METHODS - INTERVENTION AND CONSIDERATIONS
7a Pre-intervention considerations – comprehensively describe:
• Preoperative patient optimisation (e.g. weight loss, smoking cessation,
 glycaemic control etc.)
• Pre-intervention treatment (e.g. medication review, bowel preparation,
correcting hypothermia/-volemia/-tension, mitigating bleeding risk, ICU
care etc.)
7b Intervention – comprehensively describe:
• Type of intervention and reasoning (e.g. pharmacological, surgical,
physiotherapy, psychological etc.)
• Aim of intervention (preventative/therapeutic)
• Concurrent treatments (e.g. antibiotics, analgesia, anti-emetics, VTE
prophylaxis etc.)
• Manufacturer and model details, where applicable
7c Intra-intervention considerations – comprehensively describe:
• Details pertaining to administration of intervention (e.g. anaesthetic,
positioning, location, preparation, equipment needed, devices, sutures,
operative techniques, operative time etc.)
• Details of pharmacological therapies used, including formulation,
dosages, routes, and durations
• Figures and other media are used to illustrate
7d Operator details – comprehensively describe:
• Requirement for additional training
• Learning curve for technique
• Relevant training, specialisation and operator’s experience (e.g. average
number of the relevant procedures performed annually)
7e Quality control – comprehensively describe:
• Measures taken to reduce inter-operator variability
• Measures taken to ensure consistency in other aspects of intervention
delivery
• Measures taken to ensure quality in intervention delivery
7f Post-intervention considerations – comprehensively describe:
• Post-operative instructions (e.g. avoid heavy lifting) and care
• Follow-up measures
• Future surveillance requirements (e.g. blood tests, imaging etc.)
8 Outcomes – comprehensively describe:
• Primary outcomes, including validation, where applicable
• Secondary outcomes, where appropriate
• Definition of outcomes
• If any validated outcome measurement tools are used, give full reference
• Follow-up period for outcome assessment, divided by group
9 Statistics – comprehensively describe:
• Statistical tests and statistical package(s)/software used
• Confounders and their control, if known
• Analysis approach (e.g. intention to treat/per protocol)
• Any sub-group analyses
• Level of statistical significance
RESULTS
10a Participants – comprehensively describe:
• Flow of participants (recruitment, non-participation, cross-over and
withdrawal, with reasons). Use figure to illustrate.
• Population demographics (e.g. age, gender, relevant socioeconomic
features, prognostic features etc.)
• Any significant numerical differences should be highlighted
10b Participant comparison
• Include table comparing baseline characteristics of cohort groups
• Give differences, with statistical relevance
• Describe any group matching, with methods
10c Intervention – comprehensively describe:
• Degree of novelty of intervention
• Learning required for interventions
• Any changes to interventions, with rationale and diagram, if appropriate
11a Outcomes – comprehensively describe:
• Clinician-assessed and patient-reported outcomes for each group
• Relevant photographs and imaging are desirable
• Any confounding factors and state which ones are adjusted
11b Tolerance – comprehensively describe:
• Assessment of tolerability of exposure/intervention
• Cross-over with explanation
• Loss to follow-up (fraction and percentage), with reasons
11c Complications – comprehensively describe:
• Adverse events and classify according to Clavien-Dindo classification*
• Timing of adverse events
• Mitigation for adverse events (e.g. blood transfusion, wound care, revision
surgery etc.)

*Dindo D, Demartines N, Clavien P-A. Classification of Surgical Complications. A

New Proposal with Evaluation in a Cohort of 6336 Patients and Results of a Survey.
Ann Surg. 2004; 240(2): 205-213
12 Key results – comprehensively describe:
• Key results with relevant raw data
• Statistical analyses with significance
• Include table showing research findings and statistical analyses with
significance
DISCUSSION
13 Discussion – comprehensively describe:
• Conclusions and rationale
• Reference to relevant literature
• Implications for clinical practice
• Comparison to current gold standard of care
• Relevant hypothesis generation
14 Strengths and limitations – comprehensively describe:
• Strengths of the study
• Weaknesses and limitations of the study and potential impact on results
and their interpretation
• Assessment and management of bias
• Deviations from protocol, with reasons
15 Relevance and implications – comprehensively describe:
• Relevance of findings and potential implications for clinical practice
• Need for and direction of future research, with optimal study designs
mentioned
CONCLUSION
16 Conclusions
• Summarise key conclusions
• Outline key directions for future research
 DECLARATIONS
17a Conflicts of interest
• Conflicts of interest, if any, are described
17b Funding
• Sources of funding (e.g. grant details), if any, are clearly
stated • Role of funder
17c Contributorship
• Acknowledge patient and public involvement in research; report the extent of
involvement of each contributor
Table 2: The full revised STROCSS 2021 checklist