Table 3.

PROCESS 2023 guidelines.

PROCESS 2023 Guidelines
Topic	Item	Item description
Title	1	The phrase ‘case series’ is included • The focus of the research study is mentioned (e.g. patient population, setting, diagnosis, intervention, outcome etc.)
Keywords	2	Include three to six keywords that identify what is covered in the case series (e.g. patient population, setting, diagnosis, intervention, outcome etc.) • Include ‘case series’ as one of the keywords • Include the surgical subspeciality the case series pertains to as a keyword
Abstract	3a	Introduction – briefly describe: • Background • Scientific rationale for this study • Overarching theme of the case series • Aims and objectives
	3b	Methods – briefly describe: • Sample size • Timeframe of research • Characteristics of study design (e.g. prospective/retrospective, single-/multicentre, informal/formal, consecutive/nonconsecutive, exposure-/outcome-based sampling, clinical/population-based etc.)
	3c	Outcomes • Describe the outcomes of the intervention and management strategy
	3d	Conclusion – briefly describe: • Key findings and take-home messages • Impact on future clinical practice • Direction of future research
	3e	Present a structured abstract • Informal case series – introduction, case presentations (brief description of each case) and discussion/conclusion • Formal case series – introduction, methods, results and discussion/conclusion
Highlights	4	Convey the key findings of the research study in 3 to 5 bullet points
Introduction	5	Introduction – comprehensively describe: • Relevant background and scientific rationale for case series with reference to key scientific literature • Overarching theme (e.g. common patient population, setting, diagnosis, intervention, outcome etc.) • Aims and objectives
Methods	6a	Registration • State the research registry number in accordance with the Declaration of Helsinki - “Every research study involving human subjects must be registered in a publicly accessible database”. This can be obtained from, for example, ResearchRegistry.com, ClinicalTrials.gov, or ISRCTN. • If a protocol already exists, state the corresponding registration number and access directions (e.g. website or journal, and include a hyperlink that is publicly accessible). It must be written in the English language
	6b	Ethical approval • State whether ethical approval was needed or not, with reason(s) • If appropriate, state name of body giving ethical approval and approval number
	6c	Study design •State that the study is a case series • Describe key characteristics of study design (e.g. prospective/retrospective, single-/multicentre, informal/formal, consecutive/nonconsecutive, exposure-/outcome-based sampling, clinical/population-based etc.)
	6d	Setting and timeframe – comprehensively describe: •Geographical location • Nature of setting(s) where the patient was managed (e.g. primary/secondary/tertiary care setting, district general hospital/teaching hospital, public/private, low-resource setting etc.) • Relevant dates (e.g. recruitment, intervention, follow-up, data collection etc.)
	6e	Participants – comprehensively describe: •Relevant participant characteristics (e.g. demographics, comorbidities, ASA score, severity of surgery, urgency of surgery, smoking status, tumour staging etc.) and if relevant, exposure(s) of the participants (e.g. COVID-19) • Subsequent inclusion and exclusion criteria with clear definitions • Approach to selecting patients (e.g. consecutive/nonconsecutive, exposure-/outcome-based, formal/informal etc.) • Methods used to ensure de-identification of patient information
	6f	Recruitment – comprehensively describe: • Sources of recruitment (e.g. physician referral, electronic health record etc.) • Any monetary incentivisation of patients for recruitment and retention should be declared; clarify the nature of any incentives provided
	6g	Preintervention patient optimisation: • Lifestyle (e.g. weight loss, nutritional support, exercise, smoking cessation etc.) • Medication review (e.g. anticoagulation, oral hypoglycemics, insulin, oral contraceptive pill etc.) • Presurgical stabilisation/preparation (e.g. treating hypothermia/-volemia/-tension, ICU care, nil by mouth, bowel preparation etc.) • Other (e.g. psychological support, preoperative education/counselling etc.)
	6h	Interventions – comprehensively describe: • Type of intervention (e.g. pharmacological, surgical, physiotherapy, psychological etc.) • Aim of intervention (preventative/therapeutic) • Concurrent treatments (e.g. antibiotics, analgesia, antiemetics, venous thromboembolism prophylaxis etc.)
	6i	Intervention specifics – comprehensively describe: • Rationale for the treatment offered • Techniques involved in the administration of the intervention • Time to intervention • For pharmacological therapies, include details such as formulation, dosage, strength, route and duration • For surgical intervention, include details on anaesthesia, patient positioning, preparation used, equipment needed, devices, sutures, surgical stage etc. • Degree of novelty of surgical technique/device (e.g. ‘first in human’ or ‘first in this context’) • Manufacturer and model of any medical devices used
	6j	Operator details – comprehensively describe: • Relevant training, specialisation and operator’s experience (e.g. average number of the relevant procedures performed annually, independent, needs direct/indirect supervision etc.) • Learning curve for technique • Requirement for additional training
	6k	Quality control – comprehensively describe: • Measures taken to reduce inter- or intra-operator/operation variation, ensure quality and maintain consistency between cases (e.g. independent observers, lymph node counts, standard surgical technique etc.) • Any specific disparities between cases
	6l	Postoperative care and follow-up – comprehensively describe: • Postoperative care (e.g. patient education, postoperative medications, early mobilisation, targeted physiotherapy, early enteral nutrition, early removal of catheters/drains, psychological therapy etc.) • Follow-up time-frames (e.g. first follow-up post-discharge, follow-up duration at the time of submission etc.) and frequency • Follow-up setting (e.g. home via phone/video consultation, primary care, secondary care etc.) • Follow-up method (e.g. history, clinical examination, blood tests, imaging etc.) • Follow-up personnel (e.g. operating surgeon) • Any specific long-term surveillance requirements (e.g. imaging surveillance of endovascular aneurysm repair, clinical/ultrasound examination of regional lymph nodes for skin cancer etc.) • State if any participants were lost to follow-up and why
Results	7a	Participants – comprehensively describe: • Number of patients involved • Patient characteristics (e.g. demographics, comorbidities, ASA score, severity of surgery, urgency of surgery, smoking status, tumour staging etc.) and if relevant, exposure(s) of the participants • Include table showing baseline patient characteristics
	7b	Deviation from the initial management plan – comprehensively describe: • Any changes to the planned intervention with rationale • If appropriate, include a suitable schematic diagram
	7c	Outcomes and follow-up – comprehensively describe: • Expected versus attained clinician assessed outcome, providing reference to scientific literature used to inform expected outcomes (e.g. core outcome set) • If appropriate, include patient-reported outcomes (e.g. quality-of-life) • Percentage of patients lost to follow-up with rationale
	7d	Intervention adherence and compliance – comprehensively describe: • Assessment of patient’s adherence and tolerability of intervention and postoperative instructions (e.g. avoiding heavy lifting/strenuous activity, tolerance of chemotherapy/pharmacological agents etc.) • Impact on long-term applicability of intervention in clinical practice
	7e	Complications and adverse events – comprehensively describe: • Precautionary measures taken to prevent complications (e.g. antibiotic/venous thromboembolism prophylaxis) • Complications and adverse events (e.g. blood loss, wound infection, deep vein thrombosis, pulmonary embolism etc.), categorised in accordance with the Clavien–Dindo classification • Timing of adverse events • Mitigation for adverse events (e.g. blood transfusion, wound care, re-exploration/revision surgery etc.) • If appropriate, whether complications or adverse events were discussed locally (e.g. morbidity and mortality meetings) • If appropriate, whether complications or adverse events were reported to the relevant national agency or pharmaceutical company • Specify time to discharge following completion of intervention and whether this was within the expected timeframe or not (if not, why not) • Where applicable, specify the 30-day postoperative and long-term morbidity/mortality • State if there were no complications or adverse events
Discussion	8a	Key results – comprehensively describe: • Key results with relevant raw data • Include table showing key results
	8b	Scientific context and implications – comprehensively describe: • Relevant literature and if appropriate, similar published studies • Implications for clinical practice and guidelines (e.g. NICE) • Comparison to current gold standard of care • Relevant hypothesis generation
	8c	Strengths – comprehensively describe: • Strengths of the study • Any multidisciplinary or cross-speciality relevance
	8d	Weaknesses and limitations – comprehensively describe: • Weaknesses and limitations of the study, with potential impact on results and their interpretation • Deviations from protocol, with reasons • For novel techniques or devices, outline any contraindications/alternatives and potential risks/complications if applied to a larger population
	8e	Directions for future research – comprehensively describe: • Impact on future research and clinical practice • Questions that have arisen as a result of the study • Alternative study design(s) best suited to address these questions
	8f	Cost – comprehensively describe: • Cost of intervention • Justify cost if intervention more expensive than current gold standard of care • Any cheaper alternatives
Conclusions	9a	Key conclusions • Outline the key conclusions from this study
	9b	Rationale • Explain the rationale behind those conclusions
	9c	Future work – briefly describe: • Any questions arisen from the study • Any differences in approach to patient diagnosis or management which authors might adopt in future similar studies
Patient and/or Carer Perspective	10	Where appropriate, the patients should be given the opportunity to share their perspective on the intervention(s) they received (e.g. sharing quotes from a consented, anonymised interview or questionnaire)
Informed Consent	11	The authors must provide evidence of consent, where applicable, and if requested by the journal • State the method of consent at the end of the article (e.g. verbal or written) • If not provided by the patients, explain why (e.g. death of patient and consent provided by next of kin). If the patients or family members were untraceable then document the tracing efforts undertaken
Additional Information	12a	State any conflicts of interest
	12b	State any sources of funding (e.g. grant details) • Role of funder
	12c	Other relevant disclosures • State any author contributions and acknowledgements • If appropriate, give details of institutional review board and ethical committee approval • Disclose whether the case has been presented at a conference or regional meeting
Clinical Images and Videos	13	Where relevant and available, include clinical images to help demonstrate the cases pre-, peri- and postintervention (e.g. radiological, histopathological, patient photographs, intraoperative images etc.) • Where relevant and available, include a link (e.g. Google Drive, YouTube etc.) to the narrated operative video to highlight specific techniques or operative findings • Ensure all media files are appropriately captioned and indicate points of interest to allow for easy interpretation
Referencing the Checklist	14	Include reference to the PROCESS 2023 publication by stating: ‘This case series has been reported in line with the PROCESS Guideline’ at the end of the methods section and include citation in the references section