Core information set for informed consent to surgery for oral or oropharyngeal cancer: A mixed‐methods study

Main, Barry; McNair, Angus G K; Haworth, Simon; Rooshenas, Leila; Hughes, Charles L.; Tierney, Paul; Donovan, Jenny; Thomas, Steve; Blazeby, Jane M

doi:10.1111/coa.13037

Cited by 12 publications

(9 citation statements)

References 22 publications

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“…It has the advantages of being feasible and transferable to a wide number of settings, possible to define using established health services research methodology, aligned with contemporary ethical theory, and potentially meeting the ‘reasonable patient’ legal standard of IC. CISs are available for oesophageal and oropharyngeal cancers 12 16…”

Section: Introductionmentioning

confidence: 99%

Development of a core information set for colorectal cancer surgery: a consensus study

et al. 2019

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Objective‘Core information sets’ (CISs) represent baseline information, agreed by patients and professionals, to stimulate individualised patient-centred discussions. This study developed a CIS for use before colorectal cancer (CRC) surgery.DesignThree phase consensus study: (1) Systematic literature reviews and patient interviews to identify potential information of importance to patients, (2) UK national Delphi survey of patients and professionals to rate the importance of the information, (3) international consensus meeting to agree on the final CIS.SettingUK CRC centres.ParticipantsPurposive sampling was conducted to ensure CRC centre representation based upon geographical region and caseload volume. Responses were received from 63/81 (78%) centres (90 professionals). Adult patients who had undergone CRC surgery were eligible, and purposive sampling was conducted to ensure representation based on age, sex and cancer location (rectum, left and right colon). Responses were received from 97/267 (35%) patients with a wide age range (29–87), equal sex ratio and cancer location. Attendees of the international Tripartite Colorectal Conference were eligible for the consensus meeting.OutcomesPhase 1: Information of potential importance to patients was extracted verbatim and operationalised into a Delphi questionnaire. Phase 2: Patients and professionals rated the importance information on a 9-point Likert scale, and resurveyed following group feedback. Information rated of low importance were discarded using predefined criteria. Phase 3: A modified nominal group technique was used to gain final consensus in separate consensus meetings with patients and professionals.ResultsData sources identified 1216 pieces of information that informed a 98-item questionnaire. Analysis led to 50 and 23 information domains being retained after the first and second surveys, respectively. The final CIS included 11 concepts including specific surgical complications, short and long-term survival, disease recurrence, stoma and quality of life issues.ConclusionsThis study has established a CIS for professionals to discuss with patients before CRC surgery.

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Section: Introductionmentioning

confidence: 99%

Development of a core information set for colorectal cancer surgery: a consensus study

et al. 2019

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“…CIS are therefore designed to be a starting point to help professionals, patients and their carers ensure key information is considered. They are intended to be personalised during each consultation and have been pioneered in surgical oncology [ 63 – 65 ].…”

Section: Discussionmentioning

confidence: 99%

A scoping review of information provided within degenerative cervical myelopathy education resources: Towards enhancing shared decision making

et al. 2022

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Background Degenerative cervical myelopathy (DCM) is a chronic neurological condition estimated to affect 1 in 50 adults. Due to its diverse impact, trajectory and management options, patient-centred care and shared decision making are essential. In this scoping review, we aim to explore whether information needs in DCM are currently being met in available DCM educational resources. This forms part of a larger Myelopathy.org project to promote shared decision making in DCM. Methods A search was completed encompassing MEDLINE, Embase and grey literature. Resources relevant to DCM were compiled for analysis. Resources were grouped into 5 information types: scientific literature, videos, organisations, health education websites and patient information leaflets. Resources were then further arranged into a hierarchical framework of domains and subdomains, formed through inductive analysis. Frequency statistics were employed to capture relative popularity as a surrogate marker of potential significance. Results Of 2674 resources, 150 information resources addressing DCM were identified: 115 scientific literature resources, 28 videos, 5 resources from health organisations and 2 resources from health education websites. Surgical management was the domain with the largest number of resources (66.7%, 100/150). The domain with the second largest number of resources was clinical presentation and natural history (28.7%, 43/150). Most resources (83.3%, 125/150) were designed for professionals. A minority (11.3% 17/150) were written for a lay audience or for a combined audience (3.3%, 5/150). Conclusion Educational resources for DCM are largely directed at professionals and focus on surgical management. This is at odds with the needs of stakeholders in a lifelong condition that is often managed without surgery, highlighting an unmet educational need.

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“…The direct impact on patients of complications following neck dissection has been borne out by a 'core information set' for informed consent to surgery for oral or oropharyngeal cancer [9]. Using the Delphi method, this study found details of major or common complications including pain, swelling and bleeding that may require a return to the operating theatre; the likelihood of wound problems; and details of drips, drains and tubes were important to both patients and healthcare professionals alike [9]. Patient opinion is further supported by robust data from a meta-analysis on the use of surgical drains in thyroid surgery demonstrating that they (drains) increased both post-operative pain and infection rates [10].…”

Section: Introductionmentioning

confidence: 99%

Determining the effectiveness of fibrin sealants in reducing complications in patients undergoing lateral neck dissection (DEFeND): study protocol for a randomised external pilot trial

Bajwa

Carruthers

Hanson

et al. 2020

Pilot Feasibility Stud

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Background: Complications after major surgery are a significant cause of morbidity and mortality. Neck dissection is one of the most commonly performed major operations in Head and Neck Surgical Oncology. Significant surgical complications occur in approximately 10-20% of all patients, increasing to 40% in patients who have had previous treatment to the area or have multiple co-morbidities and/or polypharmacy. Current evidence suggests that fibrin sealants (FS) may have potential clinical advantages in Head and Neck Surgery through the reduction of complications, volume of wound drainage and retention time of the drains. However, a paucity of high-quality trial-based evidence means that a surgical trial to determine the effectiveness of FS in reducing the rate and severity of complications in patients undergoing lateral neck dissection is warranted. The DEFeND randomised external pilot trial will address critical questions on how well key components of the proposed study design work together as well as the feasibility of a future phase III trial. Methods: The study design that is being piloted is that of a two-arm, parallel group, superiority trial with block randomisation in a 1:1 allocation ratio. The interventional arm will constitute the application of FS (Artiss, Baxter Healthcare Ltd.) to the surgical wound following completion of a neck dissection procedure, in addition to standard of care (SOC). The control arm will constitute SOC alone. Eligible patients will include patients who require a lateral neck dissection with a minimum of three cervical nodal levels. Patients who require bilateral neck procedures or undergoing immediate reconstruction with free or regional flaps will be excluded. The outcomes being assessed will be recruitment rate, screened to randomisation rate, fidelity of blinding process using blinding indices, number of missing or incomplete data entries, number of protocol deviations and number of losses to follow-up. Suitability of the outcome measures proposed for the future phase III trial will also be assessed.

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Core information set for informed consent to surgery for oral or oropharyngeal cancer: A mixed‐methods study

Abstract: This study produced a core information set for surgeons and patients to discuss before surgery for oral/oropharyngeal cancer. Future work will optimise ways to integrate core information into routine consultations.

Cited by 12 publications

References 22 publications

Development of a core information set for colorectal cancer surgery: a consensus study

Development of a core information set for colorectal cancer surgery: a consensus study

A scoping review of information provided within degenerative cervical myelopathy education resources: Towards enhancing shared decision making

Determining the effectiveness of fibrin sealants in reducing complications in patients undergoing lateral neck dissection (DEFeND): study protocol for a randomised external pilot trial

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