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Background Degenerative cervical myelopathy (DCM) is a progressive chronic spinal cord injury estimated to affect 1 in 50 adults. Without standardised guidance, clinical research studies have selected outcomes at their discretion, often underrepresenting the disease and limiting comparability between studies. Utilising a standard minimum data set formed via multi-stakeholder consensus can address these issues. This combines processes to define a core outcome set (COS)-a list of key outcomes-and core data elements (CDEs), a list of key sampling characteristics required to interpret the outcomes. Further 'how' these outcomes should be measured and/or reported is then defined in a core measurement set (CMS). This can include a recommendation of a standardised time point at which outcome data should be reported. This study defines a COS, CDE, and CMS for DCM research. Methods and findings A minimum data set was developed using a series of modified Delphi processes. Phase 1 involved the setup of an international DCM stakeholder group. Phase 2 involved the development of a longlist of outcomes, data elements, and formation into domains. Phase 3 prioritised the outcomes and CDEs using a two-stage Delphi process. Phase 4 determined the final DCM minimal data set using a consensus meeting. Using the COS, Phase 5 finalised definitions of the measurement construct for each outcome. In Phase 6, a systematic review of the literature was performed, to scope and define the psychometric properties of measurement tools. Phase 7 used a modified Delphi process to inform the short-listing of candidate measurement tools. The final measurement set was then formed through a consensus meeting (Phase 8). To support implementation, the data set was then integrated into template clinical research forms (CRFs) for use in future clinical trials (Phase 9). In total, 28 outcomes and 6 domains (Pain, Neurological Function, Life Impact, Radiology, Economic Impact, and Adverse Events) were entered into the final COS. Thirty two outcomes and 4 domains (Individual, Disease, Investigation, and Intervention) were entered into the final CDE. Finally, 4 outcome instruments (mJOA, NDI, SF-36v2, and SAVES2) were identified for the CMS, with a recommendation for trials evaluating outcomes after surgery, to include baseline measurement and at 6 months from surgery. Conclusions The AO Spine RECODE-DCM has produced a minimum data set for use in DCM clinical trials today. These are available at https://myelopathy.org/minimum-dataset/. While it is anticipated the CDE and COS have strong and durable relevance, it is acknowledged that new measurement tools, alongside an increasing transition to study patients not undergoing surgery, may necessitate updates and adaptation, particularly with respect to the CMS., Author(s): Benjamin M. Davies 1,2,*, Xiaoyu Yang 1, Danyal Z. Khan 3,4, Oliver D. Mowforth 1,2, Alvaro Y. Touzet 5, Aria Nouri 1,6, James S. Harrop 7, Bizhan Aarabi 8, [...]

Background Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard 'core' set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. Methods and Findings The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). Conclusion This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice., Author(s): Angus G. K. McNair 1,2,*, Robert N. Whistance 1,3, Rachael O. Forsythe 1,3, Rhiannon Macefield 1, Jonathan Rees 1, Anne M. Pullyblank 4, Kerry N. L. Avery 1, Sara [...]

Background: Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians' views of outcomes to include in a core outcome set for colorectal cancer (CRC) surgery, with what clinicians considered important information for clinical practice (core information).Methods: Potential outcome/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients. These were organized into six categories and used to design a questionnaire survey that asked surgeons and nurses from a sample of CRC centers to rate the importance of each domain as an outcome or as information on a nine-point Likert scale. Respondents were re-surveyed (round 2) following group feedback (Delphi methods). Comparisons were made by calculating the difference in mean scores between the outcomes and information domains, and paired t tests were used to explore the difference between mean scores of the six outcome/information categories.Results: Data sources identified 1216 outcome/information items for CRC surgery that informed a 94-item questionnaire. First-round questionnaires were returned from 63/81 (78 %) of centers. Clinicians rated 76/94 (84 %) domains of higher importance to measure in trials than information to communicate to patients in round 1. This was reduced to 24/47 (51 %) in round 2. The greatest difference was evident in domains regarding survival, which was rated much more highly as a trial outcome than an important piece of information for decision-making (difference in mean 2.3, 95 % CI 1.9 to 2.8, p <0.0001). Specific complications and quality-of-life domains were rated similarly (difference in mean 0.18, 95 % CI -0.1 to 0.4, p = 0.2 and difference in mean 0.2, 95 % CI -0.1 to 0.5, p = 0.2, respectively).Conclusions: Whilst clinicians want to measure key outcomes in trials, they rate these as less important to communicate in decision-making with patients. This discrepancy needs to be explored and addressed to maximize the impact of trials on clinical practice. [ABSTRACT FROM AUTHOR]

In this article, the author reflects on the difficulties of surgeons in communicating to patients about surgical innovations before operating them in relation to young people with aortic valve disease. He says that integration of qualitative research with consultation is a way of understanding and improving information. He also says that number of patients being offered, accepting and declining should be recorded to evaluate surgical innovations.

An abstract of the article "Incorporating patient reported outcomes (PROs) in gastro-intestinal (GI) cancer randomised controlled trials (RCTs): the need for adequate rationale and integrated reporting," by Rhiannon C. Macefield and colleagues, is presented.

Background: Understanding the use of invasive procedures (IPs) at the end of life (EoL) is important to avoid undertreatment and overtreatment, but epidemiologic analysis is hampered by limited methods to define treatment intent and EoL phase. This study applied novel methods to report IPs at the EoL using a colorectal cancer case study., Methods: An English population-based cohort of adult patients diagnosed between 2013 and 2015 was used with follow-up to 2018. Procedure intent (curative, noncurative, diagnostic) by cancer site and stage at diagnosis was classified by two surgeons independently. Joinpoint regression modeled weekly rates of IPs for 36 subcohorts of patients with incremental survival of 0-36 months. EoL phase was defined by a significant IP rate change before death. Zero-inflated Poisson regression explored associations between IP rates and clinical/sociodemographic variables., Results: Of 87,731 patients included, 41,972 (48%) died. Nine thousand four hundred ninety two procedures were classified by intent (inter-rater agreement 99.8%). Patients received 502,895 IPs (1.39 and 3.36 per person year for survivors and decedents). Joinpoint regression identified significant increases in IPs 4 weeks before death in those living 3-6 months and 8 weeks before death in those living 7-36 months from diagnosis. Seven thousand nine hundred eight (18.8%) patients underwent IPs at the EoL, with stoma formation the most common major procedure. Younger age, early-stage disease, men, lower comorbidity, those receiving chemotherapy, and living longer from diagnosis were associated with IPs., Conclusion: Methods to identify and classify IPs at the EoL were developed and tested within a colorectal cancer population. This approach can be now extended and validated to identify potential undertreatment and overtreatment., Competing Interests: Declaration of competing interest All authors declare no competing financial interests., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: During development of complex surgical innovations, modifications occur to optimize safety and efficacy. Operators' experiences (how professionals feel undertaking the innovation) drive this process but comprehensive overviews of measures of this concept are lacking. This study identified and appraised measures to assess operators' experience of surgical innovation., Study Design and Setting: There were three phases: (1) Literature reviews identified measures of operators' experience and concepts measured were extracted and grouped into domains. (2) Quality appraisal was conducted to assess content validity of identified instruments and was supported by COnsensus-based Standards for the selection of health Measurement Instruments methodology. Self-reported measurement instruments that had underdone formal development were eligible. Content validity was assessed using COnsensus-based Standards for the selection of health Measurement Instruments criteria for good content validity (rated sufficient/insufficient/indeterminate/inconsistent), informed by standards for measurement development and domains identified in phase 1. (3) Instruments determined suitable and of sufficient quality underwent supplemental appraisal in interviews with international multidisciplinary professionals and a focus group., Results: Literature reviews identified 16 measurement instruments from 243 studies. Most assessed 'psychological' experiences and 'usability'. No instrument was specifically validated for innovative surgery. Three instruments were rated 'sufficient' (Surgery Task Load Index [SURG-TLX]) or 'indeterminate' (Spielberger State-Trait Anxiety Inventory, Imperial Stress Assessment Tool). Twenty professionals were interviewed (seven female; 15 specialties; six countries) and the focus group included 10 participants (four professionals, six researchers). The SURG-TLX was considered the most relevant, comprehensive, and comprehensible instrument., Conclusion: The SURG-TLX is preliminarily recommended to measure operators' experiences of innovation. Further work exploring its role and impact on surgical innovation is required., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate how information about innovative surgical procedures is communicated to patients., Summary Background Data: Despite national and international guidance that patients should be informed if a procedure is innovative and has uncertain outcomes, little is known about current practice., Methods: This qualitative study followed seven 'case studies' of surgical innovation in hospitals across the UK. Pre-operative interviews were conducted with clinician innovators (n=9), pre-operative real-time consultations between clinicians and patients were audio-recorded (n=37). Patients were interviewed post-operatively (n=30). Data were synthesised using thematic analytical methods., Results: Interviews with clinicians demonstrated strong intentions to inform patients about the innovative nature of the procedure in a neutral manner, although tensions between fully informing patients and not distressing them were raised. In the consultations, only a minority of clinicians actually made explicit statements about, i) the procedure being innovative, ii) their limited clinical experience with it, iii) the paucity of evidence and iv) uncertainty/unknown outcomes. Discussions about risks were generalised and often did not relate to the innovative component. Instead, all clinicians optimistically presented potential benefits and many disclosed their own positive beliefs. Post-operative patient interviews revealed that many believed that the procedure was more established than it was and were unaware of the unknown risks., Conclusions: There were contradictions between clinicians' intentions to inform patients about the uncertain outcomes of innovative and their actual discussions with patients. There is a need for communication interventions and training to support clinicians to provide transparent data and shared decision-making for innovative procedures., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Study Design: Survey., Introduction: AO Spine Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy (AO Spine RECODE-DCM) is an international initiative that aims to accelerate knowledge discovery and improve outcomes by developing a consensus framework for research. This includes defining the top research priorities, an index term and a minimum data set (core outcome set and core data elements set - core outcome set (COS)/core data elements (CDE))., Objective: To describe how perspectives were gathered and report the detailed sampling characteristics., Methods: A two-stage, electronic survey was used to gather and seek initial consensus. Perspectives were sought from spinal surgeons, other healthcare professionals and people with degenerative cervical myelopathy (DCM). Participants were allocated to one of two parallel streams: (1) priority setting or (2) minimum dataset. An email campaign was developed to advertise the survey to relevant global stakeholder individuals and organisations. People with DCM were recruited using the international DCM charity Myelopathy.org and its social media channels. A network of global partners was recruited to act as project ambassadors. Data from Google Analytics, MailChimp and Calibrum helped optimise survey dissemination., Results: Survey engagement was high amongst the three stakeholder groups: 208 people with DCM, 389 spinal surgeons and 157 other healthcare professionals. Individuals from 76 different countries participated; the United States, United Kingdom and Canada were the most common countries of participants., Conclusion: AO Spine RECODE-DCM recruited a diverse and sufficient number of participants for an international PSP and COS/CDE process. Whilst PSP and COS/CDE have been undertaken in other fields, to our knowledge, this is the first time they have been combined in one process.

Objectives: AO Spine REsearch objectives and Common Data Elements for Degenerative Cervical Myelopathy [RECODE-DCM] is a multi-stakeholder consensus process aiming to promote research efficiency in DCM. It aims to establish the top 10 research uncertainties, through a James Lind Alliance Priority Setting Partnership [PSP]. Through a consensus process, research questions are generated and ranked. The inclusion of people with cervical myelopathy [PwCM] is central to the process. We hypothesized that presenting PwCM experience through word cloud generation would stimulate other key stakeholders to generate research questions better aligned with PwCM needs. This protocol outlines our plans to evaluate this as a nested methodological study within our PSP., Methods: An online poll asked PwCM to submit and vote on words associated with aspects of DCM. After review, a refined word list was re-polled for voting and word submission. Word clouds were generated and an implementation plan for AO Spine RECODE-DCM PSP surveys was subsequently developed., Results: Seventy-nine terms were submitted after the first poll. Eighty-seven refined words were then re-polled (which added a further 39 words). Four word clouds were generated under the categories of diagnosis, management, long-term effects, and other. A 1:1 block randomization protocol to assess word cloud impact on the number and relevance of PSP research questions was generated., Conclusions: We have shown it is feasible to work with PwCM to generate a tool for the AO Spine RECODE-DCM nested methodological study. Once the survey stage is completed, we will be able to evaluate the impact of the word clouds. Further research will be needed to assess the value of any impact in terms of stimulating a more creative research agenda.

Objective: This review summarizes reporting of complications of esophageal cancer surgery., Background: Accurate assessment of morbidity and mortality after surgery for cancer is essential to compare centers, allow data synthesis, and inform clinical decision-making. A lack of defined standards may distort clinically relevant treatment effects., Methods: Systematic literature searches identified articles published between 2005 and 2009 reporting morbidity and mortality after esophagectomy for cancer. Data were analyzed for frequency of complication reporting and to check whether outcomes were defined and classified for severity and whether a validated system for grading complications was used. Information about reporting outcomes adjusting for baseline risk factors was collated, and a descriptive summary of the results of included outcomes was undertaken., Results: Of 3458 abstracts, 224 full papers were reviewed and 122 were included (17 randomized trials and 105 observational studies), reporting outcomes of 57,299 esophagectomies. No single complication was reported in all papers, and 60 (60.6%) did not define any of the measured complications. Anastomotic leak was the most commonly reported morbidity, assessed in 80 (80.1%) articles, defined in 28 (28.3%), but 22 different descriptions were used. Five papers (5.1%) categorized morbidity with a validated grading system. One hundred fifteen papers reported postoperative mortality rates, 25 defining the term using 10 different definitions. In-hospital mortality was the most commonly used term for postoperative death, with 6 different interpretations of this phrase. Eighteen papers adjusted outcomes for baseline risk factors and 60 presented baseline measures of comorbidity., Conclusions: Outcome reporting after esophageal cancer surgery is heterogeneous and inconsistent, and it lacks methodological rigor. A consensus approach to reporting clinical outcomes should be considered, and at the minimum it is recommended that a "core outcome set" is defined and used in all studies reporting outcomes of esophageal cancer surgery. This will allow meaningful cross study comparisons and analyses to evaluate surgery.

PURPOSE Evidence suggests that patient-reported outcomes (PROs) from randomized trials in oncology may not influence clinical decision making and patient choice. Reasons for this are currently unclear and little is known about patients' interpretation of PROs. This study assessed patients' understanding of multidimensional PROs in a graphical format. PATIENTS AND METHODS Semistructured interviews in which patients interpreted a series of graphs depicting simple, then multiple different hypothetical PROs associated with two treatments with identical chances of survival were audio recorded. The interviewer and a blinded observer (listening to audio recordings) scored patients' understanding of the graphs. Logistic regression examined the associations between patient understanding of the graphs and clinical and sociodemographic details. Results One hundred thirty-two patients with esophageal and gastric cancer were interviewed and 115 understood the first two graphs depicting different PROs of two treatments (87%; 95% CI,81 to 93). Simultaneous interpretation of adverse and beneficial treatment effects was achieved by 74 (66%; 95% CI, 57 to 75). Graphs showing complex, longitudinal data were correctly interpreted by 97 (73%; 95% CI, 66 to 81) and 108 (81%; 95% CI, 75 to 88), respectively. Univariable analyses demonstrated associations between patient understanding and patient age, educational level, and cancer site (P < or = .02 for all); however, in a multivariable model each of these associations was attenuated. CONCLUSION Most patients understand graphical multidimensional PROs, although a smaller majority were able to interpret more complex, or simultaneous, presentations. Additional work is needed to define methods for communicating clinical and PRO data from trials to allow patients to make informed treatment choices.