A prospective phase II clinical trial/IDEAL Stage 2a series of single-port robotic colorectal surgery for abdominal and transanal cases.

AIM: Slow laparoscopy adoption accelerated the uptake of robotic surgery. However, the current robotic platforms have limitations in transanal applications and multiple port sites. The da Vinci single-port (SP) robot is currently used on trial for colorectal surgery, and broad assessment of outcomes is needed. We aimed to report findings of a phase II clinical trial of SP robotic colorectal surgery. METHODS: A sequentially reported prospective case series was performed on patients using SP robotics at a tertiary referral centre from 1 October 2018 to 31 August 2021. Cases were stratified into abdominal and transanal cohorts. Demographics, intra-operative variables and 30-day postoperative outcomes were evaluated. Univariate analysis was performed, with statistical process control for the docking process. Main outcomes were conversion rates, morbidity, mortality and point of standardization of docking. RESULTS: In all, 133 patients were included: 93 (69.92%) abdominal and 40 (30.08%) transanal. The main diagnosis was rectal cancer (n = 59) and the procedure performed a robotic transanal abdominal transanal radical proctosigmoidectomy (n = 30). There were no conversions to open surgery. Two abdominal (2.15%) and three transanal cases (7.50%) were converted to laparoscopy. All colorectal adenocarcinomas had negative margins, proper lymph node harvest and complete mesorectal excision, as appropriate. Docking became a standardized process at cases 34 (abdominal) and 23 (anorectal). After surgery, bowel function returned on mean day 2 (abdominal) and 1 (transanal). The morbidity rate was 15.05% (abdominal) and 27.50% (transanal). There were two major morbidities in each cohort. Overall, there were three (2.65%) readmissions, one reoperation and no mortality. CONCLUSIONS: Single-port robotics is feasible for all types of colorectal procedures, with good clinical and oncological outcomes. With this development in colorectal surgery, further studies can develop best practices with this novel technology.

Gastric Neuroendocrine Tumor Treatment and Survival Outcome Depends on Facility Type.

BACKGROUND: Gastric neuroendocrine tumors (gNETs) are rare cancers for which surgery may improve survival. We aim to determine if facility type affects treatment and survival outcomes. METHODS: The NCDB was queried for patients with gNET from 2004-2016 and stratified into Academic/Research Program (ARP), Community Cancer Program (CCP), Comprehensive Community Cancer Program (CCCP), or Integrated Network Cancer Program (INCP). Overall survival along with clinical and demographic features was compared. RESULTS: Median survival was improved in patients treated at an academic program: 137.3 months versus 88.0, 96.3, and 100.2 for CCP, CCCP, INCP, respectively (P < .0001). Patients treated at academic centers were more likely to have surgery (64.2% vs 59.1%, 57.5%, 51.4%, P < .0001). After propensity matching for age, race, grade, stage, insurance status, and comorbidity score, survival benefit from treatment at an academic center remained (P = .03), particularly for patients undergoing surgery (P < .0001) and chemotherapy (P = .04). CONCLUSION: Patients with gNET treated at an academic hospital had improved median survival after propensity matching and may benefit from treatment at academic rather than community medical centers.

OAKHQOL: a new instrument to measure quality of life in knee and hip osteoarthritis.

OBJECTIVE: To develop a questionnaire with which to measure quality of life (QoL) in patients with knee and hip osteoarthritis (OA). STUDY DESIGN AND SETTING: Thirty-two caregivers and 96 OA patients were interviewed individually (using cognitive and face-to-face techniques) and in focus groups. A group of experts working independently at first and then consensually used the interview transcripts to generate a 46-item questionnaire. RESULTS: Analysis of questionnaires completed by 263 patients with hip or knee OA resulted in the exclusion of three items (two because of low reliability and one because of a low response rate). Principal component analysis revealed four factors: physical activity, mental health, social functioning, and social support. A pain dimension was individualized. Preliminary testing showed the reliability of the five dimensions to be satisfactory (intraclass correlation coefficients: 0.70-0.85), construct validity was adequate when correlated with the SF36 (Spearman correlation coefficients: 0.43-0.75), and discrimination was satisfactory. The osteoarthritis knee and hip quality of life questionnaire (OAKHQOL) consists of 43 items in five dimensions and three independent items. CONCLUSION: The OAKHQOL is the first specific knee and hip OA quality of life instrument. Its development followed an a priori structured strategy to ensure content validity. It meets psychometric requirements for validity and reliability.

Content of quality-of-life instruments is affected by item-generation methods.

BACKGROUND: Methods used to generate items for complex measurement scales are heterogeneous and probably produce heterogeneous data, yet nothing is known about the advantages of one method over another. OBJECTIVE: We aimed to compare methods of generating items for tools designed to measure quality-of-life for patients. METHODS: We used five methods to develop a quality-of-life instrument for patients with lower-limb osteoarthritis: individual interviews with patients involving two different techniques (semi-structured and cognitive), individual interviews with health professionals, and focus groups of patients and health professionals. The process generated 80 items, of which 37 were excluded after content and psychometric analysis. With the final 43-item scale used as a 'reference standard', we estimated the contribution of each method. RESULTS: For health professionals, the focus group and individual interviews produced 35 and 81% of the items, respectively. For patients, the focus groups produced 74% of the items and both interview techniques 100% of the items. Health professionals provided a narrower picture of the effects of the disease on quality-of-life. Focus groups contributed less to social domains than did individual interviews. The two patient interview techniques highlighted different themes. CONCLUSION: In developing a complex measurement scale for patients, we found individual interviews with patients the best method for formulating items; other methods such as physician interviews and focus groups contributed no additional information. Reports of instrument generation should include details of the item-generation step, the methods used to develop items and the number of people involved.

Development and testing of a specific quality-of-life questionnaire for knee and hip osteoarthritis: OAKHQOL (OsteoArthritis of Knee Hip Quality Of Life).

OBJECTIVE: To design a quality-of-life (QOL) instrument specific for patients with knee or hip osteoarthritis and to assess its validity and reproducibility. METHODS: One-on-one or group interviews were conducted with 79 patients and 28 healthcare professionals. Of the 80 potential items identified from the results, 46 were selected based on their content and were used to develop version 1 of the OsteoArthritis of Knee and Hip Quality of Life Scale (OAKHQOL). The psychometric characteristics of the scale were evaluated in patients who met Altman's criteria for knee or hip osteoarthritis. RESULTS: Based on the results of psychometric analyses in 263 patients, three items were excluded, leaving 43 items in the final version (2.3) of the OAKHQOL. Principal components analysis identified four domains: physical activities, mental health, social functioning, and social support. A pain domain was individualized later. Construct validity, reproducibility, and discriminating power of the domains were satisfactory. Standardized response means after joint replacement surgery were close to 1 for the pain and physical functioning domains and equal to 0.7 for the mental health domain, indicating good sensitivity to change. CONCLUSIONS: The OAKHQOL is the first QOL tool specifically dedicated to lower-limb osteoarthritis. It captures specific aspects of QOL in patients with knee or hip osteoarthritis and exhibits psychometric properties consistent with use in longitudinal studies.