Formation of a conceptual framework during the development of a patient-reported outcome measure for early gastrointestinal recovery: phase I of the PRO-diGi study.

AIM: Patients admitted to hospital for abdominal surgery often experience gastrointestinal dysfunction. Many studies have reported outcomes following gastrointestinal dysfunction, yet there is no unified definition of recovery or a validated patient-reported outcome measure (PROM). The first stage of PROM development requires formation of a conceptual framework to identify key themes to patients. The aim of this study was to utilize semistructured interviews to identify core themes and concepts relevant to patients to facilitate development of a conceptual framework. METHOD: Adult patients admitted to hospital for major gastrointestinal, urological or gynaecological surgery, in an emergency or elective setting, were eligible to participate. Patients treated nonoperatively for small bowel obstruction were also eligible. Interviews were conducted by telephone, audio-recorded, transcribed, coded and analysed using NVivo software by two researchers and reviewed by lay members of the steering group. Interviews continued until data saturation was reached. Ethical approval was gained prior to interviews (21/WA/0231). RESULTS: Twenty nine interviews were completed (17 men, median age 64 years) across three specialties (20 gastrointestinal, six gynaecological, three urological). Two overarching themes of 'general recovery' and 'gastrointestinal symptoms' were identified. General recovery included three themes: 'life impact', 'mental impact', including anxiety, and 'physical impact', including fatigue. Gastrointestinal symptoms included three themes: 'abdominal symptoms' such as pain, 'diet and appetite' and 'expulsory function', such as stool frequency. A total of 18 gastrointestinal symptoms were identified during patient recovery-many of which lasted several weeks following discharge. CONCLUSION: This study reports a range of gastrointestinal and nongastrointestinal symptoms experienced by patients during early gastrointestinal recovery. Identified symptoms have been synthesized into a conceptual framework to enable development of a definitive PROM for early gastrointestinal recovery.

Surgical site infections after emergency hernia repair: substudy from the Management of Acutely Symptomatic Hernia (MASH) study.

INTRODUCTION: Acutely symptomatic abdominal wall and groin hernias (ASH) are a common acute surgical presentation. There are limited data to guide decisions related to surgical repair technique and use of antibiotics, which can be driven by increased risk of surgical site infection (SSI) in this group. This study aims to report rates of SSI following ASH repair and explore the use of patient-reported outcome measure reporting in this setting. METHODS: An 18-week, UK-based, multicentre prospective cohort study (NCT04197271) recruited adults with ASH. This study reports operatively managed patients. Data on patient characteristics, inpatient management, quality of life, complications, and wound healing (Bluebelle score) were collected. Descriptive analyses were performed to estimate event rates of SSI and regression analysis explored the relationship between Bluebelle scores and SSI. The 30 and 90-day follow-up visits assessed complications and quality of life. RESULTS: The MASH study recruited 273 patients, of whom 218 were eligible for this study, 87.2 per cent who underwent open repair. Mesh was used in 123 patients (50.8 per cent). Pre- and postoperative antibiotics were given in 163 (67.4 per cent) and 28 (11.5 per cent) patients respectively. There were 26 reported SSIs (11.9 per cent). Increased BMI, incisional, femoral, and umbilical hernia were associated with higher rates of SSI (P = 0.006). In 238 patients, there was a difference in healthy utility values at 90 days between patients with and without SSI (P = 0.025). Also, when analysing 191 patients with Bluebelle scores, those who developed an SSI had higher Bluebelle values (P < 0.001). CONCLUSION: SSI is frequent in repair of acutely symptomatic hernia and correlates with BMI and site of hernia.

Management of Acutely Symptomatic Hernia (MASH) study.

BACKGROUND: Acutely symptomatic abdominal wall and groin hernias are a common reason for acute surgical hospital admissions. There are limited data to guide the treatment of these patients. This study aimed to assess outcomes of emergency hernia surgery and identify common management strategies, to improve care for these high-risk patients. METHODS: A 20-week, national multicentre, collaborative, prospective cohort study (NCT04197271) recruited adults with acutely symptomatic abdominal wall and groin hernias across the UK. Data on patient characteristics, inpatient management, quality of life, complications, and wound healing were collected. Follow-up telephone calls at 30 and 90 days were used to assessed complications and quality of life. Descriptive analyses were undertaken to describe the population and outcomes. RESULTS: Twenty-three hospitals recruited 272 eligible patients. Inguinal (37.8 per cent) and umbilical (37.1 per cent) hernias were the most common. Some 13.9 per cent were awaiting elective surgery and 12.8 per cent had previously declined intervention. CT was performed in 47.1 per cent and 81.3 per cent underwent surgical management. Open repairs were carried out in 93.5 per cent, and 92.5 per cent of these were performed under general anaesthesia. Four of 13 laparoscopic procedures were converted to open surgery. Mesh was used in 55.1 per cent of repairs, typically synthetic non-absorbable (87.4 per cent). Complications were infrequent; surgical-site infection (9.4 per cent), delirium (3.2 per cent), and pneumonia (2.3 per cent) were the most common. The 90-day mortality rate was 4.9 per cent. Immediate surgical management was associated with a significant improvement in quality of life at 30 days (median score 0.73-0.82). CONCLUSION: There is variation in the investigation, management, and surgical technique used to treat acutely symptomatic abdominal wall and groin hernias in the UK. The optimal management strategy for specific acute presentations remains to be established. Presented to the Association of Surgeons in Training Conference, Birmingham, UK, March 2021, the Association of Surgeons of Great Britain and Ireland Congress, May 2021, the World Society of Emergency Surgery, Edinburgh, UK, September 2021, and the European Hernia Society Congress, Copenhagen, Denmark, October 2021.

Preventive use of gabapentin to decrease pain and systemic symptoms in patients with head and neck cancer undergoing chemoradiation.

BACKGROUND: Radiation for patients with head and neck cancer (HNC) is associated with painful mucositis that impacts the delivery of treatment and contributes to high symptom burden. METHODS: This was a prospective, randomized pilot trial. Eligible patients received primary or adjuvant chemoradiation. Patients were randomized to usual care vs usual care plus gabapentin titrated to drug tolerance during radiation. Patients completed a symptom survey at baseline and weekly during therapy. RESULTS: Seventy-nine patients were enrolled in the study (38 control, 41 treatment). At interim analysis, gabapentin use resulted in a decrease in pain (P = .004), with the biggest decreases being in the latter weeks of therapy. By week 7, the median pain score in the treatment group was below the 0.25 quantile of the control group. CONCLUSION: Prophylactic use of gabapentin during chemoradiation for HNC patients resulted in a decrease in pain, neurosensory symptoms, and general systemic symptoms.

Laparoscopic Transabdominal Cerclage and Subsequent Pregnancy Outcomes When Left In Situ.

OBJECTIVE: To evaluate obstetric outcomes of subsequent pregnancies in women who had a laparoscopic transabdominal cerclage. METHODS: A prospective observational study of consecutive women who became pregnant a second or third time after a laparoscopic transabdominal cerclage. Eligible women were considered not suitable for a transvaginal cerclage or had previously failed a transvaginal cerclage. The primary outcome was neonatal survival and the secondary outcome was delivery at 34 weeks of gestation or more. RESULTS: During the study period (2007-2018), 22 women who had undergone a laparoscopic transabdominal cerclage and completed one pregnancy with the cerclage in situ became pregnant a second or third time. In the first pregnancies with the cerclage in situ, the neonatal survival rate was 100% (22/22) and 86% (19/22) of women delivered after 34 weeks of gestation. In the second pregnancies, the neonatal survival rate was 95% (21/22) and 86% (19/22) of women delivered after 34 weeks of gestation. In the third pregnancies, the neonatal survival rate was 100% (3/3) and 100% (3/3) of women delivered after 34 weeks of gestation. CONCLUSION: When left in situ for subsequent pregnancies, laparoscopic transabdominal cerclage is associated with a high rate of neonatal survival.

Caregiver-reported neuropsychiatric symptoms in patients undergoing treatment for head and neck cancer: a pilot study.

BACKGROUND: Patients with cancer experience multiple neuropsychiatric symptoms. Whereas individual symptoms have been studied in patients with head and neck cancer, the broader context of neuropsychiatric symptoms needs to be explored. OBJECTIVE: The aims of this pilot study were to (a) determine the caregiver-reported prevalence and severity of neuropsychiatric symptoms in patients with head and neck cancer, (b) determine the associated level of caregiver distress, and (c) describe the effects of neuropsychiatric symptoms on patients and their caregivers. METHODS: Twenty-three family caregivers of patients with head and neck cancer completed the Neuropsychiatric Inventory Questionnaire and participated in a semistructured interview. RESULTS: All caregivers reported that patients experienced at least 1 neuropsychiatric symptom (mean, 7.5; range, 1-12). The most frequently reported symptoms were trouble with appetite and eating (95.7%), altered nighttime behaviors (82.6%), depression/dysphoria (78.3%), decreased alertness (69.6%), inattention (60.9%), apathy/indifference (56.5%), anxiety (56.5%), irritability/lability (52.5%), agitation/aggression (52.2%), and slowed behavior (43.5%). The mean severity rating for 9 symptoms was moderate to severe. Most symptoms caused mild to moderate levels of caregiver distress. Qualitative data indicated that neuropsychiatric symptoms negatively affected patients, their caregivers, and other family members. Patients required more caregiver support resulting in increased caregiver burden and distress. CONCLUSIONS: Neuropsychiatric symptoms are common and troubling in patients with head and neck cancer during treatment. Further investigation of their effects on patients and family caregivers is needed. IMPLICATIONS FOR PRACTICE: Clinicians should monitor for and treat neuropsychiatric symptoms throughout treatment and provide caregiver and patient education and support.

Expression of fungal diacylglycerol acyltransferase2 genes to increase kernel oil in maize.

Maize (Zea mays) oil has high value but is only about 4% of the grain by weight. To increase kernel oil content, fungal diacylglycerol acyltransferase2 (DGAT2) genes from Umbelopsis (formerly Mortierella) ramanniana and Neurospora crassa were introduced into maize using an embryo-enhanced promoter. The protein encoded by the N. crassa gene was longer than that of U. ramanniana. It included 353 amino acids that aligned to the U. ramanniana DGAT2A protein and a 243-amino acid sequence at the amino terminus that was unique to the N. crassa DGAT2 protein. Two forms of N. crassa DGAT2 were tested: the predicted full-length protein (L-NcDGAT2) and a shorter form (S-NcDGAT2) that encoded just the sequences that share homology with the U. ramanniana protein. Expression of all three transgenes in maize resulted in small but statistically significant increases in kernel oil. S-NcDGAT2 had the biggest impact on kernel oil, with a 26% (relative) increase in oil in kernels of the best events (inbred). Increases in kernel oil were also obtained in both conventional and high-oil hybrids, and grain yield was not affected by expression of these fungal DGAT2 transgenes.