Revisiting the use of the EORTC QLQ-STO22 to assess health-related quality of life of patients with gastric cancer: incorporating updated treatment options and cross-cultural perspectives.

BACKGROUND: The EORTC QLQ-STO22 (QLQ-STO22) is a firmly established and validated measure of health-related quality of life (HRQoL) for people with gastric cancer (GC), developed over two decades ago. Since then there have been dramatic changes in treatment options for GC. Also, East Asian patients were not involved in the development of QLQ-STO22, where GC is most prevalent and the QLQ-STO22 is widely used. A review with appropriate updating of the measure was planned. This study aims to capture HRQoL issues associated with new treatments and the perspectives of patients and health care professionals (HCPs) from different cultural backgrounds, including East Asia. METHODS: A systematic literature review and open-ended interviews were preformed to identify potential new HRQoL issues relating to GC. This was followed by structured interviews where HCPs and patients reviewed the QLQ-STO22 alongside new issues regarding relevance, importance, and acceptability. RESULTS: The review of 267 publications and interviews with 104 patients and 18 HCPs (48 and 9 from East Asia, respectively) generated a list of 58 new issues. Three of these relating to eating small amounts, flatulence, and neuropathy were recommended for inclusion in an updated version of the QLQ-STO22 and covered by five additional questions. CONCLUSIONS: This study supports the content validity of the QLQ-STO22, suggesting its continued relevance to patients with GC, including those from East Asia. The updated version with additional questions and linguistic changes will enhance its specificity, but further testing is required.

Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus.

BACKGROUND: Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)-a standardized group of outcomes important to key international stakeholders-that should be reported by future trials in this field. METHODS: Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized. RESULTS: Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and 'serious' adverse events. CONCLUSION: A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence.

Litigation claims following laparoscopic and open inguinal hernia repairs.

PURPOSE: Groin hernia repair is the most frequently performed general surgical operation in the UK. Complications from laparoscopic and open repair are well recognised; however, potential differences are yet to be considered in relation to litigation. METHODS: Administrative data were obtained and analysed from the NHS Litigation Authority for inguinal hernia-related claims from 1995 to 2016. Claims identified as using an open or laparoscopic approach were compared. RESULTS: 880 claims were made, 760 had been settled. 88 laparoscopic and 241 open procedures were identified; 65% laparoscopic and 63% open hernia claims were found to be in favour of the claimant. Payouts totalled to 4.1GBP/4.8EUR/5.3USD million and 9.4GBP/11.0EUR/12.1USD million for laparoscopic (mean 82,824GBP/96,579EUR/106,453USD) and open (mean 66,796GBP/77,892EUR/85,852USD) approaches, respectively. The most common reasons for claim initiation were visceral/vascular injury (54%) in the laparoscopic group, and testicular complications or chronic pain (35%) in the open group. Additional procedures were necessary for 48% and 44% of laparoscopic and open claims, respectively. The highest average payouts were associated with visceral injury, (laparoscopic 116,482GBP/135,820EUR/149,715USD; open 199,103GBP/232,246EUR/255,905USD) and vascular injury (laparoscopic 88,624GBP/103,369EUR/113,892USD; open 64,460GBP/75,163EUR/82,870USD). Additional procedures resulted in an average payout of 93,352GBP/108,917EUR/120,008USD (laparoscopic) and 60,408GBP/70,506EUR/77,657USD (open). The most common additional procedures were corrective visceral/vascular repairs, orchidectomy and recurrent hernia repair. CONCLUSIONS: The rate of litigation for clinical negligence in inguinal hernia surgery in the UK is increasing. Whilst there has been a recent increase in laparoscopic hernia repair claims, the volume and burden of claims related to open procedures remain greater.

Nutritional access routes following oesophagectomy--a systematic review.

Nutritional support in patients undergoing oesophagectomy is of paramount importance in this usually malnourished patient group, but encountering significant clinical practice variation between units. Our aim was therefore to assess the strength of evidence behind nutritional support routes post-oesophagectomy. The Cochrane Library and Controlled Trials Registry, MEDLINE (Ovid) (1966-April 2009), PubMed, EMBASE (1966-April 2009), CINAHL, Web of knowledge and SCOPUS databases, were electronically searched for the highest level of evidence, with English language as a limit. Reference follow-up was also used. Studies were critically reviewed based on The NHS Public Health Resource Unit Critical Appraisal Skills Programme Tools. Five randomised control trials (RCTs) and one case-control trial, with 344 patients, were included in the review. There was a significant variation in the routes assessed (including intravenous fluid therapy, peripheral and central line nutrition, feeding jejunostomy, nasojejunal and nasoduodenal tubes) and the methodological quality of each study, with small patient numbers. No route was found to be superior over another in the RCTs. In the case-control trial, the combination of enteral parenteral nutrition led to shorter hospital stay compared with parenteral feeding alone. Nasojejunal and nasoduodenal tubes are associated with a significant rate of dislodgement. There is absence of strong direct evidence supporting a single feeding access route in oesophagectomy patients. Clinical decisions should be made based on available evidence from other types of gastrointestinal surgery, currently favouring enteral nutrition. If enteral feeding is chosen, feeding jejunostomy may be superior to nasojejunal or duodenal tubes.

Litigation following groin hernia repair in England.

PURPOSE: Since 1995, litigation following surgical procedures has cost the National Health Service (NHS) over 1.3 billion GBP (Great British Pounds)/2.1 billion USD (United States Dollars)/1.4 billion Euros. Despite it being the most commonly undertaken general surgical operation, no study has examined clinical negligence claims in England following groin hernia repairs. METHODS: Data from the NHS Litigation Authority of all claims made from 1995 to 2009 was obtained and interrogated. RESULTS: In total, 398 claims were made. Of these, 209 cases had been settled, of which 144 (46.6%) were in favour of the claimant to a cost of 7.35 million GBP/12 million USD/7.93 million Euros. Testicular injury and chronic pain featured in 40% of all claims. Visceral injuries and injuries requiring corrective procedures were the only predictors of a successful claim (P = 0.015 and P = 0.002, respectively). Claims associated with visceral and vascular injuries were more likely to occur in laparoscopic than in open repairs. Sexual dysfunction and chronic pain resulted in the highest average payouts of 85,467 GBP/140,565 USD/92,177 Euros and 81,288 GBP/133,693 USD/87,674 Euros, respectively. CONCLUSION: Patients should be fully informed of the incidence of testicular injury and chronic pain during the consent process. Approaches minimising visceral and vascular injury particularly in laparoscopic repair should be adopted to reduce litigation and improve patient care.