Reporting of health-related quality of life in emergency laparotomy trials: a systematic review and narrative synthesis.

PURPOSE: Emergency laparotomy is associated with high morbidity for the surgical patient. Understanding patients' health-related quality of life after their surgery is important to enhance the informed consent process, and to enable the evaluation and improvement of surgical care. This review aims to summarise the use of health-related quality of life tools in clinical trials involving patients undergoing emergency laparotomy. METHODS: A systematic review was undertaken of the scientific literature published in the MEDLINE® and PubMed databases between January 2011 and July 2021. A narrative synthesis approach was chosen to synthesise the diverse range of studies in a structured manner. All included papers were evaluated using the Cochrane Collaboration's tool for assessing risk of bias. RESULTS: Eleven studies were selected for inclusion. Most of the studies had a low risk of bias. Two of the studies used health-related quality of life as the primary outcome measure. A variety of health-related quality of life measurement tools were used; the EQ-5D tool was the most popular questionnaire. Protocol adherence was dependent on the length of time which had elapsed after emergency surgery. CONCLUSION: There are many perceived challenges to collecting health-related quality of life data in the emergency surgery setting. Many of these can be offset with progressive trial designs. There is a need for further research in the systematic development of patient-reported outcomes for use in emergency surgery.

Impact of in-hospital postoperative complications on quality of life up to 12 months after major abdominal surgery.

BACKGROUND: Postoperative complications are common, but there are limited data regarding their implications on patients' quality of life. This study aimed to address this gap in the literature by analysing the impact of postoperative complications on patients' health-related quality of life. METHODS: Data from the Perioperative Quality Improvement Programme were analysed, and included patient-level data for 19 685 adults who underwent elective major abdominal procedures in England since 2016. Postoperative complications were graded using the Clavien-Dindo classification. Quality of life was assessed by responses to the EuroQol five-dimension five-levels-of-response (EQ-5D-5L™) questionnaire before surgery, and at 6 and 12 months after operation. Ordinal logistic regression was used to estimate the association between Clavien-Dindo grades and quality of life. Tobit and ordinary least squares regression analyses were used to estimate the quality-adjusted life-year (QALY) loss resulting from postoperative complications between admission and 12 months after surgery. RESULTS: At 6 and 12 months after surgery, increasingly severe postoperative complications were significantly associated with poorer health-related quality of life. The effect of postoperative complications on quality of life was sustained until at least 12 months after operation. Between admission and 12 months after surgery, 0.012, 0.026, 0.033, and 0.086 QALYs were lost for those experiencing a grade I, II, III, or IV postoperative complication respectively. CONCLUSION: Postoperative complications have a significant and sustained effect on patients' quality of life after surgery; this effect worsens as the severity of the complications increases.

Management of levator ani avulsion: a systematic review and narrative synthesis.

PURPOSE: Levator ani muscle (LAM) avulsion affects up to 35% of women. Unlike obstetric anal sphincter injury, LAM avulsion is not diagnosed immediately after vaginal delivery, however, has a profound impact on quality of life. The management of pelvic floor disorders is in growing demand yet the significance of LAM avulsion in the context of pelvic floor dysfunction (PFD) is poorly understood. This study collates information on success of treatment for LAM avulsion to establish the best options for management of women. METHODS: MEDLINE®, MEDLINE® In-Process, EMBASE, PubMed, CINAHL and The Cochrane Library were searched for articles that evaluated the management techniques used to treat LAM avulsion. The protocol was registered with PROSPERO (CRD42021206427). RESULTS: Natural healing of LAM avulsion occurs in 50% of women. Conservative measures, including pelvic floor exercises and pessary use are poorly studied. Pelvic floor muscle training for major LAM avulsions was of no benefit. Post-partum pessary use was only of benefit in the first three months for women. Surgeries for LAM avulsion are poorly researched but studies suggest they may provide benefit for 76-97% of patients. CONCLUSIONS: Whilst some women with PFD secondary to LAM avulsion improve spontaneously, 50% continue to have pelvic floor symptoms 1 year following delivery. These symptoms result in a significant negative impact on quality of life, however, it is not clear whether conservative or surgical methods are helpful. There is a pressing need for research to find effective treatments and explore appropriate surgical repair techniques for women with LAM avulsion.

Participants' Perspectives of Their Involvement in Medical Device Trials: A Focus Groups Study.

BACKGROUND: Medical technologies have the potential to improve quality and efficiency of healthcare. The design of clinical trials should consider participants' perspectives to optimise enrolment, engagement and satisfaction. This study aims to assess patients' perceptions of their involvement in medical device trials, to inform the designs of future medical technology implementation and evaluation. METHODS: Four focus groups were undertaken with a total of 16 participants who had participated in a study testing hospital inpatient remote monitoring devices. Interviews were audio-recorded, transcribed verbatim and underwent thematic analysis. RESULTS: Four main themes emerged: patients' motivations for participating in medical device research; patients' perceptions of technology in medicine; patients' understanding of trial methodology; and patients' perceptions of the benefits of involvement in medical device trials. The appeal of new technology is a contributing factor to the decision to consent, although concerns remain regarding risks associated with technology in healthcare settings. Perceived benefits of participating in device trials include extra care, social benefits and comradery with other participants seen using the devices, although there is a perceived lack of confidence in using technology amongst older patients. CONCLUSION: Future device trials should prioritise information sharing with participants both before and after the trial. Verbal and written information alongside practical demonstrations can help to combat a lack of confidence with technology. Randomised trials and those with placebo- or sham-controlled arms should not be considered as barriers to participation. Study results should be disseminated to participants in lay format as soon as possible, subject to participant permission.

The role of ABCG2 in modulating responses to anti-cancer photodynamic therapy.

The ATP-binding cassette (ABC) superfamily G member 2 (ABCG2) transmembrane protein transporter is known for conferring resistance to treatment in cancers. Photodynamic therapy (PDT) is a promising anti-cancer method involving the use of light-activated photosensitisers to precisely induce oxidative stress and cell death in cancers. ABCG2 can efflux photosensitisers from out of cells, reducing the capacity of PDT and limiting the efficacy of treatment. Many studies have attempted to elucidate the relationship between the expression of ABCG2 in cancers, its effect on the cellular retention of photosensitisers and its impact on PDT. This review looks at the studies which investigate the effect of ABCG2 on a range of different photosensitisers in different pre-clinical models of cancer. This work also evaluates the approaches that are being investigated to address the role of ABCG2 in PDT with an outlook on potential clinical validation.

Dementia and osteoporosis in a geriatric population: Is there a common link?

AIM: To determine the existence of a common pathological link between dementia and osteoporosis through reviewing the current evidence base. METHODS: This paper reviews the current literature on osteoporosis and dementia in order to ascertain evidence of a common predisposing aetiology. A literature search of Ovid MED-LINE (1950 to June 2016) was conducted. The keywords "osteoporosis", "osteoporotic fracture", "dementia" and "Alzheimer's disease" (AD) were used to determine the theoretical links with the most significant evidence base behind them. The key links were found to be vitamins D and K, calcium, thyroid disease, statins, alcohol and sex steroids. These subjects were then searched in combination with the previous terms and the resulting papers manually examined. Theoretical, in vitro and in vivo research were all used to inform this review which focuses on the most well developed theoretical common causes for dementia (predominantly Alzheimer's type) and osteoporosis. RESULTS: Dementia and osteoporosis are multifaceted disease processes with similar epidemiology and a marked increase in prevalence in elderly populations. The existence of a common link between the two has been suggested despite a lack of clear pathological overlap in our current understanding. Research to date has tended to be fragmented and relatively weak in nature with multiple confounding factors reflecting the difficulties of in vivo experimentation in the population of interest. Despite exploration of various possible mechanisms in search for a link between the two pathologies, this paper found that it is possible that these associations are coincidental due to the nature of the evidence available. One finding in this review is that prior investigation into common aetiologies has found raised amyloid beta peptide levels in osteoporotic bone tissue, with a hypothesis that amyloid beta disorders are systemic disorders resulting in differing tissue manifestations. However, our findings were that the most compelling evidence of a common yet independent aetiology lies in the APOE4 allele, which is a well-established risk for AD but also carries an independent association with fracture risk. The mechanism behind this is thought to be the reduced plasma vitamin K levels in individuals exhibiting the APOE4 allele which may be amplified by the nutritional deficiencies associated with dementia, which are known to include vitamins K and D. The vitamin theory postulates that malnutrition and reduced exposure to sunlight in patients with AD leads to vitamin deficiencies. CONCLUSION: Robust evidence remains to be produced regarding potential links and regarding the exact aetiology of these diseases and remains relevant given the burden of dementia and osteoporosis in our ageing population. Future research into amyloid beta, APOE4 and vitamins K and D as the most promising aetiological links should be welcomed.

Systematic Review of Retraction Devices for Laparoscopic Surgery.

BACKGROUND: Retraction plays a vital role in optimizing the field of vision in minimal-access surgery. As such, a number of devices have been marketed to aid the surgeon in laparoscopic retraction. This systematic review explores the advantages and disadvantages of the different instruments in order to aid surgeons and their institutions in selecting the appropriate device. Primary outcome measures include operation time, length of stay, use of staff, patient morbidity, ease of use, conversion rates to open surgery, and cost. METHODS: Systematic literature searches were performed in MEDLINE, EMBASE, The Cochrane Library, Current Controlled Trials, and ClinicalTrials.gov. The search strategy focused on studies testing a retraction device. The selection process was based on a predefined set of inclusion and exclusion criteria. Data were then extracted and analyzed. RESULTS: Out of 1360 papers initially retrieved, 12 articles were selected for data extraction and analysis. A total of 10 instruments or techniques were tested. Devices included the Nathanson's liver retractor, liver suspension tape, the V-List technique, a silicone disk with or without a snake retractor, the Endoloop, the Endograb, a magnetic retractor, the VaroLift, a laparoscope holder, and a retraction sponge. None of the instruments reported were associated with increased morbidity. No studies found increased rates of conversion to open surgery. All articles reported that the tested instruments might spare the use of an assistant during the procedure. It was not possible to determine the impact on length of stay or operation time. CONCLUSIONS: Each analyzed device facilitates retraction, providing a good field of view while allowing reduced staff numbers and minimal patient morbidity. Due to economic and environmental advantages, reusable devices may be preferable to disposable instruments, although the choice must be primarily based on clinical judgement.

Prognostic significance of tumour stroma ratio in inflammatory breast cancer.

Tumour stroma ratio (TSR) is emerging as an important prognostic indicator in cancer. We have previously shown TSR to be prognostic in oestrogen receptor positive breast cancer. Its role in inflammatory breast cancer, a rare but aggressive form of breast cancer, has not been identified. Here we aimed to determine the prognostic significance of TSR in a cohort of patients with inflammatory breast carcinoma. TSR was measured by point counting virtual H&E stained tissue sections in 45 inflammatory breast cancer cases. The whole tumour area was sampled. Optimum cut-offs to distinguish high and low TSR was determined by log-rank test. The relationship of TSR to overall survival and disease-free survival (DFS) was analysed alongside multivariate analysis. The optimal cut-offs between high and low TSR were determined to be 31% for OS and 46% for DFS. There was no significant difference in OS (p = 0.53) nor DFS (p = 0.66) between high and low TSR groups. Multivariate analysis did not demonstrate any new trends, within the limits of a small data sample. A significant correlation was found between pathological response to neoadjuvant chemotherapy and survival (p = 0.008). There is no evidence that TSR has prognostic significance in inflammatory breast cancer. When compared with published data in non-inflammatory breast carcinoma, this supports the view that differences in stromal biology exist between tumour types and highlights the importance of considering this when interpreting the prognostic value of TSR. However, these findings must be interpreted in the light of the small sample size.