The effect of hyperbaric oxygen therapy in head and neck cancer patients with radiation induced dysphagia-a systematic review.

PURPOSE: The aim of this systematic review was to assess the role of hyperbaric oxygen therapy  (HBOT) in patients with dysphagia after radiation therapy for head and neck cancer. METHOD: A systematic search was conducted in the electronic databases Ovid MEDLINE, Ovid Embase, and Cochrane Central Register of Controlled Trials for relevant studies until March 14, 2023. No restriction on language or publication date. The criteria for inclusion: patients with HNC who had received both radiation therapy and HBOT as 1) a preventive treatment against swallowing difficulties, 2) to preserve swallowing function, or 3) to promote swallowing difficulties. RESULTS: We identified 1396 records. After removal of 31 duplicates, 1365 records were accessible for title and abstract screening. This yielded 53 studies for full text assessment. Six studies met the eligibility criteria and were included for qualitative analysis. CONCLUSION: Evidence of HBOT benefits in patients with dysphagia after radiation therapy for head and neck cancer is inconsistent. Well-designed studies using validated outcome measures and long-term follow-up are warranted.

Missed cancer in the Danish head and neck cancer fast-track program: results from a tertiary cancer center.

BACKGROUND: The Danish head and neck cancer fast-track program is a national standardized pathway aiming to reduce waiting time and improve survival for patients suspected of cancer in the head and neck (HNC). Until now, the frequency of missed cancer in the fast-track program has not been addressed. A missed cancer leads to treatment delay and may cause disease progression and worsening of prognosis. The study objective was to estimate the frequency of patients with missed cancers in the Danish HNC fast-track program and to evaluate the accuracy of the program. MATERIALS AND METHODS: Patients who were rejected from the HNC fast-track program because cancer was not found between 1 July 2012 and 31 December 2018 at Odense University Hospital, Denmark were included and followed for three years. Patients were categorized into groups depending on the diagnostic evaluation. Group 1 included patients evaluated with standard clinical work-up without imaging and biopsy. Group 2 included patients evaluated with imaging and/or biopsy in addition to the standard clinical work-up. The local cancer database and electronic patient records were reviewed to determine if a missed cancer had occurred within the follow-up period. RESULTS: A total of 8345 HNC fast-track courses were initiated during the study period. 1499 were patients suspected of recurrent cancer and were excluded leaving 6846 patients to be assessed for eligibility. Of these, 3752 patients were rejected because cancer was not found. Ten patients were subsequently diagnosed with cancer within the follow-up period resulting in an overall frequency of 0.15%. For group 1 and 2, the frequency was 0.04% and 0.10%, respectively. The sensitivity of the fast-track program was 99.67% and the negative predictive value was 99.73%. CONCLUSION: The frequency of missed cancer in a tertiary HNC center following the Danish fast track program is low.

Diagnosis of possible nasopharyngeal malignancy in adults with isolated serous otitis media; a systematic review and proposal of a management algorithm.

PURPOSE: The objective of this study was (1) to systematically review the evidence of routine post-nasal space blind biopsies and/or imaging of adults with isolated serous otitis media (SOM) of unknown cause for detection nasopharyngeal malignancy (NPM), and (2) to design a clinical management algorithm for these patients. METHODS: A systematic search was conducted in the databases PubMed, Embase and Cochrane Library guided by the study question "Should adults with isolated SOM of unknown cause undergo routine biopsies of the post-nasal space and/or diagnostic imaging for detection of NPM?". All retrieved studies were reviewed and quantitatively analyzed. RESULTS: The systematic literature search identified 552 publications accessible for title-abstract screening. This yielded 23 studies for full text assessment, of which 6 were found eligible for inclusion. All six studies dealt with nasopharyngeal blind biopsies, whereas no studies on cross-sectional imaging were identified. The derived summarized results of the included studies showed that 5.5% (31/568) of patients with isolated SOM of unknown cause were diagnosed with NPM. Of these, 6.5% (2/31) had normal nasopharyngeal endoscopy (i.e., malignancy was discovered by blind biopsies). Finally, 0.35% (2/568) of patients with isolated SOM of unknown cause diagnosed with NPM had normal nasopharyngeal endoscopy findings (i.e., nasopharyngeal endoscopy ruled-out malignancy in 99.65% of patients). CONCLUSIONS: We found no evidence supporting routine use of blind biopsies or cross-sectional imaging in adults with isolated serous otitis media of unknown cause. We propose a pragmatic management algorithm for workup of adults with persistent secretory otitis media.

A retrospective cohort study on European Reference Network for Rare Vascular Diseases 5 outcome measures for Hereditary Haemorrhagic Telangiectasia in Denmark.

BACKGROUND: Hereditary Haemorrhagic Telangiectasia (HHT) is an autosomal dominant disorder characterized by several clinical symptoms including epistaxis, arteriovenous malformations (AVM), and telangiectasia. In 2018, European Reference Network for Rare Vascular Diseases (VASCERN) recommended five outcome measures for HHT-patients to guide health care providers, some with limited experience in treating HHT, and thereby maximizing the number of HHT-patients receiving good care. The outcome measures cover the following aspects: (1) 90% of the patients should receive a pulmonary AVM (PAVM) screening; (2) 90% of the patients should receive written advice on nosebleed; (3) 70% should be assessed for iron deficiency; (4) 100% of the patients should receive written advice on antibiotic (AB) prophylaxis prior to dental and surgical procedures, and (5) 100% of relevant patients should receive written advice on pregnancy. We have introduced the outcome measures as Benchmarks in our HHT-centre and wanted to evaluate the extend of implementation we have achieved. We constantly struggle to secure the best possible treatment of our HHT-patients. METHODS: The study was a non-interventional retrospective study. Data was collected manually from patient records and from the Danish HHT-database. RESULTS: A total of 180 HHT-patients were included, all diagnosed in the period from January 1st, 2016, to December 31st, 2020. All patients were screened for PAVM. We could confirm that 66% of patients who had epistaxis received thoroughly advice. Assessment for iron deficiency was performed in 80% of the adult patients. Thoroughly advice on AB prophylaxis was documented in 75%. Thoroughly advice on pregnancy was documented in 80% of female patients 15-45 years of age. There were no significant differences over time for any of the outcome measures. CONCLUSIONS: The Danish HHT-centre reached the target threshold for outcome measures 1 and 3. It could not be documented that the target thresholds for outcome measures 2, 4, and 5 were achieved. As information and education are a very important part of HHT care, focus on and documentation that all patients receive the relevant advice must be a priority in order to ensure best care.

Post robotic investment: Cost consequences and impact on length of stay for obese women with endometrial cancer.

INTRODUCTION: The aim of the study was to investigate whether robotic-assisted surgery is associated with lower incremental resource use among obese patients relative to non-obese patients after a Danish nationwide adoption of robotic-assisted surgery in women with early-stage endometrial cancer. This is a population-based cohort study based on registers and clinical data. MATERIAL AND METHODS: All women who underwent surgery (robotic, laparoscopic and laparotomy) from 2008 to 2015 were included and divided according to body mass index (<30 and ≥30). Robotic-assisted surgery was gradually introduced in Denmark (2008-2013). We compared resource use post-surgery in obese vs non-obese women who underwent surgery before and after a nationwide adoption of robotic-assisted surgery. The key exposure variable was exposure to robotic-assisted surgery. Clinical and sociodemographic data were linked with national register data to determine costs and bed days 12 months before and after surgery applying difference-in-difference analyses. RESULTS: In total, 3934 women were included. The adoption of robotic-assisted surgery did not demonstrate statistically significant implications for total costs among obese women (€3,417; 95% confidence interval [CI] -€854 to €7,688, p = 0.117). Further, for obese women, a statistically significant reduction in bed days related to the index hospitalization was demonstrated (-1.9 bed days; 95% CI -3.6 to -0.2, p = 0.025). However, for non-obese women, the adoption of robotic-assisted surgery was associated with statistically significant total costs increments of €9,333 (95% CI €3,729-€1,4936, p = 0.001) and no reduction in bed days related to the index hospitalization was observed (+0.9 bed days; 95% CI -0.6 to 2.3, p = 0.242). CONCLUSIONS: The national investment in robotic-assisted surgery for endometrial cancer seems to have more modest cost implications post-surgery for obese women. This may be partly driven by a significant reduction in bed days related to the index hospitalization among obese women, as well as reductions in subsequent hospitalizations.

Epithelial ovarian cancer and the use of circulating tumor DNA: A systematic review.

OBJECTIVE: One way to improve the survival rate of epithelial Ovarian Cancer (EOC) is by identifying effective biomarkers useful at different stages and time points of the disease. A potential biomarker is circulating tumor DNA (ctDNA) in plasma or serum. In this systematic review, we provide an overview of applications of ctDNA in EOC to discuss the direction of future research in this field. METHODS: We performed a systematic search in Pubmed, Embase, and Scopus to identify relevant clinical studies eligible for inclusion. Furthermore, the references in the identified studies and relevant reviews were assessed to identify additional studies. The PRISMA guideline was employed to perform the systematic review, and data from the studies were extracted using piloted data extraction forms. RESULTS: A total of 36 observational studies were included. The concordance between tumor and ctDNA was assessed in 19 studies, early diagnosis in 1, diagnosis in 23, monitoring of treatment response in 7, detection of reversion mutations in 3, prognosis in 9, but no studies assessed early detection of recurrence. Data from the studies were reported descriptively. The studies had a large variation in the methods used for ctDNA analysis and limited sample sizes of 10-126 patients. Overall, the studies show that ctDNA is a potential biomarker for EOC useful in several settings during assessment and treatment of these patients. CONCLUSIONS: Although the identified studies are limited in number and their methods for ctDNA analysis vary, it is clear that ctDNA as a biomarker for EOC is promising for several applications in diagnostics, monitoring of treatment response, and prognostics. However, more studies are needed to establish the ideal methods and settings for the clinical use of ctDNA in EOC.

One-way SMS and healthcare outcomes in Africa: Systematic review of randomised trials with meta-analysis.

BACKGROUND: The impact of one-way SMS on health outcomes in Africa is unclear. We aimed to conduct a systematic review of one-way SMS randomised trials in Africa and a meta-analysis of their effect on healthcare appointments attendance and medicine adherence. METHODS: PubMed, Embase, CENTRAL, The Global Health Library, ClinicalTrials.gov, ICTRP, and PACTR were searched for published and unpublished trials in Africa without language restriction (up to April 2018). Trials reporting effect estimates on healthcare appointment attendance and medicine adherence were assessed for risk of bias and included in meta-analyses using random-effects models. Other outcomes were reported descriptively. The protocol is registered in PROSPERO, ID:CRD42018081062. RESULTS: We included 38 one-way SMS trials conducted in Africa within a broad range of clinical conditions. Eighteen trials were included in the meta-analyses, and four were assessed as overall low risk of bias. One-way SMS improved appointment attendance, OR:2·03; 95% CI:1·40-2·95 (12 trials, 6448 participants), but not medicine adherence, RR:1·10; 95% CI:0·98-1·23 (nine trials, 4213 participants). Subgroup analyses showed that one-way SMS had the highest impact on childhood immunization attendance, OR:3·69; 95% CI:1·67-8·13 (three trials, 1943 participants). There was no clear evidence of one-way SMS improving facility delivery, knowledge level (reproductive/antenatal health, hypertension), diabetes- and hypertension management. CONCLUSION: In an African setting, the clinical effect of one-way SMS is uncertain except for appointment attendance where the effect seems to vary depending on which clinical condition it is used in.

Long term resource consequences of a nationwide introduction of robotic surgery for women with early stage endometrial cancer.

OBJECTIVE: The majority of cost-studies related to robotic surgery has a short follow-up and primarily report the costs from the index surgery. The aim of this study was to evaluate the long-term resource consequences of introducing robotic surgery for early stage endometrial cancer in Denmark. METHODS: The study included all women with early stage endometrial cancer who underwent robotic, laparoscopic and open access surgery from January 2008 to June 2015. Data was linked from national databases to determine resource consumption and costs from hospital treatments, outpatient contacts, primary health care sector visits, labor market affiliation and prescription of medication. Each patient was observed in a period of 12 months before- and after surgery. The key exposure variable was women who were exposed to robotic surgery compared to those who were not. RESULTS: A total of 4133 women underwent surgery for early stage endometrial cancer. The study found additional costs of $7309 (95% confidence interval [CI] 2100-11,620, P = 0.001) per patient in the group exposed to robotic surgery including long-term costs post-surgery compared to the non-exposed group (non-robotic group). When controlling for time trends, the introduction of robotic surgery did not reduce the number of bed days (mean diff -0.42, 95% CI -3.03-2.19, P = 0.752). CONCLUSIONS: The introduction of robotic surgery for early stage endometrial cancer did not generate any long-term cost savings. The additional costs of robotic surgery were primarily driven by the index surgery. Any reduction in bed days could be explained by time trends.

Nationwide Introduction of Minimally Invasive Robotic Surgery for Early-Stage Endometrial Cancer and Its Association With Severe Complications.

Importance: Minimally invasive laparoscopic surgery (MILS) for endometrial cancer reduces surgical morbidity compared with a total abdominal hysterectomy. However, only a minority of women with early-stage endometrial cancer undergo MILS. Objective: To evaluate the association between the Danish nationwide introduction of minimally invasive robotic surgery (MIRS) and severe complications in patients with early-stage endometrial cancer. Design, Setting, and Participants: In this nationwide prospective cohort study of 5654 women with early-stage endometrial cancer who had undergone surgery during the period from January 1, 2005, to June 30, 2015, data from the Danish Gynecological Cancer Database were linked with national registers on socioeconomic status, deaths, hospital diagnoses, and hospital treatments. The women were divided into 2 groups; group 1 underwent surgery before the introduction of MIRS in their region, and group 2 underwent surgery after the introduction of MIRS. Women with an unknown disease stage, an unknown association with MIRS implementation, unknown histologic findings, sarcoma, or synchronous cancer were excluded, as were women who underwent vaginal or an unknown surgical type of hysterectomy. Statistical analysis was conducted from February 2, 2017, to May 4, 2018. Exposure: Minimally invasive robotic surgery, MILS, or total abdominal hysterectomy. Main Outcomes and Measures: Severe complications were dichotomized and encompassed death within 30 days after surgery and intraoperative and postoperative complications diagnosed within 90 days after surgery. Results: A total of 3091 women (mean [SD] age, 67 [10] years) were allocated to group 1, and a total of 2563 women (mean [SD] age, 68 [10] years) were allocated to group 2. In multivariate logistic regression analyses, the odds of severe complications were significantly higher in group 1 than in group 2 (odds ratio [OR], 1.39; 95% CI, 1.11-1.74). The proportion of women undergoing MILS was 14.1% (n = 436) in group 1 and 22.2% in group 2 (n = 569). The proportion of women undergoing MIRS in group 2 was 50.0% (n = 1282). In group 2, multivariate logistic regression analyses demonstrated that a total abdominal hysterectomy was associated with increased odds of severe complications compared with MILS (OR, 2.58; 95% CI, 1.80-3.70) and MIRS (OR, 3.87; 95% CI, 2.52-5.93). No difference was found for MILS compared with MIRS (OR, 1.50; 95% CI, 0.99-2.27). Conclusions and Relevance: The national introduction of MIRS changed the surgical approach for early-stage endometrial cancer from open surgery to minimally invasive surgery. This change in surgical approach was associated with a significantly reduced risk of severe complications.

Survival after a nationwide introduction of robotic surgery in women with early-stage endometrial cancer: a population-based prospective cohort study.

PURPOSE: The purpose of the study was to evaluate the association between a nationwide introduction of robotic minimally invasive surgery (RMIS) and survival in women with early-stage endometrial cancer. MATERIALS AND METHODS: Prospective data on consecutive women with early-stage endometrial cancer who underwent surgery during January 2005 to June 2015 in Denmark were identified in the nationwide Danish Gynaecological Cancer Database. Data were linked with national registries regarding comorbidity, education, income and death. The cohort was divided according to the time they underwent surgery: Group 1 before RMIS introduction in their respective region and Group 2 after RMIS introduction. Five-year overall survival was compared by multivariate Cox proportional hazards models stratified by histopathological risk between Groups 1 and 2 and between surgical modalities within Group 2: total abdominal hysterectomy (TAH), laparoscopic minimally invasive surgery (LMIS) and RMIS. RESULTS: Women in Group 1 (N = 3091) had significantly lower overall survival compared with those in Group 2 (N = 2563; hazard ratio [HR], 1.22; 95% confidence interval [CI], 1.05-1.42). Age, smoking, socioeconomic status, American Society of Anaesthesiologists (ASA) score, comorbidity and histopathological risk influenced the overall survival. Following RMIS adoption, TAH was associated with higher mortality compared with LMIS and RMIS (HR, 1.42; 95% CI 1.02-1.97 and HR, 1.70; 95% CI 1.31-2.19 for LMIS and RMIS, respectively). There was no significant survival difference between RMIS and LMIS (HR, 1.19; 95% CI 0.85-1.68). CONCLUSION: The national introduction of robotic surgery for early-stage endometrial cancer was associated with improved survival irrespective of age, body mass index, ASA score, comorbidity, smoking, socioeconomic status and histopathological risk.

A systematic review about costing methodology in robotic surgery: evidence for low quality in most of the studies.

OBJECTIVES: The main objective of this review was to evaluate the methodological design in studies reporting resource use and costs related to robotic surgery in gynecology. METHODS: Systematic searches were performed in the databases PubMed, Embase, Scopus, and The Centre for Reviews and Dissemination database for relevant studies before May 2016. The quality of the methodological design was assessed with items regarding methodology from the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). The systematic review was reported according to the PRISMA guidelines. RESULTS: Thirty-two relevant studies were included. None of the reviewed studied fully complied with the CHEERS methodological checklist. Background and objectives, Target population and subgroups and Setting and location were covered in sufficient details in all studies whereas the Study perspective, Justification of the time horizon, Discount rate, and Estimating resources and costs were covered in less than 50%. Most of the studies (29/32) used the health care sector perspective whereas the societal perspective was applied in three studies. The time horizon was stated in 18/32 of the studies. CONCLUSIONS: The methodological quality of studies evaluating costs of robotic surgery was low. The longest follow-up was 4 months and in general, the use of detailed cost data were lacking in most of the investigations. Key determinants, such as purchasing, maintenance costs of the robotic platform, and the use of surgical equipment, were rarely reported. If health care cost analyses lack transparency regarding cost drivers included it may not provide a true foundation for decision-making.

Detection of recurrence in early stage endometrial cancer - the role of symptoms and routine follow-up.

BACKGROUND: Considerable controversy remains as to the optimal organization of endometrial cancer follow-up. AIM: To evaluate the relationship between the way recurrence was detected and survival after treatment for endometrial cancer. Further, to identify characteristics associated with a pre-scheduled examination in women with symptomatic recurrence. MATERIAL AND METHODS: All women with early stage endometrial cancer during 2005-2009 were included in a population-based historical cohort derived from the Danish Gynecological Cancer Database. Women diagnosed with recurrence within three years after primary surgery and the mode of recurrence detection were identified from hospital charts: asymptomatic recurrence detected at regular follow-up, symptomatic recurrence detected at regular follow-up or symptomatic recurrence detected in between follow-up. Survival of women with symptomatic and asymptomatic disease was compared. Furthermore, characteristics associated with self-referral as compared to presenting symptoms at regular follow-ups were identified using univariate analyses. RESULTS: In total, 183 cases of recurrence (7%) were identified in the cohort of 2612 women. Of these, 65.5% were symptomatic with vaginal bleeding as the most prevalent symptom. Asymptomatic women had a significantly better three-year survival rate compared to symptomatic women (80.3% vs. 54.3%, p < 0.01). A total of 2.3% of the entire population had an asymptomatic recurrence. Women diagnosed at a pre-scheduled visit due to symptoms had a higher educational level (p = 0.03) and more often high-risk disease (p = 0.02) than symptomatic women diagnosed at regular follow-up. CONCLUSION: Early stage endometrial cancer carries a low risk of recurrence. Survival appears to be superior in asymptomatic patients, but length-time bias, i.e. the effect of aggressive tumor biology in symptomatic recurrences, may bias results in non-randomized controlled trials. Well educated patients with symptoms of recurrence more often sought medical attendance compared to less educated counterparts. This should be considered if patient-initiated follow-up is the standard care.

Systematic review of same-day discharge after minimally invasive hysterectomy.

BACKGROUND: Same-day discharge has been suggested to safe and acceptable following minimally invasive hysterectomy. OBJECTIVES: To evaluate the feasibility of same-day discharge following minimally invasive hysterectomy and to identify associated factors. SEARCH STRATEGY: Medline, Embase and the Cochrane Central Register of Controlled Trials were systematically searched using the terms "same day discharge", "minimally invasive surgery", and "hysterectomy" between October 1 and October 31, 2015. No language or publication date restrictions were included. SELECTION CRITERIA: Randomized controlled trials and observational studies evaluating same-day discharge before midnight on the day of minimally invasive hysterectomy were included. DATA COLLECTION AND ANALYSIS: Study characteristics, pre-operative selection criteria, and predictive factors for same-day discharge were analyzed. MAIN RESULTS: There were 15 observational studies with 11 992 patients included. Significant heterogeneity was observed in the studies, and publication and selection bias could have potentially affected the results. All the studies concluded that same-day discharge was feasible. However, some factors were associated with a decreased possibility of same-day discharge; these were older age, beginning surgery later than 1:00 pm and completing surgery later than 6:00 pm, longer duration of operation, and high estimated blood loss. CONCLUSIONS: Same-day discharge appears feasible for a majority of patients who undergo minimally invasive hysterectomies if adequate emphasis is placed on pre-surgical planning and careful patient selection.