Quality of Reporting on Anastomotic Leaks in Colorectal Cancer Trials: A Systematic Review.

BACKGROUND: Although attempts have been made in the past to establish consensus regarding the definitions and grading of the severity of colorectal anastomotic leakage, widespread adoption has remained limited. OBJECTIVE: A systematic review of the literature was conducted with the objective of examining the various elements used to report and define anastomotic leakage in colorectal cancer resections. DATA SOURCES AND STUDY SELECTION: A systematic review, using the PubMed, Embase, and Cochrane Library Database, of all published randomized controlled trials, systematic reviews, and meta-analyses containing data related to adult patients undergoing colorectal cancer surgery and reporting anastomotic leakage as a primary or secondary outcome, with a definition of anastomotic leakage included. OUTCOMES: Definitions of anatomotic leakage, clinical symptoms, radiological modalities and findings, findings at reoperation, as well as grading terminology or classifications for anastomotic leakage. RESULTS: Of the 471 articles reporting anastomotic leakage as a primary or secondary outcome, a definition was reported in 95 studies (45 randomized controlled trials, 13 systematic reviews, and 37 meta-analyses), involving a total of 346,140 patients. Of these 95 articles, 68% reported clinical signs and symptoms of anastomotic leakage, 26% biochemical criteria, 63% radiological modalities, 62% radiological findings, and 13% findings at reintervention. Only 45% (n = 43) of included studies reported grading of anastomotic leakage severity or leak classification, and 41% (n = 39) included a timeframe for reporting. LIMITATIONS: There was a high heterogeneity between the included studies. CONCLUSION: This evidence synthesis confirmed incomplete and inconsistent reporting of anastomotic leakage across the published colorectal cancer literature. There is a great need for the development and implementation of a consensus framework for defining, grading, and reporting anastomotic leakage. REGISTRATION: Prospectively registered at PROSPERO ID 454660.

Toward a core outcome set for faecal incontinence-A systematic review of outcomes reported in the literature.

AIM: Faecal incontinence (FI) is a prevalent issue which can have a detrimental impact on the patient's quality of life. Current international guidelines lack strong treatment recommendations due to few studies in the field, in combination with the heterogeneity in outcome reporting. To address this, a core outcome set (COS) is proposed to standardize outcome reporting in FI studies, facilitating meta-analyses and enhancing therapeutic recommendations. Through several steps outlined by COMET 'what' to measure will be determined prior to determining 'how' to measure these outcomes. This systematic review aims to identify 'what' outcomes have been used in FI intervention studies so far in adult patients as a starting phase for the development of a future COS for FI. METHOD: Medline, Embase and the Cochrane library were searched to identify all outcomes reported in comparative effectiveness trials assessing one or more treatment option in adult patients suffering from FI. The outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to standardize outcome terminology, assess completeness, and inform subsequent steps in COS development. RESULTS: A total of 109 studies were included, which revealed 51 unique outcomes classified into 38 domains within four core areas. On average four outcomes were reported per study (range 1-11). The most commonly reported outcomes were "severity of FI" (83%), "quality of life" (64%), "number of FI episodes" (40%), "anorectal motor function" (39%), and "frequency of bowel movements" (16%). CONCLUSION: This systematic review offers an overview of outcomes reported in FI studies, highlighting the heterogeneity between studies. This heterogeneity emphasizes the need for standardizing outcome reporting which can be established through the creation of a COS.

English translation and cross-cultural validation of the patient-reported outcome measurement-haemorrhoidal impact and satisfaction score (PROM-HISS).

AIM: The aim of this study was to translate the Dutch patient-reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS) to English and perform a cross-cultural validation. METHOD: The ISPOR good practice guidelines for the cross-cultural validation of PROMs were followed and included two steps: (1) Two forward and two backward translations. The forward translation concerned the translation from the source language (Dutch) to the target language (English), performed by two independent English speakers, one medical doctor and one nonmedical. Subsequently, a discussion about discrepancies in the reconciled version was performed by a stakeholder group. (2) Cognitive interviews were held with patients with haemorrhoidal disease (HD), probing the comprehensibility and comprehensiveness of the PROM-HISS. RESULTS: Discrepancies in the reconciled forward translation concerned the terminology of HD symptoms. Furthermore, special attention was paid to the response options, ranging from "not at all", indicating minor symptoms, to "a lot", implying many symptoms. Consensus among the stakeholder group about the final version of the translated PROM-HISS was reached. Interviews were conducted with 10 native English-speaking HD patients (30% female), with a mean age of 44 years (24-83) and primarily diagnosed with grade II HD (80%). The mean time to complete the PROM-HISS was 1 min 43 s. Patients showed a good understanding of the questions and response options, found all items relevant and did not miss important symptoms or topics. CONCLUSION: The translated English language PROM-HISS is a valid tool to assess symptoms of HD, its impact on daily activities and patient satisfaction with HD treatment.

Responsiveness of the Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score in patients with haemorrhoidal disease.

AIM: In this study we aimed to assess the responsiveness of the symptom score of the recently developed Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score (PROM-HISS). Furthermore, the minimally relevant difference (MRD) was determined. METHOD: The responsiveness of PROM-HISS was tested using a criterion-based (i.e. anchor) and construct-based (i.e. hypotheses testing) approach. Patients with haemorrhoidal disease (HD) completed the PROM-HISS before and 1 week after treatment in hospital. A global self-assessment of change question (SCQ) was administered 1-week after treatment and functioned as the criterion. The following analyses were performed: (1) correlation between the PROM-HISS symptom score and the criterion (SCQ) and (2) hypotheses testing. The MRD was determined as change in symptoms of the subgroup reporting 'somewhat fewer complaints' on the SCQ. RESULTS: Between February and August 2022, 94 patients with grade II-IV HD from three hospitals were included. The correlation between the SCQ and a change on the PROM-HISS symptom score was 0.595 indicating that an improvement on the SCQ corresponds to an improvement on the PROM-HISS symptom score. As hypothesized, the mean change in PROM-HISS scores was significantly different between subgroups of patients based on their SCQ responses. Patients reporting a small change in HD symptoms on the SCQ corresponded to a mean change of 0.3 on the PROM-HISS symptom score. CONCLUSION: The PROM-HISS symptom score is a responsive instrument as it identifies change in HD symptoms because of treatment. The estimated MRD of 0.3 can be used to inform clinical research and practice.

The patient perspective on the preoperative colorectal cancer care pathway and preparedness for surgery and postoperative recovery-a qualitative interview study.

BACKGROUND AND OBJECTIVES: This study aimed to explore colorectal cancer (CRC) patients' perspectives and experiences regarding the preoperative surgical care pathway and their subsequent preparedness for surgery and postoperative recovery. METHODS: CRC patients were recruited using purposive sampling and were interviewed three times (preoperatively, and 6 weeks and 3 months postoperatively) using semistructured telephone interviews. Interviews were audiotaped, transcribed verbatim and analysed independently by two researchers using thematic analysis with open coding. RESULTS: Data saturation was achieved after including 18 patients. Preoperative factors that contributed to a feeling of preparedness for surgery and recovery were patient-centred- and professional healthcare organization, sincere and personal guidance, and thorough information provision. Postoperatively, patients with complications or physical complaints experienced unmet information needs regarding the impact of complications and what to expect from postoperative recovery. CONCLUSIONS: The preoperative period is a vital period to prepare patients for surgery and recovery in which patients most value personalized information, personal guidance and professionalism. According to CRC patients, the feeling of preparedness for surgery and recovery can be improved by continually providing dosed information. This information should provide the patient with patient-tailored perspectives regarding the impact of (potential) complications and what to expect during recovery.

The effectiveness of health education interventions on cervical cancer prevention in Africa: A systematic review.

Low levels of knowledge and awareness on cervical cancer play a role in limiting cervical cancer prevention uptake. This systematic review aimed to identify effective educational interventions to increase cervical cancer awareness, knowledge, and subsequently screening or vaccination uptake in African women. A literature search was conducted in Medline and EMBASE databases. We examined original, peer-reviewed English literature published between 2005 and 2020. Nineteen studies examining health education interventions' impact on awareness, knowledge, and screening or vaccination uptake in African women were included. Ten studies were controlled trials, nine performed pre- and post-measurements in one group. Most studies were published between 2015 and 2020 (86%), many were from Nigeria (47%). Studies were mostly set up in communities and schools. The most frequently used intervention was lectures, alone or combined with videos and practical demonstrations. Sixteen studies evaluated knowledge or awareness, and all showed a statistically significant improvement following the intervention. Of the ten studies that evaluated screening uptake, either as the single outcome or combined with knowledge or awareness, six found a significant rise in screening uptake after intervention. Educational interventions increased knowledge and awareness in African women, some boosted uptake of cervical cancer screening, especially when using peer health educators and culturally tailored methods. Innovative approaches such as self-collected HPV testing and mHealth also demonstrated a potential to increase uptake of screening. More research is needed to identify and analyse barriers to screening uptake, which can still be present even after a successful educational intervention.

Patient reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS): Development, reliability and construct validity.

AIM: Haemorrhoidal disease (HD) is a frequently occurring disorder with a significant negative impact on a patient's quality of life. Here, we describe the development and validation of the Dutch patient reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS). METHODS: The development of the PROM-HISS followed recommended guidelines. Face and content validity, structural properties, reliability and construct validity were evaluated in a HD population. Reliability was tested by assessing the test-retest reliability, defined by the intraclass correlation coefficient (ICC), and internal consistency measured with Cronbach's alpha. Construct validity was evaluated using confirmatory factor analysis (CFA) and hypotheses testing. RESULTS: The PROM-HISS consists of three domains: (1) HD symptoms (blood loss; pain; prolapse; soiling; itching), (2) impact of symptoms on daily activities, and (3) satisfaction with treatment. The PROM-HISS showed good face and content validity. The PROM-HISS was completed by 102 patients (65% male), with a mean age of 58 years (23-81 years). The ICCs of the different items in the domain HD symptoms ranged between 0.56 and 0.79 and were interpreted as good. The Cronbach's alpha value was 0.80 and considered satisfactory. The CFA provided further evidence for construct validity with a good model fit. A high score on the symptoms of HD correlated with a high impact of HD on daily activities (Pearson's r = 0.632, p < 0.01) and a low degree of satisfaction (Pearson's r = 0.378, p < 0.01). CONCLUSION: The PROM-HISS is a reliable and valid instrument to evaluate symptoms of HD, impact on daily activities and satisfaction with treatment.

Living with cryptoglandular anal fistula: a qualitative investigation of the patient's experience through semi-structured patient interviews.

PURPOSE: Cryptoglandular anal fistula continues to be a subject of extensive surgical research due to the lack of effective and enduring treatments, some of which incur risks to continence and quality of life. However, the patient experience of disease has seldom been reported. The aims of this study are to understand the impact of living with a fistula and the treatment outcomes that are valued by patients. METHODS: Patients with cryptoglandular anal fistula were recruited using purposive sampling from two tertiary referral centres in the UK and the Netherlands. Patients underwent semi-structured interviews that were audio-recorded and transcribed verbatim. Dutch transcripts were translated into English and underwent independent, thematic analysis using open coding by two study team members to identify common themes and sub-themes. RESULTS: Twenty interviews were conducted before saturation was reached (11 male, median age 49, Interquartile range 39-55 years). Four broad themes emerged, covering the physical symptoms of fistula, the patient journey towards understanding the condition, life impact, and treatment. Several inter-related sub-themes were found, reflecting the extensive impact and adjustment that the disease entails. CONCLUSION: The impact of cryptoglandular anal fistula extends beyond the physical symptoms of pain and discharge, requires significant readjustment, and often negatively impacts psycho-social wellbeing. These aspects of disease should receive greater attention in future assessment of treatment and quality of life.

The development of a faecal incontinence core outcome set: an international Delphi study protocol.

PURPOSE: Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI. METHODS: Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS. DISCUSSION: This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care. TRIAL REGISTRATION: This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554 . The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336 .

Burden of disease experienced by patients following a watch-and-wait policy for locally advanced rectal cancer: A qualitative study.

AIM: Patient-reported outcome measures (PROMs) are increasingly being used in routine cancer care to evaluate treatment and monitor symptoms, function and other aspects of quality of life (QoL). There is no suitable PROM for rectal cancer patients following a watch-and-wait (W&W) programme. Insight into patient experiences with this programme is an essential step in the development of a PROM. The aim of this qualitative study was to provide insights into the most important functional outcomes and QoL features experienced by patients during our W&W programme. METHOD: Patients with locally advanced rectal cancer who are enrolled in the W&W programme in the Netherlands were interviewed by telephone using a semistructured interview guide. All interviews were digitally audio-recorded, transcribed verbatim and coded. A thematic approach was used to analyse the data and identify themes and subthemes of importance to patients. RESULTS: Eighteen patients were interviewed (78% male, mean age 68 years, range 52-83 years). Physical complaints after treatment were present, most notably gastrointestinal problems, neuropathy and fatigue. Furthermore, patients were anxious about a possible recurrence, had a fear of surgery or a stoma, or were experiencing a general feeling of apprehension in daily life. Many patients had different coping mechanisms, such as acceptance, and there were few limitations in daily life. CONCLUSION: We identified important functional outcomes, such as gastrointestinal complaints, fatigue and neuropathy, in patients who were enrolled in this W&W programme. Furthermore, an emotional burden and unmet needs were reported by these patients. These findings can be used to improve clinical practice and inform the development of a PROM.

Patient outcomes, patient experiences and process indicators associated with the routine use of patient-reported outcome measures (PROMs) in cancer care: a systematic review.

PURPOSE: In current cancer care, there is a growing debate about the value of using patient-reported outcome measures (PROMs) in daily clinical follow-up. A systematic review of the literature was conducted to assess the evidence of the effectiveness of the routine use of PROMs in daily cancer care in terms of patient outcomes, patient experiences and process indicators and to identify the effect of giving feedback about PROM findings to patients and/or health care professionals (HCPs). METHODS: A systematic search was performed. Studies were eligible for inclusion when they (1) used a PROM as an intervention, with or without feedback to patients and/or HCPs, compared with not using a PROM, and (2) used a PROM as an intervention with feedback to patients and/or HCPs, compared with using a PROM without giving feedback to patients and/or HCPs. RESULTS: After screening of 8341 references, 22 original studies met the inclusion criteria. Most studies found a positive effect on survival, symptoms, HRQoL and patient satisfaction. In general, using feedback to patient and/or HCPs about the PROM results led to better symptom control, HRQoL, patient satisfaction and patient-doctor communication. The majority of included studies had insufficient power to detect significant differences in the outcomes assessed. CONCLUSION: This review shows that predominantly positive findings were found in the use of a PROM in daily cancer care. Additionally, more positive effects were seen when feedback is provided to patient and/or health care professionals, and it is thus highly recommended that this is always done.

Heterogeneous outcome reporting in adult slow-transit constipation studies: Systematic review towards a core outcome set.

BACKGROUND AND AIM: Standardizing evaluative outcomes and their assessment facilitates comparisons between clinical studies and provides a basis for comparing direct effects of different treatment options. The aim of this study was to systematically review types of outcomes and measurement instruments used in studies regarding treatment options for slow-transit constipation (STC) in adults. METHODS: In this systematic review of the literature, we searched MEDLINE, Embase, and PsycINFO from inception through February 2018, for papers assessing any STC treatment in adult patients. Outcomes were systematically extracted and categorized in domains using the conceptual framework of the Outcome Measures in Rheumatology filter 2.0. Outcome reporting was stratified by decade of publication, intervention, and study type. RESULTS: Forty-seven studies were included in this systematic review. Fifty-nine different types of outcomes were identified. The outcomes were structured in three core areas and 18 domains. The most commonly reported domains were defecation functions (94%), gastrointestinal transit (53%), and health-care service use (51%). The most frequently reported outcomes were defecation frequency (83%), health-related quality of life (43%), and adverse events and complications (43%). In 62% of the studies, no primary outcome was defined, whereas in two studies, more than one primary outcomes were selected. A wide diversity of measurement instruments was used to assess the reported outcomes. CONCLUSION: Outcomes reported in studies on STC in adults are heterogeneous. A lack of standardization complicates comparisons between studies. Developing a core outcome set for STC in adults could contribute to standardization of outcome reporting in (future) studies.

Health-related quality of life and psychological distress among cancer survivors in a middle-income country.

OBJECTIVES: Quality of life and psychological well-being are important patient-centered outcomes, which are useful in evaluation of cancer care delivery. However, evidence from low-income and middle-income countries remains scarce. We assessed health-related quality of life (HRQoL) and prevalence of psychological distress (anxiety or depression), as well as their predictors, among cancer survivors in a middle-income setting. METHODS: Through the Association of Southeast Asian Nations Costs in Oncology study, 1490 newly diagnosed cancer patients were followed-up in Malaysia for 1 year. Health-related quality of life was assessed by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EuroQol-5 (EQ-5D) dimension questionnaires at baseline, 3 and 12 months. Psychological distress was assessed by using Hospital Anxiety and Depression Scale. Data were modeled by using general linear and logistic regressions analyses. RESULTS: One year after diagnosis, the mean EORTC QLQ-C30 Global Health score of the cancer survivors remained low at 53.0 over 100 (SD 21.4). Fifty-four percent of survivors reported at least moderate levels of anxiety, while 27% had at least moderate levels of depression. Late stage at diagnosis was the strongest predictor of low HRQoL. Increasing age, being married, high-income status, hospital type, presence of comorbidities, and chemotherapy administration were also associated with worse HRQoL. The significant predictors of psychological distress were cancer stage and hospital type. CONCLUSION: Cancer survivors in this middle-income setting have persistently impaired HRQoL and high levels of psychological distress. Development of a holistic cancer survivorship program addressing wider aspects of well-being is urgently needed in our settings.

Catastrophic health expenditure and 12-month mortality associated with cancer in Southeast Asia: results from a longitudinal study in eight countries.

BACKGROUND: One of the biggest obstacles to developing policies in cancer care in Southeast Asia is lack of reliable data on disease burden and economic consequences. In 2012, we instigated a study of new cancer patients in the Association of Southeast Asian Nations (ASEAN) region - the Asean CosTs In ONcology (ACTION) study - to assess the economic impact of cancer. METHODS: The ACTION study is a prospective longitudinal study of 9,513 consecutively recruited adult patients with an initial diagnosis of cancer. Twelve months after diagnosis, we recorded death and household financial catastrophe (out-of-pocket medical costs exceeding 30% of annual household income). We assessed the effect on these two outcomes of a range of socio-demographic, clinical, and economic predictors using a multinomial regression model. RESULTS: The mean age of participants was 52 years; 64% were women. A year after diagnosis, 29% had died, 48% experienced financial catastrophe, and just 23% were alive with no financial catastrophe. The risk of dying from cancer and facing catastrophic payments was associated with clinical variables, such as a more advanced disease stage at diagnosis, and socioeconomic status pre-diagnosis. Participants in the low income category within each country had significantly higher odds of financial catastrophe (odds ratio, 5.86; 95% confidence interval, 4.76-7.23) and death (5.52; 4.34-7.02) than participants with high income. Those without insurance were also more likely to experience financial catastrophe (1.27; 1.05-1.52) and die (1.51; 1.21-1.88) than participants with insurance. CONCLUSIONS: A cancer diagnosis in Southeast Asia is potentially disastrous, with over 75% of patients experiencing death or financial catastrophe within one year. This study adds compelling evidence to the argument for policies that improve access to care and provide adequate financial protection from the costs of illness.

The effectiveness of interventions to reduce the household economic burden of illness and injury: a systematic review.

OBJECTIVE: To determine the nature, scope and effectiveness of interventions to reduce the household economic burden of illness or injury. METHODS: We systematically reviewed reports published on or before 31 January 2014 that we found in the CENTRAL, CINAHL, Econlit, Embase, MEDLINE, PreMEDLINE and PsycINFO databases. We extracted data from prospective controlled trials and assessed the risk of bias. We narratively synthesized evidence. FINDINGS: Nine of the 4330 studies checked met our inclusion criteria ­ seven had evaluated changes to existing health-insurance programmes and two had evaluated different modes of delivering information. The only interventions found to reduce out-of-pocket expenditure significantly were those that eliminated or substantially reduced co-payments for a given patient population. However, the reductions only represented marginal changes in the total expenditures of patients. We found no studies that had been effective in addressing broader household economic impacts ­ such as catastrophic health expenditure ­ in the disease populations investigated. CONCLUSION: In general, interventions designed to reduce the complex household economic burden of illness and injury appear to have had little impact on household economies. We only found a few relevant studies using rigorous study designs that were conducted in defined patient populations. The studies were limited in the range of interventions tested and they evaluated only a narrow range of household economic outcomes. There is a need for method development to advance the measurement of the household economic consequences of illness and injury and facilitate the development of innovative interventions to supplement the strategies based on health insurance.

The relationship between economic characteristics and health-related quality of life in newly diagnosed cancer patients in Southeast Asia: results from an observational study.

PURPOSE: We investigate whether cancer patients' economic characteristics are independent determinants of health-related quality of life (HRQoL) in low- and middle-income settings to identify priorities for health policy and research. METHODS: A cross-sectional survey of 9,513 cancer patients from Southeast Asia provided data on demographics, economic status and HRQoL. HRQoL was measured using the EORTC QLQ-C30 and EQ-5D. Information on cancer site and stage was collected using the patients' medical records. Multiple linear regression analysis estimated the relative impact of economic characteristics (i.e. health insurance, employment status, household income and economic hardship) on HRQoL. RESULTS: All economic characteristics were significant independent determinants of HRQoL, when we controlled for demographic and clinical characteristics. Economic hardship was found to be most important. The adjusted mean differences in HRQoL scores between patients who had experienced economic hardship in the year before diagnosis compared to patients who did not were -5.6, -6.7, -7.3 and -0.06, respectively, for global health, physical function, emotional function and the EQ-5D index (all p values <0.001). Subgroup analyses showed that this significant result for economic hardship as a predictor of poor HRQoL was consistent across all age groups, for males and females, and across all levels of education. CONCLUSIONS: Living in poor economic circumstances before a cancer diagnosis is associated with greatly impaired HRQoL after diagnosis. There is wide scope for research on innovative interventions that provide low-cost and targeted support aimed to improve health outcomes of disadvantaged cancer patients in low- and middle-income settings.

The N-LVA Study: effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) for patients with cancer who suffer from chronic peripheral lymphoedema - study protocol of a multicentre, randomised sham-controlled trial.

INTRODUCTION: Cancer-related lymphoedema is one of the most debilitating side-effects of cancer treatment with an overall incidence of 15.5%. Patients may suffer from a variety of symptoms, possibly resulting in a diminished health-related quality of life (HRQoL). A microsurgical technique known as lymphaticovenous anastomosis (LVA) might be a promising treatment option. The objective of this study is to evaluate whether LVA is effective and cost-effective compared with sham surgery in improving the HRQoL. METHODS AND ANALYSIS: A multicentre, double-blind, randomised sham-controlled trial conducted in three university hospitals in the Netherlands. The study population comprises 110 patients over the age of 18 years with unilateral, peripheral cancer-related lymphoedema, including 70 patients with upper limb lymphoedema and 40 patients with lower limb lymphoedema. A total of 55 patients will undergo the LVA operation, while the remaining 55 will undergo sham surgery. The follow-up will be at least 24 months. Patients are encouraged to complete the follow-up by explaining the importance of the study. Furthermore, patients may benefit from regular monitoring moments for their lymphoedema. The primary outcome is the HRQoL. The secondary outcomes are the limb circumference, excess limb volume, changes in conservative therapy, postoperative complications, patency of the LVA and incremental cost-effectiveness. ETHICS AND DISSEMINATION: The study was approved by the Medical Ethical Committee of Maastricht University Medical Center on 20 September 2023 (NL84169.068.23). The results will be presented at scientific conferences and published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT06082349.

Supporting follow-up care in colorectal cancer patients: first experiences with the Assessment of Burden of ColoRectal Cancer (ABCRC)-tool.

PURPOSE: The Assessment of Burden of ColoRectal Cancer (ABCRC)-tool is a unique tool that includes a PROM focused on health-related quality of life (HRQoL), functional outcomes and lifestyle assessment. Furthermore, it provides visualization of results and treatment advice. The tool aims to support follow-up consultations of colorectal cancer (CRC) patients. The purpose of this study was to evaluate the first experiences of patients and healthcare professionals (HCPs) with the ABCRC-tool. METHODS: The ABCRC-tool was implemented in two Dutch hospitals and used by 25 patients and 5 HCPs during follow-up care. Consultations were audio-recorded and their content was analyzed independently by two researchers. Semi-structured interviews with patients and HCPs were conducted after the consultation. Interviews focused on the overall experience with the tool, ease of use, interpretation of the PROM and the visualized results and on the added value of the tool. RESULTS: Audio recording revealed that multiple topics, relevant to patients, were discussed during consultations with the ABCRC-tool. Patients and HCPs appreciated the ABCRC-tool as it added structure to the consultation, was helpful in the preparation of consultations and provided useful and convenient treatment options. The tool was easy to use, and the visualization was clear and informative. HCPs suggested that the tool is likely to be most relevant for patients in the first year of follow-up. CONCLUSIONS: This study implies that the ABCRC-tool is of added value for patients and their HCPs. Future research should focus on the evaluation of broad implementation, across a wide range of CRC patients. IMPLICATIONS FOR CANCER SURVIVORS: The ABCRC-tool is a valid tool to support CRC survivors and HCPs to monitor and visualize experienced burden of disease and lifestyle parameters in order to optimize personalized care.

Cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: 12-month and cost-effectiveness results from the multicenter COCOGEN trial.

BACKGROUND: Radiofrequency (RF) treatment of the genicular nerves reduces chronic knee pain in patients with osteoarthritis (OA) or persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The objective of this study is to compare long-term outcomes of cooled and conventional RF and perform an economic evaluation. METHODS: The COCOGEN trial is a double-blinded, non-inferiority, pilot, randomized controlled trial that compared the effects up to 12 months of cooled and conventional RF in patients with chronic knee pain suffering from OA or PPSP after TKA following a 1:1 randomization rate. Outcomes were knee pain, functionality, quality of life, emotional health, medication use, and adverse events. A trial-based economic evaluation was performed with a 12-month societal perspective. Here, the primary outcome was the incremental costs per quality-adjusted life year (QALY). RESULTS: 41 of the 49 included patients completed the 12-month follow-up. One patient in the PPSP cooled RF group had substantial missing data at 12-month follow-up. The proportion of patients with ≥50% pain reduction at 12 months was 22.2% (4/18) in patients treated with conventional RF versus 22.7% (5/22) in patients treated with cooled RF (p>0.05). There was a statistically significant difference in the mean absolute numerical rating scale at 12 months after cooled RF and conventional RF in patients with PPSP (p=0.02). Differences between other outcomes were not statistically significant. The health economic analysis indicated that cooled RF resulted in lower costs and improved QALYs compared with conventional RF in PPSP but not in OA. There were no serious adverse events. CONCLUSIONS: Both RF treatments demonstrated in approximately 22% of patients a ≥50% pain reduction at 12 months. In patients with PPSP, contrary to OA, cooled RF seems to be more effective than conventional RF. Additionally, cooled RF has in patients with PPSP, as opposed to OA, greater effectiveness at lower costs compared with conventional RF. TRIAL REGISTRATION NUMBER: NCT03865849.