28 research outputs found
Systematic Review of Patient-Reported Outcome Measures in Locally Recurrent Rectal Cancer
Background
The availability of high-quality patient-reported outcome (PRO) data is crucial to guiding shared decision-making in the context of locally recurrent rectal cancer (LRRC), where potential treatment benefits must be balanced against the impact of both the disease and treatment on PROs, such as quality of life. This review aimed to identify the patient-reported outcome measures (PROMs) currently being reported in LRRC and to appraise the methodological quality of studies using these measures.
Methods
PubMed, Embase and CINAHL databases were searched, including studies published up until 14th September 2022. Studies in adults with LRRC reporting PROMS as a primary or secondary outcome measure were included. Data were extracted concerning the methodological quality of the reporting of PROMs using criteria informed by the CONSORT-PRO checklist and the psychometric properties of the PROMs identified using the COSMIN Risk of Bias checklist.
Results
Thirty-five studies including 1914 patients with LRRC were identified. None of the studies included in the review met all eleven criteria for the quality of reporting of PROMs. Seventeen PROMs and two clinician-reported outcome measures were identified, none of which have been validated for use in patients with LRRC.
Conclusions
None of the PROMs which are currently being used to report PROs in LRRC have been validated for use in this cohort of patients. Future studies in this disease area should focus on utilising PROMs that have undergone a robust development process including patients with LRRC, to produce data which is high quality, accurate and relevant
Development and validation of a patient reported outcome measure for health-related quality of life for locally recurrent rectal cancer: a multicentre, three-phase, mixed-methods, cohort study
Background
Locally recurrent rectal cancer (LRRC) occurs in 5â10% of patients following previous treatment of rectal cancer. It has a significant impact on patientsâ overall health-related quality of life (HrQoL). Major advances in surgical treatments have led to improved survival outcomes. However, due to the lack of disease-specific, validated patient-reported outcome measure (PROM), HrQoL, is variably assessed. The aim of this study is to develop a disease-specific, psychometrically robust, and validated PROM for use in LRRC.
Methods
A multicentre, three phase, mixed-methods, observational study was performed across five centres in the UK and Australia. Adult patients (>18 years old) with an existing or previously treated LRRC within the last 2 years were eligible to participate. Patients completed the proposed LRRC-QoL, EORTC QLQ-CR29, and FACT-C questionnaires. Scale structure was analysed using multi-trait scaling analysis and exploratory factor analysis, reliability was assessed using Cronbach's and the intra-class coefficient, convergent validity was assessed using Pearson's correlation, and known-groups comparison was assessed using the student t-test or ANOVA.
Findings
Between 01/03/2015 and 31/12/2019, 117 patients with a diagnosis of LRRC were recruited. The final scale structure of the LRRC-QoL consisted of nine multi-item scales (healthcare services, psychological impact, pain, urostomy-related symptoms, lower limb symptoms, stoma, sexual function, sexual interest, and urinary symptoms) and three single items. Cronbach's Alpha and Intraclass correlation values of >0.7 across the majority of scales supported overall reliability. Convergent validity was demonstrated between LRRC-QoL Pain Scale and FACT-C Physical Well Being scale (r = 0.528, p < 0.001), LRRC-QoL Psychological Impact scale with EORTC QLQ CR29 Body Image (r = 0.680, p < 0.001) and the FACT-C Emotional Well Being scale (r = 0.326, p < 0.001), and LRRC-QoL Urinary Symptoms scale with EORTC QLQ-CR29 Urinary Frequency scale (r = 0.310, p < 0.001). Known-groups validity was demonstrated for gender, disease location, treatment intent, and re-recurrent disease.
Interpretation
The LRRC-QoL has demonstrated robust psychometric properties and can be used in clinical and academic practice.
Funding
None
Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II)
Background A resection with clear margins (R0 resection) is the most important prognostic factor in patients with locally recurrent rectal cancer (LRRC). However, this is achieved in only 60 per cent of patients. The aim of this study is to investigate whether the addition of induction chemotherapy to neoadjuvant chemo(re)irradiation improves the R0 resection rate in LRRC. Methods This multicentre, international, open-label, phase III, parallel-arms study will enrol 364 patients with resectable LRRC after previous partial or total mesorectal resection without synchronous distant metastases or recent chemo- and/or radiotherapy treatment. Patients will be randomized to receive either induction chemotherapy (three 3-week cycles of CAPOX (capecitabine, oxaliplatin), four 2-week cycles of FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) or FOLFORI (5-fluorouracil, leucovorin, irinotecan)) followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm). Tumours will be restaged using MRI and, in the experimental arm, a further cycle of CAPOX or two cycles of FOLFOX/FOLFIRI will be administered before chemoradiotherapy in case of stable or responsive disease. The radiotherapy dose will be 25 Ă 2.0 Gy or 28 Ă 1.8âGy in radiotherapy-naive patients, and 15 Ă 2.0âGy in previously irradiated patients. The concomitant chemotherapy agent will be capecitabine administered twice daily at a dose of 825âmg/m2 on radiotherapy days. The primary endpoint of the study is the R0 resection rate. Secondary endpoints are long-term oncological outcomes, radiological and pathological response, toxicity, postoperative complications, costs, and quality of life. Discussion This trial protocol describes the PelvEx II study. PelvEx II, designed as a multicentre, open-label, phase III, parallel-arms study, is the first randomized study to compare induction chemotherapy followed by neoadjuvant chemo(re)irradiation and surgery with neoadjuvant chemo(re)irradiation and surgery alone in patients with locally recurrent rectal cancer, with the aim of improving the number of R0 resections
Systematic review of health-related quality of life in patients undergoing pelvic exenteration
Background Pelvic exenteration is a radical operative treatment reserved for the management of a number of advanced primary and recurrent pelvic malignancies, including, rectal, gynaecological and urological. The advances in radiological staging, surgical techniques and greater use of chemotherapeutic agents haves translated clinically into improvements in the overall survival of this cohort of patients, irrespective of underlying disease pathology. Consequently, a greater proportion of the surviving population will present to healthcare professionals with a range of physical and psychological issues, therefore the profiling and understanding of the health-related quality of life (HrQoL) is integral to the long term management of this cohort of patients. The aim of this systematic review is to identify HrQoL themes from the current literature relevant to patients undergoing a pelvic exenteration. Methods Literature searches were performed in three databases: MEDLINE (1975âNovember 2015), EMBASE and CINAHL. Each study was evaluated with regards to its design and statistical methodology. Data quality was reviewed in accordance with the Newcastle-Ottowa score and Critical Appraisal Skills Programme Checklist (CAPS) for quantitative and qualitative data accordingly. A narrative synthesis of all identified HrQoL issues was undertaken using the principles of content analysis. Results A total of 24 studies were identified; 20 quantitative and 4 qualitative with 976 patients assessed in total. HrQoL was assessed as the main primary endpoint in 15 studies. The majority of studies were retrospective. Baseline data prior to the initiation of treatments were available in 6 studies alone. Nine themes were identified across the literature, which included body image, social impact, sexual function, treatment expectations, symptoms, communication, psychological impact, relationships and work and finance. Conclusions Pelvic exenteration has a wide ranging impact on patients HrQoL affecting a range of physical and psychological domains
An unexpected abdominal tumour in an elderly woman.
We report the case of a 73-year-old woman who presented with pain and an abdominal mass and was found to have an abdominal tumour of unexpected origin
Laparoscopic versus open colorectal surgery in the acute setting (LaCeS trial): a multicentre randomized feasibility trial
Background
Approximately 30â000 people undergo major emergency abdominal gastrointestinal surgery annually, and 36 per cent of these procedures (around 10â800) are carried out for emergency colorectal pathology. Some 14 per cent of all patients requiring emergency surgery have a laparoscopic procedure. The aims of the LaCeS (laparoscopic versus open colorectal surgery in the acute setting) feasibility trial were to assess the feasibility, safety and acceptability of performing a largeâscale definitive phase III RCT, with a comparison of emergency laparoscopic versus open surgery for acute colorectal pathology.
Methods
LaCeS was designed as a prospective, multicentre, singleâblind, parallelâgroup, pragmatic feasibility RCT with an integrated qualitative study. Randomization was undertaken centrally, with patients randomized on a 1â:â1 basis between laparoscopic or open surgery.
Results
A total of 64 patients were recruited across five centres. The overall mean steadyâstate recruitment rate was 1·2 patients per month per site. Baseline compliance for clinical and healthârelated qualityâofâlife data was 99·8 and 93·8 per cent respectively. The conversion rate from laparoscopic to open surgery was 39 (95 per cent c.i. 23 to 58) per cent. The 30âday postoperative complication rate was 27 (13 to 46) per cent in the laparoscopic arm and 42 (25 to 61) per cent in the open arm.
Conclusion
Laparoscopic emergency colorectal surgery may have an acceptable safety profile. Registration number: ISRCTN15681041 ( http://www.controlledâtrials.com)
Short-term outcomes of health-related quality of life in patients with locally recurrent rectal cancer: multicentre, international, cross-sectional cohort study
Background
Overall survival rates for locally recurrent rectal cancer (LRRC) continue to improve but the evidence concerning health-related quality of life (HrQoL) remains limited. The aim of this study was to describe the short-term HrQoL differences between patients undergoing surgical and palliative treatments for LRRC.
Methods
An international, cross-sectional, observational study was undertaken at five centres across the UK and Australia. HrQoL in LRRC patients was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 and functional assessment of cancer therapy â colorectal (FACT-C) questionnaires and subgroups (curative versus palliative) were compared. Secondary analyses included the comparison of HrQoL according to the margin status, location of disease and type of treatment. Scores were interpreted using minimal clinically important differences (MCID) and Cohen effect size (ES).
Results
Out of 350 eligible patients, a total of 95 patients participated, 74.0 (78.0 per cent) treated with curative intent and 21.0 (22.0 per cent) with palliative intent. Median time between LRRC diagnosis and HrQoL assessments was 4 months. Higher overall FACT-C scores denoting better HrQoL were observed in patients undergoing curative treatment, demonstrating a MCID with a mean difference of 18.5 (P < 0.001) and an ES of 0.6. Patients undergoing surgery had higher scores denoting a higher burden of symptoms for the EORTC CR29 domains of urinary frequency (P < 0.001, ES 0.3) and frequency of defaecation (P < 0.001, ES 0.4). Higher overall FACT-C scores were observed in patients who underwent an R0 resection versus an R1 resection (P = 0.051, ES 0.6). EORTC CR29 scores identified worse body image in patients with posterior/central disease (P = 0.021). Patients undergoing palliative chemoradiation reported worse HrQoL scores with a higher symptom burden on the frequency of defaecation scale compared with palliative chemotherapy (P = 0.041).
Conclusion
Several differences in short-term HrQoL outcomes between patients undergoing curative and palliative treatment for LRRC were documented. Patients undergoing curative surgery reported better overall HrQoL and a higher burden of pelvic symptoms
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 64âyears) across three specialties (20 gastrointestinal, six gynaecological, three urological). Two overarching themes of âgeneral recoveryâ and âgastrointestinal symptomsâ were identified. General recovery included three themes: âlife impactâ, âmental impactâ, including anxiety, and âphysical impactâ, including fatigue. Gastrointestinal symptoms included three themes: âabdominal symptomsâ such as pain, âdiet and appetiteâ and âexpulsory functionâ, such as stool frequency. A total of 18 gastrointestinal symptoms were identified during patient recoveryâmany 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