Recommendations for optimising pilot and feasibility work in surgery.

BACKGROUND: Surgical trials are recognised as inherently challenging. Pilot and feasibility studies (PAFS) are increasingly acknowledged as a key method to optimise the design and conduct of randomised trials but remain limited in surgery. We used a mixed methods approach to develop recommendations for how surgical PAFS could be optimised. METHODS: The findings from a quantitative analysis of funded surgical PAFS over a 10-year period and in-depth qualitative interviews with surgeons, methodologists and funders were triangulated and synthesised with available methodological guidance on PAFS. RESULTS: The synthesis informed the development of an explanatory model describing root causes and compounding challenges that contribute to how and why surgical PAFS is not currently optimised. The four root causes identified include issues relating to (i) understanding the full scope of PAFS; (ii) design and conduct of PAFS; (iii) reporting of PAFS; and (iv) lack of appreciation of the value of PAFS by all stakeholder groups. Compounding challenges relate to both cultural issues and access to and interpretation of available methodological PAFS guidance. The study findings and explanatory model were used to inform the development of a practical guidance tool for surgeons and study teams to improve research practice. CONCLUSIONS: Optimisation of PAFS in surgery requires a cultural shift in research practice amongst funders, academic institutions, regulatory bodies and journal editors, as well as amongst surgeons. Our 'Top Tips' guidance tool offers an accessible framework for surgeons designing PAFS. Adoption and utilisation of these recommendations will optimise surgical PAFS, facilitating successful and efficient future surgical trials.

Electronic collection of patient-reported outcomes following discharge after surgery: systematic review.

BACKGROUND: Little is known about the electronic collection and clinical feedback of patient-reported outcomes (ePROs) following surgical discharge. This systematic review summarized the evidence on the collection and uses of electronic systems to collect PROs after discharge from hospital after surgery. METHOD: Systematic searches of MEDLINE, Embase, PsycINFO, CINAHL and Cochrane Central were undertaken from database inception to July 2019 using terms for 'patient reported outcomes', 'electronic', 'surgery' and 'at home'. Primary research of all study designs was included if they used electronic systems to collect PRO data in adults after hospital discharge following surgery. Data were collected on the settings, patient groups and specialties, ePRO systems (including features and functions), PRO data collected, and integration with health records. RESULTS: Fourteen studies were included from 9474 records, including two RCTs and six orthopaedic surgery studies. Most studies (9 of 14) used commercial ePRO systems. Six reported types of electronic device were used: tablets or other portable devices (3 studies), smartphones (2), combination of smartphones, tablets, portable devices and computers (1). Systems had limited features and functions such as real-time clinical feedback (6 studies) and messaging service for patients with care teams (3). No study described ePRO system integration with electronic health records to support clinical feedback. CONCLUSION: There is limited reporting of ePRO systems in the surgical literature, and ePRO systems lack integration with hospital clinical systems. Future research should describe the ePRO system and ePRO questionnaires used, and challenges encountered during the study, to support efficient upscaling of ePRO systems using tried and tested approaches.

Patient experiences of an electronic PRO tailored feedback system for symptom management following upper gastrointestinal cancer surgery.

PURPOSE: Complications following upper gastrointestinal (UGI) surgery are common. Symptom-monitoring following discharge is not standardized. An electronic patient-reported outcome (ePRO) system providing feedback to patients and clinicians could support patients and improve outcomes. Little is known about patients' experiences of using such systems. This qualitative sub-study explored patients' perspectives of the benefits of using a novel ePRO system, developed as part of the mixed methods eRAPID pilot study, to support recovery following discharge after UGI surgery. METHODS: Patients completed the online ePRO symptom-report system post-discharge. Weekly interviews explored patients' experiences of using ePRO, the acceptability of feedback generated and its value for supporting their recovery. Interviews were audio-recorded and targeted transcriptions were thematically analysed. RESULTS: Thirty-five interviews with 16 participants (11 men, mean age 63 years) were analysed. Two main themes were identified: (1) reassurance and (2) empowerment. Feelings of isolation were common; many patients felt uninformed regarding their expectations of recovery and whether their symptoms warranted clinical investigation. Participants were reassured by tailored feedback advising them to contact their care team, alleviating their anxiety. Patients reported feeling empowered by the ePRO system and in control of their symptoms and recovery. CONCLUSION: Patients recovering at home following major cancer surgery regarded electronic symptom-monitoring and feedback as acceptable and beneficial. Patients perceived that the system enhanced information provision and provided a direct link to their care team. Patients felt that the system provided reassurance at a time of uncertainty and isolation, enabling them to feel in control of their symptoms and recovery.

Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set.

BACKGROUND: Outcome selection, measurement and reporting for the evaluation of new surgical procedures and devices is inconsistent and lacks standardization. A core outcome set may promote the safe and transparent evaluation of surgical innovations. This systematic review examined outcome selection, measurement and reporting in studies conducted within the IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) framework to examine current practice and inform the development of a core outcome set for early-phase studies of surgical procedures/devices. METHODS: Web of Science and Scopus citation searches were performed to identify author-reported IDEAL/IDEAL-D studies for any surgical procedure/device. Outcomes were extracted verbatim, including contextual information regarding outcome selection and measurement. Outcomes were categorized to inform a conceptual framework of outcome domains relevant to evaluating innovation. RESULTS: Some 48 studies were identified. Outcome selection, measurement and reporting varied widely across studies in different IDEAL stages. From 1737 outcomes extracted, 22 domains specific to evaluating innovation were conceptualized under seven broad categories: procedure completion success/failure; modifications; unanticipated events; surgeons' experiences; patients' experiences; resource use specific to the innovative procedure/device; and other innovation-specific outcomes. Most innovation-specific outcomes were measured and reported in only a small number of studies. CONCLUSION: This review highlighted the need for guidance and standardization in outcome selection and reporting in the evaluation of new surgical procedures/devices. Novel outcome domains specific to innovation have been identified to establish a core outcome set for future evaluations of surgical innovations.

ANTECEDENTES: La selección de resultados, mediciones y redacción de los informes para la evaluación de nuevos procedimientos y dispositivos quirúrgicos es inconsistente y carece de estandarización. Determinar un conjunto de resultados básicos (core outcome set, COS) podría contribuir a la transparencia y seguridad de las evaluaciones de las innovaciones quirúrgicas. Esta revisión sistemática analizó la selección de resultados, medición de los mismos e informes de estudios efectuados en el marco metodológico IDEAL, a fin de valorar la práctica actual y presentar el desarrollo de un COS para estudios en fase inicial de procedimientos/dispositivos quirúrgicos. MÉTODOS: Se realizaron búsquedas en las bases de datos Web of Science y Scopus para identificar estudios efectuados por los autores en el marco IDEAL/IDEAL-D referentes a cualquier procedimiento/dispositivo quirúrgico. Los resultados se extrajeron literalmente, incluida la información contextualizada referente a la selección y medición de los resultados. Los resultados se categorizaron para presentar información en un marco conceptual de dominios de resultados que fueran relevantes para poder evaluar la innovación. RESULTADOS: Se identificaron 48 estudios. Los estudios mostraban una amplia variedad en la selección de resultados, mediciones e información correspondientes a diferentes estadios IDEAL. A partir de 1.737 resultados extraídos, se conceptualizaron 22 dominios específicos para evaluar la innovación agrupados en 7 amplias categorías: éxito/fracaso para completar el procedimiento; modificaciones; eventos imprevistos; experiencias de los cirujanos; experiencias de los pacientes; uso de recursos específicos del procedimiento/dispositivo innovador y otros resultados específicos de la innovación. La mayoría de los resultados específicos de la innovación se midieron y notificaron solo en un pequeño número de estudios. CONCLUSIÓN: Esta revisión ha puesto de manifiesto la necesidad de orientación y estandarización en la selección de resultados y la notificación en la evaluación de nuevos procedimientos/dispositivos quirúrgicos. Se han identificado nuevos dominios de resultados específicos de innovación para establecer un COS para futuras evaluaciones de innovaciones quirúrgicas.

A systematic review and in-depth analysis of outcome reporting in early phase studies of colorectal cancer surgical innovation.

AIM: Early phase studies are essential to evaluate new technologies prior to randomized evaluation. Evaluation is limited, however, by inconsistent measurement and reporting of outcomes. This study examines outcome reporting in studies of innovative colorectal cancer surgery. METHODS: Systematic searches identified studies of invasive procedures treating primary colorectal adenocarcinoma. Included were a random sample of studies which authors reported as 'new' or 'modified'. Outcomes were extracted verbatim and categorized using an existing framework of 32 domains relevant to early phase studies. Outcomes were classified as 'measured' (where there was an explicit statement to that effect or evidence that data collection had occurred) or 'mentioned but not measured' (where outcomes were discussed but data collection was not evident). Patterns of identified outcomes are described. RESULTS: Of 8373 records, 816 were potentially eligible. Full-text review of a random sample of 218 studies identified 51 for inclusion of which 34 (66%) were 'new' and 17 (33%) were 'modified'. Some 2073 outcomes were identified, and all mapped to domains. 'Anticipated disadvantages' were most frequently identified [660 (32%) outcomes identified across 50 (98%) studies]. No domain was represented in all studies. Under half (944, 46%) of outcomes were 'measured'. 'Surgeon's/operator's experience of the innovation' was more frequently 'mentioned but not measured' [207 (18%) outcomes across 46 (90%) studies] than 'measured' [17 (2%) outcomes, 11 (22%) studies]. CONCLUSION: There is outcome reporting heterogeneity in studies of early phase colorectal cancer surgery. The adoption of core outcome sets may help to resolve these inconsistencies and enable efficient evaluation of surgical innovations.

A real-time electronic symptom monitoring system for patients after discharge following surgery: a pilot study in cancer-related surgery.

BACKGROUND: Advances in peri-operative care of surgical oncology patients result in shorter hospital stays. Earlier discharge may bring benefits, but complications can occur while patients are recovering at home. Electronic patient-reported outcome (ePRO) systems may enhance remote, real-time symptom monitoring and detection of complications after hospital discharge, thereby improving patient safety and outcomes. Evidence of the effectiveness of ePRO systems in surgical oncology is lacking. This pilot study evaluated the feasibility of a real-time electronic symptom monitoring system for patients after discharge following cancer-related upper gastrointestinal surgery. METHODS: A pilot study in two UK hospitals included patients who had undergone cancer-related upper gastrointestinal surgery. Participants completed the ePRO symptom-report at discharge, twice in the first week and weekly post-discharge. Symptom-report completeness, system actions, barriers to using the ePRO system and technical performance were examined. The ePRO surgery system is an online symptom-report that allows clinicians to view patient symptom-reports within hospital electronic health records and was developed as part of the eRAPID project. Clinically derived algorithms provide patients with tailored self-management advice, prompts to contact a clinician or automated clinician alerts depending on symptom severity. Interviews with participants and clinicians determined the acceptability of the ePRO system to support patients and their clinical management during recovery. RESULTS: Ninety-one patients were approached, of which 40 consented to participate (27 male, mean age 64 years). Symptom-report response rates were high (range 63-100%). Of 197 ePRO completions analysed, 76 (39%) triggered self-management advice, 72 (36%) trigged advice to contact a clinician, 9 (5%) triggered a clinician alert and 40 (20%) did not require advice. Participants found the ePRO system reassuring, providing timely information and advice relevant to supporting their recovery. Clinicians regarded the system as a useful adjunct to usual care, by signposting patients to seek appropriate help and enhancing their understanding of patients' experiences during recovery. CONCLUSION: Use of the ePRO system for the real-time, remote monitoring of symptoms in patients recovering from cancer-related upper gastrointestinal surgery is feasible and acceptable. A definitive randomised controlled trial is needed to evaluate the impact of the system on patients' wellbeing after hospital discharge.

Value of surgical pilot and feasibility study protocols.

BACKGROUND: RCTs in surgery are challenging owing to well established methodological issues. Well designed pilot and feasibility studies (PFS) may help overcome such issues to inform successful main trial design and conduct. This study aimed to analyse protocols of UK-funded studies to explore current use of PFS in surgery and identify areas for practice improvement. METHODS: PFS of surgical interventions funded by UK National Institute for Health Research programmes from 2005 to 2015 were identified, and original study protocols and associated publications sourced. Data extracted included study design characteristics, reasons for performing the work including perceived uncertainties around conducting a definitive main trial, and whether the studies had been published. RESULTS: Thirty-five surgical studies were identified, of which 29 were randomized, and over half (15 of 29) included additional methodological components (such as qualitative work examining recruitment, and participant surveys studying current interventions). Most studies focused on uncertainties around recruitment (32 of 35), with far fewer tackling uncertainties specific to surgery, such as intervention stability, implementation or delivery (10 of 35). Only half (19 of 35) had made their results available publicly, to date. CONCLUSION: The full potential of pretrial work to inform and optimize definitive surgical studies is not being realized.

What surgeons tell patients and what patients want to know before major cancer surgery: a qualitative study.

BACKGROUND: The information surgeons impart to patients and information patients want about surgery for cancer is important but rarely examined. This study explored information provided by surgeons and patient preferences for information in consultations in which surgery for oesophageal cancer surgery was discussed. METHODS: Pre-operation consultations in which oesophagectomy was discussed were studied in three United Kingdom hospitals and patients were subsequently interviewed. Consultations and interviews were audio-recorded, transcribed in full and anonymized. Interviews elicited views about the information provided by surgeons and patients' preferences for information. Thematic analysis of consultation-interview pairs was used to investigate similarities and differences in the information provided by surgeons and desired by patients. RESULTS: Fifty two audio-recordings from 31 patients and 7 surgeons were obtained (25 consultations and 27 patient interviews). Six consultations were not recorded because of equipment failure and four patients declined an interview. Surgeons all provided consistent, extensive information on technical operative details and in-hospital surgical risks. Consultations rarely included discussion of the longer-term outcomes of surgery. Whilst patients accepted that information about surgery and risks was necessary, they really wanted details about long-term issues including recovery, impact on quality of life and survival. CONCLUSIONS: This study demonstrated a need for surgeons to provide information of importance to patients concerning the longer term outcomes of surgery. It is proposed that "core information sets" are developed, based on surgeons' and patients' views, to use as a minimum in consultations to initiate discussion and meet information needs prior to cancer surgery.

Assessing the quality of written information provision for surgical procedures: a case study in oesophagectomy.

OBJECTIVE: To examine the content and quality of written information provided by surgical centres for patients undergoing oesophagectomy for cancer. DESIGN: Cross-sectional study of the content of National Health Service (NHS) patient information leaflets (PILs) about oesophageal cancer surgery, using a modified framework approach. DATA SOURCES: Written information leaflets from 41 of 43 cancer centres undertaking surgery for oesophageal cancer in England and Wales (response rate 95.3%). ELIGIBILITY CRITERIA: All English language versions of PILs about oesophagectomy. RESULTS: 32 different PILs were identified, of which 2 were generic tools (Macmillan 'understanding cancer of the gullet' and EIDO 'oesophagectomy'). Although most PILs focused on describing in-hospital adverse events, information varied widely and was often misleading. Just 1 leaflet described survival benefits of surgery and 2 mentioned the possibility of disease recurrence. CONCLUSIONS: Written information provided for patients by NHS cancer centres undertaking oesophagectomy is inconsistent and incomplete. It is recommended that surgeons work together with patients to agree on standards of information provision of relevance to all stakeholders' needs.

Synthesis and summary of patient-reported outcome measures to inform the development of a core outcome set in colorectal cancer surgery.

AIM: Patient-reported outcome (PRO) measures (PROMs) are standard measures in the assessment of colorectal cancer (CRC) treatment, but the range and complexity of available PROMs may be hindering the synthesis of evidence. This systematic review aimed to: (i) summarize PROMs in studies of CRC surgery and (ii) categorize PRO content to inform the future development of an agreed minimum 'core' outcome set to be measured in all trials. METHOD: All PROMs were identified from a systematic review of prospective CRC surgical studies. The type and frequency of PROMs in each study were summarized, and the number of items documented. All items were extracted and independently categorized by content by two researchers into 'health domains', and discrepancies were discussed with a patient and expert. Domain popularity and the distribution of items were summarized. RESULTS: Fifty-eight different PROMs were identified from the 104 included studies. There were 23 generic, four cancer-specific, 11 disease-specific and 16 symptom-specific questionnaires, and three ad hoc measures. The most frequently used PROM was the EORTC QLQ-C30 (50 studies), and most PROMs (n = 40, 69%) were used in only one study. Detailed examination of the 50 available measures identified 917 items, which were categorized into 51 domains. The domains comprising the most items were 'anxiety' (n = 85, 9.2%), 'fatigue' (n = 67, 7.3%) and 'physical function' (n = 63, 6.9%). No domains were included in all PROMs. CONCLUSION: There is major heterogeneity of PRO measurement and a wide variation in content assessed in the PROMs available for CRC. A core outcome set will improve PRO outcome measurement and reporting in CRC trials.

Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

BACKGROUND: Screening for prostate cancer continues to generate controversy because of concerns about over-diagnosis and unnecessary treatment. We describe the rationale, design and recruitment of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP) trial, a UK-wide cluster randomised controlled trial investigating the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. METHODS: Seven hundred and eighty-five general practitioner (GP) practices in England and Wales were randomised to a population-based PSA testing or standard care and then approached for consent to participate. In the intervention arm, men aged 50-69 years were invited to undergo PSA testing, and those diagnosed with localised prostate cancer were invited into a treatment trial. Control arm practices undertook standard UK management. All men were flagged with the Health and Social Care Information Centre for deaths and cancer registrations. The primary outcome is prostate cancer mortality at a median 10-year-follow-up. RESULTS: Among randomised practices, 271 (68%) in the intervention arm (198,114 men) and 302 (78%) in the control arm (221,929 men) consented to participate, meeting pre-specified power requirements. There was little evidence of differences between trial arms in measured baseline characteristics of the consenting GP practices (or men within those practices). CONCLUSIONS: The CAP trial successfully met its recruitment targets and will make an important contribution to international understanding of PSA-based prostate cancer screening.

A systematic review of outcome reporting in colorectal cancer surgery.

AIM: Evaluation of surgery for colorectal cancer (CRC) is necessary to inform clinical decision-making and healthcare policy. The standards of outcome reporting after CRC surgery have not previously been considered. METHOD: Systematic literature searches identified randomized and nonrandomized prospective studies reporting clinical outcomes of CRC surgery. Outcomes were listed verbatim, categorized into broad groups (outcome domains) and examined for a definition (an appropriate textual explanation or a supporting citation). Outcome reporting was considered inconsistent if results of the outcome specified in the methods were not reported. Outcome reporting was compared between randomized and nonrandomized studies. RESULTS: Of 5644 abstracts, 194 articles (34 randomized and 160 nonrandomized studies) were included reporting 766 different clinical outcomes, categorized into seven domains. A mean of 14 ± 8 individual outcomes were reported per study. 'Anastomotic leak', 'overall survival' and 'wound infection' were the three most frequently reported outcomes in 72, 60 and 44 (37.1%, 30.9% and 22.7%) studies, respectively, and no single outcome was reported in every publication. Outcome definitions were significantly more often provided in randomized studies than in nonrandomized studies (19.0% vs 14.9%, P = 0.015). One-hundred and twenty-seven (65.5%) papers reported results of all outcomes specified in the methods (randomized studies, n = 21, 61.5%; nonrandomized studies, n = 106, 66.2%; P = 0.617). CONCLUSION: Outcome reporting in CRC surgery lacks consistency and method. Improved standards of outcome measurement are recommended to permit data synthesis and transparent cross-study comparisons.

Integration of clinical and patient-reported outcomes in surgical oncology.

BACKGROUND: Patient-reported outcomes (PROs) provide information about the patient perspective and experience of undergoing surgery for cancer, but evidence suggests that they are not used widely to influence practice. This review considers key challenges and opportunities for using PROs effectively in gastrointestinal surgical oncology, drawing on principles learnt from surgical oncology in general. METHODS: Systematic reviews of randomized controlled trials (RCTs) in surgical oncology reporting PROs as primary or secondary outcomes, and studies examining methods to communicate PRO information, were identified. Common themes are summarized and the future of PRO studies considered. RESULTS: Reviews highlighted the need for improved design, conduct and reporting of PROs in RCTs in surgical oncology. Main issues related to the multiplicity of PRO measures hindering data synthesis and clinical understanding, problems with missing data risking bias, and limited integration of clinical and PRO data undermining the role of PRO data in practice. Reviews indicated that patients want PRO data to meet information needs and early work shows that graphically displayed PROs are understood by patients. CONCLUSION: PROs have a role in the evaluation of surgical oncology, but increased consensus and collaboration between surgeons and methodologists is needed to improve the design, conduct and reporting of PROs with clinical outcomes in trials. Possible solutions include investing more effort and systematic thought into the PRO rationale in RCTs, the development and use of 'core outcome sets' with PROs, and implementation of the extension to the Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting PROs in RCTs.

Reporting clinical outcomes of breast reconstruction: a systematic review.

BACKGROUND: Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered. METHODS: We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ² tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided. RESULTS: Surgical complications following breast reconstruction in 42,146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent. CONCLUSIONS: The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.

Impact of prostate cancer testing: an evaluation of the emotional consequences of a negative biopsy result.

BACKGROUND: When testing for prostate cancer, as many as 75% of men with a raised prostate-specific antigen (PSA) have a benign biopsy result. Little is known about the psychological effect of this result for these men. METHODS: In all, 330 men participating in the prostate testing for cancer and treatment (ProtecT) study were studied; aged 50-69 years with a PSA level of > or = 3 ng ml(-1) and a negative biopsy result. Distress and negative mood were measured at four time-points: two during diagnostic testing and two after a negative biopsy result. RESULTS: The majority of men were not greatly affected by testing or a negative biopsy result. The impact on psychological health was highest at the time of the biopsy, with around 20% reporting high distress (33 out of 171) and tense/anxious moods (35 out of 180). Longitudinal analysis on 195 men showed a significant increase in distress at the time of the biopsy compared with levels at the PSA test (difference in Impact of Events Scale (IES) score: 9.47; 95% confidence interval (CI) (6.97, 12.12); P<0.001). These levels remained elevated immediately after the negative biopsy result (difference in score: 7.32; 95% CI (5.51, 9.52); P<0.001) and 12 weeks later (difference in score: 2.42; 95% CI (0.50, 1.15); P=0.009). Psychological mood at the time of PSA testing predicted high levels of distress and anxiety at subsequent time-points. CONCLUSIONS: Most men coped well with the testing process, although a minority experienced elevated distress at the time of biopsy and after a negative result. Men should be informed of the risk of distress relating to diagnostic uncertainty before they consent to PSA testing.

The role of health-related quality of life outcomes in clinical decision making in surgery for esophageal cancer: a systematic review.

BACKGROUND: Esophagectomy for cancer offers a chance of cure but is associated with morbidity, at least a temporary reduction in health-related quality of life (HRQL), and a 5-year survival of approximately 30%. This research evaluated how and whether HRQL outcomes contribute to surgical decision making. METHODS: A systematic review identified randomized trials and longitudinal and cross-sectional studies that assessed HRQL after esophagectomy with multidimensional validated questionnaires. Articles were independently evaluated by two reviewers, and the value of HRQL in clinical decision making was categorized in three ways: (1) the assessment of the quality of HRQL methodology according to predefined criteria; (2) the influence of HRQL outcomes on treatment recommendations and/or informed consent; and (3) the HRQL after esophagectomy for cancer in methodologically robust studies. RESULTS: Eighteen publications were identified, of which 16 (89%) were categorized as having robust HRQL design. Of these studies, 3 concluded that HRQL influenced treatment recommendations and 11 (including the former 3) informed patient consent. The remaining five papers were well designed, but the authors did not use HRQL to influence treatment recommendations or informed consent. After esophagectomy, patients report major deterioration in most aspects of HRQL with slow recovery. CONCLUSION: HRQL outcomes are relevant to surgical decision making. Methods to communicate HRQL outcomes to patients are required to inform consent and clinical practice.

Quality of life during potentially curative treatment for locally advanced oesophageal cancer.

BACKGROUND: Combination chemoradiotherapy with or without surgery are internationally applied alternative strategies for potential cure of oesophageal cancer. This study compared health-related quality of life (HRQL) between patients selected for chemoradiation and those who had combination treatment including oesophagectomy. METHODS: Patients with stage II or III oesophageal cancer completed HRQL assessments at baseline, at the worst expected HRQL time point and at expected recovery. HRQL was compared between groups using linear regression, adjusting for age, sex, performance status, tumour stage and type, and baseline HRQL. RESULTS: Some 132 patients began treatment, of whom 51 had chemoradiotherapy and 81 combination treatment including surgery. Patients selected for chemoradiotherapy were older, more likely to have squamous cell cancer and reported poorer HRQL than those selected for surgery. At the worst expected time point after treatment, both groups reported multiple symptoms and poor function, but surgery was associated with a greater reduction in HRQL from baseline than chemoradiotherapy. Recovery of HRQL was achieved within 6 months after chemoradiotherapy, but complete recovery had not occurred 6 months after surgery and there was persistent significant deterioration in some aspects. CONCLUSION: The negative treatment-related impact of chemoradiation on short-term HRQL is less than that experienced with combination treatment including surgery. Patients preferring early recovery should consider definitive chemoradiation.

Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire.

The European Organisation for Research and Treatment of Cancer (EORTC) has a portfolio of questionnaire modules to supplement the QLQ-C30 to assess patient reported outcomes in cancer clinical trials. This study updated the module for colorectal cancer. A review of the literature identified 20 articles that used the EORTC colorectal module. Eight papers did not report data from scales addressing sexual function and 8 added additional scales to assess ano-rectal function. Interviews with patients (n=79) and professionals (n=11) informed item selection, reduction and modification. A new 29 item module was devised and further patient interviews (n=120) examined its format and content validity. Patients found the new module acceptable with relevant content. The new module, the EORTC QLQ-CR29, is hypothesised as containing 6 scales and 11 single items. An international study examining its clinical and psychometric validity will be performed.

Questionnaires to assess urinary and anal incontinence: review and recommendations.

PURPOSE: We reviewed and provide recommendations about the most scientifically robust and appropriate questionnaires for evaluating symptoms and the quality of life impact of urinary and/or anal incontinence, and vaginal and pelvic floor problems. We also investigated the use of these questionnaires in randomized, controlled trials of treatment strategies. MATERIALS AND METHODS: The Symptom and Quality of Life Committee of the International Consultation on Incontinence performed a systematic review of questionnaires related to urinary and anal incontinence, and vaginal and pelvic floor problems, searching MEDLINE, The Cochrane Library and other electronic databases between 2001 and 2004. RESULTS: A total of 23 robust and relevant questionnaires could be recommended in clinical practice and research. The development of questionnaires to assess anal incontinence, and pelvic floor and vaginal problems has been limited with some promising measures but with none achieving the highest level of rigor. From 2001 to 2004 there were 150 published randomized trials of treatments for incontinence. Increasingly trials of incontinence are using recommended measures (38% of those for urinary incontinence and 22% of those for anal incontinence used the highest quality questionnaires in 2001 to 2004) but none of vaginal and pelvic floor problems used recommended questionnaires. CONCLUSIONS: With increasing acknowledgment of the value of patient based assessment much attention has been given to the development of questionnaires to assess symptoms and quality of life. Sufficient measures are now available for urinary incontinence, and researchers and clinicians are encouraged to use the 18 achieving the highest level of rigor and their validated translations. In contrast, the development of questionnaires for anal incontinence and pelvic/vaginal problems is in its infancy and further study in this area is needed. Randomized trials of treatments for incontinence should use only questionnaires achieving the highest level of scientific rigor.