Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT).

INTRODUCTION: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life. METHODS AND ANALYSIS: We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery. ETHICS AND DISSEMINATION: This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10386621.

The revised Bristol Rheumatoid Arthritis Fatigue measures and the Rheumatoid Arthritis Impact of Disease scale: validation in six countries.

Objective: To evaluate the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ), the revised Bristol Rheumatoid Arthritis Numerical Rating Scales (BRAF-NRS V2) and the Rheumatoid Arthritis Impact of Disease (RAID) scale in six countries. Methods: We surveyed RA patients in France, Germany, The Netherlands, Spain, Sweden and the UK, including the HAQ, 36-item Short Form Health Survey (SF-36) and potential revisions of the BRAF-NRS coping and Spanish RAID coping items. Factor structure and internal consistency were examined by factor analysis and Cronbach's α and construct validity by Spearman's correlation. Results: A total of 1276 patients participated (76% female, 25% with a disease duration <5 years, median HAQ 1.0). The original BRAF-MDQ four-factor structure and RAID single-factor structure were confirmed in every country with ⩾66% of variation in items explained by each factor and all item factor loadings of 0.71-0.98. Internal consistency for the BRAF-MDQ total and subscales was a Cronbach's α of 0.75-0.96 and for RAID, 0.93-0.96. Fatigue construct validity was shown for the BRAF-MDQ and BRAF-NRS severity and effect scales, correlated internally with SF-36 vitality and with RAID fatigue (r = 0.63-0.93). Broader construct validity for the BRAFs and RAID was shown by correlation with each other, HAQ and SF-36 domains (r = 0.46-0.82), with similar patterns in individual countries. The revised BRAF-NRS V2 Coping item had stronger validity than the original in all analyses. The revised Spanish RAID coping item performed as well as the original. Conclusion: Across six European countries, the BRAF-MDQ identifies the same four aspects of fatigue, and along with the RAID, shows strong factor structure and internal consistency and moderate-good construct validity. The revised BRAF-NRS V2 shows improved construct validity and replaces the original.

Translating patient reported outcome measures: methodological issues explored using cognitive interviewing with three rheumatoid arthritis measures in six European languages.

OBJECTIVE: Cross-cultural translation of patient-reported outcome measures (PROMs) is a lengthy process, often performed professionally. Cognitive interviewing assesses patient comprehension of PROMs. The objective was to evaluate the usefulness of cognitive interviewing to assess translations and compare professional (full) with non-professional (simplified) translation processes. METHODS: A full protocol used for the Bristol RA Fatigue Multi-dimensional Questionnaire and Numerical Rating Scale (BRAF-MDQ, BRAF-NRS) was compared with a simplified protocol used for the RA Impact of Disease scale (RAID). RA patients in the UK, France, the Netherlands, Germany, Spain and Sweden completed the PROMs during cognitive interviewing (BRAFs in the UK were omitted as these were performed during development). Transcripts were deductively analysed for understanding, information retrieval, judgement and response options. Usefulness of cognitive interviewing was assessed by the nature of problems identified, and translation processes by percentage of consistently problematic items (⩾40% patients per country with similar concerns). RESULTS: Sixty patients participated (72% women). For the BRAFs (full protocol) one problematic item was identified (of 23 items × 5 languages, 1/115 = 0.9%). For the RAID (simplified protocol) two problematic items were identified (of 7 items × 6 languages, 2/42 = 4.8%), of which one was revised (Dutch). Coping questions were problematic in both PROMs. CONCLUSION: Conceptual and cultural challenges though rare were important, as identified by formal evaluation, demonstrating that cognitive interviewing is crucial in PROM translations. Proportionately fewer problematic items were found for the full than for the simplified translation procedure, suggesting that while both are acceptable, professional PROM translation might be preferable. Coping may be a particularly challenging notion cross-culturally.

Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs).

BACKGROUND: Synthesis of patient-reported outcome (PRO) data is hindered by the range of available PRO measures (PROMs) composed of multiple scales and single items with differing terminology and content. The use of core outcome sets, an agreed minimum set of outcomes to be measured and reported in all trials of a specific condition, may improve this issue but methods to select core PRO domains from the many available PROMs are lacking. This study examines existing PROMs and describes methods to identify health domains to inform the development of a core outcome set, illustrated with an example. METHODS: Systematic literature searches identified validated PROMs from studies evaluating radical treatment for oesophageal cancer. PROM scale/single item names were recorded verbatim and the frequency of similar names/scales documented. PROM contents (scale components/single items) were examined for conceptual meaning by an expert clinician and methodologist and categorised into health domains. A patient advocate independently checked this categorisation. RESULTS: Searches identified 21 generic and disease-specific PROMs containing 116 scales and 32 single items with 94 different verbatim names. Identical names for scales were repeatedly used (for example, 'physical function' in six different measures) and others were similar (overlapping face validity) although component items were not always comparable. Based on methodological, clinical and patient expertise, 606 individual items were categorised into 32 health domains. CONCLUSION: This study outlines a methodology for identifying candidate PRO domains from existing PROMs to inform a core outcome set to use in clinical trials.

Reliability and sensitivity to change of the Bristol Rheumatoid Arthritis Fatigue scales.

OBJECTIVE: To examine the reliability (stability) and sensitivity of the Bristol Rheumatoid Arthritis Fatigue scales (BRAFs) and patient-reported outcome measures (PROMs) developed to capture the fatigue experience. The Multi-Dimensional Questionnaire (BRAF-MDQ) has a global score and four subscales (Physical Fatigue, Living with Fatigue, Cognitive Fatigue and Emotional Fatigue), while three numerical rating scales (BRAF-NRS) measure fatigue Severity, Effect and Coping. METHODS: RA patients completed the BRAFs plus comparator PROMs. Reliability (study 1): 50 patients completed questionnaires twice. A same-day test-retest interval (minimum 60 min) ensured both time points related to the same 7 days, minimizing the capture of fatigue fluctuations. Reliability (study 2): 50 patients completed the same procedure with a re-worded BRAF-NRS Coping. Sensitivity to change (study 3): 42 patients being given clinically a single high dose of i.m. glucocorticoids completed questionnaires at weeks 0 and 2. RESULTS: The BRAF-MDQ, its subscales and the BRAF-NRS showed very strong reliability (r = 0.82-0.95). BRAF-NRS Coping had lower moderate reliability in both wording formats (r = 0.62, 0.60). The BRAF-MDQ, its subscales and the BRAF-NRS Severity and Effect were sensitive to change, with effect sizes (ESs) of 0.33-0.56. As hypothesized, the BRF-NRS Coping was not responsive to the pharmaceutical intervention (ES 0.05). Preliminary exploration suggests a minimum clinically important difference of 17.5% for improvement and 6.1% for fatigue worsening. CONCLUSION: The BRAF scales show good reliability and sensitivity to change. The lack of BRAF-NRS Coping responsiveness to medication supports the theory that coping with fatigue is a concept distinct from severity and effect that is worth measuring separately.

Measuring fatigue in rheumatoid arthritis: a cross-sectional study to evaluate the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional questionnaire, visual analog scales, and numerical rating scales.

OBJECTIVE: Current patient-reported outcome measures of fatigue in rheumatoid arthritis (RA) have limitations, providing only a global perspective. This study constructed a questionnaire (the Bristol RA Fatigue Multi-Dimensional Questionnaire [BRAF-MDQ]) from 45 preliminary questions derived from analysis of patient interviews and surveys and explored its structure for fatigue dimensions. The BRAF-MDQ and short BRAF numerical rating scales (NRS) and visual analog scales (VAS) for severity, effect, and ability to cope with fatigue were evaluated for validity. METHODS: Two hundred twenty-nine RA patients with fatigue (VAS score ≥5 of 10) completed preliminary BRAF and comparator fatigue scales. Iterative analyses informed item removal or retention in the BRAF-MDQ and identification of subscales (using Cronbach's alpha for internal consistency and factor analysis to identify dimensions). The BRAF-MDQ and short scales were tested in relation to potentially associated variables for criterion and construct validity (Spearman's correlation). RESULTS: The 20-item BRAF-MDQ had good internal consistency (Cronbach's α = 0.932), criterion validity (correlation with other fatigue scales: r = 0.643-0.813), and construct validity (correlations with disability, mood, helplessness, and pain: r = 0.340-0.627). Factor analysis showed 4 distinct dimensions (physical fatigue, living with fatigue, cognition fatigue, and emotional fatigue), which correlated well with the RA Multidimensional Assessment of Fatigue scale (r = 0.548-0.834). The BRAF VAS and NRS showed similar criterion and construct validity. CONCLUSION: The BRAF instruments include standardized NRS and VAS for fatigue severity, effect, and coping, are RA specific, and have evidence to support validity. The BRAF-MDQ uniquely measures 4 separate dimensions, which may facilitate development of individually-tailored fatigue management programs.

Collaboration with patients in the design of patient-reported outcome measures: capturing the experience of fatigue in rheumatoid arthritis.

OBJECTIVE: Patient-reported outcome measures (PROMs) need to include concepts and language relevant to patients and be easily understood. These studies aimed to develop draft PROMs to measure rheumatoid arthritis (RA) fatigue and its impact by collaborating with patients to identify language and experiences, create draft PROM items, and test them for comprehension, with decisions supported throughout by a patient research partner. METHODS: In study 1, interview transcripts of RA patients describing their fatigue (n = 15) were subjected to content and inductive thematic analysis to identify fatigue language and experiences. In study 2, 3 focus groups of RA patients (n = 17) explored these and developed the wording for visual analog scales (VAS) and identical numerical rating scales (NRS), then a draft multi-item questionnaire was developed with the patient research partner. Study 3 comprised 15 RA patients who completed the PROMs during cognitive interviewing to explore understanding. RESULTS: Studies 1 and 2 identified key patient terminology (fatigue, exhaustion) and 12 potential fatigue concepts (Cognition, Coping, Duration, Emotion, Energy, Frequency, Impact, Planning, Quality of Life, Relationships, Sleep, and Social Life). Patients' proposals were clarified into draft screening VAS/NRS for fatigue severity, effect, and coping, plus a draft 45-item questionnaire. Study 3 showed that 14 questions required clarification or revision of response options. CONCLUSION: Collaboration with patients enabled development of draft RA fatigue PROMs grounded in the patient data, strengthening face and content validity and ensuring comprehension. The draft conceptual framework that emerged has resulted in draft PROMS ready for item reduction, and testing of construct and criterion validity and reliability.

Satisfaction with care: an independent outcome measure in surgical oncology.

BACKGROUND: Outcomes for treatment for upper gastrointestinal cancer traditionally include procedure-related morbidity and mortality and long-term survival. Patient-reported outcomes, such as quality of life (QOL) and satisfaction measures, add to standard end points, but associations between these factors are not fully understood. This study examined how patient satisfaction related to surgical morbidity, treatment type, and QOL outcomes after inpatient treatment for upper gastrointestinal cancer. METHODS: Consecutive patients who had completed treatment in one unit were invited to participate in this study and complete the European Organization for Research and Treatment of Cancer QLQ-PATSAT32 and QLQ-C30 questionnaires within 2 months of discharge. Regression analyses examined relationships between satisfaction and surgical morbidity (major complications and type of treatment) and between satisfaction and QOL variables, adjusting for age and sex. RESULTS: During the study, 181 patients were treated, 162 were eligible, and 139 returned both questionnaires (response rate, 86%). Of the study sample, the treatment outcome was potential cure in 105 (67 esophagectomy and 38 D2 gastrectomy), and 34 received palliative treatment. Thirty-seven patients (27%) had major complications. Patients who received palliative treatment reported satisfaction and QOL scores similar to those of patients who received curative treatment. However, patients who experienced major morbidity reported significantly worse QOL than those without morbidity (P<.01). Satisfaction scores were the same in patients with or without complications. There were no associations between satisfaction and QOL scores (r<.34). CONCLUSIONS: Patient satisfaction with hospital care is independent of morbidity, treatment type, and QOL outcomes. It may be used to feed back information to providers of health care to improve patients' experiences of treatment.

Improving the quality of written information for patients.

Good communication with patients is vital. A national audit reported that written information for patients was of poor quality (Audit Commission 1993): this was followed by a number of interrelating studies reinforcing aspects of the report. This literature review has identified sufficient evidence to influence a change in practice. A protocol for the provision of written patient information is required, and this has been developed.