Integrating the patients' voice in designing and delivering a research study: The Yorkshire Cancer Research funded PREHABS study's experience.

INTRODUCTION: Engaging with patients when designing a clinical or research project is beneficial; feedback from the intended audience provides invaluable insight form the patients' perspective. Working with patients can result in developing successful research grants and interventions. The benefit of including the voice of the patient in the Yorkshire Cancer Research funded PREHABS study is described in this article. METHODS: Patients were included in the PREHABS study from inception to completion. The Theory of Change methodology was used to provide a framework to implement patient feedback to refine the study intervention. RESULTS: In total, 69 patients engaged with the PREHABS project. Two patients were recruited as co-applicants on the grant and were members on the Trial Management Group. Six patients attended the pre application workshop and provided feedback on their lived experiences of being a lung cancer patient. Commentary from the patients influenced the interventions selected and the design of the prehabs study. Following ethical approval (21/EE/0048) and informed written consent, 61 patients were recruited into the PREHABS study between October 2021 and November 2022. The breakdown of recruited patients was 19 males: mean age 69.1 years (SD 8.91) and 41 females; mean age 74.9 years (SD 8.9). CONCLUSION: It is practicable and beneficial to include patients at all stages of designing and delivering a research study. Patient feedback can help refine the study interventions to allow for maximum acceptance, recruitment and retention. IMPLICATIONS FOR PRACTICE: Including patients in the design of radiotherapy research studies can provide invaluable insight that can support the selection and delivery of interventions that are acceptable to the patient cohort.

Prehabilitation and Rehabilitation for Patients with Lung Cancer: A Review of Where we are Today.

Lung cancer is the third most common type of cancer in the UK, with nearly 50 000 new cases diagnosed a year. Treatments for lung cancer have improved in recent years with the advent of new surgical and radiotherapy techniques and the increased use of immunotherapies. These advances have resulted in increasing numbers of patients surviving beyond the completion of their treatment. Lung cancer patients are now not dying from their cancer diagnosis, but from other co-existing pathologies. Lung cancer patients commonly present with multiple comorbidities. Mitigating the effects of poor lifestyles and changing behaviours may improve the efficacy of treatments, reduce side-effects and improve the quality of life for lung cancer patients. Published evidence supports the use of interventions to manage behavioural habits, to optimise the health of patients. There is no consensus as to what, when or how to embed these into the patient pathway. Supporting patients before, during and after their cancer treatments to increase activity, eat well and stop smoking have been seen to decrease side-effects and improve patient outcomes and wellbeing. The challenge is to provide a package of interventions that is acceptable to patients and fits within the patient pathway so as not to conflict with diagnostic and therapeutic activities. This article reviews where we are today with providing behavioural support to optimise the health of lung cancer patients undergoing treatment.

Fluticasone versus placebo for chronic asthma in adults and children.

BACKGROUND: Inhaled fluticasone propionate (FP) is a relatively new inhaled corticosteroid for the treatment of asthma. OBJECTIVES: 1. To assess efficacy and safety outcomes in studies that compared FP to placebo for treatment of chronic asthma.2. To explore the presence of a dose-response effect. SEARCH STRATEGY: We searched the Cochrane Airways Group Specialised Register (January 2005), reference lists of articles, contacted trialists and searched abstracts of major respiratory society meetings (1997-2004). SELECTION CRITERIA: Randomised trials in children and adults comparing FP to placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data. Quantitative analyses were undertaken using RevMan 4.2 MAIN RESULTS: Seventy-five studies met the inclusion criteria (14,208 participants). Methodological quality was high. In non-oral steroid treated asthmatics with mild and moderate disease FP resulted in improvements from baseline compared with placebo across all dose ranges (100 to 1000 mcg/d) in FEV1 (between 0.13 to 0.45 litres); morning PEF (between 23 and 47 L/min); symptom scores (based on a standardised scale, between 0.5 and 0.85); reduction in rescue beta-2 agonist use (between 1.2 and 2.2 puffs/day). High dose FP increased the number of patients who could withdraw from prednisolone: FP 1000-1500 mcg/day Peto Odds Ratio 14.07 (95% CI 7.17 to 27.57). FP at all doses led to a greater likelihood of sore throat, hoarseness and oral Candidiasis. Twenty-one patients would need to be treated for one extra to develop Candidiasis (FP 500 mcg/day), whilst only three or four patients need to be treated to avoid one extra patient being withdrawn due to lack of efficacy at all doses of FP. AUTHORS' CONCLUSIONS: Doses of FP in the range 100-1000 mcg/day are effective. In most patients with mild-moderate asthma improvements with low dose FP are only a little less than those associated with high doses when compared with placebo. High dose FP appears to have worthwhile oral-corticosteroid reducing properties. FP use is accompanied by an increased likelihood of oropharyngeal side effects.

Inhaled fluticasone at different doses for chronic asthma in adults and children.

BACKGROUND: Inhaled fluticasone propionate (FP) is a high-potency inhaled corticosteroid used in the treatment of asthma. OBJECTIVES: 1. To assess the efficacy and safety outcomes of inhaled fluticasone at different nominal daily doses in the treatment of chronic asthma. 2. To test for the presence of a dose-response effect. SEARCH STRATEGY: We searched the Cochrane Airways Group Trials Register (January 2005) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997 to 2004). SELECTION CRITERIA: Randomised trials in children and adults comparing fluticasone at different nominal daily doses in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality. DATA COLLECTION AND ANALYSIS: One reviewer extracted data. These were checked and verified by a second reviewer. Quantitative analyses where undertaken using RevMan (Analyses 1.0.2). MAIN RESULTS: Forty-three studies (45 data sets with 8913 participants) met the inclusion criteria. Methodological quality was high. In asthmatics with mild to moderate disease who were not on oral steroids a dose-response effect was present with FP for change in morning peak expiratory flow (PEF). For low doses (100 versus 200 microg/day) the weighted mean difference (WMD) was 6.29 litres/min, 95% confidence interval (CI) 2.28 to 10.29. Comparing medium (400 to 500 microg/day) to low dose (200 microg/day) FP the WMD was 6.46 litres/min (95% CI 3.02 to 9.89); this effect was more pronounced in one trial with more severely asthmatic children. For FP 100 versus 400 to 500 microg/day the WMD was 8 litres/min (95% CI 1 to 15) and at high versus low doses (800 to 1000 versus 50 to 100 microg/d) the WMD was 22 litres/min (95% CI 15 to 29). When high and medium doses were compared there was no significant difference in the change in morning PEF: at 400 to 500 versus 800 to 1000 microg/day the WMD was 0.16 litres/min (95% CI 6.95 to 6.63). There was no dose-response effect on symptoms or rescue beta-2 agonist use. The likelihood of hoarseness and oral candidiasis was significantly greater for the higher doses (800 to 1000 microg/day). People with oral steroid-dependent asthma treated with FP (2000 microg/day) were significantly more likely to reduce oral prednisolone than those on 1000 to 1500 microg/day (Peto odds Ratio 2.8, 95% CI 1.3 to 6.3). The highest dose also allowed a significant reduction in daily oral prednisolone dose compared to 1000 to 1500 microg/day (WMD 2.0 mg/day, 95% CI 0.1 to 4.0 mg/day). AUTHORS' CONCLUSIONS: Effects of fluticasone are dose dependent but relatively small. At dose ratios of 1:2, there are significant differences in favour of the higher dose in morning peak flow across the low dose range. The clinical impact of these differences is open to interpretation. Patients with moderate disease achieve similar levels of asthma control on medium doses of fluticasone (400 to 500 microg/day) as they do on high doses (800 to 1000 microg/day). More work in severe asthma would help to confirm that doses of FP above 500 microg/day confer greater benefit in this subgroup than doses of around 200 microg/day. In oral corticosteroid-dependent asthmatics, reductions in prednisolone requirement may be gained with FP 2000 microg/day.

Inhaled fluticasone versus placebo for chronic asthma in adults and children.

BACKGROUND: Inhaled fluticasone propionate (FP) is a relatively new inhaled corticosteroid for the treatment of asthma. OBJECTIVES: 1. To assess efficacy and safety outcomes in studies that compared FP to placebo for treatment of chronic asthma.2. To explore the presence of a dose-response effect. SEARCH STRATEGY: We searched the Cochrane Airways Group Trial Register (January 2004), reference lists of articles, contacted trialists and searched abstracts of major respiratory society meetings (1997-2004). SELECTION CRITERIA: Randomised trials in children and adults comparing FP to placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data. Quantitative analyses where undertaken using RevMan Analyses 4.2.7. MAIN RESULTS: Sixty eight studies met the inclusion criteria (11, 104 participants). Methodological quality was high. In non-oral steroid treated asthmatics with mild and moderate disease FP resulted in improvements from baseline compared with placebo across all dose ranges (100 to 1000 mcg/d) in FEV1 (between 0.13 to 0.45 litres); morning PEF (between 27 and 47 L/min); symptom scores (based on a standardised scale, between 0.5 and 0.85); reduction in rescue beta-2 agonist use (between 1.2 and 2.2 puffs/d). High dose FP reduced the number of patients dependent on prednisolone: FP 1000-1500 mcg/d Peto Odds Ratio 0.07 (95% CI 0.05 to 0.10). FP at all doses led to a greater likelihood of sore throat, hoarseness and oral Candidiasis, but 21 patients would need to be treated for one extra to develop Candidiasis (FP 500 mcg/day), whilst only three or four patients need to be treated to avoid one extra patient being withdrawn due to lack of efficacy at all doses of FP. AUTHORS' CONCLUSIONS: Doses of FP in the range 100-1000 mcg/d are effective. In most patients with mild-moderate asthma improvements with low dose FP are only a little less than those associated with high doses when compared with placebo. High dose FP appears to have worthwhile oral-corticosteroid reducing properties. FP use is accompanied by an increased likelihood of oropharyngeal side effects.

Systematic review of the problems and issues of accessing specialist palliative care by patients, carers and health and social care professionals.

OBJECTIVES: To determine the problems and issues of accessing specialist palliative care by patients, informal carers and health and social care professionals involved in their care in primary and secondary care settings. DATA SOURCES: Eleven electronic databases (medical, health-related and social science) were searched from the beginning of 1997 to October 2003. Palliative Medicine (January 1997-October 2003) was also hand-searched. STUDY SELECTION: Systematic search for studies, reports and policy papers written in English. DATA EXTRACTION: Included papers were data-extracted and the quality of each included study was assessed using 10 questions on a 40-point scale. RESULTS: The search resulted in 9921 hits. Two hundred and seven papers were directly concerned with symptoms or issues of access, referral or barriers and obstacles to receiving palliative care. Only 40 (19%) papers met the inclusion criteria. Several barriers to access and referral to palliative care were identified including lack of knowledge and education amongst health and social care professionals, and a lack of standardized referral criteria. Some groups of people failed to receive timely referrals e.g., those from minority ethnic communities, older people and patients with nonmalignant conditions as well as people that are socially excluded e.g., homeless people. CONCLUSIONS: There is a need to improve education and knowledge about specialist palliative care and hospice care amongst health and social care professionals, patients and carers. Standardized referral criteria need to be developed. Further work is also needed to assess the needs of those not currently accessing palliative care services.

Longitudinal trends in exercise capacity and health status after pulmonary rehabilitation in patients with COPD.

Pulmonary rehabilitation (PR) programmes produce initial improvements in exercise tolerance and health status in patients with chronic obstructive pulmonary disease (COPD). However, there is limited data on the longer term effects of PR. This study has examined whether the initial benefits gained in exercise tolerance and health status may be maintained after a 1-year follow-up programme. Sixty-six patients with COPD were assessed with the MRC Dyspnoea Scale and found to be moderately disabled due to dyspnoea (MRC Grades 3 and 4). These patients were then randomised to an 8 week outpatient programme of either exercise training and education (Exercise group) or to education alone (Control group). Exercise performance was assessed with the shuttle walking test and health status assessed with two disease-specific measures, the St Georges Respiratory Questionnaire and the Chronic Respiratory Disease Questionnaire. After PR, all patients were invited to attend monthly follow-up sessions for 1 year. Fifty-six patients were available for follow-up immediately after the programme and were assessed at 6 months and 1 year. This study has shown that the patients in the Exercise group maintained improvements in exercise capacity and health status up to 6 months after an 8 week programme. At 1 year there was a significant difference between the Exercise and Control groups in terms of exercise tolerance due to a considerable decline experienced by the Control group. However, neither group had maintained improvements in health status at 1 year. Further study is required to assess whether benefit may be sustained for a longer period using alternative follow-up strategies.

Development and validation of a standardized measure of activity of daily living in patients with severe COPD: the London Chest Activity of Daily Living scale (LCADL).

Activities of daily living (ADL) may be severely restricted in patients with COPD and assessment requires evaluation of the impact of disability and handicap on daily life. This study is concerned with the development and validation of a standardized 15-item questionnaire to assess routine ADL. Sixty (33 male, 27 female) patients with severe COPD, mean (SD) FEV1 0.91 (0.43) l, median (range) age 70 (50-82) years, completed a 59-item ADL list previously generated by open-ended interview and by literature review. Patients also performed the Shuttle Walk Test (SWT), and completed the St George's Respiratory Questionnaire (SGRQ), the Nottingham Extended Activity of Daily Living Questionnaire (EADL) and the Hospital Anxiety and Depression score (HAD). Criteria for item reduction in the development of The London Chest ADL scale (LCADL) consisted of removal of items where the majority of respondents showed no limitation in the activity (n = 19), where there was no association with perception of global health (n = 9), where an association with age or gender was detected (n = 4), or where items showed poor reliability on test re-test (n = 9). Fifteen items were identified as core activities of daily living. The LCADL was then compared with other measures of health status in these patients. There were good correlations with the SGRQ activity and impact components (p=0.70; P<0.0001) and (p=0.58; P<0.0001), respectively, and EADL (p=0.45; P<0.001), and a moderate correlation with HAD anxiety (p=0.28; P<0.03). There was a significant relationship between the SWT and LCADL (p=0.58; P<0.0001), suggesting a relationship between impaired exercise performance and lower ADL scores. There was evidence of high internal consistency of the questionnaire with Chronbach's alpha of 0.98. These findings suggest that the LCADL scale is a valid tool for the assessment of ADL in patients with severe COPD.

Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease.

BACKGROUND: Methods of classifying chronic obstructive pulmonary disease (COPD) depend largely upon spirometric measurements but disability is only weakly related to measurements of lung function. With the increased use of pulmonary rehabilitation, a need has been identified for a simple and standardised method of categorising disability in COPD. This study examined the validity of the Medical Research Council (MRC) dyspnoea scale for this purpose. METHODS: One hundred patients with COPD were recruited from an outpatient pulmonary rehabilitation programme. Assessments included the MRC dyspnoea scale, spirometric tests, blood gas tensions, a shuttle walking test, and Borg scores for perceived breathlessness before and after exercise. Health status was assessed using the St George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Questionnaire (CRQ). The Nottingham Extended Activities of Daily Living (EADL) score and Hospital Anxiety and Depression (HAD) score were also measured. RESULTS: Of the patients studied, 32 were classified as having MRC grade 3 dyspnoea, 34 MRC grade 4 dyspnoea, and 34 MRC grade 5 dyspnoea. Patients with MRC grades 1 and 2 dyspnoea were not included in the study. There was a significant association between MRC grade and shuttle distance, SGRQ and CRQ scores, mood state and EADL. Forced expiratory volume in one second (FEV1) was not associated with MRC grade. Multiple logistic regression showed that the determinants of disability appeared to vary with the level of disability. Between MRC grades 3 and 4 the significant covariates were exercise performance, SGRQ and depression score, whilst between grades 4 and 5 exercise performance and age were the major determinants. CONCLUSIONS: The MRC dyspnoea scale is a simple and valid method of categorising patients with COPD in terms of their disability that could be used to complement FEV1 in the classification of COPD severity.

Evaluation of pulsed dose oxygen delivery during exercise in patients with severe chronic obstructive pulmonary disease.

BACKGROUND: Oxygen conserving devices may lead to substantial increases in the duration of oxygen provided. A study was undertaken to compare the performance of a pulsed dose oxygen delivery (PDOD) system with continuous flow oxygen or air during a maximal walking test. METHODS: Fourteen patients with chronic obstructive pulmonary disease (COPD) and arterial oxygen desaturation on exercise (mean (SD) forced expiratory volume in one second (FEV1) 0.83 (0.28) 1, arterial oxygen pressure (PaO2) 8.38 (1.24) kPa, arterial carbon dioxide pressure (PaCO2) 5.95 (0.86) kPa) were randomised to perform a walking test using air administered via a cylinder or continuous flow oxygen at 2 l/min or by a PDOD system. RESULTS: There was no significant difference in the mean arterial oxygen saturation (SaO2) using the PDOD system or with continuous flow oxygen (p = 0.33). Patients showed greatest desaturation whilst walking with the air cylinder (SaO2 79.2 (8.59)%) which was significantly different from the desaturation with both continuous flow oxygen (87.6 (5.85)%, p = 0.001) and PDOD (85.6 (7.36)%, p = 0.004). There was no significant difference between the distance walked using oxygen delivered at 2 l/min by continuous flow or via the PDOD (p = 0.72; CI 0.34 to 1.08). The mean (SD) distance walked on continuous flow oxygen (203.6 (106.1) m) and PDOD (207.9 (109.8) m) was significantly greater than the distance walked with the air cylinder (188.6 (110.02) m); (1.12 fold increase in distance, CI 1.01 to 1.23, p = 0.02, and 1.14 fold increase in distance, CI 1.01 to 1.28, p = 0.03, respectively). CONCLUSIONS: These findings suggest that the pulsed dose oxygen conserving device was as effective as continuous flow oxygen in maintaining arterial oxygen saturation and that the use of this device was associated with similar improvements in exercise tolerance to patients taking continuous flow oxygen therapy.

Randomized controlled trial of pulmonary rehabilitation in severe chronic obstructive pulmonary disease patients, stratified with the MRC dyspnoea scale.

This study tested the hypothesis that severity of respiratory disability may affect the outcome of pulmonary rehabilitation. In this randomized, controlled study, 126 patients with chronic obstructive pulmonary disease (COPD) were stratified for dyspnoea using the Medical Research Council (MRC) dyspnoea score into MRC3/4 (Moderate) (n=66) and MRC 5 (Severe) dyspnoeic (n=60) groups. The patients were randomly assigned to an eight week programme of either exercise plus education (Exercise group) or education (Control group). Education and exercise programmes for the moderately dyspnoeic patients were carried out in a hospital outpatient setting. Severely dyspnoeic patients were all treated at home. Those in the Exercise group received an individualized training programme. There was a significant improvement in shuttle walking distance in the moderate dyspnoeic group, who received exercise training; baseline (mean+/-SEM) 191+/-22 m, post-rehabilitation 279+/-22 m (p<0.001). There was no improvement in exercise performance in the severely dyspnoeic patients receiving exercise. Neither group of control patients improved. Health status, assessed by the Total Chronic Respiratory Disease Questionnaire score, increased in the moderately dyspnoeic patients receiving exercise from 80+/-18 to 95+/-17 (p<0.0001) after rehabilitation. Much smaller changes were seen in the other three groups. Improvement in exercise performance and health status in patients with chronic obstructive pulmonary disease after an exercise programme depends on the initial degree of dyspnoea.

Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease.

Exacerbations occur commonly in patients with moderate or severe chronic obstructive pulmonary disease (COPD) but factors affecting their severity and frequency or effects on quality of life are unknown. We measured daily peak expiratory flow rate (PEFR) and daily respiratory symptoms for 1 yr in 70 COPD patients (52 male, 18 female, mean age [+/- SD] 67.5 +/- 8.3 yr, FEV1 1.06 +/- 0.45 L, FVC 2.48 +/- 0.82 L, FEV1/FVC 44 +/- 15%, FEV1 reversibility 6.7 +/- 9.1%, PaO2 8.8 +/- 1.1 kPa). Quality of life was measured by the St. George's Respiratory Questionnaire (SGRQ). Exacerbations (E) were assessed at acute visit (reported exacerbation) or from diary card data each month (unreported exacerbation). In 61 (87%) patients there were 190 exacerbations (median 3; range, 1 to 8) of which 93 (51%) were reported. There were no differences in major symptoms (increase in dyspnea, sputum volume, or purulence) or physiological parameters between reported and unreported exacerbations. At exacerbation, median peak flow fell by an average of 6.6 L/min (p = 0.0003). Using the median number of exacerbations as the cutoff point, patients were classified as infrequent exacerbators (E = 0 to 2) or frequent exacerbators (E = 3 to 8). The SGRQ Total and component scores were significantly worse in the group that had frequent exacerbations: SGRQ Total score (mean difference = 14.8, p < 0.001), Symptoms (23.1, p < 0.001), Activities (12.2, p = 0.003), Impacts (13.9, p = 0.002). However there was no difference between frequent and infrequent exacerbators in the fall in peak flow at exacerbation. Factors predictive of frequent exacerbations were daily cough (p = 0.018), daily wheeze (p = 0.011), and daily cough and sputum (p = 0.009) and frequent exacerbations in the previous year (p = 0.001). These findings suggest that patient quality of life is related to COPD exacerbation frequency.