Nasal sprays and behavioural interventions compared with usual care for acute respiratory illness in primary care: a randomised, controlled, open-label, parallel-group trial.

BACKGROUND: A small amount of evidence suggests that nasal sprays, or physical activity and stress management, could shorten the duration of respiratory infections. This study aimed to assess the effect of nasal sprays or a behavioural intervention promoting physical activity and stress management on respiratory illnesses, compared with usual care. METHODS: This randomised, controlled, open-label, parallel-group trial was done at 332 general practitioner practices in the UK. Eligible adults (aged ≥18 years) had at least one comorbidity or risk factor increasing their risk of adverse outcomes due to respiratory illness (eg, immune compromise due to serious illness or medication; heart disease; asthma or lung disease; diabetes; mild hepatic impairment; stroke or severe neurological problem; obesity [BMI ≥30 kg/m2]; or age ≥65 years) or at least three self-reported respiratory tract infections in a normal year (ie, any year before the COVID-19 pandemic). Participants were randomly assigned (1:1:1:1) using a computerised system to: usual care (brief advice about managing illness); gel-based spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); saline spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); or a brief behavioural intervention in which participants were given access to a website promoting physical activity and stress management. The study was partially masked: neither investigators nor medical staff were aware of treatment allocation, and investigators who did the statistical analysis were unaware of treatment allocation. The sprays were relabelled to maintain participant masking. Outcomes were assessed using data from participants' completed monthly surveys and a survey at 6 months. The primary outcome was total number of days of illness due to self-reported respiratory tract illnesses (coughs, colds, sore throat, sinus or ear infections, influenza, or COVID-19) in the previous 6 months, assessed in the modified intention-to-treat population, which included all randomly assigned participants who had primary outcome data available. Key secondary outcomes were possible harms, including headache or facial pain, and antibiotic use, assessed in all randomly assigned participants. This trial was registered with ISRCTN, 17936080, and is closed to recruitment. FINDINGS: Between Dec 12, 2020, and April 7, 2023, of 19 475 individuals screened for eligibility, 13 799 participants were randomly assigned to usual care (n=3451), gel-based nasal spray (n=3448), saline nasal spray (n=3450), or the digital intervention promoting physical activity and stress management (n=3450). 11 612 participants had complete data for the primary outcome and were included in the primary outcome analysis (usual care group, n=2983; gel-based spray group, n=2935; saline spray group, n=2967; behavioural website group, n=2727). Compared with participants in the usual care group, who had a mean of 8·2 (SD 16·1) days of illness, the number of days of illness was significantly lower in the gel-based spray group (mean 6·5 days [SD 12·8]; adjusted incidence rate ratio [IRR] 0·82 [99% CI 0·76-0·90]; p<0·0001) and the saline spray group (6·4 days [12·4]; 0·81 [0·74-0·88]; p<0·0001), but not in the group allocated to the behavioural website (7·4 days [14·7]; 0·97 [0·89-1·06]; p=0·46). The most common adverse event was headache or sinus pain in the gel-based group: 123 (4·8%) of 2556 participants in the usual care group; 199 (7·8%) of 2498 participants in the gel-based group (risk ratio 1·61 [95% CI 1·30-1·99]; p<0·0001); 101 (4·5%) of 2377 participants in the saline group (0·81 [0·63-1·05]; p=0·11); and 101 (4·5%) of 2091 participants in the behavioural intervention group (0·95 [0·74-1·22]; p=0·69). Compared with usual care, antibiotic use was lower for all interventions: IRR 0·65 (95% CI 0·50-0·84; p=0·001) for the gel-based spray group; 0·69 (0·45-0·88; p=0·003) for the saline spray group; and 0·74 (0·57-0·94; p=0·02) for the behavioural website group. INTERPRETATION: Advice to use either nasal spray reduced illness duration and both sprays and the behavioural website reduced antibiotic use. Future research should aim to address the impact of the widespread implementation of these simple interventions. FUNDING: National Institute for Health and Care Research.

A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors.

BACKGROUND: Many cancer survivors following primary treatment have prolonged poor quality of life. AIM: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. DESIGN: Pragmatic parallel open randomised trial. SETTING: UK general practices. METHODS: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. RESULTS: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. CONCLUSION: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.

Ha Ora: secondary care barriers and enablers to early diagnosis of lung cancer for Maori communities.

BACKGROUND: Lung Cancer is the leading cause of cancer deaths in Aotearoa New Zealand. Maori communities in particular have higher incidence and mortality rates from Lung Cancer. Diagnosis of lung cancer at an early stage can allow for curative treatment. This project aimed to document the barriers to early diagnosis and treatment of lung cancer in secondary care for Maori communities. METHODS: This project used a kaupapa Maori approach. Nine community hui (focus groups) and nine primary healthcare provider hui were carried out in five rural localities in the Midland region. Community hui included cancer patients, whanau (families), and other community members. Healthcare provider hui comprised staff members at the local primary healthcare centre, including General Practitioners and nurses. Hui data were thematically analysed. RESULTS: Barriers and enablers to early diagnosis of lung cancer were categorised into two broad themes: Specialist services and treatment, and whanau journey. The barriers and enablers that participants experienced in specialist services and treatment related to access to care, engagement with specialists, communication with specialist services and cultural values and respect, whereas barriers and enablers relating to the whanau journey focused on agency and the impact on whanau. CONCLUSIONS: The study highlighted the need to improve communication within and across healthcare services, the importance of understanding the cultural needs of patients and whanau and a health system strategy that meets these needs. Findings also demonstrated the resilience of Maori and the active efforts of whanau as carers to foster health literacy in future generations.

Indigenous perspectives on breaking bad news: ethical considerations for healthcare providers.

Most healthcare providers (HCPs) work from ethical principles based on a Western model of practice that may not adhere to the cultural values intrinsic to Indigenous peoples. Breaking bad news (BBN) is an important topic of ethical concern in health research. While much has been documented on BBN globally, the ethical implications of receiving bad news, from an Indigenous patient perspective in particular, is an area that requires further inquiry. This article discusses the experiences of Maori (Indigenous peoples of New Zealand) lung cancer patients and their families, in order to investigate the ethical implications of receiving bad news. Data collection occurred through 23 semistructured interviews and nine focus groups with Maori lung cancer patients and their families in four districts in the Midland Region of New Zealand: Waikato, Bay of Plenty, Lakes and Tairawhiti. The findings of this study were categorised into two key themes: communication and context. Avenues for best practice include understanding the centrality of the HCP-patient relationship and family ties in the healthcare journey, and providing patients with the full range of viable treatment options including hope, clear advice and guidance when the situation calls for it. Overall, the findings of this study hold implications for providing culturally safe and humanistic cancer care when BBN to Maori and Indigenous patients.

Ha Ora: Barriers and enablers to early diagnosis of lung cancer in primary healthcare for Maori communities.

OBJECTIVE: The objective of this research was to document the barriers to early presentation and diagnosis of lung cancer within primary healthcare, identified by Maori whanau (families) and primary healthcare providers in the Midland region of Aotearoa New Zealand. METHODS: This project used a kaupapa Maori approach. Nine community hui (focus groups) and nine primary healthcare provider hui were carried out in five rural localities in the Midland region. Each community hui included cancer patients, whanau, and other community members. Each healthcare provider hui comprised staff members at the local primary healthcare centre, including General Practitioners and nurses. Hui data were thematically analysed. RESULTS: Barriers and enablers to early diagnosis of lung cancer were categorised into three key themes: GP relationship and position in the community, health literacy and pathways to diagnosis. CONCLUSION: This study demonstrates that culturally responsive, patient-centred healthcare, and positive GP-patient relationships are significant factors for Maori patients and whanau serving as barriers and enablers to early diagnosis of lung cancer.

Management of patients with early stage lung cancer - why do some patients not receive treatment with curative intent?

BACKGROUNDS: This study aims to understand the factors that influence whether patients receive potentially curative treatment for early stage lung cancer. A key question was whether indigenous Maori patients were less likely to receive treatment. METHODS: Patients included those diagnosed with early stage lung cancer in 2011-2018 and resident in the New Zealand Midland Cancer Network region. Logistic regression model was used to estimate the odds ratios of having curative surgery/ treatment. The Kaplan Meier method was used to examine the all-cause survival and Cox proportional hazard model was used to estimate the hazard ratio of death. RESULTS: In total 419/583 (71.9%) of patients with Stage I and II disease were treated with curative intent - 272 (46.7%) patients had curative surgery. Patients not receiving potentially curative treatment were older, were less likely to have non-small cell lung cancer (NSCLC), had poorer lung function and were more likely to have an ECOG performance status of 2+. Current smokers were less likely to be treated with surgery and more likely to receive treatment with radiotherapy and chemotherapy. Those who were treated with surgery had a 2-year survival of 87.8% (95% CI: 83.8-91.8%) and 5-year survival of 69.6% (95% CI: 63.2-76.0%). Stereotactic ablative body radiotherapy (SABR) has equivalent effect on survival compared to curative surgery (hazard ratio: 0.77, 95% CI: 0.37-1.61). After adjustment we could find no difference in treatment and survival between Maori and non-Maori. CONCLUSIONS: The majority of patients with stage I and II lung cancer are managed with potentially curative treatment - mainly surgery and increasingly with SABR. The outcomes of those being diagnosed with stage I and II disease and receiving treatment is positive with 70% surviving 5 years.

A Patient Safety Toolkit for Family Practices.

OBJECTIVE: Major gaps remain in our understanding of primary care patient safety. We describe a toolkit for measuring patient safety in family practices. METHODS: Six tools were used in 46 practices. These tools were as follows: National Health Service Education for Scotland Trigger Tool, National Health Service Education for Scotland Medicines Reconciliation Tool, Primary Care Safequest, Prescribing Safety Indicators, Patient Reported Experiences and Outcomes of Safety in Primary Care, and Concise Safe Systems Checklist. RESULTS: Primary Care Safequest showed that most practices had a well-developed safety climate. However, the trigger tool revealed that a quarter of events identified were associated with moderate or substantial harm, with a third originating in primary care and avoidable. Although medicines reconciliation was undertaken within 2 days in more than 70% of cases, necessary discussions with a patient/carer did not always occur. The prescribing safety indicators identified 1435 instances of potentially hazardous prescribing or lack of recommended monitoring (from 92,649 patients). The Concise Safe Systems Checklist found that 25% of staff thought that their practice provided inadequate follow-up for vulnerable patients discharged from hospital and inadequate monitoring of noncollection of prescriptions. Most patients had a positive perception of the safety of their practice although 45% identified at least one safety problem in the past year. CONCLUSIONS: Patient safety is complex and multidimensional. The Patient Safety Toolkit is easy to use and hosted on a single platform with a collection of tools generating practical and actionable information. It enables family practices to identify safety deficits that they can review and change procedures to improve their patient safety across a key sets of patient safety issues.

Characteristics of lung cancers and accuracy and completeness of registration in the New Zealand Cancer Registry.

AIMS: This study aims to report the characteristics of newly diagnosed lung cancer cases, and to examine the data accuracy of registrations in the New Zealand Cancer Registry (NZCR) in 2011-2015. METHODS: The accuracy and completeness of lung cancer registrations in the NZCR was explored using the Midland Lung Cancer Register (MLCR, including Lakes, Waikato, Tairawhiti and Bay of Plenty District Health Boards) and clinical records. A combined Midland Lung Cancer Dataset was created based on the NZCR and the MLCR. The characteristics of lung cancer cases was described and compared between Maori and non-Maori patients. The subgroup differences were examined by Chi-Square tests. The odds ratio of having small cell lung cancer compared to non-small cell lung cancer between Maori patients and non-Maori patients was estimated using the logistic regression model. RESULTS: The combined Midland Lung Cancer Dataset included 2,057 verified lung cancer registrations, including 656 (31.9%) Maori patients and 1,401 (68.1%) non-Maori patients. Maori patients were more likely to be diagnosed at a younger age, more likely to be female, more likely to be a current or ex-smoker and more likely to have small cell lung cancer than non-Maori. The difference of cancer stage at diagnosis between Maori and others was not significant. After adjustment, the odds ratio of having small cell lung cancer for Maori patients compared to non-Maori patients was 1.55 (95% CI: 1.17-2.05). The adjusted odds ratio of having small cell lung cancer was 4.06 (95% CI: 1.72-9.60) for current smokers and 2.68 (95% CI: 1.14-6.30) for ex-smokers compared to patients who never smoked. CONCLUSIONS: Combining the two sources of data gives a more complete picture of the incidence and tumour characteristics of lung cancer in our region. Our dataset suggests that Maori patients are more likely to have small cell lung cancer than non-Maori patients.

An internet-delivered handwashing intervention to modify influenza-like illness and respiratory infection transmission (PRIMIT): a primary care randomised trial.

BACKGROUND: Handwashing to prevent transmission of respiratory tract infections (RTIs) has been widely advocated, especially during the H1N1 pandemic. However, the role of handwashing is debated, and no good randomised evidence exists among adults in non-deprived settings. We aimed to assess whether an internet-delivered intervention to modify handwashing would reduce the number of RTIs among adults and their household members. METHODS: We recruited individuals sharing a household by mailed invitation through general practices in England. After consent, participants were randomised online by an automated computer-generated random number programme to receive either no access or access to a bespoke automated web-based intervention that maximised handwashing intention, monitored handwashing behaviour, provided tailored feedback, reinforced helpful attitudes and norms, and addressed negative beliefs. We enrolled participants into an additional cohort (randomised to receive intervention or no intervention) to assess whether the baseline questionnaire on handwashing would affect handwashing behaviour. Participants were not masked to intervention allocation, but statistical analysis commands were constructed masked to group. The primary outcome was number of episodes of RTIs in index participants in a modified intention-to-treat population of randomly assigned participants who completed follow-up at 16 weeks. This trial is registered with the ISRCTN registry, number ISRCTN75058295. FINDINGS: Across three winters between Jan 17, 2011, and March 31, 2013, we enrolled 20,066 participants and randomly assigned them to receive intervention (n=10,040) or no intervention (n=10,026). 16,908 (84%) participants were followed up with the 16 week questionnaire (8241 index participants in intervention group and 8667 in control group). After 16 weeks, 4242 individuals (51%) in the intervention group reported one or more episodes of RTI compared with 5135 (59%) in the control group (multivariate risk ratio 0·86, 95% CI 0·83-0·89; p<0·0001). The intervention reduced transmission of RTIs (reported within 1 week of another household member) both to and from the index person. We noted a slight increase in minor self-reported skin irritation (231 [4%] of 5429 in intervention group vs 79 [1%] of 6087 in control group) and no reported serious adverse events. INTERPRETATION: In non-pandemic years, an effective internet intervention designed to increase handwashing could have an important effect in reduction of infection transmission. In view of the heightened concern during a pandemic and the likely role of the internet in access to advice, the intervention also has potential for effective implementation during a pandemic. FUNDING: Medical Research Council.

Patients' views of receiving lessons in the Alexander technique and an exercise prescription for managing back pain in the ATEAM trial.

BACKGROUND: Lessons in the Alexander Technique and exercise prescription proved effective for managing low back pain in primary care in a clinical trial. OBJECTIVES: To understand trial participants' expectations and experiences of the Alexander Technique and exercise prescription. METHODS: A questionnaire assessing attitudes to the intervention, based on the Theory of Planned Behaviour, was completed at baseline and 3-month follow-up by 183 people assigned to lessons in the Alexander Technique and 176 people assigned to exercise prescription. Semi-structured interviews to assess the beliefs contributing to attitudes to the intervention were carried out at baseline with14 people assigned to the lessons in the Alexander Technique and 16 to exercise prescription, and at follow-up with 15 members of the baseline sample. RESULTS: Questionnaire responses indicated that attitudes to both interventions were positive at baseline but became more positive at follow-up only in those assigned to lessons in the Alexander Technique. Thematic analysis of the interviews suggested that at follow-up many patients who had learned the Alexander Technique felt they could manage back pain better. Whereas many obstacles to exercising were reported, few barriers to learning the Alexander Technique were described, since it 'made sense', could be practiced while carrying out everyday activities or relaxing, and the teachers provided personal advice and support. CONCLUSION: Using the Alexander Technique was viewed as effective by most patients. Acceptability may have been superior to exercise because of a convincing rationale and social support and a better perceived fit with the patient's particular symptoms and lifestyle.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain.

OBJECTIVE: To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. DESIGN: Factorial randomised trial. Setting 64 general practices in England. PARTICIPANTS: 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. INTERVENTIONS: Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. MAIN OUTCOME MEASURES: Roland Morris disability score (number of activities impaired by pain) and number of days in pain. RESULTS: Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks were lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. CONCLUSIONS: One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation.

OBJECTIVE: An economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain. DESIGN: Cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial. PARTICIPANTS: 579 patients with chronic or recurrent low back pain recruited from primary care. INTERVENTIONS: Normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse. MAIN OUTCOME MEASURES: Costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves. RESULTS: Intervention costs ranged from pound30 for exercise prescription to pound596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from pound50 for 24 lessons in Alexander technique to pound124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value ( pound61 per point on disability score, pound9 per additional pain-free day, pound2847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional pound64 per point on disability score, pound43 per additional pain-free day, pound5332 per QALY gain). CONCLUSIONS: An exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above pound20 000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain.

OBJECTIVE: To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. DESIGN: Factorial randomised trial. SETTING: 64 general practices in England. PARTICIPANTS: 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. INTERVENTIONS: Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. MAIN OUTCOME MEASURES: Roland Morris disability score (number of activities impaired by pain) and number of days in pain. RESULTS: Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. CONCLUSIONS: One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons. TRIAL REGISTRATION: National Research Register N0028108728.