BACKGROUND: Thyroid dysfunction is common in older people, with females at higher risk. Evidence suggests that thyroid-stimulating hormone (TSH) levels naturally increase with age. However, as uniform serum TSH reference ranges are applied across the adult lifespan, subclinical hypothyroidism (SCH) diagnosis is more likely in older people, with some individuals also being commenced treatment with levothyroxine (LT4). It is unclear whether LT4 treatment in older people with SCH is associated with adverse cardiovascular or bone health outcomes. METHODS: A systematic review and meta-analysis were performed to synthesise previous studies evaluating cardiovascular and bone health outcomes in older people with SCH, comparing LT4 treatment with no treatment. PubMed, Embase, Cochrane Library, MEDLINE, and Web of Science databases were searched from inception until March 13, 2023, and studies that evaluated cardiovascular and bone health events in people with SCH over 50 years old were selected. RESULTS: Six articles that recruited 3853 participants were found, ranging from 185 to 1642 participants, with the proportion of females ranging from 45 to 80%. The paucity of data resulted in analysis for those aged over 65 years only. Additionally, a study with 12,212 participants aged 18 years and older was identified; however, only data relevant to patients aged 65 years and older were considered for inclusion in the systematic review. Of these 7 studies, 4 assessed cardiovascular outcomes, 1 assessed bone health outcomes, and 2 assessed both. A meta-analysis of cardiovascular outcomes revealed a pooled hazard ratio of 0.89 (95% CI 0.71-1.12), indicating no significant difference in cardiovascular risk between older individuals with SCH treated with LT4 compared to those without treatment. Due to overlapping sub-studies, meta-analysis for bone health outcomes was not possible. CONCLUSIONS: This systematic review and meta-analysis found no significant association between LT4 use and cardiovascular and bone health outcomes in SCH participants over 65 years. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022308006.
Cardiovascular Diseases , Hypothyroidism , Thyroxine , Humans , Hypothyroidism/drug therapy , Thyroxine/therapeutic use , Aged , Female , Bone Density/drug effects , Male , Middle Aged
Intervention by members of the public during an out of hospital cardiac arrest (OHAC) including resuscitation attempts and accessible automated external defibrillator (AED) has been shown to improve survival. This study aimed to investigate the OHCA and AED knowledge and confidence, and barriers to intervention, of the public of North East England, UK. This study used a face-to-face cross-sectional survey on a public high street in Newcastle, UK. Participants were asked unprompted to explain what they would do when faced with an OHCA collapse. Chi-Square analysis was used to test the association of the independent variables sex and first aid trained on the participants' responses. Of the 421 participants recruited to our study, 82.9% (n = 349) reported that they would know what to do during an OHCA collapse. The most frequent OHCA action mentioned was call 999 (64.1%, n = 270/421) and 58.2% (n = 245/421) of participants reported that they would commence CPR. However, only 14.3% (n = 60/421) of participants spontaneously mentioned that they would locate an AED, while only 4.5% (n = 19/421) recounted that they would apply the AED. Just over half of participants (50.8%, n = 214/421) were first aid trained, with statistically more females (57.3%, n = 126/220) than males (43.9%, n = 87/198) being first aiders (p = 0.01 χ2 = 7.41). Most participants (80.3%, n = 338/421) knew what an AED was, and 34.7% (n = 326/421) reported that they knew how to use one, however, only 11.9% (n = 50/421) mentioned that they would actually shock a patient. Being first aid trained increased the likelihood of freely recounting actions for OHCA and AED intervention. The most common barrier to helping during an OHCA was lack of knowledge (29.9%, n = 126/421). Although most participants reported they would know what to do during an OHCA and had knowledge of an AED, low numbers of participants spontaneously mentioned specific OHCA and AED actions. Improving public knowledge would help improve the public's confidence of intervening during an OHCA and may improve OHCA survival.
BACKGROUND: Subclinical hypothyroidism is diagnosed when serum thyroid stimulating hormone levels are higher whilst free thyroxine levels remain within their respective reference ranges. These reference ranges are uniformly applied in all adults, despite serum thyroid stimulating hormone levels naturally increasing with age. Research has found that mildly elevated thyroid stimulating hormone levels may be associated with some benefits in ageing patients, including reduced mortality and better cardiorespiratory fitness. Levothyroxine is typically prescribed to patients with hypothyroidism, but no conclusive evidence exists on whether levothyroxine therapy is beneficial or detrimental in older subclinical hypothyroid patients. Despite this, prescriptions for levothyroxine are increasing year-on-year. This study aims to determine if receiving levothyroxine affects the cardiovascular and bone health outcomes of subclinical patients in primary care aged 50 years and over. METHODS: This project includes a retrospective cohort analysis and a target trial emulation study using electronic patient records collected between 2006 and 2021 and recorded in The Health Improvement Network database. The primary outcome of this study is to compare the cardiovascular outcomes of subclinical hypothyroid patients aged over 50 years treated with levothyroxine compared to those untreated. Secondary outcomes are bone health and all-cause mortality outcomes. Descriptive and inferential statistics will both be employed to analyse the data. Secondary analysis will explore confounding factors, including age, sex, smoking status, body mass index, co-morbidities, and levothyroxine dosage. DISCUSSION: There needs to be a greater understanding of the potential risks of the current treatment for older patients with subclinical hypothyroidism in a primary care setting. We will investigate the clinical importance of this issue and whether older subclinical hypothyroid patients have poorer outcomes when treated. Clarifying this concern may help address the healthcare resource implications of ageing patients being misclassified as having mild hypothyroidism, as these patients are more likely to repeat their blood tests. This could reduce prescription wastage and improve patient outcomes and quality of life in the ageing population. TRIAL REGISTRATION: Not applicable.
Background: Subclinical hypothyroidism (SCH) is a common endocrine problem with prevalence estimates between 4% and 20%. Symptoms are often non-specific but can substantially affect well-being leading to repeated medical consultations. The effect of thyroid hormone replacement therapy (THRT) in patients with SCH remains uncertain. Current guidelines, limited by the lack of high-quality evidence, have been controversial with limited adherence in clinical practice. Methods: Three-round modified Delphi method to establish consensus regarding diagnosis and treatment of individuals with SCH with and without affective disorder or anxiety, conducted with clinicians from three specialties, general practice, endocrinology and psychiatry, and two countries, Sweden and the United Kingdom. Results: Sixty clinicians, 20 per specialty, were recruited. Fifty-three (88%) participants completed all three rounds. The participants reached consensus on five of the 26 practice statements that (a) repeated testing was required for the diagnosis of subclinical hypothyroidism, (b) antibody screening should usually occur, and (c and d) antibody screening would strengthen the indication for thyroid hormone replacement therapy in both individuals with or without affective disorder or anxiety. The participants disagreed with (e) a requirement of a TSH threshold ≥ 20 mIU/L for thyroid hormone replacement therapy start. Psychiatrists and GPs but not endocrinologists, agreed that there was a frequent discrepancy between laboratory results and clinical symptoms, and disagreed that testing for thyroid dysfunction was overused in patients presenting with depression or anxiety, or fatigue. Conclusions: In many aspects, attitudes toward diagnosing and treating SCH remain diverse. The inability of our Delphi panel to achieve consensus on most items and the disagreement with a TSH ≥ 20 mIU/L threshold for treatment suggest that the concept of SCH may need rethinking with a better understanding of the hypothalamic-pituitary-thyroid physiology. Given that the scientific evidence is currently not conclusive, guidelines in this area should not be taken as definitive.
Hypothyroidism , Thyroxine , Humans , Thyroxine/therapeutic use , Thyrotropin , Mental Health , Hypothyroidism/complications , Hypothyroidism/diagnosis , Hypothyroidism/drug therapy , Thyroid Function Tests
INTRODUCTION: Head and neck cancer (HNC) is the eighth most common cancer in the United Kingdom. Survival rates improve when the cancer is diagnosed at an early stage, highlighting a key need to identify at-risk patients. This study aimed to explore opportunistic HNC identification and referral by community pharmacists (CPs) using a symptom-based risk assessment calculator, from the perspective of patients with a diagnosis of HNC. METHODS: Purposive sampling was used to recruit patients from the HNC pathway in three large teaching hospitals in Northern England. Qualitative methodology was used to collect data through an iterative series of semistructured telephone interviews. Framework analysis was utilised to identify key themes. RESULTS: Four main themes were constructed through the analytic process: (1) HNC presentation and seeking help; (2) the role of the CP; (3) public perception of HNC and (4) the role of a symptom-based risk calculator. Participants agreed that CPs could play a role in the identification and referral of suspected HNCs, but there were concerns about access as patients frequently only encounter the medicine counter assistant when they visit the pharmacy. HNC symptoms are frequently attributed to common or minor conditions initially and therefore considered not urgent, leading to delays in seeking help. While there is public promotion for some cancers, there is little known about HNC. Early presentation of HNC can be quite variable, therefore raising awareness would help. The use of a symptom-based risk calculator was considered beneficial if it enabled earlier referral and diagnosis. Participants suggested that it would also be useful if the public were made aware of it and could self-assess their symptoms. CONCLUSION: In principle, CPs could play a role in the identification and referral of HNC, but there was uncertainty as to how the intervention would work. Future research is needed to develop an intervention that would facilitate earlier identification and referral of HNC while not disrupting CP work and that would promote HNC and the risk calculator more widely. PATIENT OR PUBLIC CONTRIBUTION: Patient and public involvement and engagement (PPIE) was integrated throughout the project. Initially, the proposal was discussed during a Cancer Head and Neck Group Experience (CHANGE) PPIE meeting. CHANGE was set up to support HNC research in 2018. The group is composed of seven members (four female, three male) with an age range of 50-71 years, who were diagnosed at Sunderland Royal Hospital. A patient representative from the University of Sunderland PPIE group and a trustee of the Northern HNC Charity were recruited as co-applicants. They attended project management group meetings and reviewed patient-facing documentation.
Head and Neck Neoplasms , Pharmacists , Humans , Male , Female , Middle Aged , Aged , England , Qualitative Research , Head and Neck Neoplasms/diagnosis , Referral and Consultation
BACKGROUND: Tonsillectomy is regularly performed in adults with acute tonsillitis, but with scarce evidence. A reduction in tonsillectomies has coincided with an increase in acute adult hospitalisation for tonsillitis complications. We aimed to assess the clinical effectiveness and cost-effectiveness of conservative management versus tonsillectomy in patients with recurrent acute tonsillitis. METHODS: This pragmatic multicentre, open-label, randomised controlled trial was conducted in 27 hospitals in the UK. Participants were adults aged 16 years or older who were newly referred to secondary care otolaryngology clinics with recurrent acute tonsillitis. Patients were randomly assigned (1:1) to receive tonsillectomy or conservative management using random permuted blocks of variable length. Stratification by recruiting centre and baseline symptom severity was assessed using the Tonsil Outcome Inventory-14 score (categories defined as mild 0-35, moderate 36-48, or severe 49-70). Participants in the tonsillectomy group received elective surgery to dissect the palatine tonsils within 8 weeks after random assignment and those in the conservative management group received standard non-surgical care during 24 months. The primary outcome was the number of sore throat days collected during 24 months after random assignment, reported once per week with a text message. The primary analysis was done in the intention-to-treat (ITT) population. This study is registered with the ISRCTN registry, 55284102. FINDINGS: Between May 11, 2015, and April 30, 2018, 4165 participants with recurrent acute tonsillitis were assessed for eligibility and 3712 were excluded. 453 eligible participants were randomly assigned (233 in the immediate tonsillectomy group vs 220 in the conservative management group). 429 (95%) patients were included in the primary ITT analysis (224 vs 205). The median age of participants was 23 years (IQR 19-30), with 355 (78%) females and 97 (21%) males. Most participants were White (407 [90%]). Participants in the immediate tonsillectomy group had fewer days of sore throat during 24 months than those in the conservative management group (median 23 days [IQR 11-46] vs 30 days [14-65]). After adjustment for site and baseline severity, the incident rate ratio of total sore throat days in the immediate tonsillectomy group (n=224) compared with the conservative management group (n=205) was 0·53 (95% CI 0·43 to 0·65; <0·0001). 191 adverse events in 90 (39%) of 231 participants were deemed related to tonsillectomy. The most common adverse event was bleeding (54 events in 44 [19%] participants). No deaths occurred during the study. INTERPRETATION: Compared with conservative management, immediate tonsillectomy is clinically effective and cost-effective in adults with recurrent acute tonsillitis. FUNDING: National Institute for Health Research.
Pharyngitis , Respiration Disorders , Tonsillectomy , Tonsillitis , Male , Female , Humans , Adult , Young Adult , Tonsillectomy/adverse effects , Conservative Treatment , Tonsillitis/surgery , Tonsillitis/complications , Pharyngitis/etiology , Pain/etiology , United Kingdom/epidemiology
OBJECTIVE: To explore pharmacists' perceptions of, and attitudes towards, the early identification and referral of patients with signs and symptoms indicating potential diagnosis of head and neck cancer (HNC) in community pharmacy settings. DESIGN: Qualitative methodology, using constant comparative analysis to undertake an iterative series of semistructured interviews. Framework analysis facilitated the identification of salient themes. SETTING: Community pharmacies in Northern England. PARTICIPANTS: 17 community pharmacists. RESULTS: Four salient and inter-related categories emerged: (1) Opportunity and access, indicating frequent consultations with patients presenting with potential HNC symptoms and the accessible nature of community pharmacists; (2) Knowledge gap, indicating knowledge of key referral criteria, but limited experience and expertise in undertaking more holistic patient assessments to inform clinical decision making; (3) Referral pathways and workloads; indicating good working relationships with general medical practices, but limited collaboration with dental services, and a desire to engage with formal referral pathways, but current practices based entirely on signposting resulting in a potential lack of safety-netting, no auditable trail, feedback mechanism or integration into the multidisciplinary team; (4) Utilisation of clinical decision support tools; indicating that no participants were aware the Head and Neck Cancer Risk Calculator (HaNC-RC V2) for HNC but were positive towards the use of such tools to improve decision making. HaNC-RC V2 was seen as a potential tool to facilitate a more holistic approach to assessing patient's symptoms, acting as a prompt to further explore a patient's presentation, requiring further investigation in this context. CONCLUSIONS: Community pharmacies offer access to patients and high-risk populations that could support HNC awareness initiatives, earlier identification and referral. However, further work to develop a sustainable and cost-effective approach to integrating pharmacists into cancer referral pathways is needed, alongside appropriate training for pharmacists to successfully deliver optimum patient care.
Neoplasms , Pharmacists , Humans , Referral and Consultation , England , Qualitative Research
BACKGROUND: Recent evidence suggests that the first consultation with a general practitioner (GP) for symptoms of depression may be more than just a vehicle for assessment and management planning (as current guidelines imply). OBJECTIVES: To identify what patients find helpful, or otherwise, in their first consultation for low mood with a GP. METHODS: A cross-sectional questionnaire and interview study of patients with low mood who had recently consulted their GP, in the North of England. Patients were asked to complete a questionnaire regarding the consultation, and a Patient Health Questionnaire-9 (PHQ-9), within 2 weeks. They were also invited to take part in a face-face interview with a researcher. Both sources of data were subjected to qualitative thematic analysis. RESULTS: Thirty-seven questionnaires were returned; 5 interviews took place. The majority of participants felt better after consulting a GP for the first time for low mood. The factors most commonly cited as helpful were "being listened to" and "understanding or empathy from the GP." Others included "admitting the problem," "being reassured of normality," and "being provided with optimism or hope for change." The most commonly reported difficulty was the patients' struggle to express themselves. Patients often felt that GP follow-up was inadequate. CONCLUSIONS: These results suggest that the therapeutic benefit of the GP consultation is under-recognized in current guidelines. The results of our study will provide crucial information as to how such consultations can be tailored to improve patient satisfaction.
Although patients often tell their general practitioner (GP) that they feel better after a first consultation with symptoms of depression, the degree of patient satisfaction after such consultations seems to vary greatly. In this questionnaire and interview study, patients were asked to state which aspects of the consultation they had found helpful, or otherwise. The results showed that well-recognized factors of patient-centredness (where patients are involved in all decisions about their healthcare) such as "having time to talk" and "being listened to" were highly valued in the current setting. In addition, several aspects of the GP consultation that are more specific to depression were also highly rated, namely: "Admitting the problem," "being reassured of normality," and "being provided with optimism or hope for change." Overall, most patients felt better after the first consultation for low mooda therapeutic effect that is not well recognized in current guidelines for depression. However, patients consistently reported that they felt GP follow-up after their first consultation for low mood was insufficient. These results should help us to optimize GP consultations for patients presenting for the first symptoms of depression.
Peripheral arterial disease (PAD) is associated with cerebral and coronary artery disease. Symptomatic PAD affects about 5% of people over 55 years; many more have asymptomatic PAD. Early detection enables modification of arterial disease risk factors. Diagnostically, assessment of symptoms or signs can be unreliable; ankle brachial pressure index (ABPI) testing is time-consuming and few healthcare professionals are properly trained. This study assessed the diagnostic accuracy of multi-site photoplethysmography (MPPG), an alternative non-invasive test for PAD, in primary care. PAD patients identified from general practice registers were age- and sex-matched with controls. Participants were assessed using MPPG, ABPI and duplex ultrasound (DUS). Outcome measures were sensitivity and specificity of MPPG and ABPI (relative to DUS) and concordance. MPPG test results were available in 249 of 298 eligible participants from 16 practices between May 2015 and November 2016. DUS detected PAD in 101/249 (40.6%). MPPG sensitivity was 79.8% (95% confidence interval [CI] 69.9-87.6%), with specificity 71.9% (95% CI 63.7-79.2%). ABPI sensitivity was 80.2% (95% CI 70.8-87.6%), with specificity 88.6% (95% CI 82-93.5%). With comparable sensitivity to ABPI, MPPG is quick, automated and simpler to do than ABPI; it offers the potential for rapid and accessible PAD assessments in primary care.
Peripheral Arterial Disease , Photoplethysmography , Humans , Prospective Studies , Peripheral Arterial Disease/diagnosis , Ankle Brachial Index , Primary Health Care
Background: The place of tonsillectomy in the management of sore throat in adults remains uncertain. Objectives: To establish the clinical effectiveness and cost-effectiveness of tonsillectomy, compared with conservative management, for tonsillitis in adults, and to evaluate the impact of alternative sore throat patient pathways. Design: This was a multicentre, randomised controlled trial comparing tonsillectomy with conservative management. The trial included a qualitative process evaluation and an economic evaluation. Setting: The study took place at 27 NHS secondary care hospitals in Great Britain. Participants: A total of 453 eligible participants with recurrent sore throats were recruited to the main trial. Interventions: Patients were randomised on a 1 : 1 basis between tonsil dissection and conservative management (i.e. deferred surgery) using a variable block-stratified design, stratified by (1) centre and (2) severity. Main outcome measures: The primary outcome measure was the total number of sore throat days over 24 months following randomisation. The secondary outcome measures were the number of sore throat episodes and five characteristics from Sore Throat Alert Return, describing severity of the sore throat, use of medications, time away from usual activities and the Short Form questionnaire-12 items. Additional secondary outcomes were the Tonsil Outcome Inventory-14 total and subscales and Short Form questionnaire-12 items 6 monthly. Evaluation of the impact of alternative sore throat patient pathways by observation and statistical modelling of outcomes against baseline severity, as assessed by Tonsil Outcome Inventory-14 score at recruitment. The incremental cost per sore throat day avoided, the incremental cost per quality-adjusted life-year gained based on responses to the Short Form questionnaire-12 items and the incremental net benefit based on costs and responses to a contingent valuation exercise. A qualitative process evaluation examined acceptability of trial processes and ramdomised arms. Results: There was a median of 27 (interquartile range 12-52) sore throats over the 24-month follow-up. A smaller number of sore throats was reported in the tonsillectomy arm [median 23 (interquartile range 11-46)] than in the conservative management arm [median 30 (interquartile range 14-65)]. On an intention-to-treat basis, there were fewer sore throats in the tonsillectomy arm (incident rate ratio 0.53, 95% confidence interval 0.43 to 0.65). Sensitivity analyses confirmed this, as did the secondary outcomes. There were 52 episodes of post-operative haemorrhage reported in 231 participants undergoing tonsillectomy (22.5%). There were 47 re-admissions following tonsillectomy (20.3%), 35 relating to haemorrhage. On average, tonsillectomy was more costly and more effective in terms of both sore throat days avoided and quality-adjusted life-years gained. Tonsillectomy had a 100% probability of being considered cost-effective if the threshold for an additional quality-adjusted life year was £20,000. Tonsillectomy had a 69% probability of having a higher net benefit than conservative management. Trial processes were deemed to be acceptable. Patients who received surgery were unanimous in reporting to be happy to have received it. Limitations: The decliners who provided data tended to have higher Tonsillectomy Outcome Inventory-14 scores than those willing to be randomised implying that patients with a higher burden of tonsillitis symptoms may have declined entry into the trial. Conclusions: The tonsillectomy arm had fewer sore throat days over 24 months than the conservative management arm, and had a high probability of being considered cost-effective over the ranges considered. Further work should focus on when tonsillectomy should be offered. National Trial of Tonsillectomy IN Adults has assessed the effectiveness of tonsillectomy when offered for the current UK threshold of disease burden. Further research is required to define the minimum disease burden at which tonsillectomy becomes clinically effective and cost-effective. Trial registration: This trial is registered as ISRCTN55284102. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/146/06) and is published in full in Health Technology Assessment; Vol. 27, No. 31. See the NIHR Funding and Awards website for further award information.
Tonsillectomy is an operation to take out the pair of tonsil glands at the back of the throat. It is an option for adults who suffer from repeated, severe sore throats. Adults who have a tonsillectomy say that they get fewer sore throats afterwards, but it is not clear whether or not they would have got better over time without the operation. There is pressure on doctors to limit the number of tonsillectomies carried out. At the same time, emergency hospital admissions for adults with severe throat infections have been increasing. NAtional Trial of Tonsillectomy IN Adults aimed to find out whether tonsillectomy is an effective and worthwhile treatment for repeated severe sore throats or whether patients would be better off treated without an operation. A total of 453 patients from 27 hospitals in Great Britain took part in the study. Patients were assigned at random to receive either tonsillectomy or conservative management (treatment as needed from their general practitioner). We measured how many sore throats patients had in the next 2 years by sending them text messages every week. We asked about the impact of their sore throats on their quality of life and time off work, and looked at the costs of treatment. We also interviewed 47 patients, general practitioners and hospital staff about their experiences of tonsillectomy and NAtional Trial of Tonsillectomy IN Adults. The typical patient in the tonsillectomy arm had 23 days of sore throat compared with 30 days of sore throat in the conservative management arm. Tonsillectomy resulted in higher quality of life. We looked to see whether or not it was only those with the most severe sore throats who benefited from tonsillectomy, but we found that patients with more or less severe sore throats at the start all did better with tonsillectomy. Patients who had a tonsillectomy were happy to have undertaken this. Our findings suggest a clear benefit of tonsillectomy using modest additional NHS resources for adults with repeated severe sore throats.
Pharyngitis , Tonsillectomy , Tonsillitis , Adult , Humans , Cost-Benefit Analysis , Conservative Treatment , Pharyngitis/etiology , Tonsillitis/surgery , Hemorrhage
BACKGROUND: Reviews of digital communication technologies suggest that they can be effective in supporting medication use; however, their use alongside nondigital components is unclear. We also explored the delivery of a digital communication intervention in a relatively novel setting of community pharmacies and how such an intervention might be delivered to patients with multiple long-term conditions. This meant that despite the large number of intervention examples available in the literature, design questions remained, which we wanted to explore with key stakeholders. Examples of how to involve stakeholders in the design of complex health care interventions are lacking; however, human-centered design (HCD) has been suggested as a potential approach. OBJECTIVE: This study aimed to design a new community pharmacy text messaging intervention to support medication use for multiple long-term conditions, with patient and health care professional stakeholders in primary care. METHODS: HCD was used to map the intervention "journey" and identify design questions to explore with patients and health care professionals. Six prototypes were developed to communicate the intervention concept, and a modified version of the Nominal Group Technique was used to gather feedback. Nominal group meetings generated qualitative data using questions about the aspects that participants liked for each prototype and any suggested changes. The discussion was analyzed using a framework approach to transform feedback into statements. These statements were then ranked using a web-based questionnaire to establish a consensus about what elements of the design were valued by stakeholders and what changes to the design were most important. RESULTS: A total of 30 participants provided feedback on the intervention design concept over 5 nominal group meetings (21 health care professionals and 9 patients) with a 57% (17/30) response rate to the ranking questionnaire. Furthermore, 51 proposed changes in the intervention were generated from the framework analysis. Of these 51 changes, 27 (53%) were incorporated into the next design stage, focusing on changes that were ranked highest. These included suggestions for how text message content might be tailored, patient information materials, and the structure for pharmacist consultation. All aspects that the participants liked were retained in the future design and provided evidence that the proposed intervention concept had good acceptability. CONCLUSIONS: HCD incorporating the Nominal Group Technique is an appropriate and successful approach for obtaining feedback from key stakeholders as part of an iterative design process. This was particularly helpful for our intervention, which combined digital and nondigital components for delivery in the novel setting of a community pharmacy. This approach enabled the collection and prioritization of useful multiperspective feedback to inform further development and testing of our intervention. This model has the potential to minimize research waste by gathering feedback early in the complex intervention design process.
INTRODUCTION: Unmet needs in patients with cancer and their carers are common but poorly identified and addressed. The Needs Assessment Tool-Cancer (NAT-C) is a structured consultation guide to identify and triage patient and carer unmet needs. The NAT-C is validated, but its effectiveness in reducing unmet patient and carer needs in primary care is unknown. METHODS AND ANALYSIS: Cluster randomised controlled trial with internal pilot and embedded process evaluation to test the clinical and cost effectiveness of the NAT-C in primary care for people with active cancer in reducing unmet patient and carer need, compared with usual care. We will recruit 1080 patients with active cancer (and carers if relevant) from 54 general practices in England.Participating practices will be randomised 1:1 to either deliver an NAT-guided clinical consultation plus usual care or to usual care alone. Consenting participants with active cancer and their carers (if nominated) will be asked to complete study questionnaires at baseline, 1 and 3 months for all, 6 months except for those recruited outside of the last 3 months of recruitment, and attend an NAT-C appointment if allocated to an intervention practice. An internal pilot will assess: site and participant recruitment, intervention uptake and follow-up rates. The primary outcome, the proportion of patients with an unmet need on the Supportive Care Needs Survey Short Form 34 at 3 months postregistration, will be analysed using a multilevel logistic regression. Mixed-methods process evaluation informed by Normalisation Process Theory will use quantitative survey and interview data from clinicians and key stakeholders in cancer care to develop an implementation strategy for nationwide rollout of the NAT-C if the intervention is cost-effective. ETHICS AND DISSEMINATION: Ethical approval from London-Surrey REC (20/LO/0312). Results will be peer-reviewed, published and made available to research participants. TRIAL REGISTRATION NUMBER: ISRCTN15497400.
Neoplasms , Quality of Life , Caregivers , Cost-Benefit Analysis , Humans , Needs Assessment , Neoplasms/therapy , Primary Health Care , Randomized Controlled Trials as Topic
OBJECTIVES: To explore barriers and facilitators to prescribing error reporting across primary care. DESIGN: Qualitative semi-structured face-to-face and telephone interviews were conducted to explore facilitators and barriers to reporting prescribing errors. Data collection and thematic analysis were informed by the COM-B model of behaviour change. Framework analysis was used for coding and charting the data with the assistance of NVivo software (V.12). General and context specific influences on prescribing error reporting were mapped to constructs from the COM-B model (ie, capability, opportunity and motivation). SETTING: Primary care organisations, including community pharmacy, general practice and community care from North East England. PARTICIPANTS: We interviewed a maximal variation purposive sample of 25 participants, including prescribers, community pharmacists and key stakeholders with primary care or medicines safety roles at local, regional and national levels. RESULTS: Our findings describe a range of factors that influence the capability, opportunity and motivation to report prescribing errors in primary care. Three key contextual factors are also highlighted that were found to underpin many of the behavioural influences on reporting in this setting: the nature of prescribing; heterogeneous priorities for error reporting across and within different primary care organisations; and the complex infrastructure of reporting and learning pathways across primary care. Findings suggest that there is a lack of consistency in how, when and by whom, prescribing errors are reported across primary care. CONCLUSIONS: Further research is needed to identify cross-organisational and interprofessional consensus on agreed reporting thresholds and how best to facilitate a more collaborative approach to reporting and learning, that is, sensitive to the needs and priorities of disparate organisations across primary care. Despite acknowledged challenges, there may be potential for an increased role of community pharmacy in prescribing error reporting to support future learning.
General Practice , Humans , Medication Errors/prevention & control , Motivation , Pharmacists , Primary Health Care , Qualitative Research
PURPOSE: Around half of prescribed medications for long-term conditions are not taken as directed. Automated two-way digital communication, such as text messaging and interactive voice response technology, could deliver interventions to improve medication adherence, and subsequently health. However, exploration of how such interventions may improve medication adherence is limited. This review aimed to explore how automated two-way digital communication can improve medication taking with or without using non-digital intervention components, such as phone calls with healthcare professionals. METHODS: A theory-informed narrative synthesis systematic review. Several databases were searched including CINAHL, Embase, Medline, and Web of Science using key words relating to 'medication adherence' and digital communication technologies. The Behavior Change Technique (BCT) coding using the BCT Taxonomy V1 and the Behavior Change Wheel were used to identify BCTs delivered within the included interventions. RESULTS: A total of 3,018 records were screened with 43 study reports included in the review. Four medication-taking behaviors: taking medication, obtaining medication, self-testing, and asking for support were identified as targets for behavior change within the included interventions. Most BCTs within the digital communication component aimed to increase motivation for medication adherence, with non-digital intervention components included to address other medication taking barriers, such as physical and psychological capability. CONCLUSION: Automated two-way digital communication can detect barriers to medication adherence by monitoring performance of the taking medication behavior. Monitoring outcomes from taking medication may increase reflective motivation to take medicines. Addressing physical opportunity to taking medication by facilitating the behavior obtaining medication may also increase adherence.
Text Messaging , Behavior Therapy/methods , Communication , Humans , Medication Adherence , Telephone
Clomifene citrate has long been associated with a multiple pregnancy rate of up to 8-10%. Studies from which these figures originated have largely included patients who received clomifene outside of current national and international treatment guidelines. In January 2020, a systematic review of MEDLINE and relevant reference lists was conducted. Studies were included that reported multiple pregnancy rate in a cohort of patients undergoing treatment with single agent clomifene citrate for WHO group II dysovulatory subfertility. Twelve studies were included in the analysis, with a total sample size of 1,387 patients. The overall multiple pregnancy rate was 3.8% (3.6% twins/0.2% triplets); this dropped to 2.4% (all twins) when studies with a mean BMI ≥35kg/m2 were excluded. This review suggests that contemporary single agent clomifene use following current guidelines in terms of indication, results in a lower than expected multiple pregnancy rate. Further evidence from clinical practice is required to ensure that patients are adequately informed.
Infertility, Female , Polycystic Ovary Syndrome , Pregnancy , Female , Humans , Ovulation Induction/methods , Infertility, Female/drug therapy , Polycystic Ovary Syndrome/complications , Clomiphene/therapeutic use , Pregnancy Rate , Pregnancy, Multiple , Citrates/therapeutic use , World Health Organization , Fertility Agents, Female/therapeutic use
Male hypogonadism (MH) is a common endocrine disorder. However, uncertainties and variations in its diagnosis and management exist. There are several current guidelines on testosterone replacement therapy that have been driven predominantly by single disciplines. The Society for Endocrinology commissioned this new guideline to provide all care providers with a multidisciplinary approach to treating patients with MH. This guideline has been compiled using expertise from endocrine (medical and nursing), primary care, clinical biochemistry, urology and reproductive medicine practices. These guidelines also provide a patient perspective to help clinicians best manage MH.
Endocrine System Diseases , Endocrinology , Hypogonadism , Hormone Replacement Therapy , Humans , Hypogonadism/drug therapy , Male , Testosterone/therapeutic use
BACKGROUND: Acute otitis media is a painful infection of the middle ear that is commonly seen in children. In some children, the eardrum spontaneously bursts, discharging visible pus (otorrhoea) into the outer ear. OBJECTIVE: To compare the clinical effectiveness of immediate topical antibiotics or delayed oral antibiotics with the clinical effectiveness of immediate oral antibiotics in reducing symptom duration in children presenting to primary care with acute otitis media with discharge and the economic impact of the alternative strategies. DESIGN: This was a pragmatic, three-arm, individually randomised (stratified by age < 2 vs. ≥ 2 years), non-inferiority, open-label trial, with economic and qualitative evaluations, supported by a health-record-integrated electronic trial platform [TRANSFoRm (Translational Research and Patient Safety in Europe)] with an internal pilot. SETTING: A total of 44 English general practices. PARTICIPANTS: Children aged ≥ 12 months and < 16 years whose parents (or carers) were seeking medical care for unilateral otorrhoea (ear discharge) following recent-onset (≤ 7 days) acute otitis media. INTERVENTIONS: (1) Immediate ciprofloxacin (0.3%) solution, four drops given three times daily for 7 days, or (2) delayed 'dose-by-age' amoxicillin suspension given three times daily (clarithromycin twice daily if the child was penicillin allergic) for 7 days, with structured delaying advice. All parents were given standardised information regarding symptom management (paracetamol/ibuprofen/fluids) and advice to complete the course. COMPARATOR: Immediate 'dose-by-age' oral amoxicillin given three times daily (or clarithromycin given twice daily) for 7 days. Parents received standardised symptom management advice along with advice to complete the course. MAIN OUTCOME MEASURE: Time from randomisation to the first day on which all symptoms (pain, fever, being unwell, sleep disturbance, otorrhoea and episodes of distress/crying) were rated 'no' or 'very slight' problem (without need for analgesia). METHODS: Participants were recruited from routine primary care appointments. The planned sample size was 399 children. Follow-up used parent-completed validated symptom diaries. RESULTS: Delays in software deployment and configuration led to small recruitment numbers and trial closure at the end of the internal pilot. Twenty-two children (median age 5 years; 62% boys) were randomised: five, seven and 10 to immediate oral, delayed oral and immediate topical antibiotics, respectively. All children received prescriptions as randomised. Seven (32%) children fully adhered to the treatment as allocated. Symptom duration data were available for 17 (77%) children. The median (interquartile range) number of days until symptom resolution in the immediate oral, delayed oral and immediate topical antibiotic arms was 6 (4-9), 4 (3-7) and 4 (3-6), respectively. Comparative analyses were not conducted because of small numbers. There were no serious adverse events and six reports of new or worsening symptoms. Qualitative clinician interviews showed that the trial question was important. When the platform functioned as intended, it was liked. However, staff reported malfunctioning software for long periods, resulting in missed recruitment opportunities. Troubleshooting the software placed significant burdens on staff. LIMITATIONS: The over-riding weakness was the failure to recruit enough children. CONCLUSIONS: We were unable to answer the main research question because of a failure to reach the required sample size. Our experience of running an electronic platform-supported trial in primary care has highlighted challenges from which we have drawn recommendations for the National Institute for Health Research (NIHR) and the research community. These should be considered before such a platform is used again. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12873692 and EudraCT 2017-003635-10. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 67. See the NIHR Journals Library website for further project information.
Ear infections are common in childhood. Some are complicated by a burst eardrum, followed by discharge from the ear. The usual treatment for this is a short course of antibiotics taken by mouth. However, alternative treatment using antibiotic drops, or a 'wait and see' policy before starting antibiotics, would result in less antibiotic use and reduce the subsequent risk of antibiotic resistance, which is bad for both patients and the environment. This study set out to see if these alternative treatments were as effective as the usual treatment for children with ear discharge. Although ear infections are common, only one in six children develops ear discharge, so only a few children might be available to take part at each general practice. We planned to use an electronic recruitment system to help us to gather enough patients. The system [called the 'TRANSFoRm' (Translational Research and Patient Safety in Europe) platform] was designed to remind busy general practitioners and nurses about the study and take them through the recruitment process step by step, as well as to support trial processes. Although the TRANSFoRm platform had been developed and tested, it had not been used in general practices before. We were surprised to find that there were many technical problems in setting up the TRANSFoRm platform in general practices, and staff were too busy and/or did not have the skills to overcome the technical issues. As a result, recruiting patients was slow and the study was halted before we had enough children to answer the main research question. In total, we managed to get 44 general practices and 22 children, but this was not enough. We still think that this kind of research and electronic trial platforms are important. We have noted many system and technical issues that need to be solved to enable funders and researchers to use this recruitment approach in the future.
Anti-Bacterial Agents , Otitis Media , Anti-Bacterial Agents/therapeutic use , Child , Child, Preschool , Cost-Benefit Analysis , Electronics , Female , Humans , Male , Otitis Media/drug therapy , Technology Assessment, Biomedical
BACKGROUND: Within-consultation recruitment to primary care trials is challenging. Ensuring procedures are efficient and self-explanatory is the key to optimising recruitment. Trial recruitment software that integrates with the electronic health record to support and partially automate procedures is becoming more common. If it works well, such software can support greater participation and more efficient trial designs. An innovative electronic trial recruitment and outcomes software was designed to support recruitment to the Runny Ear randomised controlled trial, comparing topical, oral and delayed antibiotic treatment for acute otitis media with discharge in children. A qualitative evaluation investigated the views and experiences of primary care staff using this trial software. METHODS: Staff were purposively sampled in relation to site, role and whether the practice successfully recruited patients. In-depth interviews were conducted using a flexible topic guide, audio recorded and transcribed. Data were analysed thematically. RESULTS: Sixteen staff were interviewed, including GPs, practice managers, information technology (IT) leads and research staff. GPs wanted trial software that automatically captures patient data. However, the experience of getting the software to work within the limited and complex IT infrastructure of primary care was frustrating and time consuming. Installation was reliant on practice level IT expertise, which varied between practices. Although most had external IT support, this rarely included supported for research IT. Arrangements for approving new software varied across practices and often, but not always, required authorisation from Clinical Commissioning Groups. CONCLUSIONS: Primary care IT systems are not solely under the control of individual practices or CCGs or the National Health Service. Rather they are part of a complex system that spans all three and is influenced by semi-autonomous stakeholders operating at different levels. This led to time consuming and sometimes insurmountable barriers to installation at the practice level. These need to be addressed if software supporting efficient research in primary care is to become a reality.
Primary Health Care , State Medicine , Child , Electronic Health Records , Electronics , Humans , Qualitative Research
OBJECTIVE: To determine whether robot-assisted training is cost-effective compared with an enhanced upper limb therapy (EULT) programme or usual care. DESIGN: Economic evaluation within a randomised controlled trial. SETTING: Four National Health Service (NHS) centres in the UK: Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust; Northwick Park Hospital, London Northwest Healthcare NHS Trust; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde; and North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust. PARTICIPANTS: 770 participants aged 18 years or older with moderate or severe upper limb functional limitation from first-ever stroke. INTERVENTIONS: Participants randomised to one of three programmes provided over a 12-week period: robot-assisted training plus usual care; the EULT programme plus usual care or usual care. MAIN ECONOMIC OUTCOME MEASURES: Mean healthcare resource use; costs to the NHS and personal social services in 2018 pounds; utility scores based on EQ-5D-5L responses and quality-adjusted life years (QALYs). Cost-effectiveness reported as incremental cost per QALY and cost-effectiveness acceptability curves. RESULTS: At 6 months, on average usual care was the least costly option (£3785) followed by EULT (£4451) with robot-assisted training being the most costly (£5387). The mean difference in total costs between the usual care and robot-assisted training groups (£1601) was statistically significant (p<0.001). Mean QALYs were highest for the EULT group (0.23) but no evidence of a difference (p=0.995) was observed between the robot-assisted training (0.21) and usual care groups (0.21). The incremental cost per QALY at 6 months for participants randomised to EULT compared with usual care was £74 100. Cost-effectiveness acceptability curves showed that robot-assisted training was unlikely to be cost-effective and that EULT had a 19% chance of being cost-effective at the £20 000 willingness to pay (WTP) threshold. Usual care was most likely to be cost-effective at all the WTP values considered in the analysis. CONCLUSIONS: The cost-effectiveness analysis suggested that neither robot-assisted training nor EULT, as delivered in this trial, were likely to be cost-effective at any of the cost per QALY thresholds considered. TRIAL REGISTRATION NUMBER: ISRCTN69371850.
Robotics , Stroke , Cost-Benefit Analysis , Humans , London , Quality of Life , Quality-Adjusted Life Years , State Medicine , Stroke/therapy , Upper Extremity
OBJECTIVE: Clinical Cancer Decision Tools (CCDTs) aim to alert general practitioners (GPs) to signs and symptoms of cancer, supporting prompt investigation and onward referral. CCDTs are available in primary care in the UK but are not widely utilised. Qualitative research has highlighted the complexities and mechanisms surrounding their implementation and use; this has focused on specific cancer types, formats, systems or settings. This study aims to synthesise qualitative data of GPs' attitudes to and experience with a range of CCDTs to gain better understanding of the factors shaping their implementation and use. DESIGN: A systematic search of the published (MEDLINE, CINAHL, Web of Science and EMBASE) and grey literature (July 2020). Following screening, selection and assessment of suitability, the data were analysed and synthesised using normalisation process theory. RESULTS: Six studies (2011 to 2019), exploring the views of GPs were included for analysis. Studies focused on the use of several different types of CCDTs (Risk Assessment Tools (RAT) or electronic version of RAT (eRAT), QCancer and the 7-point checklist). GPs agreed CCDTs were useful to increase awareness of signs and symptoms of undiagnosed cancer. They had concerns about the impact on trust in their own clinical acumen, whether secondary care clinicians would consider referrals generated by CCDT as valid and whether integration of the CCDTs within existing systems was achievable. CONCLUSIONS: CCDTs might be a helpful adjunct to clinical work in primary care, but without careful development to legitimise their use GPs are likely to give precedence to clinical acumen and gut instinct. Stakeholder consultation with secondary care clinicians and consideration of how the CCDTs fit into a GP consultation are crucial to successful uptake. The role and responsibilities of a GP as a clinician, gatekeeper, health promoter and resource manager affect the interaction with and implementation of innovations such as CCDTs.
General Practitioners , Neoplasms , Attitude of Health Personnel , Humans , Neoplasms/diagnosis , Neoplasms/therapy , Primary Health Care , Qualitative Research , Referral and Consultation
