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Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.
A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.
Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.
To evaluate gynaecological patients' preferences and satisfaction regarding information provision, exploring enablers and barriers to information access.
A descriptive cross-sectional survey design was used.
A total of 293 women accessing gynaecological services responded to the survey. Quantitative analysis included descriptive and inferential statistics. Content analysis was conducted on qualitative data.
Health professionals were the most common and preferred sources of gynaecological health information. Enablers to information provision included positive communication strategies by health professionals, participants having prior knowledge and doing their own research. Despite its widespread availability, only 24.2% of women preferred the internet as an information source. Poor communication and inadequate information provision were identified as barriers to information access. Statistically significant associations were identified between location of residence, education level, year of birth, diagnostic group and health information preferences. Recommendations from women included improved communication strategies, system changes and provision of individualized information.
Health professionals are central to women accessing information about gynaecological diagnoses. Areas for improvement include communication strategies, facilitating access to internet-based resources for information and consideration of women's preferences when providing health information.
Consumer co-design of gynaecological health information and communication training for health professionals is recommended. Improved communication and facilitated use of internet-based resources may improve women's understanding of information.
This study explored gynaecological patients' preferences and satisfaction regarding information provision, exploring enablers and barriers to information access. It was found that gynaecological patients preferred individualized information provided to them directly by health professionals and despite its widespread availability, the internet is an underutilized health information resource. These findings are applicable to health professionals and patients utilizing tertiary gynaecological health services in Australia but may be generalized if demographic data aligns with other jurisdictions.
The STROBE reporting method was used in the preparation of the manuscript.
No patient or public contribution.
by Johanne Smith-Nielsen, Anne Christine Stuart, Katrine Isabella Wendelboe, Ida Egmose, Camilla Overbye Roos, Mette Skovgaard Væver
BackgroundPretend play is a signature behavior of early childhood and is considered to reflect the child’s emerging symbolic function, enabling the interpretation of social signals, language development, and emotion understanding. While theory links parental mentalizing with children’s pretend play, only a few studies have investigated this association. These studies are limited to infancy and early toddlerhood, and child pretend play is assessed during play with an adult (social play). Based on the assumption that child solitary pretend play reflects the child’s ‘baseline’ pretend play ability, in this study, we investigated children’s pretend play at its peak, i.e., during the preschool age, without the facilitation of another player. The overall objective was to investigate if parental mentalizing increases pretend play complexity in children.
MethodsThe sample consisted 99 Danish mothers and their 4-year-old children. Employing a cross-sectional design, we hypothesized that parental mental state language, as an indicator of ‘online’ mentalizing during interaction with the child, is a mechanism through which ‘offline’ mentalizing, measured as parental reflective functioning, is associated with child solitary pretend play. Child pretend play complexity was observed and coded with an adapted version of the 12-Step Play Scale. Maternal offline mentalizing was assessed with the Parental Reflective Functioning Questionnaire, and maternal online mentalizing was assessed by coding the mothers’ mental state language during interaction with the child using a modified version of the mind-mindedness coding scheme.
ResultsWhile there was no direct effect of maternal offline reflective functioning on child pretend play, online mental state language mediated the link between offline maternal reflective functioning and child pretend play.
ConclusionsThese results provide support for the theoretically assumed link between parental mentalizing and children’s capacity for pretend play. Furthermore, our study contributes to the literature on parental mentalization, suggesting that parental mentalizing facilitates child development only if the parent can translate this ability into ’mentalizing in action’.
Infections in primary care are often treated with non-steroidal anti-inflammatory drugs (NSAIDs). This study evaluates whether NSAID prescribing is associated with adverse outcomes for respiratory (RTIs) or urinary track (UTI) infections.
To determine whether there is an association between NSAID prescribing and the rate of adverse outcomes for infections for individual consulting in primary care.
Cohort study of electronic health records.
87 general practices in the UK Clinical Practice Research Datalink GOLD.
142 925 patients consulting with RTI or UTI.
Repeat consultations, hospitalisation or death within 30 days of the initial consultation for RTI or UTI. Poisson models estimated the associations between NSAID exposure and outcome. Rate ratios were adjusted for gender, age, ethnicity, deprivation, antibiotic use, seasonal influenza vaccination status, comorbidities and general practice. Since prescribing variations by practice are not explained by case mix—hence, less impacted by confounding by indication—both individual-level and practice-level analyses are included.
There was an increase in hospital admission/death for acute NSAID prescriptions (RR 2.73, 95% CI 2.10 to 3.56) and repeated NSAID prescriptions (6.47, 4.46–9.39) in RTI patients, and for acute NSAID prescriptions for UTI (RR 3.03; 1.92 to 4.76). Practice-level analysis, controlling for practice population characteristics, found that for each percentage point increase in NSAID prescription, the percentages of hospital admission/death within 30 days increased by 0.32 percentage points (95% CI 0.16 to 0.47).
In this non-randomised study, prescription of NSAIDs at consultations for RTI or UTIs in primary care is infrequent but may be associated with increased risk of hospital admission. This supports other observational and limited trial data that NSAID prescribing might be associated with worse outcomes following acute infection and should be prescribed with caution.
This study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks.
Economic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial.
Primary and secondary healthcare, community and social media advertising.
Women ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment.
Participants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment.
Cost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator’s global assessment, IGA
Spironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence’s threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis).
The results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis.
ISRCTN registry (ISRCTN12892056).
The abbreviated World Health Organisation Quality of Life tool (WHOQOL-BREF) is a short-form quality of life (QoL) assessment commonly used worldwide in both healthy and ill populations. Normative data for the Australian general population are limited. The objective of this study was to present normative data for the WHOQOL-BREF based on a general population sample. A secondary aim was to explore sociodemographic factors related to QoL.
Population-based cross-sectional study.
929 men and 830 women aged 24–94 years participating in the Geelong Osteoporosis Study.
The 26-item WHOQOL-BREF.
Means and SD for each domain are presented by age group and sex. Percentile scores were also generated. Mean scores for WHOQOL-BREF domains were 74.52 (SD=16.22) for physical health, 72.07 (SD=15.35) for psychological, 72.87 (SD=18.78) for social relationships and 79.68 (SD=12.55) for environment. We identified significant associations between sociodemographic factors and WHOQOL-BREF domains. Notably, being married or in a relationship was associated with increased odds for high QoL across all four WHOQOL-BREF domains: physical health (women OR 2.46, 95% CI 1.36 to 4.44, p=0.003), psychological (men OR 2.07, 95% CI: 1.20 to 3.55, p=0.009; women OR 2.15, 95% CI 1.21 to 3.81, p=0.009), social relationships (men OR 2.28, 95% CI 1.29 to 4.04, p=0.005; women OR 2.77, 95% CI 1.42 to 5.41, p=0.003) and environment (women OR 2.07, 95% CI 1.13 to 3.80, p=0.019).
This study provides population norms for the WHOQOL-BREF based on a representative sample of Australian adults. Our results will be useful to researchers and clinicians who can use these data as a reference point for interpreting WHOQOL-BREF scores.
by Kenneth S. Noguchi, Kevin Moncion, Elise Wiley, Ashley Morgan, Eric Huynh, Marla K. Beauchamp, Stuart M. Phillips, Lehana Thabane, Ada Tang
BackgroundStroke impacts nearly 14 million people annually. Muscle strength and physical function are often affected by stroke and important determinants of stroke recovery. Resistance exercise training (RT) has been shown to improve muscle strength, but RT prescriptions may be suboptimal for other aspects of stroke recovery. Parameters such as frequency, intensity, type, and duration may influence the effectiveness of RT interventions but have not been systematically evaluated.
Objectives1) To determine the effects of RT on stroke recovery, and 2) to examine the influence of RT parameters on intervention effects.
Eligibility criteriaRandomized controlled trials examining the effects of RT will be eligible for this systematic review if they: 1) included only adults with stroke or transient ischemic attack, 2) compared RT to no exercise or usual care, and 3) did not apply a co-intervention.
Study selectionEight databases (MEDLINE, EMBASE, EMCARE, AMED, PsychINFO, CINAHL, SPORTDiscus, and Web of Science) and 2 clinical trials registries (ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform) will be searched from inception. Two independent pairs of authors will compare titles, abstracts, and full-text reports against the eligibility criteria. Conflicts will be resolved by consensus or third author.
Main outcome measuresThe construct of interest is stroke recovery. An advisory group of clinicians, researchers, and partners with lived experience of stroke will be consulted to determine specific outcome measures of interest, and to rank their relative importance. We expect to include measures of physical function, strength, cognition, and quality of life. Random-effects meta-analyses will be used to pool results for each outcome across studies, and RT parameters (frequency, intensity, type, and duration) will be used as covariates in meta-regression analyses.
ConclusionThe results of this review will inform the optimal RT prescription parameters for promoting stroke recovery.
by Irene Boateng, Beth Stuart, Taeko Becque, Bruce Barrett, Jennifer Bostock, Robin Bruyndonckx, Lucy Carr-Knox, Emily J. Ciccone, Samuel Coenen, Mark Ebell, David Gillespie, Gail Hayward, Katarina Hedin, Kerenza Hood, Tin Man Mandy Lau, Paul Little, Dan Merenstein, Edgar Mulogo, Jose Ordóñez-Mena, Peter Muir, Kirsty Samuel, Nader Shaikh, Sharon Tonner, Alike W. van der Velden, Theo Verheij, Kay Wang, Alastair D. Hay, Nick Francis
BackgroundResistance to antibiotics is rising and threatens future antibiotic effectiveness. ‘Antibiotic targeting’ ensures patients who may benefit from antibiotics receive them, while being safely withheld from those who may not. Point-of-care tests may assist with antibiotic targeting by allowing primary care clinicians to establish if symptomatic patients have a viral, bacterial, combined, or no infection. However, because organisms can be harmlessly carried, it is important to know if the presence of the virus/bacteria is related to the illness for which the patient is being assessed. One way to do this is to look for associations with more severe/prolonged symptoms and test results. Previous research to answer this question for acute respiratory tract infections has given conflicting results with studies has not having enough participants to provide statistical confidence.
AimTo undertake a synthesis of IPD from both randomised controlled trials (RCTs) and observational cohort studies of respiratory tract infections (RTI) in order to investigate the prognostic value of microbiological data in addition to, or instead of, clinical symptoms and signs.
MethodsA systematic search of Cochrane Central Register of Controlled Trials, Ovid Medline and Ovid Embase will be carried out for studies of acute respiratory infection in primary care settings. The outcomes of interest are duration of disease, severity of disease, repeated consultation with new/worsening illness and complications requiring hospitalisation. Authors of eligible studies will be contacted to provide anonymised individual participant data. The data will be harmonised and aggregated. Multilevel regression analysis will be conducted to determine key outcome measures for different potential pathogens and whether these offer any additional information on prognosis beyond clinical symptoms and signs.
Trial registrationPROSPERO Registration number: CRD42023376769.
Malignant mesothelioma is a rapidly lethal cancer that has been increasing at an epidemic rate over the last three decades. Targeted therapies for mesothelioma have been lacking. A previous study called MiST1 (NCT03654833), evaluated the efficacy of Poly (ADP-ribose) polymerase (PARP) inhibition in mesothelioma. This study met its primary endpoint with 15% of patients having durable responses exceeding 1 year. Therefore, there is a need to evaluate PARP inhibitors in relapsed mesothelioma patients, where options are limited. Niraparib is the PARP inhibitor used in NERO.
NERO is a multicentre, two-arm, open-label UK randomised phase II trial designed to evaluate the efficacy of PARP inhibition in relapsed mesothelioma. 84 patients are being recruited. NERO is not restricted by line of therapy; however, eligible participants must have been treated with an approved platinum based systemic therapy. Participants will be randomised 2:1, stratified according to histology and response to prior platinum-based chemotherapy, to receive either active symptom control (ASC) and niraparib or ASC alone, for up to 24 weeks. Participants will be treated until disease progression, withdrawal, death or development of significant treatment limiting toxicity. Participants randomised to niraparib will receive 200 or 300 mg daily in a 3-weekly cycle. The primary endpoint is progression-free survival, where progression is determined by modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1; investigator reported progression; or death from any cause, whichever comes first. Secondary endpoints include overall survival, best overall response, 12-week and 24 week disease control, duration of response, treatment compliance and safety/tolerability. If NERO shows niraparib to be safe and biologically effective, it may lead to future late phase randomised controlled trials in relapsed mesothelioma.
The study received ethical approval from London-Hampstead Research Ethics Committee on 06-May-2022 (22/LO/0281). Data from all centres will be analysed together and published as soon as possible.
ISCRTN16171129; NCT05455424.
FreshRSS 