The Primary Care Outcomes Questionnaire (PCOQ) is a new patient-reported outcome measure designed specifically for primary care. This paper describes the developmental process of improving the item ...quality and testing the face validity of the PCOQ through cognitive interviews with primary care patients.
Two formats of the PCOQ were developed and assessed: the PCOQ-Status (which has an adjectival scale) and the PCOQ-Change (which has the same items as the PCOQ-Status, but a transitional scale). Three rounds of cognitive interviews were held with twenty patients from four health centres in Bristol. Patients seeking healthcare were recruited directly by their GP or practice nurse, and others not currently seeking healthcare were recruited from patient participation groups. An adjusted form of Tourangeau's model of cognitive processing was used to identify problems. This contained four categories: general comprehension, temporal comprehension, decision process, and response process. The resultant pattern of problems was used to assess whether the items and scales were working as intended, and to make improvements to the questionnaires.
The problems identified in the PCOQ-Status reduced from 41 in round one to seven in round three. It was noted that the PCOQ-Status seemed to be capturing a subjective view of health which might not vary with age or long-term conditions. However, as it is designed to be evaluative (measuring change over time) as opposed to discriminative (measuring change between different groups of people), this does not present a problem for validity. The PCOQ-Status was both understood by patients and was face valid. The PCOQ-Change had less face validity, and was misunderstood by three out of six patients in round 1. It was not taken forward after this round.
The cognitive interviews successfully contributed to the development of the PCOQ. Through this study, the PCOQ-Status was found to be well understood by patients, and it was possible to improve comprehension through each round of interviews. The PCOQ-Change was poorly understood and, given that this corroborates existing research, this may call into question the use of transitional questionnaires generally.
ObjectivesTo investigate how the COVID-19 pandemic affected the number of people aged 50+ years presenting to primary care with features that could potentially indicate cancer, and to explore how ...reporting differed by patient characteristics and in face-to-face vs remote consultations.Design, setting and participantsA retrospective cohort study of general practitioner (GP), nurse and paramedic primary care consultations in 21 practices in South-West England covering 123 947 patients. The models compared potential cancer indicators reported in April–July 2019 with April–July 2020.Main outcome measuresPotential indicators of cancer were identified using code lists for symptoms, signs, test results and diagnoses listed in the National Institute for Health and Care Excellence suspected cancer referral guidance (NG12).ResultsDuring April–July 2019, 17% of registered patients aged 50+ years reported a potential cancer indicator in a consultation with a GP or nurse. During April–July 2020, this reduced to 11% (incidence rate ratio (IRR) 0.64, 95% CI 0.62 to 0.67, p<0.001). Reductions in potential cancer indicators were stable across age group, sex, ethnicity, index of multiple deprivation quintile and shielding status, but less marked in patients with mental health conditions than without (IRR 0.75, 95% CI 0.72 to 0.79, interaction p<0.001). Proportions of GP consultations with potential indicators of cancer reduced between 2019 and 2020 for face-to-face consultations (IRR 0.84, 95% CI 0.76 to 0.92, p<0.001) and increased for remote consultations (IRR 1.17, 95% CI 1.07 to 1.29, p=0.001), although it remained lower in remote consulting than face-to-face in April–July 2020. This difference was greater for nurse/paramedic consultations (face-to-face: IRR 0.61, 95% CI 0.44 to 0.83, p=0.002; remote: IRR 1.60, 95% CI 1.10 to 2.333, p=0.014).ConclusionThe number of patients consulting with presentations that could potentially indicate cancer reduced during the first wave of the COVID-19 pandemic. Patients should be encouraged to continue contacting primary care for persistent signs and symptoms, and GPs and nurses should be encouraged to probe patients for further information during remote consulting, in the absence of non-verbal cues.
The complexity of general practice consultations may be increasing and varies in different settings. A measure of complexity is required to test these hypotheses.
To develop a valid measure of ...general practice consultation complexity applicable to routine medical records.
Delphi study to select potential indicators of complexity followed by a cross-sectional study in English general practices to develop and validate a complexity measure.
The online Delphi study over two rounds identified potential indicators of consultation complexity. The cross-sectional study used an age-sex stratified random sample of patients and general practice face-to-face consultations from 2013/2014 in the Clinical Practice Research Datalink. The authors explored independent relationships between each indicator and consultation duration using mixed-effects regression models, and revalidated findings using data from 2017/2018. The proportion of complex consultations in different age-sex groups was assessed.
A total of 32 GPs participated in the Delphi study. The Delphi panel endorsed 34 of 45 possible complexity indicators after two rounds. After excluding factors because of low prevalence or confounding, 17 indicators were retained in the cross-sectional study. The study used data from 173 130 patients and 725 616 face-to-face GP consultations. On defining complexity as the presence of any of these 17 factors, 308 370 consultations (42.5%) were found to be complex. Mean duration of complex consultations was 10.49 minutes, compared to 9.64 minutes for non-complex consultations. The proportion of complex consultations was similar in males and females but increased with age.
The present consultation complexity measure has face and construct validity. It may be useful for research, management and policy, and for informing decisions about the range of resources needed in different practices.
Despite the benefits of relational continuity of care, particularly for patients with multimorbidity, the traditional model of continuity is changing. Revisiting what patients with ongoing problems ...want from relational continuity could encourage initiatives to achieve these within a modern healthcare system.
To examine the attributes of GPs that patients with long-term conditions value most, and which attributes patients believe are facilitated by relational continuity.
Qualitative study in UK general practice.
A thematic analysis was carried out, based on secondary analysis of interviews with 25 patients with long-term conditions that were originally conducted to inform a patient-reported outcome measure for primary care.
Patients with long-term conditions wanted their GPs to be clinically competent, to examine, listen to, care for, and take time with them, irrespective of whether they have seen them before. They believed that relational continuity facilitates a GP knowing their history, giving consistent advice, taking responsibility and action, and trusting and respecting them. Patients acknowledged practical difficulties and safety issues in achieving the first three of these without relational continuity. However, patients felt that GPs should trust and respect them even when continuity was not possible.
Policy initiatives promoting continuity with a GP or healthcare team should continue. Many patients see continuity as a safety issue. When patients experience relationship discontinuity, they often feel that they are not taken seriously or believed by their GP. GPs should therefore consistently seek to visibly demonstrate trust in their patients, particularly when they have not seen them before.
Background
In March 2020, the COVID-19 pandemic required a rapid reconfiguration of UK general practice to minimise face-to-face contact with patients to reduce infection risk. However, some ...face-to-face contact remained necessary and practices needed to ensure such contact could continue safely.
Aim
To examine how practices determined when face-to-face contact was necessary and how face-to-face consultations were reconfigured to reduce COVID-19 infection risk.
Design & setting
Qualitative interview study in general practices in Bristol, North Somerset, and South Gloucestershire.
Method
Longitudinal semi-structured interviews with clinical and managerial practice staff were undertaken at four timepoints between May and July 2020.
Results
Practices worked flexibly within general national guidance to determine when face-to-face contact with patients was necessary, influenced by knowledge of the patient, experience, and practice resilience. For example, practices prioritised patients according to clinical need using face-to-face contact to resolve clinician uncertainty or provide adequate reassurance to patients. To make face-to-face contact as safe as possible and keep patients separated, practices introduced a heterogeneous range of measures that exploited features of their indoor and outdoor spaces, and altered their appointment processes. As national restrictions eased in June and July, the number and proportion of patients seen face to face generally increased. However, the reconfiguration of buildings and processes reduced the available capacity and put increased pressure on practices.
Conclusion
Practices responded rapidly and creatively to the initial lockdown restrictions. The variety of ways practices organised face-to-face contact to minimise infection highlights the need for flexibility in guidance.
Use of telephone, video and e-consultations is increasing. These can make consultations more transactional, potentially missing patients' concerns. This study aimed to develop a complex intervention ...to address patients' concerns more comprehensively in general practice and test the feasibility of this in a cluster-randomised framework.The complex intervention used two technologies: a patient-completed pre-consultation form used at consultation opening and a doctor-provided summary report provided at consultation closure. This paper reports on the development and realist evaluation of the pre-consultation questionnaire.
A person-based approach was used to develop the pre-consultation form. An online questionnaire system was designed to allow patient self-completion of a form which could be shared with GPs. This was tested with 45 patients in three rounds, with iterative adjustments made based on feedback after each round.Subsequently, an intervention incorporating the pre-consultation form with the summary report was then tested in a cluster-randomised framework with 30 patients per practice in six practices: four randomised to intervention, and two to control. An embedded realist evaluation was carried out. The main feasibility study results are reported elsewhere.
Intervention Development: 15 patients were recruited per practice. Twelve patients, six GPs and three administrators were interviewed and 32 changes were made iteratively in three rounds. Recruitment rates (proportion of patients responding to the text) increased from 15% in round one to 50% in round three.Realist evaluation: The pre-consultation form was most useful for people comfortable with technology and with hidden concerns or anxiety about the consultation. It resulted in more issues being discussed and support provided, more effective use of time and greater patient satisfaction.
The person-based approach was successful. The pre-consultation form uncovers more depth and improves satisfaction in certain consultations and patients. Technological improvements are required before this could be rolled out more widely.
A key challenge for qualitative methods in applied health research is the fast pace that can characterize the public health and health and care service landscape, where there is a need for research ...informed by immediate pragmatic questions and relevant findings are required quickly to inform decision-making. The COVID-19 pandemic accelerated the pace at which evidence was needed to inform urgent public health and healthcare decision-making. This required qualitative researchers to step up to the challenge of conducting research at speed whilst maintaining rigor and ensuring the findings are credible. This article illustrates how working with multidisciplinary, collaborative teams and the tailoring of qualitative methods to be more pragmatic and efficient can provide timely and credible results. Using time-limited case studies of applied qualitative health research drawn from the work of the Behavioral and Qualitative Science Team from the National Institute for Health and Care Research Applied Research Collaboration West (NIHR ARC West), we illustrate our collaborative and intensive pragmatic qualitative (CLIP-Q) approach. CLIP-Q involves (i) collaboration at all stages of the design, conduct and implementation of projects and, where possible, co-production with people with lived experience, (ii) an intensive team-based approach to data collection and analysis at pace, and (iii) pragmatic study design and efficient strategies at each stage of the research process. The case studies include projects conducted pre COVID-19 and during the first wave of the pandemic, where urgent evidence was required in weeks rather than months to inform rapid public health and healthcare decision making.
One of the deadly hallmarks of cancer is its ability to prosper within the constraints of the host immune system. Recent advances in immunoproteomics and high-throughput technologies have lead to ...profiling of the antibody repertoire in cancer patients. This in turn has lead to the identification of tumour associated antigens/autoantibodies. Autoantibodies are extremely attractive and promising biomarker entities, however there has been relatively little discussion on how to interpret the humoral immune response. It may be that autoantibody profiles hold the key to ultimately uncovering neoplastic associated pathways and through the process of immunosculpting the tumour may have yielded an immune response in the early stages of malignant tumour development. The aim of this review is to discuss the utility of the autoantibody response that is elicited as a result of malignancy and discuss the advantages and limitations of autoantibody profiling. This article is part of a Special Issue entitled: Translational Proteomics.
This model proposes the generation of circulating autoantibodies in cancer patients. At the site of tumour development, tissue damage leads to the release of proteins and cellular debris. The antigen presenting cells (APC) then present these proteins to the immune response, ultimately resulting in B cell proliferation and antibody production. Display omitted
► Cancer and its interplay with the immune system is a complex process and an evolving research area. ► The interaction between the immune response and malignancy is still poorly understood. ► Increased knowledge may elucidate the immune response's role in prevention of cancer progression. ► Immunoproteomics may reveal critical neoplastic events and mechanisms of disease progression.
To reduce contagion of COVID-19, in March 2020 UK general practices implemented predominantly remote consulting via telephone, video, or online consultation platforms.
To investigate the rapid ...implementation of remote consulting and explore impact over the initial months of the COVID-19 pandemic.
Mixed-methods study in 21 general practices in Bristol, North Somerset and South Gloucestershire.
Longitudinal observational quantitative analysis compared volume and type of consultation in April to July 2020 with April to July 2019. Negative binomial models were used to identify if changes differed among different groups of patients. Qualitative data from 87 longitudinal interviews with practice staff in four rounds investigated practices' experience of the move to remote consulting, challenges faced, and solutions. A thematic analysis utilised Normalisation Process Theory.
There was universal consensus that remote consulting was necessary. This drove a rapid change to 90% remote GP consulting (46% for nurses) by April 2020. Consultation rates reduced in April to July 2020 compared to 2019; GPs and nurses maintained a focus on older patients, shielding patients, and patients with poor mental health. Telephone consulting was sufficient for many patient problems, video consulting was used more rarely, and was less essential as lockdown eased. SMS-messaging increased more than three-fold. GPs were concerned about increased clinical risk and some had difficulties setting thresholds for seeing patients face-to-face as lockdown eased.
The shift to remote consulting was successful and a focus maintained on vulnerable patients. It was driven by the imperative to reduce contagion and may have risks; post-pandemic, the model will need adjustment.
Autoantibodies represent an attractive biomarker for diagnostic assays principally due to the stability of immunoglobulin in patient serum facilitating measurement with conventional assays. Immune ...responses to tumorigenesis may facilitate detection of ovarian cancer in the early stages of the disease with identification of a panel of tumour specific autoantibodies. Despite the reporting of many tumour associated autoantibodies using arrays of tumour antigens, this has not led to the advance in diagnostic capability as rapidly as was initially expected. Here we examine the potential diagnostic utility of candidate autoantibody biomarkers identified via screening of serum samples on a high content human protein array from a unique cohort of early stage and late stage ovarian cancer patients. We analyse the performance of autoantibodies to the tumour suppressor protein p53 and the novel autoantigens alpha adducin and endosulfine alpha identified in our array screen. Each antigen has different performance characteristics using conventional ELISA format and Western blot immunoassay. The high attrition rate of promising autoantigens identified by array screening can in part be explained by the presentation of the epitope of the antigen in the subsequent method of validation and this study provides directions on maximising the potential of candidate biomarkers. This article is part of a Special Issue entitled: Translational Proteomics.
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► Assessment of diagnostic utility of early and late stage ovarian cancer candidate biomarkers. ► Epitope presentation in validation phase as partly explaining high attrition rate of autoantigens. ► Results of autoantibodies to tumour suppressor p53 and to novel adducin and endosulphine alpha proteins.
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