Do doctors and other healthcare professionals know overdiagnosis in screening and how are they dealing with it? A protocol for a mixed methods systematic review

Introduction
Overdiagnosis is the diagnosis of a disease that would never have caused any symptom or problem. It is a harmful side effect of screening and may lead to unnecessary treatment, costs and emotional drawbacks. Doctors and other healthcare professionals (HCPs) have the opportunity to mitigate these consequences, not only by informing their patients or the public but also by adjusting screening methods or even by refraining from screening. However, it is unclear to what extent HCPs are fully aware of overdiagnosis and whether it affects their screening decisions. With this systematic review, we aim to synthesise all available research about what HCPs know and think about overdiagnosis, how it affects their position on screening policy and whether they think patients and the public should be informed about it.

Methods and analysis
We will systematically search several databases (MEDLINE, Embase, Web of Science, Scopus, CINAHL and PsycArticles) for studies that directly examine HCPs’ knowledge and subjective perceptions of overdiagnosis due to health screening, both qualitatively and quantitatively. We will optimise our search by scanning reference and citation lists, contacting experts in the field and hand searching abstracts from the annual conference on ‘Preventing Overdiagnosis’. After selection and quality appraisal, we will analyse qualitative and quantitative findings separately in a segregated design for mixed-method reviews. The data will be examined and presented descriptively. If the retrieved studies allow it, we will review them from a constructivist perspective through a critical interpretive synthesis.

Ethics and dissemination
For this type of research, no ethical approval is required. Findings from this systematic review will be published in a peer-reviewed journal and presented at the annual congress of ‘Preventing Overdiagnosis’. In addition, the results will serve as guidance for further research on this topic.

PROSPERO registration number
CRD42021244513.

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Ottobre 2022

It stayed there, front and centre: perspectives on community pharmacys contribution to front-line healthcare services during the COVID-19 pandemic in Northern Ireland

Objectives
To explore community pharmacists and key stakeholders’ perspectives and reflections on the community pharmacy workforce’s preparedness for, and response to, COVID-19, including lessons for future public health crises.

Design, setting and participants
Qualitative study using semistructured interviews (via telephone or online videoconferencing platform), with community pharmacists and a range of key stakeholders (representing other health professions, professional/governing organisations concerned with community pharmacy and patient advocacy groups) from across Northern Ireland. Data were analysed using thematic analysis and constant comparison.

Results
Thirty interviews were conducted with community pharmacists (n=15) and key stakeholders (n=15). Four themes were identified: (1) adaptation and adjustment (reflecting how community responded quickly to the need to maintain services and adjusted and adapted services accordingly); (2) the primary point of contact (the continuing accessibility of community pharmacy when other services were not available and role as a communication hub, particularly in relation to information for patients and maintaining contact with other healthcare professionals); (3) lessons learnt (the flexibility of community pharmacy, the lack of infrastructure, especially in relation to information technology, and the need to build on the pandemic experience to develop practice); and (4) planning for the future (better infrastructure which reinforced concerns about poor technology, coordination of primary care services and preparing for the next public health crisis). There was a general view that community pharmacy needed to build on what had been learnt to advance the role of the profession.

Conclusions
The strengths of community pharmacy and its contribution to healthcare services in the COVID-19 pandemic were noted by community pharmacists and acknowledged by key stakeholders. The findings from this study should inform the policy debate on community pharmacy and its contribution to the public health agenda.

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Settembre 2022

'Like building a plane and flying it all in one go: an interview study of infection prevention and control in Australian general practice during the first 2 years of the SARS-CoV-2 pandemic

Objectives
General practitioners (GPs) and their staff have been at the frontline of the SARS-CoV-2 pandemic in Australia. However, their experiences of responding to and managing the risks of viral transmission within their facilities are poorly described. The aim of this study was to describe the experiences, and infection prevention and control (IPC) strategies adopted by general practices, including enablers of and challenges to implementation, to contribute to our understanding of the pandemic response in this critical sector.

Design
Semistructured interviews were conducted in person, by telephone or online video conferencing software, between November 2020 and August 2021.

Participants
Twenty general practice personnel working in New South Wales, Australia, including nine GPs, one general practice registrar, four registered nurses, one nurse practitioner, two practice managers and two receptionists.

Results
Participants described implementing wide-ranging repertoires of IPC strategies—including telehealth, screening of patients and staff, altered clinic layouts and portable outdoor shelters, in addition to appropriate use of personal protective equipment (PPE)—to manage the demands of the SARS-CoV-2 pandemic. Strategies were proactive, influenced by the varied contexts of different practices and the needs and preferences of individual GPs as well as responsive to local, state and national requirements, which changed frequently as the pandemic evolved.

Conclusions
Using the ‘hierarchy of controls’ as a framework for analysis, we found that the different strategies adopted in general practice often functioned in concert with one another. Most strategies, particularly administrative and PPE controls, were subjected to human variability and so were less reliable from a human factors perspective. However, our findings highlight the creativity, resilience and resourcefulness of general practice staff in developing, implementing and adapting their IPC strategies amidst constantly changing pandemic conditions.

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Settembre 2022

'Is it painful? A qualitative study on experiences of patients before prostate needle biopsy

Objective
To assess the experiences and emotional reactions of men prior to receiving a prostate needle biopsy (PNB).

Design
This was a qualitative study involving (1) material research and filter, (2) interviewer training, (3) cognitive semistructured interviews with open-ended questions, (4) data analysis, including translation and back translation and (5) group discussions to determine common themes in the data. All interviews were digitally audio-recorded. The thematic analysis was conducted by repeatedly reading the data manuscript and engaging in group discussion.

Setting and participants
A total of 30 participants with suspected prostate cancer (PC) who were scheduled to receive a PNB were interviewed. Eligible participants were Chinese native men aged 51–77 years, and the study was conducted in China between September and December 2020. All participants were informed about the purpose of the study and provided written informed consent.

Results
Four main themes were identified based on the interview content: (1) fear (of pain, adverse effects and bad results), (2) impact of lower urinary tract symptoms (on emotional impact, work and sleeping), (3) inner struggles (relating to hesitation, regret and embarrassment) and (4) lifestyle change (including diet, exercise and receipt of traditional Chinese medicine).

Conclusions
This patient cohort had a low level of knowledge about PC and PNB. Providing additional education about these topics would help to reduce patient fear and anxiety and improve experiences of the procedure.

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Settembre 2022

Unmet Needs in Health Disparities Research—It’s Not Just About Patients

Racial and ethnic disparities in kidney disease care are well documented. These inequities are particularly stark for Black individuals, who have a 2-fold to 4-fold higher prevalence of kidney failure, less access to predialysis nephrology care and kidney transplants, and higher risk of kidney disease–related death than White individuals. Adding to this research, Butler et al examined racial differences in “unmet existential and supportive care needs” in a cross-sectional survey of 948 Asian American or Native Hawaiian or Pacific Islander, Black or African American, and White individuals who were receiving dialysis at 31 facilities in Seattle, Washington, and Nashville, Tennessee, between 2015 and 2018. In adjusted analyses, compared with White individuals, Asian American or Native Hawaiian or Pacific Islander and Black individuals were more likely to want to learn what to do about pain and symptoms of kidney disease and to want someone to talk to about the meaning of life. Black individuals were also more likely to want to talk about care plans, treatments, and future treatment options.

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Settembre 2022

Reporting dose in complex self-management support interventions for long-term conditions: is it defined by researchers and received by participants? A systematic review

Background
The minimum clinically effective dose, and whether this is received in randomised controlled trials (RCTs) of complex self-management interventions in long-term conditions (LTCs), can be unclear. The Template for Intervention Description and Replication (TIDieR) checklist states that dose should be clearly reported to ensure validity and reliable implementation.

Objectives
To identify whether the expected minimum clinically effective dose, and the dose participants received is reported within research articles and if reporting has improved since the TIDieR checklist was published.

Methods
Four databases were systematically searched (MEDLINE, PsycINFO, AMED and CINAHL) to identify published reports between 2008 and 2022 for RCTs investigating complex self-management interventions in LTCs. Data on reporting of dose were extracted and synthesised from the eligible articles.

Results
94 articles covering various LTCs including diabetes, stroke and arthritis were included. Most complex interventions involved behaviour change combined with education and/or exercise. The maximum dose was usually reported (n=90; 97.8%), but the expected minimum clinically effective dose and the dose received were reported in only 28 (30.4%) and 62 (67.4%) articles, respectively. Reporting of the expected minimum clinically effective dose and the dose participants received did not improve following the publication of the TIDieR checklist in 2014.

Conclusions
Interpreting results and implementing effective complex self-management interventions is difficult when researchers’ reporting of dose is not in line with guidelines. If trial findings indicate benefit from the intervention, clear reporting of dose ensures reliable implementation to standard care. If the results are non-significant, detailed reporting enables better interpretation of results, that is, differentiating between poor implementation and lack of effectiveness. This ensures quality of interventions and validity and generalisability of trial findings. Therefore, wider adoption of reporting the TIDieR checklist dose aspects is strongly recommended. Alternatively, customised guidelines for reporting dose in complex self-management interventions could be developed.

PROSPERO registration number
CRD42020180988.

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Agosto 2022

'It was like being hit with a brick: a qualitative study on the effect of clinicians delivery of a diagnosis of eye disease for patients in primary and secondary care

Objectives
To explore patients’ experiences of getting a diagnosis of eye disease, the psychological impact of this and how this could be improved.

Design
An exploratory qualitative interview study using a narrative approach and inductive methods.

Setting
This study was conducted with patients who had attended ophthalmic appointments in primary and secondary care and in opticians located in the South of England.

Participants
18 people diagnosed with eye disease in England.

Results
Four themes were identified: the convoluted process of being diagnosed, the impact of clinicians’ words, the search for information and reflections on what could be improved. The prolonged wait for a definitive diagnosis was a source of frustration and anxiety for many patients. Professionals’ words and tone when delivering a diagnosis sometimes affected a patient’s view of their diagnosis and their later ability to come to terms with it. Patients were desperate for information, but many felt they were not provided with sufficient information at the time of diagnosis and did not know whether to trust information found online. Participants felt the provision of a hospital liaison service and/or counselling could mitigate the impact on patients and families.

Conclusions
Interactions with clinicians can have a lasting impact on how a diagnosis is experienced and how well the patient is able to come to terms with their visual impairment. Receiving little or no information left patients feeling lost and unsupported. This led them to search for information from less reliable sources. Clinicians should consider how they communicate a diagnosis to patients, how and when they offer information about diagnosis and prognosis and where possible signpost patients to additional support systems and counselling services as early as possible.

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Luglio 2022

Economic evaluation of tranexamic acid for the treatment of acute gastrointestinal bleeding: a cost-effectiveness analysis using data from the HALT-IT randomised controlled trial

Objective
To perform an economic evaluation of tranexamic acid (TXA) versus no-TXA, in addition to current clinical practice, for acute gastrointestinal bleeding, using the results of the HALT-IT trial (NCT01658124), a large randomised controlled trial which included 11 937 patients.

Design
A cost-effectiveness modelling analysis, performed over a lifetime time horizon.

Setting
The analysis was performed from a UK health service perspective.

Participants
The model includes adults with acute gastrointestinal bleeding.

Outcomes measures
The model reports costs in Great British pounds in 2021 and outcomes as life years (LYs) and quality-adjusted life years (QALYs). Cost-effectiveness was evaluated using incremental cost-effectiveness ratios (ICERs), reported as the cost per QALY gained.

Methods
A Markov model was developed to calculate the overall costs and health outcomes of TXA administration versus no-TXA. The model used data of the treatment effectiveness from the HALT-IT trial, which showed that TXA administration for acute gastrointestinal bleeding did not reduce all-cause mortality (risk ratio 1.03, 95% CI 0.92 to 1.16) compared with no-TXA. Data on health-related quality of life, costs and long-term mortality risks were derived from the literature. Costs and effects are discounted at 3.5% per annum.

Results
TXA was associated with marginally fewer LYs and QALYs, and lower costs, than treatment without TXA. The ICER associated with no-TXA was £1576 per LY gained and £2209 per QALY gained. No-TXA was 64% likely to be cost-effective at a £20 000 willingness-to-pay threshold, while TXA was 36% likely to be cost-effective.

Conclusion
Though inexpensive, TXA administration for patients with acute gastrointestinal bleeding is unlikely to be cost-effective.

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Luglio 2022

Does digital, multimedia information increase recruitment and retention in a childrens wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT)

Objectives
To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information.

Design
Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study.

Setting
Emergency departments in 23 UK hospitals.

Participants
1409 children aged 4–16 years attending with a torus (buckle) fracture, and their parents/guardian. Children’s mean age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language.

Interventions
Participants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728).

Outcome measures
Primary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three ‘free text’ questions (deriving subjective evaluations) and trial retention.

Results
MMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI –1.23 to 1.32, p=0.94). The MMI group was more likely to report the information ‘very easy’ to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks’ timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%).

Conclusions
MMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively.

Trial registration number
ISRCTN73136092 and ISRCTN13955395.

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Luglio 2022

Thrombophilia screening in women with recurrent first trimester miscarriage: is it time to stop testing? – a cohort study and systematic review of the literature

Objective
There are numerous studies reporting a disproportionally high prevalence of thrombophilia in women with a history of recurrent miscarriage (RM), which has led to overdiagnosis and treatment without an improvement in clinical outcomes. The objective of our study was to assess the prevalence of inherited and acquired thrombophilia in a large cohort of women with a history of early RM using internationally agreed diagnostic criteria and inclusion parameters and compare it to the meta-analysis results of existing literature.

Methods

Design
Retrospective cohort study and systematic review of literature.

Setting
This is a retrospective cohort study set-up in two dedicated tertiary centres for women with RM in Southwest London and Surrey. We reviewed all the available literature related to causes of RMs. We ascertained the prevalence of thrombophilia in the study population and compared it with historical and published prevalence in the general population.

Participants
1155 women between 2012 and 2017. All patients had three or more first trimester miscarriages and a full thrombophilia screen.

Results
The overall prevalence of thrombophilia in our study population is 9.2% (106/1155) with 8.1% (94/1155) of cases positive for inherited thrombophilia, which is similar to the general population; Factor V Leiden (4.9%; 57/1155) and prothrombin gene mutation (2.9%; 34/1155) were the most common inherited thrombophilias, while only 1% (12/1155) tested positive for acquired thrombophilia. Persistent positive lupus anticoagulant (LA) was found in 0.5% (6/1155) and persistent positive anticardiolipin (ACL) antibodies with a value ≥40 U/mL was found in 0.5% (6/1155) of patients. Tests for LA/ACL were performed a minimum of 12 weeks apart thus meeting the revised Sapporo criteria for a diagnosis of antiphospholipid syndrome.

Conclusion
The findings of our study demonstrate that the prevalence of inherited thrombophilia is similar in women with RM to that in the general population. Similarly, the prevalence of acquired thrombophilia, using the revised Sapporo criteria, in the cohort of RMs is similar to that in the general population. Therefore, we do not recommend investigation or treatment of inherited or acquired thrombophilia in women with RM.

PROSPERO registration number
CRD42020223554.

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Luglio 2022

Mixed methods evaluation of the Getting it Right First Time programme in elective orthopaedic surgery in England: an analysis from the National Joint Registry and Hospital Episode Statistics

Objective
To evaluate the impact of the ‘Getting it Right First Time’ (GIRFT) national improvement programme in orthopaedics, which started in 2012.

Design
Mixed-methods study comprising statistical analysis of linked national datasets (National Joint Registry; Hospital Episode Statistics; Patient-Reported Outcomes); economic analysis and qualitative case studies in six National Health Service (NHS) Trusts.

Setting
NHS elective orthopaedic surgery in England.

Participants
736 088 patients who underwent primary hip or knee replacement at 126 NHS Trusts between 1 April 2009 and 31 March 2018, plus 50 NHS staff.

Intervention
Improvement bundle including ‘deep dive’ visits by senior clinician to NHS Trusts, informed by bespoke set of routine performance data, to discuss how improvements could be made locally.

Main outcome measures
Number of procedures conducted by low volume surgeons; use of uncemented hip implants in patients >65; arthroscopy in year prior to knee replacement; hospital length of stay; emergency readmissions within 30 days; revision surgery within 1 year; health-related quality of life and functional status.

Results
National trends demonstrated substantial improvements beginning prior to GIRFT. Between 2012 and 2018, there were reductions in procedures by low volume surgeons (ORs (95% CI) hips 0.58 (0.53 to 0.63), knees 0.77 (0.72 to 0.83)); uncemented hip prostheses in >65 s (OR 0.56 (0.51 to 0.61)); knee arthroscopies before surgery (OR 0.48 (0.41 to 0.56)) and mean length of stay (hips –0.90 (–1.00 to -0.81), knees –0.74 days (–0.82 to –0.66)). The additional impact of visits was mixed and comprised an overall economic saving of £431 848 between 2012 and 2018, but this was offset by the costs of the visits. Staff reported that GIRFT’s influence ranged from procurement changes to improved regional collaboration.

Conclusion
Nationally, we found substantial improvements in care, but the specific contribution of GIRFT cannot be reliably estimated due to other concurrent initiatives. Our approach enabled additional analysis of the discrete impact of GIRFT visits.

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Giugno 2022

It depends on how you tell: a qualitative diagnostic analysis of the implementation climate for community-wide mass drug administration for soil-transmitted helminth

Objectives
Current soil-transmitted helminth (STH) morbidity control guidelines primarily target deworming of preschool and school-age children. Emerging evidence suggests that community-wide mass drug administration (cMDA) may interrupt STH transmission. However, the success of such programmes depends on achieving high treatment coverage and uptake. This formative analysis was conducted to evaluate the implementation climate for cMDA and to determine barriers and facilitators to launch.

Settings
Prior to the launch of a cMDA trial in Benin, India and Malawi.

Participants
Community members (adult women and men, children, and local leaders), community drug distributors (CDDs) and health facility workers.

Design
We conducted 48 focus group discussions (FGDs) with community members, 13 FGDs with CDDs and 5 FGDs with health facility workers in twelve randomly selected clusters across the three study countries. We used the Consolidated Framework for Implementation Research to guide the design of the interview guide and thematic analysis.

Results
Across all three sites, aspects of the implementation climate that were facilitators to cMDA launch included: high community member demand for cMDA, integration of cMDA into existing vaccination campaigns and/or health services, and engagement with familiar health workers. Barriers to launching cMDA included mistrust towards medical interventions, fear of side effects and limited perceived need for interrupting STH transmission. We include specific recommendations from community members regarding cMDA distribution sites, personnel requirements, delivery timing and incentives, leaders to engage and methods for mobilising participants.

Conclusions
Prior to launching the cMDA programme as an alternative to school-based MDA, cMDA was found to be generally acceptable across diverse geographical and demographic settings. Community members, CDDs and health workers felt that engaging communities and tailoring programmes to the local context are critical for success. Potential barriers may be mitigated by identifying local concerns and addressing them via targeted community sensitisation prior to implementation.

Trial registration number
NCT03014167; Pre-results.

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Giugno 2022