Paul Sutcliffe

Background: The worldwide prevalence of paternal perinatal anxiety (PPA) ranges between 3.4% and 25.0% antenatally, and 2.4% and 51.0% postnatally. Experiencing PPA can adversely impact the individual, partners, and infants. Research concerning PPA is lagging and fragmented compared to research for new mothers. Objectives: To establish the effectiveness of prevention or treatment interventions for PPA in adults identifying as male. Data sources: We completed searches of Medline, EMBASE, PsycINFO and Web of Science from inception to 2 December 2021, as well as hand searches of references from relevant papers. Search selection and data extraction: Randomised controlled trials delivering prevention or treatment interventions and reporting anxiety outcomes for new/expectant fathers in the perinatal mental health period were included. Our review follows the PRISMA reporting guidelines. One reviewer independently screened 5170 titles/abstracts; second reviewers screened 50%. Two reviewers independently screened full text, extracted data, and conducted risk of bias assessments. Synthesis: Cochrane’s collaboration tool 2 was used to assess quality. Primarily results are synthesised narratively, a post-hoc sub-group analysis was completed on four studies using the same outcome measure. Main results: Twelve of the 5170 studies fulfilled the inclusion criteria. Studies used psychoeducational or practical skills interventions. Interventions mostly involved couple-dyads and three studies assessed PPA as a primary outcome. Included interventions were prevention-based; no treatment interventions were found. Father-only interventions consistently reported a significant reduction of PPA. Conclusions: Systematic searching yielded no treatment interventions, highlighting a substantial gap in the evidence base. Within a limited and heterogenous sample, no studies targeted diagnosed PPA. Evidence suggested father-focused interventions may be effective in preventing PPA, regardless of the intervention delivery mode or intervention content. However, consistency between study design and options within the field are lacking compared to interventions available for mothers.

Background: Attempts to utilize eHealth in diabetes mellitus (DM) management have shown promising outcomes, mostly targeted at patients; however, few solutions have been designed for health care providers. Objective: The purpose of this study was to conduct a feasibility project developing and evaluating a mobile clinical decision support system (CDSS) tool exclusively for health care providers to manage chronic kidney disease (CKD) in patients with DM. Methods: The design process was based on the 3 key stages of the user-centered design framework. First, an exploratory qualitative study collected the experiences and views of DM specialist nurses regarding the use of mobile apps in clinical practice. Second, a CDSS tool was developed for the management of patients with DM and CKD. Finally, a randomized controlled trial examined the acceptability and impact of the tool. Results: We interviewed 15 DM specialist nurses. DM specialist nurses were not currently using eHealth solutions in their clinical practice, while most nurses were not even aware of existing medical apps. However, they appreciated the potential benefits that apps may bring to their clinical practice. Taking into consideration the needs and preferences of end users, a new mobile CDSS app, “Diabetes & CKD,” was developed based on guidelines. We recruited 39 junior foundation year 1 doctors (44% male) to evaluate the app. Of them, 44% (17/39) were allocated to the intervention group, and 56% (22/39) were allocated to the control group. There was no significant difference in scores (maximum score=13) assessing the management decisions between the app and paper-based version of the app’s algorithm (intervention group: mean 7.24 points, SD 2.46 points; control group: mean 7.39, SD 2.56; t37=–0.19, P=.85). However, 82% (14/17) of the participants were satisfied with using the app. Conclusions: The findings will guide the design of future CDSS apps for the management of DM, aiming to help health care providers with a personalized approach depending on patients’ comorbidities, specifically CKD, in accordance with guidelines.

BACKGROUND Attempts to utilize eHealth in diabetes mellitus (DM) management have shown promising outcomes, mostly targeted at patients; however, few solutions have been designed for health care providers. OBJECTIVE The purpose of this study was to conduct a feasibility project developing and evaluating a mobile clinical decision support system (CDSS) tool exclusively for health care providers to manage chronic kidney disease (CKD) in patients with DM. METHODS The design process was based on the 3 key stages of the user-centered design framework. First, an exploratory qualitative study collected the experiences and views of DM specialist nurses regarding the use of mobile apps in clinical practice. Second, a CDSS tool was developed for the management of patients with DM and CKD. Finally, a randomized controlled trial examined the acceptability and impact of the tool. RESULTS We interviewed 15 DM specialist nurses. DM specialist nurses were not currently using eHealth solutions in their clinical practice, while most nurses were not even aware of existing medical apps. However, they appreciated the potential benefits that apps may bring to their clinical practice. Taking into consideration the needs and preferences of end users, a new mobile CDSS app, “Diabetes & CKD,” was developed based on guidelines. We recruited 39 junior foundation year 1 doctors (44% male) to evaluate the app. Of them, 44% (17/39) were allocated to the intervention group, and 56% (22/39) were allocated to the control group. There was no significant difference in scores (maximum score=13) assessing the management decisions between the app and paper-based version of the app’s algorithm (intervention group: mean 7.24 points, SD 2.46 points; control group: mean 7.39, SD 2.56; t37=–0.19, P=.85). However, 82% (14/17) of the participants were satisfied with using the app. CONCLUSIONS The findings will guide the design of future CDSS apps for the management of DM, aiming to help health care providers with a personalized approach depending on patients’ comorbidities, specifically CKD, in accordance with guidelines.

Background: Young people (aged 16–24 years) with long-term health conditions tend to disengage from health services, resulting in poor health outcomes. They are prolific users of digital communications. Innovative UK NHS clinicians use digital communication with these young people. The NHS plans to use digital communication with patients more widely.Objectives: To explore how health-care engagement can be improved using digital clinical communication (DCC); understand effects, impacts, costs and necessary safeguards; and provide critical analysis of its use, monitoring and evaluation.Design: Observational mixed-methods case studies; systematic scoping literature reviews; assessment of patient-reported outcome measures (PROMs); public and patient involvement; and consensus development through focus groups.Setting: Twenty NHS specialist clinical teams from across England and Wales, providing care for 13 different long-term physical or mental health conditions.Participants: One hundred and sixty-five young people aged 16–24 years living with a long-term health condition; 13 parents; 173 clinical team members; and 16 information governance specialists.Interventions: Clinical teams and young people variously used mobile phone calls, text messages, e-mail and voice over internet protocol.Main outcome measures: Empirical work – thematic and ethical analysis of qualitative data; annual direct costs; did not attend, accident and emergency attendance and hospital admission rates plus clinic-specific clinical outcomes. Scoping reviews–patient, health professional and service delivery outcomes and technical problems. PROMs: scale validity, relevance and credibility.Data sources: Observation, interview, structured survey, routinely collected data, focus groups and peer-reviewed publications.Results: Digital communication enables access for young people to the right clinician when it makes a difference for managing their health condition. This is valued as additional to traditional clinic appointments. This access challenges the nature and boundaries of therapeutic relationships, but can improve them, increase patient empowerment and enhance activation. Risks include increased dependence on clinicians, inadvertent disclosure of confidential information and communication failures, but clinicians and young people mitigate these risks. Workload increases and the main cost is staff time. Clinical teams had not evaluated the impact of their intervention and analysis of routinely collected data did not identify any impact. There are no currently used generic outcome measures, but the Patient Activation Measure and the Physicians’ Humanistic Behaviours Questionnaire are promising. Scoping reviews suggest DCC is acceptable to young people, but with no clear evidence of benefit except for mental health.Limitations: Qualitative data were mostly from clinician enthusiasts. No interviews were achieved with young people who do not attend clinics. Clinicians struggled to estimate workload. Only eight full sets of routine data were available.Conclusions: Timely DCC is perceived as making a difference to health care and health outcomes for young people with long-term conditions, but this is not supported by evidence that measures health outcomes. Such communication is challenging and costly to provide, but valued by young people.Future work: Future development should distinguish digital communication replacing traditional clinic appointments and additional timely communication. Evaluation is needed that uses relevant generic outcomes.Study registration: Two of the reviews in this study are registered as PROSPERO CRD42016035467 and CRD42016038792.Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet

Objective: To describe the latest evidence of effectiveness and impact of networked communication interventions for young people with mental health conditions. Methods: Searching five databases from 2009 onwards, we included studies of any design investigating two-way communication interventions for the treatment of young people (mean age 12–25) with a chronic mental health disorder. The data were synthesised using narrative summary. Results: Six studies met the inclusion criteria, covering a range of mental health conditions (depression, psychosis, OCD). Interventions included an online chat room ( n = 2), videoconferencing ( n = 3) and telephone ( n = 1). Where studies compared two groups, equivalence or a statistically significant improvement in symptoms was observed compared to control. Views of patients and clinicians included impact on the patient-clinician interaction. Clinicians did not feel it hindered their diagnostic ability. Conclusion: Networked communication technologies show promise in the treatment of young people with mental health problems but the current available evidence remains limited and the evidence base has not advanced much since the previous inception of this review in 2011. Practice implications: Although the available research is generally positive, robust evidence relating to the provision of care for young persons via these technologies is lacking and healthcare providers should be mindful of this.

Barriers to reporting of adverse drugs reactions: a cross sectional study among community pharmacists in United Kingdom

Background: Rapid reviews are increasingly used to replace/complement systematic reviews to support evidence‐based decision‐making. Little is known about how this expedited process affects results.Objectives: To assess differences between rapid and systematic review approaches for a case study of test accuracy of succinylacetone for detecting tyrosinemia type 1.Methods: Two reviewers conducted an “enhanced” rapid review then a systematic review. The enhanced rapid review involved narrower searches, a single reviewer checking 20% of titles/abstracts and data extraction, and quality assessment using an unadjusted QUADAS‐2. Two reviewers performed the systematic review with a tailored QUADAS‐2. Post hoc analysis examined rapid reviewing with a single reviewer (basic rapid review).Results: Ten papers were included. Basic rapid reviews would have missed 1 or 4 of these (dependent on which reviewer). Enhanced rapid and systematic reviews identified all 10 papers; one paper was only identified in the rapid review through reference checking. Two thousand one hundred seventy‐six fewer title/abstracts and 129 fewer full texts were screened during the enhanced rapid review than the systematic review. The unadjusted QUADAS‐2 generated more “unclear” ratings than the adjusted QUADAS‐2 [29/70 (41.4%) versus 16/70 (22.9%)], and fewer “high” ratings [22/70 (31.4%) versus 42/70 (60.0%)]. Basic rapid reviews contained important inaccuracies in data extraction, which were detected by a second reviewer in the enhanced rapid and systematic reviews.Conclusions: Enhanced rapid reviews with 20% checking by a second reviewer may be an appropriate tool for policymakers to expeditiously assess evidence. Basic rapid reviews (single reviewer) have higher risks of important inaccuracies and omissions.

Timely and accurate identification of people with latent tuberculosis infection (LTBI) is important for controlling Mycobacterium tuberculosis (TB). There is no gold standard for diagnosis of LTBI. Screening tests such as interferon gamma release assays (IGRAs) and tuberculin skin test (TST) provide indirect and imperfect information. This systematic review compared two types of IGRAs QuantiFERON®-TB Gold In-Tube test (QFT-GIT) and T-SPOT.TB with TST for identification of LTBI by predicting progression to a diagnosis of active TB in three subgroups: children, immunocompromised people, and those recently arrived from countries with high TB burden. Cohort studies were eligible for inclusion. We searched MEDLINE, EMBASE, the Cochrane Library and other databases from December 2009 to June 2015. One reviewer screened studies, extracted data, and assessed risk of bias with cross checking by a second reviewer. Strength of association between test results and incidence of TB was summarised using cumulative incidence ratios (CIRs with 95% CIs). Summary effect measures: the ratio of CIRs (R-CIR) with 95% CIs. R-CIRs, were pooled using a random-effects model. Heterogeneity was assessed using Chi-squared and I2 statistics. Seventeen studies, mostly of moderate or high risk of bias (five in children, 10 in immunocompromised people, and two in those recently arrived) were included. In children, while in two studies, there was no significant difference between QFT-GIT and TST (≥5 mm) (pooled R-CIR = 1.11, 95% CI: 0.71, 1.74), two other studies showed QFT-GIT to outperform TST (≥10 mm) in identifying LTBI. In immunocompromised people, IGRA (T-SPOT.TB) was not significant different from TST (≥10 mm) for identifying LTBI, (pooled R-CIR = 1.01, 95% CI: 0.65, 1.58). The forest plot of two studies in recently arrived people from countries with high TB burden demonstrated inconsistent findings (high heterogeneity; I2 = 92%). Prospective studies comparing IGRA testing against TST on the progression from LTBI to TB were sparse, and these results should be interpreted with caution due to uncertainty, risk of bias, and unexplained heterogeneity. Population-based studies with adequate sample size and follow-up are required to adequately compare the performance of IGRA with TST in people at high risk of TB.

Background and objectives: Systematic reviews and economic modelling of clinical effectiveness and cost-effectiveness of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [using LISA-TRACKER^®enzyme-linked immunosorbent assay (ELISA) kits (Theradiag, Marne La Vallee, France, or Alpha Laboratories, Heriot, UK), TNF-α-Blocker ELISA kits (Immundiagnostik AG, Bensheim, Germany) and Promonitor^®ELISA kits (Proteomika, Progenika Biopharma, Bizkaia, Spain)] versus standard care for Crohn’s disease (CD).Methods: Multiple electronic databases were searched from inception to December 2014 in order to identify primary studies and meta-analyses.Population: Patients with moderate to severe active CD treated with infliximab (IFX) (Remicade^®, Merck Sharp & Dohme Ltd, Kenilworth, NJ, USA) or adalimumab (ADA) (Humira^®, AbbVie Inc., North Chicago, IL, USA).Intervention: Monitoring of serum anti-TNF-α (IFX or ADA) and/or of anti-drug antibody levels using test assays with a test–treatment algorithm.Comparator: Standard care.Outcomes: Any patient-related outcome, test agreement and cost-effectiveness estimates. The quality assessments used recognised checklists (Quality Assessment of Diagnostic Accuracy Studies-2, Cochrane, Philips and Consolidated Health Economic Evaluation Reporting Standards). Evidence was synthesised using narrative review and meta-analysis. A Markov model was built in TreeAge Pro 2013 (TreeAge Software, Inc., Williamstown, MA, USA). The model had a 4-week cycle and a 10-year time horizon, adopted a NHS and Personal Social Services perspective and used a linked evidence approach. Costs were adjusted to 2013/14 prices and discounted at 3.5%.Results: We included 68 out of 2434 and 4 out of 2466 studies for the clinical effectiveness and cost-effectiveness reviews, respectively. Twenty-three studies comparing test methods were identified. Evidence on test concordance was sparse and contradictory, offering scant data for a linked evidence approach. Three studies [two randomised controlled trials (RCTs) and one retrospective observational study] investigated outcomes following implementation of a test algorithm. None used the specified commercial ELISA immunoassay test kits. Neither of the two RCTs demonstrated clinical benefit of a test–treatment regimen. A meta-analysis of 31 studies to estimate test accuracy for predicting clinical status indicated that 20–30% of test results are likely to be inaccurate. The four cost-effectiveness studies suggested that testing results in small cost reductions. In the economic analysis the base-case analysis showed that standard practice (no testing/therapeutic monitoring with the intervention tests) was more costly and more effective than testing for IFX. Sensitivity and scenario analyses gave similar results. The probabilistic sensitivity analysis indicated a 92% likelihood that the ‘no-testing’ strategy was cost-effective at a willingness to pay of £20,000 per quality-adjusted life-year.Strengths and limitations: Rigorous systematic reviews were undertaken; however, the underlying evidence base was poor or lacking. There was uncertainty about a linked evidence approach and a lack of gold standard for assay comparison. The only comparative evidence available for economic evaluation was for assays other than the intervention assays.Conclusions: Our finding that testing is not cost-effective for IFX should be viewed cautiously in view of the limited evidence. Clinicians should be mindful of variation in performance of different assays and of the absence of standardised approaches to patient assessment and treatment algorithms.Future work recommendations: There is substantial variation in the underlying treatment pathways and uncertainty in the relative effectiveness of assay- and test-based treatment algorithms, which requires further investigation. There is very little research evidence on ADA or on drug monitoring in children with CD, and conclusions on cost-effectiveness could not be reached for these.Study registration: This study is registered as PROSPERO CRD42014015278.Funding: The National Institute for Health Research Health Technology Assessment programme.