Medical Research Council Guidelines Research Articles

What and how do different stakeholders contribute to intervention development? A mixed methods study.

Background: UK Medical Research Council guidelines recommend end-user involvement in intervention development. There is limited evidence on the contributions of different end-users to this process. The aim of this Study Within A Trial (SWAT) was to identify and compare contributions from two groups of end-users - people with diabetes' (PWD) and healthcare professionals' (HCPs), during consensus meetings to inform an intervention to improve retinopathy screening uptake. Methods: A mixed method, explanatory sequential design comprising a survey and three semi-structured consensus meetings was used. PWD were randomly assigned to a PWD only or combined meeting. HCPs attended a HCP only or combined meeting, based on availability. In the survey, participants rated intervention proposals on acceptability and feasibility. Survey results informed the meeting topic guide. Transcripts were analysed deductively to compare feedback on intervention proposals, suggestions for new content, and contributions to the final intervention. Results: Overall, 13 PWD and 17 HCPs completed the survey, and 16 PWD and 15 HCPs attended meetings. For 31 of the 39 intervention proposals in the survey, there were differences (≥10%) between the proportion of HCPs and PWD who rated proposals as acceptable and/or feasible. End-user groups shared and unique concerns about proposals; both were concerned about informing but not scaring people when communicating risk, while concerns about resources were mostly unique to HCPs and concerns about privacy were mostly unique to PWD. Fewer suggestions for new intervention content from the combined meeting were integrated into the final intervention as they were not feasible for implementation in general practice. Participants contributed four new behaviour change techniques not present in the original proposals: goal setting (outcome), restructuring the physical environment, material incentive (behaviour) and punishment. Conclusions: Preferences for intervention content may differ across end-user groups, with feedback varying depending on whether end-users are involved simultaneously or separately.

Group antenatal care (gANC) for Somali-speaking women in Sweden – a process evaluation

BackgroundLanguage supported group antenatal care (gANC) for Somali-born women was implemented in a Swedish public ANC clinic. The women were offered seven 60-min sessions, facilitated by midwives and starting with a presentation of a selected topic, with an additional 15-min individual appointment before or after. The aim of this study was to assess the feasibility for participants and midwives of implementing The Hooyo (“mother” in Somali) gANC intervention, including implementation, mechanisms of impact and contextual factors.MethodsA process evaluation was performed, using The Medical Research Council (MRC) guidelines for evaluating complex interventions as a framework. A range of qualitative and quantitative data sources were used including observations (n = 9), complementary, in-depth and key-informant interviews (women n = 6, midwives n = 4, interpreters and research assistants n = 3) and questionnaire data (women n = 44; midwives n = 8).ResultsLanguage-supported gANC offered more comprehensive ANC that seemed to correspond to existing needs of the participants and could address knowledge gaps related to pregnancy, birth and the Swedish health care system. The majority of women thought listening to other pregnant women was valuable (91%), felt comfortable in the group (98%) and supported by the other women (79%), and they said that gANC suited them (79%). The intervention seemed to enhance knowledge and cultural understanding among midwives, thus contributing to more women-centred care. The intervention was not successful at involving partners in ANC.ConclusionsThe Hooyo gANC intervention was acceptable to the Somali women and to midwives, but did not lead to greater participation by fathers-to-be. The main mechanisms of impact were more comprehensive ANC and enhanced mutual cultural understanding. The position of women was strengthened in the groups, and the way in which the midwives expanded their understanding of the participants and their narratives was promising. To be feasible at a large scale, gANC might require further adaptations and the “othering” of women in risk groups should be avoided.Trial registrationThe study was registered in ClinicalTrials.gov (Identifier: NCT03879200).

Implementation of a Health Promotion Practice Using Individually Targeted Lifestyle Interventions in Primary Health Care: Protocol for the "Act in Time" Mixed Methods Process Evaluation Study.

BackgroundThere is growing evidence that noncommunicable diseases (NCDs) can be attributable to unhealthy lifestyle habits. However, there has been little application of this knowledge in primary health care (PHC).ObjectiveThis study aims to evaluate the process and outcomes of a multifaceted implementation strategy for a healthy lifestyle-promoting practice in a PHC setting. This practice is based on national guidelines targeting unhealthy lifestyle habits with a potential risk for NCDs.MethodsA pre-post implementation study design with a control group is used in a PHC setting in central Sweden. The Medical Research Council guidelines for process evaluation of complex interventions will be applied. The implementation process and outcomes will be assessed using a mix of qualitative and quantitative methods. A strategic sample of up to 6 PHC centers will be included as intervention centers, which will receive a 12-month multifaceted implementation strategy. Up to 6 matched PHC centers will serve as controls. Core components in the implementation strategy are external and internal facilitators in line with the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework and the Astrakan change leadership model. Data will be collected at baseline, during the implementation phase, and 4-6 months after the implementation strategy. Questionnaires will be sent to roughly 500 patients in every PHC center and 200 health care professionals (HCPs) before and after implementation. In addition, purposeful sampling will be used for interviews and focus group discussions with managers, HCPs, patient representatives, and internal and external facilitators. Use of data from medical records and activity logs will be an additional data source.ResultsRecruitment of PHC centers began in March 2021 and ended in Spring 2022. Based on the planned timeline with the 12-month implementation strategy and 4-6-month follow-up, we expect to collect the final data in Summer 2023.ConclusionsThis study will explain implementation process and outcomes using a multifaceted implementation strategy for a healthy lifestyle-promoting practice in a real-world PHC context. The study is expected to provide new knowledge about the role of facilitators and their contribution to implementation outcomes. These findings can guide policy makers, managers, and PHC staff to integrate health promotion and disease prevention in PHC and provide methodological support to facilitators.Trial RegistrationClinicalTrials.gov NCT04799860; https://clinicaltrials.gov/ct2/show/NCT04799860International Registered Report Identifier (IRRID)DERR1-10.2196/37634

Assessing the impact of the 2018 National Health and Medical Research Council polyp surveillance guidelines on compliance with surveillance intervals at two public hospitals.

Several studies have highlighted poor compliance with surveillance colonoscopy guidelines. The National Health and Medical Research Council (NHMRC) guidelines were revised in 2018 and were more complex than the previous iteration (2011). The aim of this study was to determine the impact of 2018 NHMRC polyp surveillance guidelines on compliance with colonoscopy surveillance intervals. A multicentre retrospective clinical audit was conducted between January 2020 and February 2021. Patients awaiting a colonoscopy for polyp surveillance at two public tertiary care hospitals in South Australia were included. Compliance rates of recommended polyp surveillance colonoscopy intervals after implementation of 2018 NHMRC guidelines were compared with 2011 NHMRC guidelines. The projected impact on colonoscopy bookings of the change in guideline intervals was modelled to 5 and 10 years, factoring in differences in compliance. Of 3996 patients awaiting colonoscopy services at two public hospitals in South Australia, 1984 patients (60% male, median age 61 years) were waitlisted for polyp surveillance. Overall compliance with surveillance guidelines was >60%. Implementation of the 2018 NHMRC guidelines significantly reduced compliance from 65.8% (2011 guidelines) to 50.8% (2018) (χ2 <0.001, OR 0.5). Modelling projections to 5 and 10 years demonstrated that application of the 2018 guidelines significantly increases the projected number of colonoscopy bookings per year. The revised 2018 NHMRC guidelines have resulted in significantly poorer compliance post-implementation, possibly due to their increased complexity. This has potential to increase the surveillance colonoscopy waiting list burden.

What and how do different stakeholders contribute to intervention development? A mixed methods study.

Background: UK Medical Research Council guidelines recommend end-user involvement in intervention development. There is limited evidence on the contributions of different end-users to this process. The aim of this Study Within A Trial (SWAT) was to identify and compare contributions from two groups of end-users - people with diabetes' (PWD) and healthcare professionals' (HCPs), during consensus meetings to inform an intervention to improve retinopathy screening uptake. Methods: A mixed method, explanatory sequential design comprising a survey and three semi-structured consensus meetings was used. PWD were randomly assigned to a diabetes only or combined meeting. HCPs attended a HCP only or combined meeting, based on availability. In the survey, participants rated intervention proposals on acceptability and feasibility. Survey results informed the meeting topic guide. Transcripts were analysed deductively to compare feedback on intervention proposals, suggestions for new content, and contributions to the final intervention. Results: Overall, 13 PWD and 17 HCPs completed the survey, and 16 PWD and 15 HCPs attended meetings. For 31 of the 39 intervention proposals in the survey, there were differences (≥10%) between the proportion of HCPs and PWD who rated proposals as acceptable and/or feasible. End-user groups shared and unique concerns about proposals; both were concerned about informing but not scaring people when communicating risk, while concerns about resources were mostly unique to HCPs and concerns about privacy were mostly unique to PWD. Fewer suggestions for new intervention content from the combined meeting were integrated into the final intervention as they were not feasible for implementation in general practice. Participants contributed four new behaviour change techniques not present in the original proposals: goal setting (outcome), restructuring the physical environment, material incentive (behaviour) and punishment. Conclusions: Preferences for intervention content may differ across end-user groups, with feedback varying depending on whether end-users are involved simultaneously or separately.

Reducing exacerbations in children and adults with primary ciliary dyskinesia using erdosteine and/or azithromycin therapy (REPEAT trial): study protocol for a multicentre, double-blind, double-dummy, 2×2 partial factorial, randomised controlled trial

IntroductionPrimary ciliary dyskinesia (PCD) is a rare, progressive, inherited ciliopathic disorder, which is incurable and frequently complicated by the development of bronchiectasis. There are few randomised controlled trials (RCTs) involving...

Congenital Hypertrophy of the Retinal Pigment Epithelium (CHRPE) as a Screening Marker for Familial Adenomatous Polyposis (FAP): Systematic Literature Review and Screening Recommendations.

PurposeFamilial adenomatous polyposis (FAP) has an almost 100% colorectal cancer risk warranting early detection in gene carriers. This study presents congenital hypertrophy of the retinal pigment epithelium (CHRPE) as a highly specific phenotypical marker for FAP that can be used in screening at-risk individuals. Screening recommendations including morphological subclassification were formulated with supporting literature.MethodsA systematic literature review with a comprehensive search strategy was conducted using online databases. Manual searches of bibliographies and reference lists were also performed. Studies meeting inclusion criteria were graded with respect to their hierarchy of evidence and strength of recommendations according to the National Health and Medical Research Council (NHMRC) guidelines of Australia.ResultsAlmost 4500 participants were analysed across 28 included studies. The mean specificity of CHRPE as a phenotypical screening marker of FAP was 89% (standard deviation (SD); 14) with a mean sensitivity of 79% (SD; 8). The mean prevalence of CHRPE amongst FAP participants; at-risk participants were found to be 76% (SD; 24) and 37% (SD; 21) respectively. Bilateralism and multiple lesion number ≥3 are features highly specific for FAP.ConclusionCHRPE was found to be a non-invasive, rapid, early phenotypical screening marker of FAP. Clinical recognition further allows increased gene analysis efficiency. The absence of CHRPE alone cannot exclude FAP. Our screening recommendations provide guidance to clinicians on evidence based CHRPE assessment. We would advocate inclusion of ocular examinations as part of a three-pronged approach, along with endoscopy and genetic testing, for efficient, timely FAP assessment in at-risk individuals.

Exclusive enteral nutrition: An optimal care pathway for use in children with active luminal Crohn's disease.

Exclusive enteral nutrition (EEN) is recommended as a first-line therapy for active luminal paediatric Crohn's disease, by many contemporary consensus guidelines. However, EEN protocols vary internationally. A key enabler for the use of EEN therapy has been identified as the standardisation of protocols. The aim of this study was to develop an optimal care pathway for use of EEN in children with active luminal Crohn's disease. A working group of 11 paediatric gastroenterology dietitians and one paediatric gastroenterologist from Australia and New Zealand was convened to develop a standard optimal care pathway. Seven key areas were identified; clinical indications, workup assessments, EEN prescription, monitoring, food reintroduction, partial enteral nutrition and maintenance enteral nutrition. Recent literature was reviewed, assessed according to the National Health and Medical Research Council guidelines, and consensus statements were developed and voted on. Consensus opinion was used where literature gaps existed. A total of nineteen consensus statements from the seven key areas were agreed upon. The consensus statements informed the optimal care pathway for children with active luminal undertaking EEN in Australia and New Zealand. This study developed an EEN optimal care pathway to facilitate standardisation of clinical care for children with active luminal Crohn's disease, and hopefully improve clinical outcomes and identify areas for future research.

Web-Based Structured Education for Type 2 Diabetes: Interdisciplinary User-Centered Design Approach.

BackgroundDigital health research encompasses methods from human-computer interaction and health research.ObjectiveThis paper aims to describe how these methods were combined to develop HeLP-Diabetes: Starting Out, a web-based structured education program for people newly diagnosed with type 2 diabetes.MethodsThe development process consisted of three phases: initial design for effectiveness, optimization for usability, and in the wild testing in the National Health Service with people newly diagnosed with type 2 diabetes, and further revisions. We adopted an iterative user-centered approach and followed steps from the human-computer interaction design life cycle and the Medical Research Council guidelines on developing and evaluating complex interventions.ResultsThe initial design process resulted in an 8-session program containing information and behavior change techniques targeting weight loss, being more active, and taking medication. The usability testing was highlighted at an early stage, where changes needed to be made to the language and layout of the program. The in the wild testing provided data on uptake of and barriers to use. The study suggested low uptake and completion of the program, but those who used it seemed to benefit from it. The qualitative findings suggested that barriers to use included an expectation that the program would take too long. This informed refinements to the program.ConclusionsThe use of interdisciplinary methods resulted in an iterative development process and refinements to the program that were based on user needs and data on uptake. The final intervention was more suitable for a definitive evaluation than the initial version. The description of our approach informs other digital health researchers on how to make interventions more sensitive to user needs.

Guidelines development protocol and findings: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease

BackgroundDiabetes-related foot disease (DFD) is a leading cause of the Australian disease burden. The 2011 Australian DFD guidelines were outdated. We aimed to develop methodology for systematically adapting suitable international guidelines to the Australian context to become the new Australian evidence-based guidelines for DFD.MethodsWe followed the Australian National Health Medical Research Council (NHMRC) guidelines for adapting guidelines. We systematically searched for all international DFD guideline records. All identified records were independently screened and assessed for eligibility. Those deemed eligible were further assessed and included if scoring at least moderate quality, suitability and currency using AGREE II and NHMRC instruments. The included international guidelines had all recommendations extracted into six sub-fields: prevention, wound classification, peripheral artery disease, infection, offloading and wound healing. Six national panels, each comprising 6–8 multidisciplinary national experts, screened all recommendations within their sub-field for acceptability and applicability in Australia using an ADAPTE form. Where panels were unsure of any acceptability and applicability items, full assessments were undertaken using a GRADE Evidence to Decision tool. Recommendations were adopted, adapted, or excluded, based on the agreement between the panel’s and international guideline’s judgements. Each panel drafted a guideline that included all their recommendations, rationale, justifications, and implementation considerations. All underwent public consultation, final revision, and approval by national peak bodies.ResultsWe screened 182 identified records, assessed 24 full text records, and after further quality, suitability, and currency assessment, one record was deemed a suitable international guideline, the International Working Group Diabetic Foot Guidelines (IWGDF guidelines). The six panels collectively assessed 100 IWGDF recommendations, with 71 being adopted, 27 adapted, and two excluded for the Australian context. We received 47 public consultation responses with > 80% (strongly) agreeing that the guidelines should be approved, and ten national peak bodies endorsed the final six guidelines. The six guidelines and this protocol can be found at: https://www.diabetesfeetaustralia.org/new-guidelines/ConclusionNew Australian evidence-based guidelines for DFD have been developed for the first time in a decade by adapting suitable international guidelines. The methodology developed for adaptation may be useful for other foot-related conditions. These new guidelines will now serve as the national multidisciplinary best practice standards of DFD care in Australia.

ASHA-Led Community-Based Groups to Support Control of Hypertension in Rural India Are Feasible and Potentially Scalable.

Background: To improve the control of hypertension in low- and middle-income countries, we trialed a community-based group program co-designed with local policy makers to fit within the framework of India's health system. Trained accredited social health activists (ASHAs), delivered the program, in three economically and developmentally diverse settings in rural India. We evaluated the program's implementation and scalability.Methods: Our mixed methods process evaluation was guided by the United Kingdom Medical Research Council guidelines for complex interventions. Meeting attendance reports, as well as blood pressure and weight measures of attendees and adherence to meeting content and use of meeting tools were used to evaluate the implementation process. Thematic analysis of separate focus group discussions with participants and ASHAs as well as meeting reports and participant evaluation were used to investigate the mechanisms of impact.Results: Fifteen ASHAs led 32 community-based groups in three rural settings in the states of Kerala and Andhra Pradesh, Southern India. Overall, the fidelity of intervention delivery was high. Six meetings were delivered over a 3-month period to each of the intervention groups. The mean number of meetings attended by participants at each site varied significantly, with participants in Rishi Valley attending fewer meetings [mean (SD) = 2.83 (1.68)] than participants in West Godavari (Tukeys test, p = 0.009) and Trivandrum (Tukeys test, p < 0.001) and participants in West Godavari [mean (SD) = 3.48 (1.72)] attending significantly fewer meetings than participants in Trivandrum [mean (SD) = 4.29 (1.76), Tukeys test, p < 0.001]. Culturally appropriate intervention resources and the training of ASHAs, and supportive supervision of them during the program were critical enablers to program implementation. Although highly motivated during the implementation of the program ASHA reported historical issues with timely remuneration and lack of supportive supervision.Conclusions: Culturally appropriate community-based group programs run by trained and supported ASHAs are a successful and potentially scalable model for improving the control of hypertension in rural India. However, consideration of issues related to unreliable/insufficient remuneration for ASHAs, supportive supervision and their formal role in the wider health workforce in India will be important to address in future program scale up.Trial Registration: Clinical Trial Registry of India [CTRI/2016/02/006678, Registered prospectively].

An mHealth App to Support Fertility Patients Navigating the World of Infertility (Infotility): Development and Usability Study.

BackgroundThe experience of infertility and its treatment engenders considerable stress and is often described as an emotional rollercoaster. A mobile health (mHealth) app may be a novel solution to address the psychoeducational and psychosocial support needs of fertility patients because of its potential to reduce stress and increase patient empowerment. There are a few fertility-related apps that provide information and support to both men and women undergoing fertility treatment; however, none have documented their development and evaluation process.ObjectiveThis study aims to describe the development and evaluation process of a bilingual mHealth app, Infotility, designed to meet the psychoeducational and psychosocial support needs of men and women undergoing fertility treatment.MethodsTo develop the Infotility app, we adhered to the Medical Research Council guidelines for the development and evaluation of complex interventions. First, we conducted literature reviews and needs assessment surveys of fertility patients and health care providers who informed the content and design of the app. Second, we tested the intervention with a small group of end users who provided feedback on the design and appropriateness of the app’s content. Third, we evaluated the uptake and usability of the app using a pre-post study design. Finally, we updated the app’s content based on participants’ feedback and searched for partners to disseminate the app to the broader public.ResultsThis study is the first to describe the development and evaluation process of an mHealth app for men and women undergoing fertility treatment. The app met its goal in providing fertility patients with a clinician-approved, portable resource for reliable information about medical and psychosocial aspects of infertility and its treatments and a confidential peer support forum monitored by trained peer supporters. Participants rated the engagement, functionality, information, and esthetics of the app positively, with an overall app quality mean score of 3.75 (SD 0.53) and a star rating of 3.43 (SD 0.75), with a total possible score and star rating of 5.00.ConclusionsBy documenting the systematic development and evaluation of the mHealth app for men and women undergoing fertility treatment, this paper can facilitate the replication of the study intervention and the development of similar mHealth apps.

Process evaluation of the Bridging the Age Gap in Breast Cancer decision support intervention cluster randomised trial

BackgroundThe Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial (n = 1339 patients), two decision support interventions (DESIs). Both DESIs were used in the intervention arm and each comprised an online risk prediction model, brief decision aid and information booklet. One DESI supported the decision to have either primary endocrine therapy (PET) or surgery with adjuvant therapies and the second supported the decision to have adjuvant chemotherapy after surgery or not.MethodsSixteen sites were randomly selected to take part in the process evaluation. Multiple methods of data collection were used. Medical Research Council (MRC) guidelines for the evaluation of complex interventions were used.ResultsEighty-two patients, mean age 75.5 (range 70–93), provided data for the process evaluation. Seventy-three interviews were completed with patients. Ten clinicians from six intervention sites took part in telephone interviews. Dose: Ninety-one members of staff in the intervention arm received intervention training. Reach: The online tool was accessed on 324 occasions by 27 clinicians. Reasons for non-use of the online tool were commonly that the patient had already made a decision or that there was no online access in the clinic. Of the 32 women for whom there were data available, fifteen from the intervention arm and six from the usual care arm were offered a choice of treatment. Fidelity: Clinicians used the online tool in different ways, with some using it during the consultation and others checking the online survival estimates before the consultation. Adaptation: There was evidence of adaptation when using the DESIs. A lack of infrastructure, e.g. internet access, was a barrier to the use of the online tool. The brief decision aid was rarely used. Mediators: Shared decision-making: Most patients felt able to contribute to decision-making and expressed high levels of satisfaction with the process. Participants’ responses to intervention: Six patients reported the DESIs to be very useful, one somewhat useful and two moderately useful.ConclusionsClinicians who participated were mainly supportive of the interventions and had attempted some adaptations to make the interventions applicable, but there were practical and engagement barriers that led to sub-optimal adoption in routine practice.Trial registrationISRCTN46099296. Registered on 11 August 2016—retrospectively registered

Profiling rTMS: A critical response.

This article is a detailed response to the criticisms levelled by the authors of an accompanying viewpoint, which claims that the positioning of repetitive transcranial magnetic stimulation (rTMS) in the 2020 Royal Australian and New Zealand College of Psychiatrists (RANZCP) clinical practice guidelines for the management mood disorders (MDcpg2020) is incorrect. We, the authors of the MDcpg2020, strongly refute these assertions and argue that first we have determined the positioning of rTMS using the same criteria as those applied to other treatments for depression. Second, in accordance with National Health and Medical Research Council (NHMRC) guidelines, the processes by which we have developed the MDcpg2020 have been guided by best practice and have been overseen throughout by the RANZCP. Third, our objective and detailed examination of the relevant research has shown that the evidence needed to support the positioning of rTMS alongside standard therapies for depression is severely deficient. And therefore, as a consequence, we set out clearly both our logic and reasoning with respect to interpreting rTMS data and outline our evidence-informed position in which rTMS remains a potential alternative therapy that can be considered in certain clinical circumstances once both suitable psychological and pharmacological treatments have been trialled. We also discuss why, until further research is conducted, rTMS is perhaps best regarded as an experimental therapy and an investigational tool, and to assist in this regard, we propose a framework for consideration by those conducting rTMS studies in the future. Thus, based on current knowledge, we conclude that rTMS does not have a sufficient evidence base to warrant recognition as a standard therapy for depression alongside established treatments such as psychological interventions, pharmacotherapy, and electroconvulsive therapy. Furthermore, there is no clinical profile for depressed patients that might benefit from rTMS and therefore tolerability alone is not good enough reason to promote rTMS in the management of major depression.

Melatonin serum level, sleep functions, and depression level after bilateral anodal transcranial direct current stimulation in patients with Parkinson's disease: a feasibility study.

ObjectiveParkinson’s disease (PD) is associated with non-motor complications such as sleep disturbance and depression. Transcranial direct current stimulation (tDCS) showed therapeutic effects on the motor dysfunctions. However, the potential effects of tDCS therapy on melatonin hormone, sleep dysfunctions, and depression in patients with PD still unclear. This feasibility study aimed to identify any potential changes in melatonin serum level, sleep functions and depression after the bilateral anodal tDCS in patients with PD.Material and MethodsTensessions of bilateral anodal tDCS stimulation applied over left and right prefrontal and motor areas were given to twenty-five patients with PD. Melatonin serum level, Pittsburgh sleep quality index, and geriatric depression scale examined before and after tDCS stimulation.ResultsAfter bilateral anodal tDCS, there was a significant reduction in melatonin serum level, improvement in depression, improvements in overall sleep quality, and sleep latency. Correlations test showed significant associations between melatonin serum level reduction and changes in subjective sleep quality, and sleep duration, as well as between improvements in depression and overall sleep quality, sleep latency, and sleep disturbance.ConclusionBilateral anodal tDCS therapy was a feasible and safe tool that showed potential therapeutic effects on melatonin serum level, sleep quality, and depression level in patients with PD. Although the further large scale and randomized-control trial studies are crucially needed, there is still a need for such a feasibility study to be established before such trials can be implemented as is recommended in the new medical research council guidelines.

COVID concerns highlight the importance of adequate fecal immunochemical test sample collection.

COVID concerns highlight the importance of adequate fecal immunochemical test sample collection.

Protocol for process evaluation of integration of mental health into primary healthcare in two states in Nigeria: the mhSUN programme.

Current international recommendations to address the large treatment gap for mental healthcare in low- and middle-income countries are to scale up integration of mental health into primary care. There are good outcome studies to support this, but less robust evidence for effectively carrying out integration and scale-up of such services, or for understanding how to address contextual issues that routinely arise. This protocol is for a process evaluation of a programme called Mental Health Scale Up Nigeria. The study aims are to determine the extent to which the intervention was carried out according to the plans developed (fidelity), to examine the effect of postulated moderating factors and local context, and the perception of the programme by primary care staff and implementers. We use a theoretical framework for process evaluation based on the Medical Research Council's Guidelines on Process Evaluation. A Theory of Change workshop was carried out in programme development, to highlight relevant factors influencing the process, ensure good adaptation of global normative guidelines and gain buy-in from local stakeholders. We will use mixed methods to examine programme implementation and outcomes, and influence of moderating factors. Data sources will include the routine health information system, facility records (for staff, medication and infrastructure), log books of intervention activities, supervision records, patient questionnaires and qualitative interviews. Evidence from this process evaluation will help guide implementers aiming to scale up mental health services in primary care in low- and middle-income countries.

The 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders: Major depression summary.

To provide a succinct, clinically useful summary of the management of major depression, based on the 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders (MDcpg2020 ). To develop the MDcpg2020 , the mood disorders committee conducted an extensive review of the available literature to develop evidence-based recommendations (EBR) based on National Health and Medical Research Council (NHMRC) guidelines. In the MDcpg2020 , these recommendations sit alongside consensus-based recommendations (CBR) that were derived from extensive deliberations of the mood disorders committee, drawing on their expertise and clinical experience. This guideline summary is an abridged version that focuses on major depression. In collaboration with international experts in the field, it synthesises the key recommendations made in relation to the diagnosis and management of major depression. The depression summary provides a systematic approach to diagnosis, and a logical clinical framework for management. The latter begins with Actions, which include important strategies that should be implemented from the outset. These include lifestyle changes, psychoeducation and psychological interventions. The summary advocates the use of antidepressants in the management of depression as Choices and nominates seven medications that can be trialled as clinically indicated before moving to Alternatives for managing depression. Subsequent strategies regarding Medication include Increasing Dose, Augmenting and Switching (MIDAS). The summary also recommends the use of electroconvulsive therapy (ECT), and discusses how to approach non-response. The major depression summary provides up to date guidance regarding the management of major depressive disorder, as set out in the MDcpg2020 . The recommendations are informed by research evidence in conjunction with clinical expertise and experience. The summary is intended for use by psychiatrists, psychologists and primary care physicians, but will be of interest to all clinicians and carers involved in the management of patients with depressive disorders.

The 2020 Royal Australian and New Zealand College of psychiatrists clinical practice guidelines for mood disorders: Bipolar disorder summary.

To provide a succinct, clinically useful summary of the management of bipolar disorder, based on the 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders (MDcpg2020 ). To develop the MDcpg2020 , the mood disorders committee conducted an extensive review of the available literature to develop evidence-based recommendations (EBR) based on National Health and Medical Research Council (NHMRC) guidelines. In the MDcpg2020 , these recommendations sit alongside consensus-based recommendations (CBR) that were derived from extensive deliberations of the mood disorders committee, drawing on their expertise and clinical experience. This guideline summary is an abridged version that focuses on bipolar disorder. In collaboration with international experts in the field, it synthesises the key recommendations made in relation to the diagnosis and management of bipolar disorder. The bipolar disorder summary provides a systematic approach to diagnosis, and a logical clinical framework for management. It addresses the acute phases of bipolar disorder (mania, depression and mixed states) and its longer-term management (maintenance and prophylaxis). For each phase it begins with Actions, which include important strategies that should be implemented from the outset wherever possible. These include for example, lifestyle changes, psychoeducation and psychological interventions. In each phase, the summary advocates the use of Choice medications for pharmacotherapy, which are then used in combinations along with additional Alternatives to manage acute symptoms or maintain mood stability and provide prophylaxis. The summary also recommends the use of electroconvulsive therapy (ECT) for each of the acute phases but not for maintenance therapy. Finally, it briefly considers bipolar disorder in children and its overlap in adults with borderline personality disorder. The bipolar disorder summary provides up to date guidance regarding the management of bipolar disorder, as set out in the MDcpg2020 . The recommendations are informed by evidence and clinical expertise and experience. The summary is intended for use by psychiatrists, psychologists and primary care physicians but will be of interest to anyone involved in the management of patients with bipolar disorder.

Evaluating implementation strategies for essential newborn care interventions in low- and low middle-income countries: a systematic review.

Neonatal mortality remains a significant health problem in low-income settings. Low-cost essential newborn care (ENC) interventions with proven efficacy and cost-effectiveness exist but have not reached high coverage (≥90%). Little is known about the strategies used to implement these interventions or how they relate to improved coverage. We conducted a systematic review of implementation strategies and implementation outcomes for ENC in low- and low middle-income countries capturing evidence from five medical and global health databases from 1990 to 2018. We included studies of implementation of delayed cord clamping, immediate drying, skin-to-skin contact (SSC) and/or early initiation of breastfeeding implemented in the first hour (facility-based studies) or the 1st day (community-based studies) of life. Implementation strategies and outcomes were categorized according to published frameworks: Expert Recommendations for Implementing Change and Outcomes for Implementation Research. The relationship between implementation strategies and outcomes was evaluated using standardized mean differences and correlation coefficients. Forty-three papers met inclusion criteria. Interventions included community-based care/health promotion and facility-based support and health care provider training. Included studies used 3–31 implementation strategies, though the consistency with which strategies were applied was variable. Conduct educational meetings was the most frequently used strategy. Included studies reported 1–4 implementation outcomes with coverage reported most frequently. Heterogeneity was high and no statistically significant association was found between the number of implementation strategies used and coverage of ENC. This review highlights several challenges in learning from implementation of ENC in low- and low middle-income countries, particularly poor description of interventions and implementation outcomes. We recommend use of UK Medical Research Council guidelines (2015) for process evaluations and checklists for reporting implementation studies. Improved reporting of implementation research in this setting is necessary to learn how to improve service delivery and outcomes and thereby reduce neonatal mortality.