Synthesizing qualitative research:reflections and lessons learnt by two new reviewers

Systematic synthesis of qualitative studies is widely used in health and social care. Regardless of the topic area, researchers need to consider several decisions when it comes to the planning and implementation of qualitative synthesis. As junior reviewers, we reflect on potential challenges and pitfalls in planning and conducting a synthesis of qualitative evidence. This article aims to elaborate on a number of key issues in order to provide insights and options on how to avoid or minimize these issues, especially for new reviewers and research students. This article examines difficulties in different stages and presents some examples of how intellectual and technical issues can be approached and resolved, including how to ensure effective identification of the relevant research to answer the review question? What are the potential pitfalls during the screening and evaluation process? The implications of different issues are examined and potential directions are discussed

Exercise as an Airway Clearance Technique in people with Cystic Fibrosis (ExACT-CF):rationale and study protocol for a randomised pilot trial

BACKGROUND: Chest physiotherapy is an established cornerstone of care for people with cystic fibrosis (pwCF), but is often burdensome. Guidelines recommend at least one chest physiotherapy session daily, using various airway clearance techniques (ACTs). Exercise (with huffs and coughs) may offer an alternative ACT, however the willingness of pwCF to be randomised into a trial needs testing. The 'ExACT-CF: Exercise as an Airway Clearance Technique in people with Cystic Fibrosis' trial will test the feasibility of recruiting pwCF to be randomised to continue usual care (chest physiotherapy) or replace it with exercise ACT (ExACT) for 28-days. Secondary aims include determining the short-term clinical impact (and safety) of stopping routine chest physiotherapy and replacing it with ExACT, and effects on physical activity, sleep, mood, quality of life and treatment burden, alongside preliminary health economic measures and acceptability.METHODS: Multi-centre, two-arm, randomised (1:1 allocation using minimisation), pilot trial at two sites. Fifty pwCF (≥10 years, FEV 1 &gt;40% predicted, stable on Elexacaftor/Tezacaftor/Ivacaftor (ETI)) will be randomised to an individually-customised ExACT programme (≥once daily aerobic exercise of ≥20-minutes duration at an intensity that elicits deep breathing, with huffs and coughs), or usual care. After baseline assessments, secondary outcomes will be assessed after 28-days, with additional home lung function and exacerbation questionnaires at 7, 14 and 21-days, physical activity and sleep monitoring throughout, and embedded qualitative and health-economic components. Feasibility measures include recruitment, retention, measurement completion, adverse events, interviews exploring the acceptability of trial procedures, and a trial satisfaction questionnaire. DISCUSSION: Co-designed with the UK CF community, the ExACT-CF pilot trial is the first multi-centre RCT to test the feasibility of recruiting pwCF stable on ETI into a trial investigating ExACT. This pilot trial will inform the feasibility, design, management, likely external validity for progression to a main phase randomised controlled trial.REGISTRATION: Clinicaltrials.gov ( NCT05482048).</p

Understanding support systems for Parkinson's disease management in community settings: A cross-national qualitative study

Background: Health and social care systems face difficulties in managing multimorbidity, disease burden and complex needs in long-term conditions such as Parkinson's disease. Objective: This study aimed to develop a European understanding of how health and social care professionals can collaborate with stakeholders from different organizations and sectors to enhance the management of Parkinson's disease in a community setting by identifying the existing gaps in this process and how people with Parkinson's disease and their family carers could benefit from these partnerships. Methods: A mixed-methods sequential study was conducted in Denmark, Norway, Spain and the United Kingdom. The findings from the qualitative phase are presented. Individual semistructured interviews were analysed using Braun's and Clarke's thematic analysis. A meta-ethnography approach was used to analyse and synthesize cross-national findings. Results: A total of 41 healthcare professionals and 39 stakeholders from different disciplines and sectors were interviewed in the four countries. The participants acknowledged a lack of awareness of available resources and poor communication between the different support systems in the management of Parkinson's disease. To promote multiagency collaborations, the participants highlighted the need to organize services along the Parkinson's disease journey, patient involvement and strategic involvement of carers in organizing resources and Parkinson's disease care pathways. According to the participants, the benefits from multiagency partnerships could lead to an enhanced continuity of care and specialized knowledge, mobilization of resources in the community, personalized support and improved access to services. Conclusions: Policymakers are called upon to create formal structures that facilitate multisectoral collaborations to promote an integrated system of care for the management of Parkinson's disease in the community. To address this challenge, we propose five strategies showing how organizations can work together to optimize the use of resources and enhance the management of Parkinson's disease throughout the illness trajectory. Patient or public contribution: Patient and Public Involvement groups made up of stakeholders, healthcare professionals, patients with Parkinson's disease and family carers participated in the design of the study, the development of the interview guides and the validation of the findings.This work was supported by the EU Joint Programme-Neurodegenerative Disease Research (JPND). In Norway, the work was funded by the Research Council of Norway (grant number: 299762) and the DAM Foundation (project number FO296567). In Denmark, the work was funded by the Innovation Fund Denmark. In the United Kingdom, the work was funded by the Alzheimer's Society (grant number: 470). The Autonomous Universityof Madrid and the Ministry of Universities of the Spanish Government (Recovery, Transformation and Resilience Plan) were the financing entities of the researcher M. V. Navarta‐Sánchez (Grant number: CA2/RSUE/2021‐00854)S

Perspectives of people with Parkinson's disease and family carers about disease management in community settings: A cross-country qualitative study

Aim: To explore perceptions of people with Parkinson's disease and family carers about the use and impact of health and social care services, community and voluntary sector resources for the management of Parkinson's disease. Background: Resources from outside the formal health care system and collaborations between different levels and sectors could address the unmet needs of people with Parkinson's disease and their family carers and improve the management of Parkinson's disease in the community setting. Design: A qualitative exploratory study was carried out in Denmark, Norway, Spain and the United Kingdom and was reported using the COREQ. Methods: Individual semi-structured interviews were conducted with people with Parkinson's disease and family carers between May and August 2020. Interviews were digitally recorded, transcribed verbatim and analysed using thematic analysis. A meta-ethnographic approach was used to analyse and synthesise cross-national findings. Results: Forty-seven people with Parkinson's disease and 39 family carers participated in the four countries. Four themes and eight sub-themes emerged: (1) Personalised care for needs throughout the Parkinson's disease journey; (2) Accessibility of different types of support systems (including initiatives to support emotional well-being, physical rehabilitation, information on the healthcare services, voluntary associations and community groups); (3) Multiagency collaborations, a more comprehensive approach; (4) Acknowledgment of people with Parkinson's and family carers own role in Parkinson's disease management. Conclusions: An integrated and person-and-community-centred approach, which includes the participation of the health, social, voluntary and community sectors, is desired by people with Parkinson's disease and their family carers to improve the management of Parkinson's in the community setting. These findings could contribute to the creation of more sustainable care systems at the European level that would better respond to individual and changing needs in people with Parkinson's disease and their family carers, and in other long-term conditions. Patient or Public Contribution: The Patient and Public Involvement groups contributed to the design of the study, the interview guides and validation of findings. Relevance to Clinical Practice: This study will inform the management of Parkinson's disease at the community level and the use of resources not only directly linked to the health system. Taking into account all the actors that provide care and support to people with Parkinson’ disease and family carers facilitates the creation of strategies that better respond to individual needs. Nurses and other health and social care professionals in the community and specialist levels of care should collaborate to develop multisectoral strategies that promote personalised and integrated care throughout the Parkinson's journeyAlzheimer´s Society; Autonomous University of Madrid and the Ministry of Universities of the Spanish Government (Recovery, Transformation and Resilience Plan); DAM Foundation; EU Joint Programme - Neurodegenerative Disease Research; Innovation Fund Denmark; Research Council of Norwa

Exercise as an Airway Clearance Technique in people with Cystic Fibrosis (ExACT-CF): rationale and study protocol for a randomised pilot trial [version 1; peer review: awaiting peer review]

Background: Chest physiotherapy is an established cornerstone of care for people with cystic fibrosis (pwCF), but is often burdensome. Guidelines recommend at least one chest physiotherapy session daily, using various airway clearance techniques (ACTs). Exercise (with huffs and coughs) may offer an alternative ACT, however the willingness of pwCF to be randomised into a trial needs testing. The ‘ExACT-CF: Exercise as an Airway Clearance Technique in people with Cystic Fibrosis’ trial will test the feasibility of recruiting pwCF to be randomised to continue usual care (chest physiotherapy) or replace it with exercise ACT (ExACT) for 28-days. Secondary aims include determining the short-term clinical impact (and safety) of stopping routine chest physiotherapy and replacing it with ExACT, and effects on physical activity, sleep, mood, quality of life and treatment burden, alongside preliminary health economic measures and acceptability. Methods: Multi-centre, two-arm, randomised (1:1 allocation using minimisation), pilot trial at two sites. Fifty pwCF (≥10 years, FEV1 >40% predicted, stable on Elexacaftor/Tezacaftor/Ivacaftor (ETI)) will be randomised to an individually-customised ExACT programme (≥once daily aerobic exercise of ≥20-minutes duration at an intensity that elicits deep breathing, with huffs and coughs), or usual care. After baseline assessments, secondary outcomes will be assessed after 28-days, with additional home lung function and exacerbation questionnaires at 7, 14 and 21-days, physical activity and sleep monitoring throughout, and embedded qualitative and health-economic components. Feasibility measures include recruitment, retention, measurement completion, adverse events, interviews exploring the acceptability of trial procedures, and a trial satisfaction questionnaire. Discussion: Co-designed with the UK CF community, the ExACT-CF pilot trial is the first multi-centre RCT to test the feasibility of recruiting pwCF stable on ETI into a trial investigating ExACT. This pilot trial will inform the feasibility, design, management, likely external validity for progression to a main phase randomised controlled trial. Registration: Clinicaltrials.gov (NCT05482048)

Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults::a feasibility double-blind, placebo-controlled randomised trial

BACKGROUND: Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries.STUDY DESIGN: Feasibility double-blind randomised placebo-controlled clinical trial.METHODS: We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2-4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial.RESULTS: Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18-21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex.CONCLUSIONS: It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition.TRIAL REGISTRATION: HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884 .</p