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Self-help friendliness and cooperation with self-help groups among rehabilitation clinics in Germany (KoReS): a mixed-methods study protocol

Por: Ziegler · E. · Bartzsch · T. · Trojan · A. · Usko · N. · Krahn · I. · Bütow · S. · Kofahl · C.
Introduction

Self-help is an important complement to medical rehabilitation for people with chronic diseases and disabilities. It contributes to stabilising rehabilitation success and further coping with disease and disability. Rehabilitation facilities are central in informing and referring patients to self-help groups. However, sustainable cooperation between rehabilitation and self-help, as can be achieved using the concept of self-help friendliness in healthcare, is rare, as is data on the cooperation situation.

Methods and analysis

The KoReS study will examine self-help friendliness and cooperation between rehabilitation clinics and self-help associations in Germany, applying a sequential exploratory mixed-methods design. In the first qualitative phase, problem-centred interviews and focus groups are conducted with representatives of self-help-friendly rehabilitation clinics, members of their cooperating self-help groups and staff of self-help clearinghouses involved based on a purposeful sampling. Qualitative data collected will be analysed through content analysis using MAXQDA. The findings will serve to develop a questionnaire for a quantitative second phase. Cross-sectional online studies will survey staff responsible for self-help in rehabilitation clinics nationwide, representatives of self-help groups and staff of self-help clearinghouses. Quantitative data analysis with SPSS will include descriptive statistics, correlation, subgroup and multiple regression analyses. Additionally, a content analysis of rehabilitation clinics’ websites will evaluate the visibility of self-help in their public relations.

Ethics and dissemination

The University Medical Center Hamburg-Eppendorf Local Psychological Ethics Committee at the Center for Psychosocial Medicine granted ethical approval (reference number LPEK-0648; 10.07.2023). Informed consent will be obtained from all participants. Results dissemination will comprise various formats such as workshops, presentations, homepages and publications for the international scientific community, rehabilitation centres, self-help organisations and the general public in Germany. For relevant stakeholders, practical guides and recommendations to implement self-help friendliness will derive from the results to strengthen patient orientation and cooperation between rehabilitation and self-help to promote the sustainability of rehabilitation processes.

Enablers and barriers to a quaternary prevention approach: a qualitative study of field experts

Por: Otte · J. A. · Llargues Pou · M.
Objective

There is a growing concern about the sustainability of healthcare and the impacts of ‘overuse’ on patients and systems. Quaternary prevention (P4), a concept promoting the protection of patients from medical interventions in which harms outweigh benefits, is well positioned to stimulate reflection and inspire solutions, yet has not been widely adopted. We sought to identify enablers and barriers to a P4 approach, according to field experts and advocates in one health system.

Design

Qualitative methodology, using semistructured interviews and a grounded theory approach facilitated thematic analysis and development of a conceptual model.

Setting

Virtual interviews, conducted in British Columbia, Canada.

Participants

12 field experts, recruited based on their interest and work related to P4 and related concepts.

Results

Four factors were seen as promoting or hindering P4 efforts depending on context: relationship between patient and clinician, education of clinicians and the public, health system design and influencers. We extracted four broad enablers of P4: evidence-based medicine, personal experiences and questioning attitude, public P4 campaigns and experience in resource-poor contexts. There were six barriers: peer pressure between clinicians, awareness and screening campaigns, cognitive biases, cultural factors, complexity of the problem and industry influence.

Conclusions

Elicited facilitators and impediments to the application of P4 were similar to those seen in existing literature but framed uniquely; our findings place increased emphasis on the clinician–patient relationship as central to decision-making and position other drivers as influencing this relationship. A transition to a model of care that explicitly integrates conscious protection of patients by reducing overtesting, overdiagnosis and overtreatment will require changes across health systems and society.

Exploring the pharmacists role in optimising antithrombotic therapy in primary care: a qualitative study

Por: van Paassen · J. G. · Tan · J. P. · Deneer · V. H. M. · Bouvy · M. L.
Objective

In antithrombotic therapy, the balance between efficacy and safety is delicate, which makes it challenging for healthcare professionals, including pharmacists, to optimise therapy. Pharmacists may play an important role in optimising antithrombotic therapy, but especially in primary care, this role has not been elucidated. Here, we study how community pharmacists (pharmacists in primary care) perceive their current and future role in antithrombotic therapy.

Design

We conducted a qualitative study using semi-structured interviews. The interview protocol and subsequent analysis were based on the Theoretical Domains Framework, and the findings were interpreted with the Capability Opportunity Motivation – Behaviour System.

Setting and participants

The interview participants were community pharmacists, located across the Netherlands, from the Utrecht Pharmacy Practice network for Education and Research.

Results

We interviewed 16 community pharmacists between February and August 2021 and identified several major themes which were important for the pharmacist’s role in antithrombotic therapy. Pharmacists felt responsible for the outcome of antithrombotic treatment and intended to invest in their role in antithrombotic therapy. Pharmacists did, however, experience barriers to their role in antithrombotic therapy, like a lack of access to clinical information such as the indication of antithrombotic treatment and a lack of specific knowledge on this treatment.

Conclusion

Community pharmacists perceive a role for themselves in antithrombotic therapy. To fulfil this role, several preconditions must be met.

Reporting and influencing factors of patient-reported outcomes in acupuncture randomised controlled trials: a cross-sectional study protocol

Por: Duan · Y. · Zhao · P. · Liu · S. · Deng · Y. · Xu · Z. · Xiong · L. · Chen · Z. · Zhu · W. · Wu · S. · Yu · L.
Introduction

Patient-reported outcomes (PROs) are health reports that come directly from the patients themselves and represented the experience and insights of the patient’s perspective on the impact of the intervention. PROs were increasingly emphasised in acupuncture randomised controlled trials (RCTs). However, the reporting quality of PROs in acupuncture RCTs has not been investigated to date. Therefore, we constructed this study to reveal the basic characteristics and reporting quality of PROs in acupuncture RCTs, and explore the relationship between concealment, blinding and RROs. We hope our findings can provide guidance for the reporting standards and future development of PROs in acupuncture RCTs in reverse.

Methods and analysis

RCTs using acupuncture treatment as the intervention and PROs as primary outcomes or secondary outcomes will be systematically searched through seven databases MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP between 1 January 2012 and 15 October 2022. The basic characteristics, concealment, blinding design and the characteristics of PROs in included RCTs will be summarised. The reporting quality of PROs will be assessed based on the CONSORT PRO extension. Logistic analysis will be performed to identify the association between concealment, blinding and RROs.

Ethics and dissemination

Ethical approval is not required for this study. This protocol has been registered in Open Science Framework (OSF) Registries. The findings of this study will be submitted to a peer-reviewed academic journal.

Meeting high-risk patient pain care needs through intensive primary care: a secondary analysis

Por: Giannitrapani · K. F. · Holliday · J. R. · McCaa · M. D. · Stockdale · S. · Bergman · A. A. · Katz · M. L. · Zulman · D. M. · Rubenstein · L. V. · Chang · E. T.
Objective

Chronic pain disproportionately affects medically and psychosocially complex patients, many of whom are at high risk of hospitalisation. Pain prevalence among high-risk patients, however, is unknown, and pain is seldom a focus for improving high-risk patient outcomes. Our objective is to (1) evaluate pain frequency in a high-risk patient population and (2) identify intensive management (IM) programme features that patients and providers perceive as important for promoting patient-centred pain care within primary care (PC)-based IM.

Design

Secondary observational analysis of quantitative and qualitative evaluation data from a multisite randomised PC-based IM programme for high-risk patients.

Setting

Five integrated local Veterans Affairs (VA) healthcare systems within distinct VA administrative regions.

Participants

Staff and high-risk PC patients in the VA.

Intervention

A multisite randomised PC-based IM programme for high-risk patients.

Outcome measures

(a) Pain prevalence based on VA electronic administrative data and (b) transcripts of interviews with IM staff and patients that mentioned pain.

Results

Most (70%, 2593/3723) high-risk patients had at least moderate pain. Over one-third (38%, 40/104) of the interviewees mentioned pain or pain care. There were 89 pain-related comments addressing IM impacts on pain care within the 40 interview transcripts. Patient-identified themes were that IM improved communication and responsiveness to pain. PC provider-identified themes were that IM improved workload and access to expertise. IM team member-identified themes were that IM improved pain care coordination, facilitated non-opioid pain management options and mitigated provider compassion fatigue. No negative IM impacts on pain care were mentioned.

Conclusions

Pain is common among high-risk patients. Future IM evaluations should consider including a focus on pain and pain care, with attention to impacts on patients, PC providers and IM teams.

Peer support impact on therapeutic adherence in patients with multiple sclerosis: a mixed-methods pilot trial protocol

Por: Guilmault · L. · Wiertlewski · S. · Malloggi · L. · Rousseau · C. · Jacq-Foucher · M. · Leclere · B. · Moret · L.
Introduction

Patient partnership is a key component of patient-centred care. One form of partnership is individual peer support, which can improve patients’ quality of life and adherence to treatment. Patient with multiple sclerosis could benefit from this type of support, but such an intervention has not been explored in the literature.

We propose in this article a pilot study protocol to assess the feasibility and acceptability of healthcare-integrated individual peer support, and the feasibility of a large-scale efficacy trial.

Methods and analysis

The PAIR-SEP study is a mixed-methods pilot clinical trial combining quantitative and qualitative approaches. Sixty patients with relapsing-remitting multiple sclerosis undergoing drug therapy from the Neurology centre of Nantes University Hospital (France) will be randomised on a 1:1 ratio to receive either usual care only or usual care combined with peer support (three individual sessions at 1, 3 and 5 months with a peer helper).

We will evaluate clinical outcomes in preparation of the large-scale trial: therapeutic adherence 6 months after baseline, therapeutic compliance, quality of life, anxiety and depression, social support. All dimensions will be assessed using validated health questionnaires at baseline and at 6 months.

Intervention’s acceptability and feasibility will be evaluated using qualitative methods: undirected interviews with patients from the intervention group and separate focus-groups with the peer helpers the healthcare team.

Ethics and dissemination

Ethical approval was obtained from the local ethics committee on 1 October 2022. This study was designed in collaboration with multiple sclerosis peer helpers.

The trial findings will be published in peer-reviewed journals.

Trial registration number

NCT05519553.

Assessment of patient satisfaction level in the State University of Haiti Hospital and responsible factors: a cross-sectional mixed-methods study protocol

Por: Millien · H. · Joseph · T.
Introduction

Over the past few years, the healthcare industry has undergone a significant transformation where patients’ perceptions of healthcare have gained a huge importance in assessing quality. Considering that it is now highly competitive, their contentment is a vital aspect in improving performance. However, practitioners in developing countries have traditionally overlooked the importance of patient views in healthcare, and this neglect is particularly prevalent in low-resource settings such as the State University of Haiti Hospital. The aim of this study is to assess patient satisfaction and identify influencing factors.

Methods and analysis

We will conduct a mixed-methods cross-sectional survey at Haiti’s largest hospital centre from January to August 2024. First, patient satisfaction will be assessed using RAND Corporation’s 18-Item-Patient Satisfaction Questionnaire, a valid self-administered questionnaire with strong potential for use in different settings. It will be translated into Creole and then tested in a pilot study. Second, a qualitative study based on individual interviews will explore patients’ views on the care they have received. Data analysis will include descriptive statistics, 2 tests, logistic regression and thematic analysis.

Ethics and dissemination

Ethical approval is granted from the Laboratoire Médecine Ethique et Société. Findings will be published in a corresponding peer-reviewed journal, shared with hospital staff and students. Social media posts, blog posts and conference debates will also be considered.

Talking numbers: how women and providers use risk scores during and after risk counseling - a qualitative investigation from the NRG Oncology/NSABP DMP-1 study

Por: Blakeslee · S. B. · Gunn · C. M. · Parker · P. A. · Fagerlin · A. · Battaglia · T. · Bevers · T. B. · Bandos · H. · McCaskill-Stevens · W. · Kennedy · J. W. · Holmberg · C.
Objectives

Little research exists on how risk scores are used in counselling. We examined (a) how Breast Cancer Risk Assessment Tool (BCRAT) scores are presented during counselling; (b) how women react and (c) discuss them afterwards.

Design

Consultations were video-recorded and participants were interviewed after the consultation as part of the NRG Oncology/National Surgical Adjuvant Breast and Bowel Project Decision-Making Project 1 (NSABP DMP-1).

Setting

Two NSABP DMP-1 breast cancer care centres in the USA: one large comprehensive cancer centre serving a high-risk population and an academic safety-net medical centre in an urban setting.

Participants

Thirty women evaluated for breast cancer risk and their counselling providers were included.

Methods

Participants who were identified as at increased risk of breast cancer were recruited to participate in qualitative study with a video-recorded consultation and subsequent semi-structured interview that included giving feedback and input after viewing their own consultation. Consultation videos were summarised jointly and inductively as a team.tThe interview material was searched deductively for text segments that contained the inductively derived themes related to risk assessment. Subgroup analysis according to demographic variables such as age and Gail score were conducted, investigating reactions to risk scores and contrasting and comparing them with the pertinent video analysis data. From this, four descriptive categories of reactions to risk scores emerged. The descriptive categories were clearly defined after 19 interviews; all 30 interviews fit principally into one of the four descriptive categories.

Results

Risk scores were individualised and given meaning by providers through: (a) presenting thresholds, (b) making comparisons and (c) emphasising or minimising the calculated risk. The risk score information elicited little reaction from participants during consultations, though some added to, agreed with or qualified the provider’s information. During interviews, participants reacted to the numbers in four primary ways: (a) engaging easily with numbers; (b) expressing greater anxiety after discussing the risk score; (c) accepting the risk score and (d) not talking about the risk score.

Conclusions

Our study highlights the necessity that patients’ experiences must be understood and put into relation to risk assessment information to become a meaningful treatment decision-making tool, for instance by categorising patients’ information engagement into types.

Trial registration number

NCT01399359.

Determinants of practice for providing decision coaching to facilitate informed values-based decision-making: protocol for a mixed-methods systematic review

Por: Berger-Höger · B. · Lewis · K. B. · Cherry · K. · Finderup · J. · Gunderson · J. · Kaden · J. · Kienlin · S. · Rahn · A. C. · Sikora · L. · Stacey · D. · Steckelberg · A. · Zhao · J.
Introduction

Decision coaching is a non-directive approach to support patients to prepare for making health decisions. It is used to facilitate patients’ involvement in informed values-based decision-making and use of evidence-based health information. A recent systematic review revealed low certainty evidence for its effectiveness with and without evidence-based information. However, there may be opportunities to improve the study and use of decision coaching in clinical practice by systematically investigating its determinants of practice. We aim to conduct a systematic review to identify and synthesise the determinants of practice for providing decision coaching to facilitate patient involvement in decision-making from multiple perspectives that influence its use.

Methods and analysis

We will conduct a mixed-methods systematic review guided by the Cochrane’ Handbook of Systematic Reviews. We will include studies reporting determinants of practice influencing decision coaching with or without evidence-based patient information with adults making a health decision for themselves or a family member. Systematic literature searches will be conducted in Medline, EMBASE, Cochrane CENTRAL and PsycINFO via Ovid and CINAHL via EBSCO including quantitative, qualitative and mixed-methods study designs. Additionally, experts in the field will be contacted.

Two reviewers will independently screen and extract data. We will synthesise determinants using deductive and inductive qualitative content analysis and a coding frame developed specifically for this review based on a taxonomy of barriers and enablers of shared decision-making mapped onto the major domains of the Consolidated Framework for Implementation Research. We will assess the quality of included studies using the Mixed Methods Appraisal Tool.

Ethics and dissemination

Ethical approval is not required as this systematic review involves only previously published literature. The results will be published in a peer-reviewed journal, presented at scientific conferences and disseminated to relevant consumer groups.

PROSPERO registration number

CRD42022338299.

Systematic literature review and network meta-analysis of therapies for psoriatic arthritis on patient-reported outcomes

Por: Nash · P. · Dutz · J. P. · Peterson · S. · Patel · B. P. · Eaton · K. · Shawi · M. · Zazzetti · F. · Wei · J. C.-C.
Objectives

Head-to-head clinical trials are common in psoriasis, but scarce in psoriatic arthritis (PsA), making treatment comparisons between therapeutic classes difficult. This study describes the relative effectiveness of targeted synthetic (ts) and biologic (b) disease-modifying antirheumatic drugs (DMARDs) on patient-reported outcomes (PROs) through network meta-analysis (NMA).

Design

A systematic literature review (SLR) was conducted in January 2020. Bayesian NMAs were conducted to compare treatments on Health Assessment Questionnaire Disability Index (HAQ-DI) and 36-item Short Form (SF-36) Health Survey including Mental Component Summary (MCS) and Physical Component Summary (PCS) scores.

Data sources

Ovid MEDLINE (including Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily),Embase and Cochrane Central Register of Controlled Trials.

Eligibility criteria

Phase III randomised controlled trials (RCTs) evaluating patients with PsA receiving tsDMARDS, bDMARDs or placebo were included in the SLR; there was no restriction on outcomes.

Data extraction and synthesis

Two independent researchers reviewed all citations. Data for studies meeting all inclusion criteria were extracted into a standardised Excel-based form by one reviewer and validated by a second reviewer. A third reviewer was consulted to resolve any discrepancies, as necessary. Risk of bias was assessed using the The National Institute for Health and Care Excellence clinical effectiveness quality assessment checklist.

Results

In total, 26 RCTs were included. For HAQ-DI, SF-36 PCS and SF-36 MCS scores, intravenous tumour necrosis factor (TNF) alpha inhibitors generally ranked higher than most other classes of therapies available to treat patients with PsA. For almost all outcomes, several interleukin (IL)-23, IL-17A, subcutaneous TNF and IL-12/23 agents offered comparable improvement, while cytotoxic T-lymphocyte-associated antigen 4, phosphodiesterase-4 and Janus kinase inhibitors often had the lowest efficacy.

Conclusions

While intravenous TNFs may provide some improvements in PROs relative to several other tsDMARDs and bDMARDs for the treatment of patients with PsA, differences between classes of therapies across outcomes were small.

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