Middle-aged adults face multifaceted physical and psychosocial challenges that impact their overall wellness. Exercise has become a key component of wellness interventions due to its positive impacts on physical and psychosocial health. However, the understanding of exercise-focused wellness interventions for this age group remains limited. Therefore, this scoping review aimed to identify and map the existing literature on exercise-focused wellness interventions for middle-aged adults and to summarise their characteristics and reported outcomes.
Scoping review.
Six databases, including PubMed, EMBASE, CINAHL, Cochrane Library, Web of Science and PsycInfo, were initially searched on 29 July 2024, and the search was updated on 12 October 2025, with no restrictions on publication date. The reference lists of articles selected in the database search were also screened for further relevant studies.
We included interventional studies, specifically randomised controlled trials (RCTs) and quasi-experimental designs, that examined exercise-focused wellness interventions for middle-aged adults.
Two independent reviewers extracted data on study characteristics and intervention details and outcomes, and assessed the risk of bias. Any discrepancies were resolved by a third reviewer.
A total of 15 studies were included in the review, of which 9 were RCTs and 6 were quasi-experimental studies. Most interventions targeted middle-aged women and were implemented in community settings. Exercise was often combined with diet and stress management. The majority of the interventions lasted for 3 months with weekly sessions. Additionally, various delivery modes were employed, including face-to-face, online, individual and group-based approaches. Outcome variables were categorised into exercise and physical activity, dietary intake, anthropometry and body composition, cardiovascular health, biochemical markers, menopausal symptoms, psychosocial health and wellness. Only one study assessed wellness as an outcome of the intervention. Across the included studies, improvements were commonly reported for physical and psychosocial health, whereas changes in biochemical markers were limited.
Exercise-focused wellness interventions for middle-aged adults encompass varied content and outcome variables, contributing to improvements in physical, psychological and social dimensions of health. Delivery modes are diverse, demonstrating flexibility and adaptability for tailored interventions. There is a need to develop a validated, midlife-specific measurement tool that reflects the multidimensional nature of wellness. Moreover, exercise-focused interventions tailored for middle-aged men, particularly in workplace settings, should be developed.
Perineal warm compresses in the second stage of labour have been demonstrated by clinical guidelines as an effective intervention for improving perineal outcomes and mothers’ psychological well-being, yet their adoption in clinical practice remains suboptimal. Therefore, this study aims to bridge the evidence-practice gap through the application of implementation science models and frameworks to facilitate clinical adoption. The investigation will systematically explore the barriers and facilitators to the application of perineal warm compresses in the second stage of labour and subsequently develop a corresponding implementation strategy addressing identified barriers.
This study was guided by the PEDALs model. Using a scoping review and a parallel mixed-methods study to systematically investigate the barriers and facilitators to the application of perineal warm compresses in the second stage of labour. The identified barriers and facilitators were mapped to the domains of the Consolidated Framework for Implementation Research (CFIR). Then we will use a modified nominal group technique to determine seven priority barriers that need to be addressed. These barriers will be input into the CFIR-ERIC implementation strategy matching tool to obtain expert-recommended implementation strategies. Finally, the Delphi method will be employed to select and refine the implementation strategies into a clear and actionable implementation strategy bundle.
This study has been approved by the Ethics Committee of Hebei Medical University, with approval number 2024043. Written informed consent will be obtained from all participants. Study findings will be disseminated through articles in scientific, peer-reviewed journals, and at national and international conferences. This study will begin in August 2025 and be completed in June 2026.
Many clinical practice guidelines (CPGs) claim to use Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, but its implementation varies. This suggests that CPG developers, methodologists and users would benefit from an instrument to evaluate the extent to which CPGs adhere to GRADE approach. Such a structured instrument is currently unavailable. Accordingly, this study will develop an evaluation instrument for assessing guideline adherence to the GRADE approach, which we have named ‘GRADE-Check’. The goal is to target items to which CPGs fail to adhere and that potentially have serious consequences resulting in inaccuracies in certainty of evidence and inappropriate direction or strength of recommendations, thereby discriminating across CPGs in issues of importance.
The panel will include up to 25 individuals with specific knowledge and expertise, including experienced authors, educators and methodologists on CPGs methodology and GRADE approach from relevant organisations. The instrument will focus on the key elements of GRADE, aiming for clarity for GRADE experts and non-GRADE experts to apply. The development process for GRADE-Check will consist of the following five phases: (1) recruitment of a panel of GRADE experts; (2) development of objectives and scope for the development of GRADE-Check and criteria for item selection; (3) generation of candidate items through a literature review and panel consultation; (4) panellist discussion to construct the initial draft and extended explanation manual and (5) user testing.
This study has been approved by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University (no. (2025047K)). Our research findings will be published in peer-reviewed journal articles and presented at academic conferences. Additionally, the dissemination plan will include considerations for the development of implementation manuals, a dedicated project website and training tools.
Traditional data extraction strategies, such as human double extraction, are both time consuming and labour-intensive. Artificial intelligence (AI) has emerged as a promising tool for facilitating data extraction. However, it is not yet suitable as a standalone solution. We will conduct a randomised controlled trial (RCT) to compare the efficiency and accuracy of the AI-human data extraction strategy with human double extraction.
This study is designed as a randomised, controlled, parallel trial. Participants will be randomly assigned to either the AI group or the non-AI group at a 1:2 allocation ratio. The AI group will use a hybrid approach that combines AI extraction followed by human verification by the same participant, while the non-AI group will use human double extraction. Data will be collected for two tasks: event count and group size. Ten RCTs will be selected from an established database that analysed data extraction errors in systematic reviews of sleep medicine. The primary outcome measure will be the percentage of correct extractions by both groups for each data extraction task.
The trial is approved by the Ethics Council of Anhui Medical University (No. 81250507). We plan to publish the main results as an academic publication in an international peer-reviewed journal in 2026.
Chinese Clinical Trial Register (Identifier: ChiCTR2500100393).
Early childhood—specifically, the period from 0 to 6 years of age—is a critical time in children’s lives with rapid growth in their cognitive, social and emotional development. This period has also been shown to be the most effective time for early interventions. The use of artificial Intelligence (AI) for supporting early child development is increasing alongside the rapid advancement of technology. AI can be used directly by children (eg, for implementing adaptive technologies), by individuals who interact with children (eg, educators, parents, nurses), and by individuals indirectly supporting early child development (eg, early childhood researchers or policy analysts). This scoping review will provide a roadmap for relevant stakeholders on how AI has been applied within and across different contexts to support infants and young children’s development, as well as the most predominant AI technologies used across various contexts.
The current study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review The search syntax will be applied in PsycINFO, ERIC, Education Source, CINHAL, MEDLINE, Embase and IEEE Xplore. The purpose of this study is to curate and synthesise academic papers to examine the application of AI for supporting the development of children between birth and age 6 years of age. Studies with children or individuals who work directly or indirectly with children will be included. Part of the abstract and full-text screening will be conducted by two researchers, with discrepancies being resolved by the lead authors. In addition, AI will be used to help with study screening and data extraction once confirmed to be reliable (Cohen’s kappa >0.80). Thematic and content analyses will be conducted to identify the types of AI products used and their applications in different contexts, the most predominant AI products used within and across each context, as well as how children’s developmental outcomes are impacted by the use of these AI products. Where applicable, visualisations such as tables, graphs and figures will be used to synthesise the data across contexts and AI products used to support early development of young children.
To assess the validity of the International Classification of Diseases, 10th Revision (ICD-10) healthcare database diagnosis codes for lithium toxicity at hospital admission in Ontario, Canada.
Population-based retrospective validation study.
A total of 152 hospitals linked to a provincial laboratory database in Ontario, Canada, from 2007 to 2023.
Patients 50 years of age or older taking lithium with hospital-based serum lithium laboratory measurements during admission to the hospital (n=2804).
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) comparing an ICD-10 diagnostic coding algorithm for lithium toxicity to a serum lithium concentration of 1.5 mmol/L or more. The codes used in the algorithm were T568, T435, Y495, X41 and X49. Serum lithium values and changes in the concentration of serum lithium from baseline levels in patients with and without a diagnosis code for lithium toxicity (code-positive and code-negative, respectively).
The sensitivity of the ICD-10 coding algorithm for identifying a serum lithium level≥1.5 mmol/L was 84% (95% CI 81% to 87%). The specificity and the NPV were over 88%, and the PPV was 63% (95% CI 60% to 66%). The median (IQR) serum lithium measurement in code-positive patients was 1.7 (1.2 to 2.2) mmol/L, and it was 0.6 (0.4 to 0.9) mmol/L in code-negative patients. The median (IQR) increase in serum lithium concentration compared with the most recent prehospital baseline values was 0.7 (0.2 to 1.3) mmol/L in code-positive patients and 0.0 (–0.2 to 0.2) mmol/L in code-negative patients.
In Ontario, the sensitivity of the ICD-10 coding algorithms was moderate for identifying a serum lithium level≥1.5 mmol/L at hospital admission. The presence or absence of the ICD-10 codes for lithium toxicity at hospital admission successfully differentiated two groups of patients with distinct serum lithium measurements.
Temporomandibular disorders (TMDs) are a prevalent group of musculoskeletal conditions affecting the temporomandibular joint, associated structures and masticatory muscles. The internet has become a primary source of health information for many patients; however, the readability, reliability, content and quality of online information on TMDs vary widely. A comprehensive synthesis of the characteristics and evaluation methods of such content is currently lacking.
This scoping review will follow the Joanna Briggs Institute methodology and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Peer-reviewed primary and secondary studies assessing online information on TMDs will be included if they report on readability, reliability, content or quality. Eligible information sources include publicly available websites, videos and social media; discussion forums and printed materials will be excluded. No language, date or geographical restrictions will be applied. A three-step search strategy will be implemented across PubMed, Web of Science, Embase, PsycINFO and CINAHL, followed by citation tracking. Screening will be conducted independently by two reviewers using Rayyan. Data will be extracted with a pilot-tested charting tool and synthesised narratively and descriptively in tabular and graphical formats.
As this study will only use data from publicly available sources, ethical approval is not required. Findings will be disseminated through publication in a peer-reviewed journal, conference presentations and professional networks, with the aim of guiding the development of accessible and reliable digital resources for individuals seeking information on TMDs.
This protocol has been prospectively registered on the Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/TAH7K.
The aim of this study was to explore why patients with hard-to-heal ulcers are treated without an aetiological diagnosis, using a grounded theory approach.
The study employed a qualitative semistructured interview design to gain in-depth insights. Data were collected in 2024, and an explanatory model was formed in accordance with grounded theory analysis.
Interviews were conducted with healthcare staff across primary, community and specialist care units in Sweden, encompassing both public and private sectors and representing a wide geographical spread.
The study involved 23 healthcare professionals, including nurses (n=18), assistant nurses (n=2) and physicians (n=3), from 22 healthcare units that participated in a preceding national mapping study. Participants were selected purposively to represent various professional roles and healthcare levels.
The analysis resulted in a theoretical model based on two categories: Healthcare traditions and clinical practices and Clinical governance. The lack of an aetiological diagnosis can be attributed to a traditional division of tasks, where ulcer care falls within the nurses’ domain. As a result, patients often receive treatment without a physician’s involvement, especially in home healthcare. Barriers and enablers for a diagnosis are present on different levels; issues close to the patient as well as structural matters. The results illustrate how healthcare units can be positioned along a scale, from traditional work distribution to evidence-based guidelines.
This study can be used to get a deeper understanding of the challenges of current wound management, where clinical governance can support or undermine the movement from a traditional work distribution towards an evidence-based clinical practice. Furthermore, this study can provide a basis for discussing quality improvement, to obtain good and equal care for patients with hard-to-heal ulcers.
Distal radius fractures (DRFs) are common injuries, especially in older adults due to age-related frailty. Most DRFs in patients aged 60 and older are treated non-operatively since surgery offers no clinically important benefits. Although anatomical alignment has traditionally been the goal of the treatment, evidence suggests that in older populations, radiographic outcomes do not reliably correlate with functional outcomes. Current evidence, including one randomised trial, shows no functional benefit of closed reduction compared with casting alone, calling into question the routine use of the procedure in older patients. The primary objective is to evaluate whether no reduction is equivalent to closed reduction in patients aged 65 years or older with a displaced DRF, based on wrist-related pain and disability measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months.
This is a multi-centre, randomised controlled, equivalence trial conducted in hospitals in Finland, Denmark, Sweden and Estonia. We aim to enrol 532 patients aged ≥65 years with a displaced DRF (AO/OTA 23A/23C). Participants will be randomised (1:1) to receive either a dorsal cast without reduction (experimental intervention) or closed reduction followed by casting (control comparator). The primary endpoint is the difference between groups assessed using the PRWE outcome score at 12 months. The equivalence margin will be set at 6 PRWE points. Key secondary endpoints will include the Numeric Rating Scale for pain, patient satisfaction, quality of life (EQ-5D-5L Index) and serious adverse events at 3 months and 12 months and cosmesis at 3 months. Our main analyses will follow an intention-to-treat principle, analysed using repeated measures mixed model.
Ethical approval has been granted by the Ethics Committee of Tampere University Hospital (R25001). Results of the trial will be disseminated through peer-reviewed journals.
6 July 2025, v1.0.
Medication returned by patients to healthcare facilities is a critical aspect of reverse logistics, intersecting healthcare delivery, patient safety and environmental sustainability, especially in low- and middle-income countries (LMICs) where systemic inefficiencies and socio-cultural factors may exacerbate the issue. While emerging medication return programmes are recognised for their potential to enhance resource efficiency and prevent misuse, they also signal inefficiencies in medical supply chains, prescribing practices and patient-provider interactions. This scoping review aims to systematically map the incidence and drivers of medication returned to health facilities by patients in LMICs.
This review follows Arksey and O'Malley’s scoping review framework and the PRISMA-ScR reporting guidelines. Searches will be conducted in Google Scholar, PubMed, CINAHL, Embase, Web of Science and Scopus, supplemented by grey literature sources and reference list screening. Searches will include studies from January 2005 to December 2025 and English-language publications, reflecting both the relevance of recent evidence and practical considerations for screening and analysis. Eligible studies must address the incidence or drivers of medication returned in LMICs and meet predefined inclusion criteria based on the Population, Concept, Context framework. Data will be extracted using a standardised charting form and analysed using narrative synthesis, supported by descriptive statistics and thematic analysis.
No ethical approval is required as this scoping review will analyse publicly available literature. Findings will be disseminated through peer-reviewed publications, academic conferences and healthcare organisations, with all data and search strategies made openly accessible through Springer Nature’s protocols.io preprint repository to support transparency and future research.
Springer Nature’s protocols.io dx.doi.org/10.17504/protocols.io.3byl4wd5ovo5/v1.
The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes.
This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1—project launch, phase 2—review of the literature, phase 3—Delphi survey, phase 4—consensus meeting and phase 5—dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes.
The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.
Most clinical practice guidelines (CPGs) for assessing and managing people’s chronic pain focus on specific pain conditions, body sites or life course stages. This creates complexity for clinicians making care choices in the absence of a diagnosis and/or where a person experiences more than one pain condition. Specific to this context is the ICD-11 classification of chronic primary pain where an experience of pain cannot be better accounted for by another condition. CPGs for chronic primary pain, agnostic to condition or body part, may support clinicians towards best pain care since many of the principles of person-centred chronic pain care are transdiagnostic. The two aims of this systematic review are to (1) identify and appraise CPGs for chronic primary pain, relevant across the life course and (2) map the CPG content against a pain care priority framework to evaluate the extent to which the CPG content aligns with the priorities of people with lived chronic pain experience.
We will systematically search nine scholarly databases, the Epistemonikos database and international and national guidelines clearinghouses. CPGs published within 2015–2025, in any language, that offer recommendations about assessment and/or management of chronic primary pain for people of any age, excluding hospitalised inpatients or institutionalised populations, will be included. Pairs of reviewers will independently screen citations for eligibility and appraise CPG quality and implementation potential using the Appraisal of Guidelines for Research and Evaluation (AGREE)-II and the AGREE-Recommendations Excellence tools, respectively. Data extraction will include the citation and scope characteristics of each CPG, methods used to develop recommendations, verbatim recommendations, guiding principles or practice information and narrative excerpts related to the GRADE Evidence-to-Decision (EtD) considerations (or equivalent). We will use the PROGRESS-PLUS framework as a checklist to identify whether determinants of health equity were considered by guideline developers. CPG recommendations will be organised according to common topics and categorised in a matrix according to strength and direction. Qualitative content analysis will be used to synthesise excerpts relating to GRADE EtD considerations (or equivalent), and we will map extracted data against an established chronic pain care priority framework to determine the extent to which the CPGs align with values and preferences of people with lived experience. Interpretation will be informed by an interdisciplinary Advisory Group, including lived experience partners.
Ethical approval is not required for this systematic review. Results will be disseminated through publication in an open-access peer-reviewed journal, through professional societies, and integrated into education curricula and public-facing resources. Reporting will be consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.
CRD420251000482.
To describe: (1) the most visible information (from individuals or organisations) on UK social media regarding hormone replacement therapy (HRT)/menopause hormone treatment for menopause; (2) claims made by these sources for HRT and testosterone outwith the indications specified by the British National Formulary (BNF) and the National Institute of Health and Care Excellence (NICE) (ie, vasomotor instability, vaginal dryness, low mood associated with the menopause and, for testosterone, low libido after treatment with HRT) and for use for the prevention of future ill health and (3) conflicts of interest of commentators.
Cross-sectional study.
Online references to HRT, for use in menopause, in UK online media, comprising Facebook, Google, Instagram, TikTok and YouTube, 30 top ranked hits between 1 January 2022 and 1 June 2023 and Twitter (X) up to 1 May 2024.
Identification of the most visible information was performed via online searching with the term ‘HRT’ using incognito searches within each modality. Statements making claims were identified and analysed as to whether they were congruent with BNF and NICE advice on indications for use. Declarations of interest were extracted from the source or searched for if not apparent using a standardised search strategy. Data were entered into an Excel spreadsheet. Summary and descriptive statistics were used to summarise the results, including description of origin and types of claims, percentage of claims in agreement with NICE/BNF indications, relationship to financial interests and readership data, where available.
180 recommendations and/or claims for HRT were examined (30 from each of six platforms), made by professional individuals (53.4%), laypeople (41.7%) and patient, media and professional organisations (4.9%) completing the total. Overall, 67.2% of claims were outside of BNF/NICE recommendations. 139 (77.2%) were associated with a conflict of interest. In 117 cases, this was a conflict either directly or indirectly related to menopause, through provision of private practice, pharmaceutical industry funding or retail products marketed at the menopause.
Social media commonly contains claims for HRT outside BNF/NICE guidance. Conflicts of interest by commentators are also common, directly or indirectly related to menopause. Less than a quarter of media contained no commercial conflict. Policymakers should consider means to ensure that non-conflicted, evidence-based information is visible to professionals, patients and the public.
Open Science Framework (https://osf.io/r7e5c/).
Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.
A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.
This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.
Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden.
Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations’ reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2–3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS.
The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round.
The study has received ethical approval by the Swedish Ethical Review Authority (Umeå medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria.
COMET registration number 3223.
A synthesis and appraisal of the recommendations for biomarkers in practice guidelines concerning sepsis is required to consolidate evidence-based practice. We generated an evidence gap map (EGM) on the use of biomarkers for managing adults with sepsis.
Scoping review.
MEDLINE, Guidelines International Network, Pan American Health Organization, Trip Database and UpToDate were searched from 2016 to March 2025.
Guidance documents (GD) that searched at least one literature source and provided clinical recommendations for the use of biomarkers for the management (diagnosis and prognosis, including treatment response) of adults with sepsis.
Two reviewers independently applied the eligibility criteria and extracted data. We used the AGREE-II (Appraisal of Guidelines for Research and Evaluation) tool to assess the GD quality. GDs that scored ≥50% on the AGREE-II 'Rigour of development' domain were considered robust. We also applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to evaluate if the recommendations were strong or conditional.
We found 10 GDs, with only half (4/8) having a robust methodology. There were 31 recommendations concerning biomarkers. Among these, 24 (77.4%) recommendations were about single biomarkers, with lactate (23; 74.2%) and procalcitonin (8; 25.8%) most frequently recommended. Biomarker testing focused on prognosis in 28 (90.3%) recommendations. Overall, 16 (51.6%) recommendations were graded strong and 13 (42.0%) were conditional, which we displayed in an EGM.
The methodology of GDs concerning adult sepsis was poor. Our review calls for more prudent use of biomarkers in specific prognostic scenarios and in combination with standard clinical assessments. Enhancing the methodological quality of future GDs is essential to generate more valid and robust recommendations for optimising patient care.
Primary dysmenorrhoea (PD) is the most common gynaecological condition among young women and is associated with significant socioeconomic repercussions. It is unclear which works best for pain relief when pharmacological and non-pharmacological interventions are compared. This systematic review and network meta-analysis (NMA) will aim to compare and rank the effects of pharmacological and non-pharmacological interventions in patients with PD.
Randomised controlled trials of pharmacological and non-pharmacological interventions for PD will be identified via a search of the PubMed, Cochrane Library, Web of Science, Embase, Scopus database and Google Scholar search engine until September 2025. The primary outcome will be a change in pain intensity among patients with PD, while the secondary outcomes include health-related quality of life, symptoms of depression and anxiety, and treatment-related adverse events. Two independent reviewers will perform document screening, study selection and data extraction. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias tool (V.2). The RevMan, Stata and Aggregate Data Drug Information System software will be used to perform a pairwise meta-analysis and Bayesian NMA in a random-effects model. The certainty of the evidence will be rated using the Grading of Recommendations, Assessment, Development, and Evaluation System.
This systematic review protocol is exempt from ethical approval as it involves analysis of previously published data. The findings of this review will be submitted to peer-reviewed journals.
CRD42024543573.