Comparative efficacy and acceptability of nonpharmacological interventions for sleep disturbance among pregnant women: protocol for a systematic review and network meta-analysis

Introduction
Sleep disturbance is prevalent in pregnancy and can result in significant adverse outcomes for women and their infants. Numerous clinical trials of various nonpharmacotherapies for preventing or treating sleep disturbances have been conducted previously; however, previous systematic reviews with direct comparisons have failed to demonstrate the best options for different kinds of treatments. This systematic review and network meta-analysis (NMA) aims to explore the comparative efficacy and acceptability of nonpharmacological interventions for sleep disturbances in pregnancy and to assist clinical decision-making through ranking interventions concerning critical clinical outcomes.

Methods and analysis
We will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. Two reviewers will systematically search five major bibliographic databases (PubMed, Embase, Cochrane Library, Web of Science and Cumulative Index to Nursing and Allied Health Literature) and registries for published and unpublished randomised controlled trials (RCTs) of any nonpharmacological interventions for sleep disturbances from inception to 24 June 2025. To ensure the search is up to date, we will also perform an updated search up to the time of final analysis submission. Primary outcomes will consider efficacy (the overall mean change of any predefined sleep disturbances, including sleep quality, sleep duration and sleep-specific symptoms) and acceptability (all-cause discontinuation). The risk of bias of each included RCT will be assessed using the Cochrane Risk of Bias 2.0 Tool (RoB2). Traditional pairwise meta-analyses and NMAs will be performed to compare the efficacy and acceptability of different nonpharmacological interventions. Surface under the cumulative ranking curve for the outcomes of interest will be used to rank the competing interventions. The Grading of Recommendations, Assessment, Development and Evaluation system will be used to assess the quality of evidence associated with the main results.

Ethics and dissemination
This review is a secondary analysis of published data and, therefore, does not require ethical approval. The results will be disseminated in a peer-reviewed journal.

PROSPERO registration number
CRD42024546340.

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Identifying and reporting modifications to surgical innovation: a systematic review of IDEAL/IDEAL-D studies

Objectives
The Idea, Development, Evaluation, Assessment and Long-term follow-up (IDEAL) framework was designed to improve the quality of surgical research and evaluation of surgical innovation. It has become a widely cited tool for evaluating innovative devices and procedures, yet challenges remain concerning the definition and reporting of incremental innovative modifications, hindering evolution and evaluation of innovations and potentially risking patient safety. This systematic review examined IDEAL studies to identify such modifications and establish recent practices around modification reporting to inform the development of future guidance to facilitate safe, transparent and efficient surgical innovation.

Design
Systematic review and thematic synthesis of studies reporting surgical innovation.

Data sources
Web of Science and Scopus were searched in July 2023 using citation tools to identify studies following the IDEAL framework (citing any of 13 key IDEAL/IDEAL framework publications and guideline papers).

Eligibility criteria
Primary research studies of any design that involved invasive innovative devices or procedures.

Data extraction and synthesis
Study characteristics and verbatim text for all reported modifications, including contextual information, were extracted. Data were analysed and synthesised using thematic synthesis.

Results
Of 1071 records screened, 104 studies published between 2011–2023 were included (n=87 (83.6%) study reports; n=17 (16.3%) protocols). 425 modifications were reported in 76 (73.1%) studies, including modifications to procedures (n=283, 66.6%), devices (n=94, 22.1%) and patient selection (n=48, 11.3%). Procedure/device modifications included technical, non-technical and cessation (conversion to other procedures or abandonment). Modifications were most often reported within IDEAL stage 2a (n=30/44, 68.2%), whereas there was considerable variation across other stages, such as stage 0 (n=2/3, 66%) and stage 2b (n=4/12, 33.3%).

Conclusion
Reporting modifications is imperative for evaluating surgical innovation. However, this review found inconsistent approaches to reporting and describing modifications. Findings will inform the development of a checklist for reporting modifications that aims to complement the IDEAL framework and further promote shared learning, avoiding the repetition of harmful/ineffective modifications and enhancing patient safety.

PROSPERO registration number
CRD42023427704.

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Protocol for a multicentre, open-label, dose-escalation phase I/II study evaluating the tolerability, safety, efficacy and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with aggressive natural killer cell leukaemia

Introduction
Aggressive natural killer cell leukaemia (ANKL) is a rare form of NK cell lymphoma with a very low incidence and poor prognosis. While multi-agent chemotherapy including L-asparaginase has been used to treat ANKL patients, they often cannot receive adequate chemotherapy at diagnosis due to liver dysfunction. PPMX-T003, a fully human monoclonal antibody targeting the transferrin receptor 1, shows promise in treating ANKL by helping patients recover from fulminant clinical conditions, potentially enabling a transition to chemotherapy. This study aimed to evaluate the tolerability, safety, efficacy, and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with ANKL.

Methods and analysis
This multicentre, open-label, dose-escalation phase I/II study will be conducted at nine hospitals in Japan. Patients diagnosed with ANKL (whether as a primary or recurrent disease) and exhibiting abnormal liver function or hepatomegaly due to the primary disease will be included. The primary endpoint is the tolerability and safety of repeated continuous intravenous administration of PPMX-T003 in the first course, based on adverse events and dose-limiting toxicities. PPMX-T003 will be administered as a continuous intravenous infusion every 24 hours for five consecutive days, followed by a 2-day break. Pretreatment will be provided to minimise the risk of infusion-related reactions. Initial doses of PPMX-T003 will be 0.5, 1.0 or 2.0 mg/kg, with subsequent dose increases determined by the Data and Safety Monitoring Committee. The sample size is set at seven participants, with enrolment increased to up to 12 participants if dose-limiting toxicities occur, based on feasibility due to the rarity of ANKL. Descriptive statistics will summarise data according to initial dose, and pharmacokinetic analysis will be conducted based on administered dose.

Ethics and dissemination
This study was approved by the institutional review boards at participating hospitals. The results will be disseminated in peer-reviewed journals.

Trial registration number
jRCT2061230008 (jRCT); NCT05863234 (ClinicalTrials.gov).

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Daily mobility, activity and environmental determinants of stress in ecological momentary assessment (EMA) and GPS studies: a scoping review protocol

Introduction
Stress is omnipresent in our everyday lives and a key risk factor for our physical and mental health. Yet little is known about the impact of geographic life environments, linked to our daily activities and mobility patterns, on our momentary and daily stress levels.
We propose this review to gather evidence on the spatio-temporal determinants of momentary or daily stress in studies using ecological momentary assessment (EMA) or experience sampling methods (ESM) in addition to global positioning systems (GPS) tracking. We will focus on the spatio-temporal definition and modelling of environmental exposures accounting for participant daily activities and mobility patterns and their association with stress.

Methods and analysis
This scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework for scoping reviews (2018). We will search the PubMed/Medline, Web of Science, PsycInfo and Scopus databases. We will include papers using EMA or ESM and GPS measuring chronic, daily or momentary stress as an outcome; these methods are also referred to as geographically-explicit ecological momentary assessment.
Articles published from January 2000–June 2025 will be screened. Two independent reviewers will screen titles and abstracts to agree on the inclusion of articles. No geographical or population limitation will be imposed.

Ethics and dissemination
This study is a scoping review based on previously published and publicly available literature. It does not involve the collection of primary data, human participants, or the processing of personal or sensitive information. Therefore, ethical approval is not required in accordance with institutional and international research ethics guidelines. The results will be submitted in peer-reviewed journals and presented at international conferences.

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Multicomponent intervention for controlling hypertension in the adult rural population of Pakistan: a protocol for a hybrid type III implementation-effectiveness cluster randomised controlled trial

Introduction
Though prior trials have shown the effectiveness of community-based hypertension detection and care delivery models, their adoption and translation to practice has been slow. In this study, we will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) in Pakistan that comprises health education, blood pressure (BP) monitoring and referrals by lady health workers (LHWs) and hypertension management by physicians in primary care settings.

Methods and analysis
In this 24-month hybrid type III implementation-effectiveness cluster-randomised controlled trial, we will recruit 3000 adult hypertensive patients from two rural districts of Pakistan. We will engage public health sector managers, physicians and LHWs and use the Consolidated Framework for Implementation Research to identify barriers and facilitators to the implementation of an already proven-to-be-effective MCHI. Using Expert Recommendations for Implementing Change and the modified Delphi technique, a set of implementation strategies addressing barriers will be identified. The strategies will be categorised as level 1 (requiring a change in processes), level 2 (requiring a change in infrastructure) and level 3 (financial restructuring). Basic health units and 250–300 households from their catchment will be considered as clusters. Clusters will be randomised in a ratio of 1:1 to intervention and control. While MCHI will be offered in both trial arms (intervention and control), the aforementioned implementation strategies will be randomised to the intervention arm only, starting with level 1 and moving to levels 2 and 3 as needed. Baseline and 6-monthly follow-up surveys, each of 6 months duration, will be conducted to collect data from the recruited participants on sociodemographics, cardiovascular disease (CVD) risk factors, CVD-related expenses and quality of life. The primary outcome will be the mean difference in BP-lowering medications per participant between the intervention and control arms. The primary outcome will be analysed using a linear mixed model with fixed effects for baseline value of the outcome. Additional outcomes include implementation outcomes: proportion of LHWs conducting health education, BP screening and monitoring, facility referrals and proportion of physicians diagnosing and treating hypertensive patients; effectiveness outcomes: proportion of participants with controlled BP and improved EQ-5D-5L score.

Ethics and dissemination
Ethical approval has been obtained from the Ethics Review Committee of Aga Khan University Pakistan (ERC # 2023-9084-26739). Findings will be reported to: (1) study participants; (2) funding body and institutes collaborating and supporting the study; (3) provincial and district health departments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications

Trial registration number
NCT06726057.

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Prevalence of low-level viremia in the treatment of chronic hepatitis B in China: a systematic review and meta-analysis

Objectives
Low-level viremia (LLV) is a risk factor affecting the prognosis of patients with chronic hepatitis B (CHB). The objective of this study was to systematically assess the prevalence of LLV, thereby providing robust evidence-based medical insights into effective clinical interventions and preventative measures against LLV.

Design
Systematic review and meta-analysis.

Data sources
A comprehensive literature search was conducted across various databases, including China National Knowledge Infrastructure, Wanfang Data (Wanfang), China Science And Technology Journal Database (VIP-CSTJ), China Biology Medicine disc (CBMdisc), PubMed, Embase, Web of Science and the Cochrane Library, spanning from the inception of these databases up to 5 January 2024.

Eligibility criteria
The research type included either a cross-sectional study or a cohort study focusing on the Chinese population, with the outcome being LLV. The languages were limited to both Chinese and English. Studies with any of the following were excluded: subjects with other comorbidities, original articles inaccessible or data unavailable, and duplicate publications.

Data extraction and synthesis
Literature management used EndNote X9.1, and an information extraction table was created using Microsoft Excel to record research information, including first author, year of publication and study type. The prevalence of LLV was assessed via meta-analysis. Meta-analyses were conducted in RStudio using the ‘metaprop ()’ function. Subgroup analysis and sensitivity analysis were used to identify sources of heterogeneity, and funnel plots and AS-Thompson tests were employed to evaluate publication bias.

Results
18 studies, encompassing a total sample of 9773 patients, were included in the analysis. Of these, 3336 patients were identified with LLV. The meta-analysis revealed that the prevalence of LLV among treated CHB patients stands at 33.6% (95% CI 30.2 to 37.0). The antigen status, antiviral treatment regimen (type of drugs and nucleos(t)ide analogues (NAs)), treatment duration, medication adherence and baseline hepatitis B virus DNA levels all affected the prevalence of LLV. Sensitivity analysis further corroborated the stability of these meta-analysis findings. The funnel plot and AS-Thompson test indicated no significant publication bias (t = –0.01, p=0.995).

Conclusions
The prevalence of LLV among CHB patients was established at 33.7% (95% CI 29.8% to 37.6%). Thus, it is imperative for clinical decision-makers to consider the various influencing factors of LLV when formulating treatment plans in order to mitigate any potential adverse outcomes.

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Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study

Background
High blood pressure (BP) is a significant global health issue, with many treated patients failing to achieve BP control. The Triple Pill vs Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial evaluated the effectiveness, cost-effectiveness and acceptability of early use of low-dose triple fixed-dose combination of BP-lowering drugs (‘triple pill’) compared with usual care in the management of hypertension. The TRIUMPH trial showed superior BP control with the triple pill strategy compared with usual care. This process evaluation of the TRIUMPH trial aimed to explore the contextual factors that influenced the trial outcomes, implementation of the triple pill strategy, mechanisms of its effects and potential barriers and facilitators for implementing the triple pill strategy in routine practice.

Methods
Guided by the UK Medical Research Council’s framework, semistructured interviews were conducted with 23 patients and 13 healthcare providers involved in the TRIUMPH trial. Data were analysed using the framework analysis method in NVivo.

Results
Hypertension care in Sri Lanka was hindered by the absence of systematic screening and overcrowded public clinics. Despite free medication provision at public clinics, long waiting times and occasional stock-outs posed challenges. In the TRIUMPH trial, both intervention and usual care were delivered in the context of ‘better than usual’ care, including team-based management, reduced waiting times, monetary assistance for travel, routine adherence monitoring and intensive follow-up. The triple pill strategy provided a simplified regimen, better access to BP-lowering medications and better BP-lowering efficacy. Key barriers to implementation in routine practice included the triple pill’s large size, therapeutic inertia and restrictive regulatory policies regarding fixed-dose combinations.

Conclusions
Implementation of the triple pill strategy into routine practice requires health system strengthening, provider training and supportive policy measures to replicate its effectiveness seen in the trial.

Trial registration number
ACTRN12612001120864, SLCTR/2015/020.

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Predictive accuracy of ophthalmic artery Doppler for pre-eclampsia: a systematic review

Objectives
This systematic review investigated available evidence on the stand-alone and incremental predictive performance of ophthalmic artery Doppler (OAD) for pre-eclampsia.

Design
Systematic review.

Data sources
We conducted a literature search from PubMed (Medline), the Cochrane CENTRAL, EMBASE and Scopus from inception to 8 April 2025.

Eligibility criteria
Studies eligible for inclusion were prospective or retrospective cohort studies, case-control studies or randomised controlled trials that reported on the predictive performance of OAD for pre-eclampsia in singleton pregnancies; and conducted in either high-income country (HIC) or low- and middle-income country (LMIC).

Data extraction and synthesis
Two reviewers independently screened and assessed articles for inclusion. One reviewer then extracted data using a standardised data extraction sheet, and any uncertainties were discussed with a second reviewer. The Prediction model Risk of Bias Assessment Tool was used for quality and risk of bias assessment. Findings were summarised and reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses statement and synthesised qualitatively.

Results
We identified and included 11 observational studies (3 from HIC and 8 from LMICs) with a total of 12 150 singleton pregnancies, of which 517 (4.3%) were complicated by pre-eclampsia at end of follow-up. The included studies were of varied quality, with three at low risk of bias, four at unclear risk and four at high risk. No interventional study was identified. Three studies (27.3%) recruited high-risk pregnancies (defined according to the American College of Obstetricians and Gynecologists (ACOG) criteria as one or more of the following: chronic hypertension, personal or family history of pre-eclampsia, early (≤18 years) or late (≥40 years) first pregnancy, primipaternity, chronic kidney disease, increased body mass index >30 kg/m2, presence of diabetes mellitus prior to pregnancy, autoimmune disease and thrombophilia), while eight studies (72.7%) recruited undetermined risk pregnancies. Stand-alone performance of OAD (interpreted by area under the receiver operating curve at 95% CI) showed that in the first trimester, the peak systolic velocity (PSV) ratio demonstrated very good predictive ability (0.97, 95% CI 0.92 to 1.0) (n=1 study), and the second PSV (PSV2) demonstrated very good predictive ability (0.91, 95% CI 0.82 to 0.99) (n=1 study). Also, PSV2 demonstrated fair predictive ability (0.61, 95% CI 0.42 to 0.79; and 0.53, 95% CI 0.40 to 0.66) for early and late pre-eclampsia, respectively (n=1 study). In the second trimester, the PSV ratio demonstrated very good predictive ability (0.88, 95% CI 0.84 to 0.91) (n=1 study), and PSV2 demonstrated good predictive ability (0.73, 95% CI 0.66 to 0.81; and 0.76, 95% CI 0.71 to 0.81) for pre-eclampsia (n=2 studies). In the third trimester, the PSV ratio demonstrated good predictive ability (0.82, 95% CI 0.73 to 0.89; and 0.77, 95% CI 0.71 to 0.82) for preterm and term pre-eclampsia, respectively (n=1 study). Also, PSV2 demonstrated good predictive ability 0.70 (0.57 to 0.84) (n=1 study).
Subsequently, in the second trimester, PSV ratio demonstrated better incremental predictive performance than uterine artery pulsatility index for preterm pre-eclampsia, when added to maternal factors and mean arterial pressure (MAP) (56.1%–80.2% vs 56.1%–74.8% detection rate (DR) at 10% FPR) (n=1 study). Also in the third trimester, adding PSV ratio to maternal factors and MAP was superior to soluble fms-like tyrosine kinase-1/placental growth factor ratio in predicting pre-eclampsia at

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Association of Covert Cerebrovascular Disease With Falls Requiring Medical Attention

Stroke, Ahead of Print. BACKGROUND:The impact of covert cerebrovascular disease on falls in the general population is not well-known. Here, we determine the time to a first fall following incidentally detected covert cerebrovascular disease during a clinical neuroimaging episode.METHODS:This longitudinal cohort study assessed computed tomography (CT) and magnetic resonance imaging from 2009 to 2019 of patients aged >50 years registered with Kaiser Permanente Southern California which is a healthcare organization combining health plan coverage with coordinated medical services, excluding those with before stroke/dementia. We extracted evidence of incidental covert brain infarcts (CBI) and white matter hyperintensities/hypoattenuation (WMH) from imaging reports using natural language processing. We examined associations of CBI and WMH with falls requiring medical attention, using Cox proportional hazards regression models with adjustment for 12 variables including age, sex, ethnicity multimorbidity, polypharmacy, and incontinence.RESULTS:We assessed 241 050 patients, mean age 64.9 (SD, 10.42) years, 61.3% female, detecting covert cerebrovascular disease in 31.1% over a mean follow-up duration of 3.04 years. A recorded fall occurred in 21.2% (51 239/241 050) during follow-up. On CT, single fall incidence rate/1000 person-years (p-y) was highest in individuals with both CBI and WMH on CT (129.3 falls/1000 p-y [95% CI, 123.4–135.5]), followed by WMH (109.9 falls/1000 p-y [108.0–111.9]). On magnetic resonance imaging, the incidence rate was the highest with both CBI and WMH (76.3 falls/1000 p-y [95% CI, 69.7–83.2]), followed by CBI (71.4 falls/1000 p-y [95% CI, 65.9–77.2]). The adjusted hazard ratio for single index fall in individuals with CBI on CT was 1.13 (95% CI, 1.09–1.17); versus magnetic resonance imaging 1.17 (95% CI, 1.08–1.27). On CT, the risk for single index fall incrementally increased for mild (1.37 [95% CI, 1.32–1.43]), moderate (1.57 [95% CI, 1.48–1.67]), or severe WMH (1.57 [95% CI, 1.45–1.70]). On magnetic resonance imaging, index fall risk similarly increased with increasing WMH severity: mild (1.11 [95% CI, 1.07–1.17]), moderate (1.21 [95% CI, 1.13–1.28]), and severe WMH (1.34 [95% CI, 1.22–1.46]).CONCLUSIONS:In a large population with neuroimaging, CBI and WMH are independently associated with greater risks of an index fall. Increasing severities of WMH are associated incrementally with fall risk across imaging modalities.

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EARLYBIRD: catching the earliest changes of the bone and intervertebral discs in children at increased risk for scoliosis development with MRI – study protocol of a prospective observational cohort study

Introduction
Adolescent idiopathic scoliosis (AIS) is an acquired deformity that develops in 2–4% of otherwise healthy children during adolescent growth, substantially reducing their quality of life and creating a life-long burden of disease. Despite many years of dedicated research, the cause and mechanism of AIS are still unknown and no effective curative treatments are available for children suffering from this spinal and chest deformity. To date, all etiological studies focused on children with an already established scoliosis. EARLYBIRD aims to uncover the earliest pathoanatomical changes in AIS, by studying longitudinal spinal growth in children at increased risk for scoliosis development with MRI, starting before adolescence.

Methods and analysis
This prospective observational cohort study will follow two groups: 60 adolescent girls (8–10 years old) who have an older sibling or parent diagnosed with AIS (cohort 1) and 60 adolescents with 22q11.2 deletion syndrome, a genetic microdeletion associated with 50% scoliosis prevalence (cohort 2). Data collection will be completely radiation-free and occur at baseline and yearly during adolescence up to 15 years of age in girls and up to 16 in boys. A comprehensive physical examination, a dedicated spine and chest MRI as well as a standing three-dimensional (3-D) spinal ultrasound will be obtained at each time point. The main parameter will be the longitudinal changes in segmental axial rotation during growth in subjects that do and do not develop AIS. Secondary endpoints are longitudinal changes in 3-D morphology of the bone and intervertebral discs (IVDs) during normal spinal development and during scoliosis development, determining biomarkers for bone growth, implementing radiation-free imaging methods for spinal monitoring in adolescent patients at risk for scoliosis development and use these for spinal skeletal maturity and patient-specific spinal biomechanical analyses.

Ethics and dissemination
This protocol has been approved by the Medical Ethics Committee NedMed and is registered on clinicaltrials.gov (NCT05924347). Written informed consent will be obtained from all parents/legal representatives. Key findings will be disseminated via peer-reviewed journals and presentation at conferences. This study is funded by the European Research Council.

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Cross-sectional study of the rates of military sexual trauma (MST) and associations with adverse mental health outcomes among UK female ex-service personnel: a study protocol

Introduction
This study investigates the rates of military sexual trauma (MST) and its associations with adverse mental health among a sample of UK female ex-service personnel who served during the Iraq/Afghanistan eras.

Methods and analysis
Female ex-service personnel, who participated in the fourth phase (Phase 4) of the King’s Centre for Military Health Research (KCMHR) Health and Well-being Cohort Study (2022–2023) and consented to be recontacted for follow-up studies (n=295), are being invited to participate in an online questionnaire between July 2024 and February 2025. The questionnaire contains surveys and questions related to experiences of sexual harassment and sexual assault during and outside of military service, disordered eating and broader female health issues. While the questionnaire relates to several female health topics, this study focuses on the surveys related to experiences of sexual trauma and eating disorders. Sociodemographic variables and some health variables, including post-traumatic stress disorder (PTSD), complex PTSD, common mental disorders, alcohol misuse, physical somatisation and social support, will be extracted from participants’ pre-existing data collected in Phase 4 of the KCMHR Cohort Study. Analyses will assess rates of MST, and hierarchical multiple logistic regressions will investigate associated health impacts. Rates and ORs, employing 95% CIs, will be reported.

Ethics and dissemination
This study has been granted full ethical approval by the King’s College London Research Ethics Committee (Ref: HR/DP-23/24–39040). Participants provide informed consent before participating and have access to a signposting booklet containing contact details for a range of support services. A risk protocol is in place, which outlines the procedure to be undertaken if a participant contacts the research team in distress. Findings will form part of a PhD thesis and will be further disseminated through peer-reviewed publication and dissemination with veteran mental health services and charities, and relevant government departments.

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Efficacy and safety of musculoskeletal manipulations in elderly population with musculoskeletal disorders: a systematic review

Introduction
Non-pharmacological interventions, including musculoskeletal manipulations (MMs), have been proven effective for musculoskeletal disorders.

Objectives
To evaluate if MMs, including osteopathic manipulation and chiropractic care, are effective to improve quality of life, pain intensity and function in older adults with musculoskeletal disorders.

Design
Systematic review.

Data sources
A systematic search was conducted on MEDLINE/PubMed, EMBASE, Scopus, Web of Science, CINAHL, Cochrane Library, from database inception up to 2 January 2025.

Eligibility criteria
Randomised controlled trials, controlled non-randomised trials and open label trials evaluating the efficacy and safety of MM such as osteopathic manipulation, chiropractic manipulation, myofascial release, craniosacral therapy, as monotherapy or adjunctive therapies in older people (age ≥65 years) with musculoskeletal disorders. The main outcomes included pain intensity, functionality and quality of life. Additionally, other related outcomes were considered, such as medical use duration, mood, mobility, motion, strength and endurance. Finally, we considered any adverse events.

Data extraction and synthesis
Selection and data extraction were performed independently by two authors. The effect estimates for each study were performed using Review Manager V.5.14. Continuous outcomes were analysed using the mean difference (95% CI). The methodological quality of the included studies was assessed using the Cochrane Risk of Bias tool 2 (RoB 2). No meta-analysis was performed.

Results
Five parallel randomised controlled trials were included, with a total sample size of 676 participants (41.6% women with a mean age of 77.3 years): 34 with chronic pain, 265 with neck pain and 377 with low back pain. MMs were not effective in patients with chronic pain, neither in pain intensity nor in functionality. For neck pain, considering the main outcomes, only in one of the two studies was there a statistically significant improvement in neck pain intensity only at week 12 for spinal manipulative treatment (SMT)+home exercise (HE) compared with HE alone (ES=–0.90 (95% CI –1.46 to –0.34); p=0.002). For low back pain, SMT+HE showed a statistically significant reduction in pain at 12 weeks compared with HE (ES=–0.79 (95% CI –1.39 to –0.19) p=0.010. For neck pain and low back pain, no statistically significant improvement in functional status and quality of life was observed with MM compared with any control group. RoB 2 showed a high risk of bias in three studies and some concerns in the others. At the domain level, the lowest risk was observed in the randomisation process (80% with some concerns). All five studies reported adverse events, none of which were serious.

Conclusions
This review provides limited and inconclusive evidence about MM to improve quality of life, pain management and functional status in older adults with musculoskeletal disorders. However, MM appears to be generally safe and well-tolerated.

PROSPERO registration number
CRD42023473203.

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How do health shocks affect preventive behaviours? An empirical examination of the mediating role of perceived risk from a longitudinal study in China

Objectives
Against the heavy burden of non-communicable diseases and the lack of preventive behaviours (PB) in China, health shocks (HSs), as a trigger, provide the teachable moment for promoting PB with a role of perceived risk (PR) in this process being discussed. The aim of this study is to examine four hypotheses on the impact of HS on PB and whether PR is mediating the relationship.

Design
A retrospective cohort.

Setting
Panel data of the China Health and Retirement Longitudinal Study, a well-designed nationally representative survey of Chinese over 45 years old in 2015 and 2018 waves.

Participants
A total of 9888 respondents were included, who were over 45 years old, followed up in both waves, and had no chronic diseases in 2015, after propensity score matching.

Primary outcome measures
The change of PB including smoking status, alcohol consumption, physical activity participation, physical examination participation, and the fitness expenditure.

Results
Hypothesis 1: HS significantly promote PB by decreasing the probability of smoking and drinking, increasing the probability of taking exercise and physical examination, and increasing the fitness expenditure. Hypothesis 2 and 3: HSs increase PR, and PR is positively associated with PB. Hypothesis 4: The indirect effects of HS on smoking (–0.016, p

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Dental neglect in children and adolescents: protocol for a scoping review on strategies for identification and prevention

Introduction
Dental neglect in children and adolescents is a form of child maltreatment and can be an indicator of other forms of maltreatment. Early identification of dental neglect is essential to initiate preventive interventions and connect families to appropriate health and social services to avoid further harm and to reduce negative impacts on child development and well-being. Articles that systematically synthesise and compare models for early detection, intersectoral cooperation and care for dental neglect have not been published yet. This scoping review aims to map the evidence on strategies for the identification and prevention of dental neglect in children and adolescents.

Methods and analysis
The study is designed as a scoping review. Based on the Population, Concept and Context (PCC) scheme, the databases PubMed, PsycInfo and Scopus are searched for publications before July 2023. Publications in all languages will be considered in case an abstract in English or German is available. The review will include articles reporting on strategies for identification and prevention related to dental neglect in children and adolescents as conducted in health service and community settings. Data from included articles will be extracted to describe and categorise the available evidence. The review will follow recommendations of the Joanna Briggs Institute Reviewer’s Manual on scoping reviews and the Critical Appraisal Tool for Health Promotion and Prevention Reviews (CAT HPPR).

Ethics and dissemination
Ethical approval is not required, as no personal data will be collected in this literature-based study. The study’s findings will be disseminated through conference presentations, scientific publications and stakeholder meetings.

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Caregivers challenges in engaging with the health system to optimise medication management of older care recipients: a qualitative study including home visits

Objectives
Medication management is a demanding task for family caregivers of older adults, adding to their care burden. The aim was to identify the challenges family caregivers experience in managing medications of older care recipients to obtain caregiver-centred evidence for developing social and health services to meet their needs.

Design
The qualitative data were collected during two consecutive home visits using thematic interviews with a narrative approach during the period of October 2017 to September 2018. The interview data were qualitatively analysed using the framework method with a combination of the inductive and deductive approaches. Human error theory with systems approach and prospective risk management was used as a theoretical framework.

Setting
Family caregiving of older adults.

Participants
21 officially contracted family caregivers and their older (≥65 years) care recipients using >1 prescription medicine from the capital region of Finland.

Results
Three conceptual models were constructed: (1) to position family caregiving in the public social and healthcare system, (2) to identify challenges and (3) needs for development in medication management prioritised from challenges. Family caregivers were not well integrated as a part of the health system, but left alone to manage the care recipient’s medications. When urgent treatment-related matters arose, caregivers were not able to reach the physician. The major development needs concerned (1) identification of the caregivers as family caregivers in healthcare and community pharmacies, (2) making familiar healthcare professionals accessible, (3) ensuring sufficient customised support for managing medications at home (up-to-date medication list, monitoring and medicines information), (4) more active involvement and communication in the care process and (5) adopting compatible electronic health records between primary and secondary care, and pharmacies and social services.

Conclusions
Family caregiving practices and support services should be developed in cooperation with the caregivers to meet their needs and place the families at the centre of the medication use process. Strengthening the integration of family caregiving to the social and healthcare system is vital, for example, by making easy access to family physician and involving pharmacists more actively in supporting medication management.

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