Notes

Store-Operated Calcium Channels.
A major development in solid malignancy treatment is the application of immune checkpoint inhibitors (ICIs), which have produced durable responses and increased survival rates. However, the therapeutic effect of ICIs has great heterogeneity in patients with cancer. We propose a systematic review to evaluate the predictive value of tumour mutation burden (TMB) on efficacy of ICIs.

A systematic literature search will be conducted in the PubMed, OVID, Web of Science, Embase and Cochrane Central Register of Controlled Trials Library databases up to 31 May 2022. We will compare the efficacy of ICIs between TMB high group and TMB low group in terms of the HRs of overall survival (OS) and progression-free survival (PFS), and the OR of the objective response rate/overall response rate (ORR). The HRs of PFS and OS, and the OR of ORR, will be measured by an inverse variance weighted fixed effects model (I
≤50%) or a DerSimonian-Laird random effects model (I
>50%). In addition, subgroup analysis, sensitivity analysis, heterogeneity analysis and publication bias will be conducted. We plan to conduct a subgroup analysis on age, sex, area, number of patients (high/low TMB), cancer type, tumour size, stage, line of therapy, TMB sequencing method, type of immunotherapy and follow-up period.

Ethical approval and informed consent are not needed, as the study will be a literature review and will not involve direct contact with patients or alterations to patient care. This systematic review is anticipated to be finished in December 2023, and the results will be published in a peer-reviewed journal.

CRD42021262480.
CRD42021262480.
When novel devices are used 'in human' for the first time, their optimal use is uncertain because clinicians only have experience from preclinical studies. This study aimed to investigate factors that might optimise use of the Odon Device for assisted vaginal birth.

We undertook qualitative case studies within the ASSIST Study, a feasibility study of the Odon Device. Each 'case' was defined as one use of the device and included at least one of the following observation of the attempted assisted birth, and an interview with the obstetrician, midwife or woman. Data collection and thematic analysis ran iteratively and in parallel.

Tertiary referral National Health Service maternity unit in the Southwest of England.

Women requiring a clinically indicated assisted vaginal birth.

The Odon Device, an innovative device for assisted vaginal birth.

Determining the optimal device technique, device design and defining clinical parameters for use.

Thirty-nine cases involving an attempted Odon-assisted birth were included in this study, of which 19 resulted in a successful birth with the device. Factors that improved use included optimisation of device technique, device design and clinical parameters for use. Technique adaptations included applying the device during, rather than between, contractions; having a flexible approach to the application angle; and deflating the air cuff sooner than originally proposed. Three design modifications were proposed involving the deflation button and sleeve. Although use of the device was found to be appropriate in all fetal positions, it was considered contraindicated when the fetal station was at the ischial spines.

Case study methodology facilitated the acquisition of rapid insights into device function in clinical practice, providing key insights regarding use, design and key clinical parameters for success. This methodology should be considered whenever innovative devices are introduced into clinical practice.

ISRCTN10203171.
ISRCTN10203171.
Prognosis following surgical rotator cuff repair (RCR) is often established through the assessment of non-modifiable biomedical factors such as tear size. This understates the complex nature of recovery following RCR. There is a need to identify modifiable psychosocial and sleep-related variables, and to find out whether changes in central pain processing influence prognosis after RCR. This will improve our knowledge on how to optimise recovery, using a holistic rehabilitation approach.

This longitudinal study will analyse 141 participants undergoing usual care for first time RCR. Data will be collected 1-21 days preoperatively (T1), then 11-14 weeks (T2) and 12-14 months (T3) postoperatively. We will use mixed-effects linear regression to assess relationships between potential prognostic factors and our primary and secondary outcome measures-the Western Ontario Rotator Cuff Index; the Constant-Murley Score; the Subjective Shoulder Value; Maximal Pain (Numeric Rating Scale); and Quality of Life (European l commission of Canton of Zurich, Switzerland, No ID_2018-02089 TRIAL REGISTRATION NUMBER NCT04946149.
The results of the study will be disseminated at conferences such as the European Pain Congress. One or more manuscripts will be published in a peer-reviewed SCI-ranked journal. Findings will be reported in accordance with the STROBE statement and PROGRESS framework. Ethical approval is granted by the Ethical commission of Canton of Zurich, Switzerland, No ID_2018-02089 TRIAL REGISTRATION NUMBER NCT04946149.
To establish the prevalence of long-term and serious harms of medical cannabis for chronic pain.

Systematic review and meta-analysis.

MEDLINE, EMBASE, PsycINFO and CENTRAL from inception to 1 April 2020.

Non-randomised studies reporting on harms of medical cannabis or cannabinoids in adults or children living with chronic pain with ≥4 weeks of follow-up.

A parallel guideline panel provided input on the design and interpretation of the systematic review, including selection of adverse events for consideration. Two reviewers, working independently and in duplicate, screened the search results, extracted data and assessed risk of bias. We used random-effects models for all meta-analyses and the Grades of Recommendations, Assessment, Development and Evaluation approach to evaluate the certainty of evidence.

We identified 39 eligible studies that enrolled 12 143 adult patients with chronic pain. Very low certainty evidence suggests that adverse events are common (prevalence 26.0%; 95% CI 13.2% to 41.2%ow certainty evidence that adverse events are common among people living with chronic pain who use medical cannabis or cannabinoids, but that few patients experience serious adverse events.
The prevalence of heart failure (HF) is increasing. Exercise-based cardiac rehabilitation (CR) reduces mortality and further improves the prognosis of patients with HF. However, the effect of different modes of CR delivery on HF remains unclear. Thus, the purpose of this study is to find out the relative efficacy and safety of different modes of CR delivery for individuals with HF using a network meta-analysis.

We will perform a systematic review and network meta-analysis of randomised controlled trials which compare different modes of exercise-based CR delivery for patients with HF. Databases including Embase, Medline, the Cochrane Central Register of Controlled Trials and Web of Science will be searched up to May 2022. The primary outcomes will focus on the functional capacity and the health-related quality of life (hr-QOL). selleckchem Functional capacity will be evaluated by peak oxygen consumption (mL/kg/min) and 6 min walking test (metres). The Minnesota Living with Heart Failure questionnaire, Short Form-36, Psychometric properties of the Kansas City cardiomyopathy questionnaire and EuroQol five dimensions questionnaire will serve as measures of hr-QOL. As secondary outcomes, we will assess hospital admissions (all-cause and cardiac) and all-cause mortality, which required a minimum follow-up of 6 months, as well as adverse events during exercise training. The risk of bias for individual studies will be evaluated according to the Cochrane Handbook. The quality of evidence will be assessed by the Grading of Recommendations, Assessment, Development and Evaluation approach.

This study does not require ethics approval as it is based on published trials. Results of this systematic review and network meta-analysis will be submitted to a peer-reviewed journal for future publication.

CRD42021278351.
CRD42021278351.
Behaviour change interventions targeting changes in physical activity (PA) can benefit by examining the underlying mechanisms that promote change. This study explored the use of the Capability, Opportunity, Motivation and Behaviour (COM-B) model and the Theoretical Domains Framework (TDF) to code and contextualise the experiences of participants who completed a PA coaching intervention underpinned by motivational interviewing and cognitive-behavioural therapy.

Semistructured interviews were conducted with a purposive sample of participants.

Interviews were conducted in a tertiary hospital in regional Victoria, Australia.

Eighteen participants who completed a PA coaching intervention were interviewed. The participants were recruited into the coaching intervention because they were insufficiently physically active at the time of recruitment.

Thirteen (72%) participants were women and the average age of participants was 54 (±5) years. Four participant themes mapped directly onto five components of the g interventions TRIAL REGISTRATION NUMBER ACTRN12619000036112. Post-results analysis.
We demonstrate the beneficial effect of using theory-informed behaviour change techniques, and delivering them in a style that promotes autonomy and relatedness. The views of participants should be a key consideration in the design and implementation of PA coaching interventions TRIAL REGISTRATION NUMBER ACTRN12619000036112. Post-results analysis.
There is an enormous imbalance between the rapid development of day surgery and the current conventional medical services. Hence, an effective day surgery management mode should be developed that can be used to constantly follow up on patients both preoperatively and postoperatively. In this study, WeChat was chosen as the platform. This study aimed to investigate the feasibility and effectiveness of a new day surgery management mode.

This randomised controlled study investigated the efficacy of a new day surgery management mode based on WeChat. The target number of participants was 1000 per group. The application (app) will send personalised information based on the medical history of the patient and the type of surgery at different time points preoperatively and postoperatively. The healthcare worker can follow up the patient and acquire clinical data by simply signing into the app. The patient and the healthcare worker can also engage in video or voice chats using the app when necessary. Multiple departments, including anaesthesiology, internal medicine, surgery, nursing and psychology, will participate in this new mode.

Ethical approval was obtained from the West China Hospital of Sichuan University Biomedical Research Ethics Committee. Results of this study will be published in peer-reviewed journals and presented at international conferences.

ChiCTR2100050793.
ChiCTR2100050793.
Health organisations should support healthcare workers who are physically and psychologically affected by patient safety incidents (second victims). There is a growing body of evidence which focuses on second victim support interventions. However, there is still limited research on the elements necessary to effectively implement and ensure the sustainability of these types of interventions. In this study, we propose to map and frame the key factors which underlie an effective implementation of healthcare worker support interventions in healthcare organisations when healthcare workers are physically and/or emotionally affected by patient safety incidents.

This scoping review will be guided by the established methodological Arksey and O'Malley framework, Levac and Joanna Briggs Institute (JBI) recommendations. We will follow the JBI three-step process (1) a preliminary search conducted on two databases; (2) the definition of clear inclusion criteria and the creation of a list of search terms to be used in the subsequent running of the search on a larger number of databases; and (3) additional searches (cross-checking/cross-referencing of reference lists of eligible studies, hand-searching in target journals relevant to the topic, conference proceedings, institutional/organisational websites and networks repositories).
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