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Approaches for the treatment of perforated peptic ulcers: a network meta-analysis of randomised controlled trials - study protocol

Por: Wadewitz · E. · Friedrichs · J. · Grilli · M. · Vey · J. · Zimmermann · S. · Kleeff · J. · Ronellenfitsch · U. · Klose · J. · Rebelo · A.
Introduction

Perforated peptic ulcers are a life-threatening complication associated with high morbidity and mortality. Several treatment approaches are available. The aim of this network meta-analysis (NMA) is to compare surgical and alternative approaches for the treatment of perforated peptic ulcers regarding mortality and other patient-relevant outcomes.

Methods and analysis

A systematic literature search of PubMed/MEDLINE, Cochrane Library, Embase, CINAHL, ClinicalTrials.gov trial registry and ICTRP will be conducted with predefined search terms.

To address the question of the most effective treatment approach, an NMA will be performed for each of the outcomes mentioned above. A closed network of interventions is expected. The standardised mean difference with its 95% CI will be used as the effect measure for the continuous outcomes, and the ORs with 95% CI will be calculated for the binary outcomes.

Ethics and dissemination

In accordance with the nature of the data used in this meta-analysis, which involves aggregate information from previously published studies ethical approval is deemed unnecessary. Results will be disseminated directly to decision-makers (eg, surgeons, gastroenterologists) through publication in peer-reviewed journals and presentation at conferences.

PROSPERO registration number

CRD42023482932.

Experiences of fatigued persons with multiple sclerosis with multimodal agility-based exercise training and the ReFEx study protocol: a qualitative extension of a feasibility study

Por: Wolf · F. · Folkerts · A.-K. · Zimmer · P. · Nielsen · J.
Objectives

(1) To explore experiences of fatigued persons with multiple sclerosis (pwMS) with a new multimodal agility-based exercise training (MAT) framework and (2) to investigate the demands of the Rehabilitation, Fatigue, and Exercise (ReFEx) study protocol, which compares high-frequency MAT and ‘traditional’ strength and endurance training (SET) to identify possible adaptations for a powered randomised controlled trial (RCT).

Design

A qualitative interview study nested within a feasibility RCT, comparing MAT and SET.

Setting

Neurological inpatient rehabilitation centre in Germany.

Participants

Twenty-two pwMS were recruited for the feasibility study. Six were selected from MAT and SET, respectively, for semistructured face-to-face interviews prior to discharge, following a purposive sampling strategy. Participants had low physical disability but were at least moderately fatigued.

Interventions

During inpatient rehabilitation (4–6 weeks) MAT participants attended group-based and manual-based MAT sessions in the gym (5x/week, 30 min) and the pool (3x/week, 30 min). SET participants exercised individually on a cycle ergometer (5x/week, 22 min) and on strength training machines (3x/week, 30 min).

Results

Three key categories emerged from the interviews: (1) facilitators regarding MAT were variety and playfulness, group setting and challenging exercises. Barriers regarding MAT were feeling overburdened, feeling pressured in the group setting and the wish to perform ‘traditional’ strength training (not part of MAT). (2) MAT benefits were of physical and psychological nature, with improved balance stated the most. (3) Demands described the perceived exertion during MAT and SET, reflecting that there is no accumulation of fatigue during the intervention.

Conclusions

MAT is appreciated by pwMS and includes facilitators less attainable with ‘traditional’ SET. Evaluation of MAT in a powered RCT is indicated, if rest breaks postsession, and screening for negative self-evaluation and social comparison are considered. Future (qualitative) research should investigate the important factors of inpatient rehabilitation contributing to fatigue reduction in pwMS.

Trial registration number

DRKS00023943; German Clinical Trials Register.

Effects of socioeconomic status on patient-reported outcome after surgically treated trigger finger: a retrospective national registry-based study

Por: Lesand · L. · Dahlin · L. B. · Rydberg · M. · Zimmerman · M.
Objectives

To investigate if socioeconomic status impacts patient-reported outcomes after a surgically treated trigger finger (TF).

Design and setting

Data on patients with TF treated with surgery were collected from the Swedish National Quality Registry of Hand Surgery (HAKIR) 2010–2019 with an evaluation of symptoms and disability before surgery and at 3 and 12 months after surgery, using the short version of the Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.

Data from HAKIR and the Swedish National Diabetes Registry (ndr.nu) were combined with socioeconomic data from Statistics Sweden (scb.sc), analysing the impact of marital status, education level, income, occupation, sickness benefits, days of unemployment, social assistance and migrant status on the outcome by a linear regression model.

Participants

In total, 5477 patients were operated on for primary TF during the study period, of whom 21% had diabetes, with a response rate of 35% preoperatively, 26% at 3 months and 25% at 12 months.

Results

At all time points, being born in Sweden (preoperatively B-coefficient: –9.74 (95% CI –13.38 to –6.11), 3 months postoperatively –9.80 (95% CI –13.82 to –5.78) and 12 months postoperatively –8.28 (95% CI –12.51 to –4.05); all p

Conclusion

Individuals with low earnings, high sick leave the same year as the surgery and those born outside of Sweden reported more symptoms both before and after surgery, but the relative improvement was not affected by socioeconomic factors.

Palliative care interventions for patients with head and neck cancer: protocol for a scoping review

Por: Ratnasekera · N. · Fazelzad · R. · Bagnarol · R. · Cunha · V. · Zimmermann · C. · Lau · J.
Introduction

A head and neck cancer (HNC) diagnosis significantly impacts a patient’s quality of life (QOL). Palliative care potentially improves their QOL. We will conduct a scoping review to identify existing knowledge about palliative care interventions for patients with HNC.

Methods and analysis

This scoping review was designed in accordance with the JBI Manual for Evidence Synthesis: Scoping Reviews and will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Our eligibility criteria follow the Population, Intervention, Comparison or Control, Outcomes and Study characteristics framework. The population is adult patients with locally advanced, metastatic, unresectable and/or recurrent HNC. We include peer-reviewed journal articles and articles in the press, in English, reporting on palliative care interventions with at least two of the eight National Consensus Project on Clinical Practice Guidelines for Quality Palliative Care domains; studies with and without comparators will be included. The outcomes are patient QOL (primary) and symptom severity, patients’ satisfaction with care, patients’ mood, advance care planning and place of death (secondary). We developed a search strategy across ten databases, to be searched from the inception to 11 September 2023: Medline ALL (Medline and EPub Ahead of Print and In-Process, In-Data-Review & Other Non-Indexed Citations), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase Classic+Embase, Emcare and PsycINFO all from the OvidSP platform; CINAHL from EBSCOhost, Scopus from Elsevier, Web of Science from Clarivate and Global Index Medicus from WHO. We will extract data using a piloted data form and analyse the data through descriptive statistics and thematic analysis.

Ethics and dissemination

Ethics approval is not needed for a scoping review. We will disseminate the findings to healthcare providers and policy-makers by publishing the results in a scientific journal.

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