Evidence map›Paper›PMID 37573352›Full record

ArticleTrials2023

The NightLife study - the clinical and cost-effectiveness of thrice-weekly, extended, in-centre nocturnal haemodialysis versus daytime haemodialysis using a mixed methods approach: study protocol for a randomised controlled trial.

Katherine L Hull, Kate Bramham, Cassandra L Brookes, Victoria Cluley, Carmel Conefrey, Nicola J Cooper, Helen Eborall, James Fotheringham, Matthew P M Graham-Brown, Laura J Gray and 7 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 1 country.

Katherine L HullDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK. kh326@leicester.ac.uk.ORCID http://orcid.org/0000-0003-0028-5408
Kate BramhamKing's Kidney Care, King's College Hospital, London, UK.
Cassandra L BrookesLeicester Clinical Trials Unit, University of Leicester, Leicester, UK.
Victoria CluleySchool of Sociology and Social Policy, University of Nottingham, Nottingham, UK.
Carmel ConefreyBristol Population Health Science Institute, University of Bristol Medical School, Bristol, UK.
Nicola J CooperDepartment of Population Health Sciences, University of Leicester, Leicester, UK.
Helen EborallCollege of Medicine and Veterinary Medicine, Usher Institute, University of Edinburgh, Edinburgh, UK.
James FotheringhamHealth Economics and Decision Science, School of Health and Related Research, University of Sheffield, Sheffield, UK.
Matthew P M Graham-BrownDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK.
Laura J GrayDepartment of Population Health Sciences, University of Leicester, Leicester, UK.
Patrick B MarkInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Sandip MitraManchester Institute of Nephrology and Transplantation, Manchester Academic Health Science Centre, Research and Innovation, Manchester University NHS Foundation Trust, Manchester, UK.
Gavin J MurphyLeicester Clinical Trials Unit, University of Leicester, Leicester, UK.
Niamh QuannLeicester Clinical Trials Unit, University of Leicester, Leicester, UK.
Leila RooshenasBristol Population Health Science Institute, University of Bristol Medical School, Bristol, UK.
Madeleine WarrenWarren-Charnock Associates, London, UK.
James O BurtonDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK.
University of Leicester · GBUniversity of Bristol · GBKing's College London · GBManchester Academic Health Science Centre · GBMore Associates · GBSheffield Teaching Hospitals NHS Foundation Trust · GBUniversity of Edinburgh · GBUniversity of Glasgow · GBUniversity of Nottingham · GB

Funding

British Heart Foundation PG/20/10132
6 · The paper itself

Abstract

backgroundIn-centre nocturnal haemodialysis (INHD) offers extended-hours haemodialysis, 6 to 8 h thrice-weekly overnight, with the support of dialysis specialist nurses. There is increasing observational data demonstrating potential benefits of INHD on health-related quality of life (HRQoL). There is a lack of randomised controlled trial (RCT) data to confirm these benefits and assess safety.

methodsThe NightLife study is a pragmatic, two-arm, multicentre RCT comparing the impact of 6 months INHD to conventional haemodialysis (thrice-weekly daytime in-centre haemodialysis, 3.5-5 h per session). The primary outcome is the total score from the Kidney Disease Quality of Life tool at 6 months. Secondary outcomes include sleep and cognitive function, measures of safety, adherence to dialysis and impact on clinical parameters. There is an embedded Process Evaluation to assess implementation, health economic modelling and a QuinteT Recruitment Intervention to understand factors that influence recruitment and retention. Adults (≥ 18 years old) who have been established on haemodialysis for > 3 months are eligible to participate. DISCUSSION: There are 68,000 adults in the UK that need kidney replacement therapy (KRT), with in-centre haemodialysis the treatment modality for over a third of cases. HRQoL is an independent predictor of hospitalisation and mortality in individuals on maintenance dialysis. Haemodialysis is associated with poor HRQoL in comparison to the general population. INHD has the potential to improve HRQoL. Vigorous RCT evidence of effectiveness is lacking. The NightLife study is an essential step in the understanding of dialysis therapies and will guide patient-centred decisions regarding KRT in the future.

trial registrationTrial registration number: ISRCTN87042063. Registered: 14/07/2020.

Indexed as

Renal DialysisRenal Replacement TherapyAdolescentAdultCost-Benefit AnalysisHumansPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicCost-effectivenessEnd-stage kidney diseaseIn-centre nocturnal haemodialysisQuality of life

Identifiers

PMID37573352
PMCPMC10422763
OpenAlexW4385781303

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.