Evidence map›Paper›PMID 28851443›Full record

Trial reportTrials2017

The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.

Patricia Masterson-Algar, Christopher R Burton, Marian C Brady, Avril Nicoll, Carl E Clarke, Caroline Rick, Max Hughes, Pui Au, Christina H Smith, Catherine M Sackley

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. 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

10 authors.

Patricia Masterson-AlgarBangor Institute for Health & Medical Research, School of Healthcare Sciences, Bangor University, Ffriddoedd Road, Bangor, UK. p.m.algar@bangor.ac.uk.ORCID 0000-0001-6344-1346
Christopher R BurtonBangor Institute for Health & Medical Research, School of Healthcare Sciences, Bangor University, Ffriddoedd Road, Bangor, UK.
Marian C BradyNursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
Avril NicollNursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
Carl E ClarkeInstitute for Applied Health Research, University of Birmingham, Vincent Drive, Birmingham, UK.
Caroline RickBirmingham Clinical Trials Unit (BCTU), University of Birmingham, Edgbaston, Birmingham, UK.
Max HughesBirmingham Clinical Trials Unit (BCTU), University of Birmingham, Edgbaston, Birmingham, UK.
Pui AuBirmingham Clinical Trials Unit (BCTU), University of Birmingham, Edgbaston, Birmingham, UK.
Christina H SmithFaculty of Brain Sciences, University College London, London, UK.
Catherine M SackleyFaculty of Life Science and Medicine, King's College London, London, UK.

Funding

Chief Scientist Office NMAHP1Department of Health HTA/10/135/02
6 · The paper itself

Abstract

backgroundThe PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. METHODS/

designDrawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. DISCUSSION: To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why.

trial registrationISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.

Indexed as

Voice QualityVoice TrainingClinical ProtocolsCost-Benefit AnalysisHealth Care CostsHumansParkinson DiseaseRecovery of FunctionResearch DesignSpeech-Language PathologyTime FactorsTreatment OutcomeUnited KingdomComplex interventionsFidelityLee Silverman Voice TreatmentProcess evaluationSpeech and language therapy

Identifiers

PMID28851443
PMCPMC5576370

What OpenQuestion holds

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Registered trials

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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.