A primary care Symptoms Clinic for patients with medically unexplained symptoms: pilot randomised trial

Burton, Christopher; Weller, David; Marsden, Wendy; Worth, Allison; Sharpe, Michael

doi:10.1136/bmjopen-2011-000513

Cited by 43 publications

(54 citation statements)

References 26 publications

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“…Of the remainder, two were clearly improving at the time they were seen and agreed to early discharge; two found further attendance difficult after a second appointment and one declined any further contact after the first appointment. Several patients randomised to usual care expressed some disappointment at the time of their allocation, although follow-up response rates were comparable between the two groups [72]. ”…”

Section: Resultsmentioning

confidence: 99%

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

Chan

Campbell

et al. 2016

Pilot Feasibility Stud

1,690

1,227

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The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

Chan

Campbell

et al. 2016

Pilot Feasibility Stud

1,690

1,227

View full text Add to dashboard Cite

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“…However, this may indicate a skewed distribution of healthcare resources with patients preferring to access healthcare providers who are nearest to them. Therefore, there is a pressing need to strengthen the network of primary care services and augment the existing facilities, perhaps by including regular surveillance programs, to increase the patronage and confidence of the public on such services (16).…”

Section: Discussionmentioning

confidence: 99%

Pathways to Care for Medically Unexplained Symptoms at a Specialty Psychosomatic Clinic in South India in 2014

Menon

Vivek

Sarkar

2016

Iran J Psychiatry Behav Sci

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Background: A growing body of evidence suggests that patients with medically unexplained symptoms (MUS) tend to delay help seeking behaviours. Objectives: The aim of this study was to explore the pathway to care for patients with MUS at a specialty psychosomatic clinic. Materials and Methods:The clinic caters to patients with MUS referred from other departments or directly seeking treatment. After detailed assessment, diagnosis was made as per ICD 10 clinical descriptions, diagnostic guidelines, and management plan. The pathway of care for patients registered in this clinic was assessed, using a structured questionnaire. Results: Pathway-of-care information was available for 49 out of the 53 patients (92.5% of the sample) registered in the first 8 months of the clinic. The median age of the participants was 36 years, of them, 25 (51.0%) were female, 40 (81.6%) married, and 32 (65.3%) belonged to nuclear family. Thirty-three patients (67.3%) visited general practitioners, 13 (26.5%) had visited traditional practitioners and faith healers, 48 (98.0%) had made visits to specialists/ tertiary care centers, and nine (18.4%) had consulted psychiatrists before being referred to our center. The first point of contact was the general practitioner in the majority of the cases (55.1%). Patients had waited for a mean of 21.73 (± 36.55) months and taken 5.53 (± 3.86) consultations before referring to our clinic. Conclusions: Patients with medically unexplained somatic symptoms may undertake considerable number of consultations before being referred to psychiatric treatment services. This signifies the need to train more doctors, particularly general practitioners, to empower them to recognize and manage unexplained medical symptoms.

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“…Here we report an analysis of data combined from two studies of the Symptoms Clinic Intervention (SCI), a moderately-intensive, primary care based consultation intervention, comprising one longand three moderate-length consultations, for patients with multiple, largely , physical symptoms which aimed to provide explanations for symptoms as a means of as a link to advice about self-management [27,28]. In this analysis we aimed to rigorously develop a taxonomy for the explanations for symptoms by doctors which would be generalisable beyond the current studies.…”

Section: Dementioning

confidence: 99%

“…The data for this analysis came from two developmental studies of the SCI. [27,28] The first study of the SCI, Multiple Symptoms Study 1 (MSS1), was a pilot randomised controlled trial of the SCI versus usual care conducted with a single GP, who was the developer of the SCI [27]. Its primary aim was to test the acceptability and feasibility of the SCI and of trial procedures such as recruitment and randomisation.…”

Section: Study Design Setting and Participantsmentioning

confidence: 99%