Qualitative Studies Linked to Trials of Complex Interventions: what does case study methodology have to offer

PosterOutput Type: Poste

Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial

This is the final version. Available on open access from BMJ Publishing Group via the DOI in this recordIntroduction Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. Methods and analysis This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. Ethics and dissemination Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review. Trial registration number ISRCTN57746448; Pre-results.National Institute for Health Research (NIHR

Traumatic brain injury rehabilitation: an overview of systematic reviews of intervention effectiveness. A pre-published protocol

INTRODUCTION. Many authors are in favour of using systematic reviews as a method for evidence synthesis in rehabilitation and the last decade has introduced several guidelines to help with their implementation in rehabilitation contexts. At present, however, there is little clear information about the quantity and quality of systematic reviews on TBI rehabilitation interventions. AIM. We aim to conduct an overview of systematic reviews published on TBI rehabilitation interventions in order to summarise the current state of evidence in this area of clinical practice. In addition to providing information on strength of evidence for intervention effectiveness, our goal is to research and summarise two additional domains: reviews’ characteristics and evidence gaps. METHODS. We will carry out a comprehensive search of the Cochrane Library database (including Database of Abstracts and Reviews of Effectiveness) MEDLINE, CINAHL, EMBASE, Epistemonikos, PDQ-evidence, and PubMed to find relevant systematic reviews. We also will make efforts to identify ongoing reviews by searching for protocols in the Cochrane Library database and in PROSPERO. We are not going to search grey literature. We will use Covidence (https://www.covidence.org/home) to manage review selection. Two review team members will independently select the reviews to be included to the overview. A third researcher will be consulted for resolving disagreements. We will use Knack software (https://www.knack.com/), to extract data on review characteristics and review findings. We will include the systematic reviews on the adult TBI population (regardless of severity, stage of recovery, or other aspects of clinical presentation), any kind of rehabilitation interventions (regardless of setting, uni- or multidisciplinarity etc) to describe review characteristics. From those systematic reviews the ones with comparisons with no treatment, placebo or sham treatment, and usual care; and with outcomes such as quality of life, activity and participation – as per International Classification of Functioning, Disability & Health –residential status, family burden, and adverse effects will provide basis for intervention effectiveness analysis. We will assess the quality of reporting with updated PRISMA (Transparent Reporting of Systematic Reviews and Meta-Analysis) by making a judgement of “yes/no/unclear” without further descriptions. We will assess the methodological quality of included reviews with AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) instrument. SYNTHESIS. We will provide a report on the characteristics of all included reviews using simple statistical analyses and narrative accounts and the main summary of results based on intervention effectiveness. Also, we aim to present conclusions specific to each intervention in terms of the current evidence base: statistical and/or narrative descriptions of effects and the evidence quality, relevant contextual factors, population, rehabilitation setting, and comparisons researched. We will not perform meta-analysis. In order to example gaps in the current evidence of TBI rehabilitation, we will separately summarise the information on ICF categorizations covered with low or very-low quality evidence or no evidence at all from existing systematic reviews. CONCLUSIONS. To support knowledge translation, we will organise the overview of reviews’ findings as comprehensive evidence maps

A 24 month longitudinal qualitative study of women's experience of electromyography biofeedback pelvic floor muscle training (PFMT) and PFMT alone for urinary incontinence: adherence, outcome and context.

Aims of study: To investigate women’s experiences of electromyography (EMG) biofeedback pelvic floor muscle training (PFMT) and PFMT alone for stress or mixed urinary incontinence (UI) to explain the contextual factors that influence intervention adherence and outcome within a randomised controlled trial. Study design, materials and methods: The study design was a two-tailed, longitudinal, qualitative case study (1) carried out in parallel to a randomised controlled trial (2). The ‘tails’ were the biofeedback PFMT group and PFMT alone group. Following ethical approval, purposive maximum variation sampling (based on difference in treatment centre, UI type, and therapist type) was used to invite a subsample of women, who had consented to the trial, to take part in the case study. Interested women were sent written information about, and asked to consent to, the case study specifically. The data from each recruited women formed one case. Women were interviewed at baseline, six, 12 and 24 months after randomisation. Interviews were semi-structured, digitally recorded and transcribed. Where possible, baseline and six month interviews were face to face and either at the participant’s home or in the clinic, and 12 and 24 month interviews were by telephone. Interviews explored women’s experiences of the social contexts within which they experienced UI, the intervention they received, adherence and outcome. Data analysis principally followed case study analytic traditions (1) whereby all data from a case were analysed and findings collected together to form a case summary with a focus on understanding a woman’s experience of UI, intervention, adherence and outcome and how these factors interacted. Case summaries within a ‘tail’ were collated, the cases compared, and the two tails were then compared to one another. Results: Sample: Forty women, 20 per group, were recruited as planned; 24 had data at all four time points (10 biofeedback PFMT and 14 PFMT alone), with 2856 minutes of interview data recorded. There was a wide age range in both groups (20 to 76 years). Eleven women had stress UI and 29 Mixed UI with similar proportions in the groups. Six women were treated in community clinics, 16 in University hospitals and 18 in District General Hospitals with similar proportions in the groups. Most women were treated by specialist women’s health physiotherapists (n=36) and four by continence nurses

Role of Digital Technologies in Training Students with Limited Healf

В данной статье описана роль цифровых технологий в обучении студентов-инвалидов и лиц с ограниченными возможностями здоровья. Раскрыты возможности получения полноценного образования для лиц с особыми потребностями.This article describes the role of digital technologies in teaching disabled students and people with disabilities. The possibilities of obtaining a full-fledged education for persons with special needs are described

Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial

This is the final version. Available on open access from BMJ Publishing Group via the DOI in this recordObjective To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. Design Parallel group randomised controlled trial. Setting 23 community and secondary care centres providing continence care in Scotland and England. Participants 600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. Interventions Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. Main outcome measures The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women’s perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. Results Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference −0.09, 95% confidence interval −0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), −£409 to £651, P=0.64) and quality adjusted life years (−0.04, −0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. Conclusions At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated.National Institute for Health Research (NIHR

Factors influencing referral to and uptake and attendance of pulmonary rehabilitation for chronic obstructive pulmonary disease: a qualitative evidence synthesis of the experiences of service users, their families, and healthcare providers (Protocol)

This is a protocol for a Cochrane Review (Qualitative). The object ives are as follows: • To identify factors that influence referral to pulmonary rehab ilitation for COPD from the perspective of service users, thei r family/carers, and healthcare providers. • To identify factors that influence uptake of pulmonary rehabil itation for COPD (i.e. at least one attendance of an assessment or first programme session) from the perspective of service users , their family/carers, and healthcare providers. • To identify factors that influence attendance at pulmonary reha bilitation programmes for COPD from the perspective of servi ce users, their family/carers, and healthcare providers. • To develop an inductive explanatory framework for how these f actors may interact to contribute to better or poorer uptake or completion of pulmonary rehabilitation in order to guide acti ons of healthcare decision-makers to improve opportunities fo r people with COPD to benefit from pulmonary rehabilitation

Consensus on exercise reporting template (Cert): Modified delphi study

© 2016 American Physical Therapy Association. Background. Exercise interventions are often incompletely described in reports of clinical trials, hampering evaluation of results and replication and implementation into practice. Objective. The aim of this study was to develop a standardized method for reporting exercise programs in clinical trials: the Consensus on Exercise Reporting Template (CERT). Design and Methods. Using the EQUATOR Network’s methodological framework, 137 exercise experts were invited to participate in a Delphi consensus study. A list of 41 items was identified from a meta-epidemiologic study of 73 systematic reviews of exercise. For each item, participants indicated agreement on an 11-point rating scale. Consensus for item inclusion was defined a priori as greater than 70% agreement of respondents rating an item 7 or above. Three sequential rounds of anonymous online questionnaires and a Delphi workshop were used. Results. There were 57 (response rate=42%), 54 (response rate=95%), and 49 (response rate=91%) respondents to rounds 1 through 3, respectively, from 11 countries and a range of disciplines. In round 1, 2 items were excluded; 24 items reached consensus for inclusion (8 items accepted in original format), and 16 items were revised in response to participant suggestions. Of 14 items in round 2, 3 were excluded, 11 reached consensus for inclusion (4 items accepted in original format), and 7 were reworded. Sixteen items were included in round 3, and all items reached greater than 70% consensus for inclusion. Limitations. The views of included Delphi panelists may differ from those of experts who declined participation and may not fully represent the views of all exercise experts. Conclusions. The CERT, a 16-item checklist developed by an international panel of exercise experts, is designed to improve the reporting of exercise programs in all evaluative study designs and contains 7 categories: materials, provider, delivery, location, dosage, tailoring, and compliance. The CERT will encourage transparency, improve trial interpretation and replication, and facilitate implementation of effective exercise interventions into practice