Completeness of exercise reporting on pelvic floor muscle training for women with pelvic organ prolapse: a systematic review of randomized controlled trials

Giagio S1, Innocenti T2, Salvioli S3, Lami A4, Meriggiola M4, Pillastrini P1, Gava G4

Research Type

Clinical

Abstract Category

Conservative Management

Abstract 49
Live Conservative Management 1 - Best of Rehabilitation: from Clinical Reasoning to Cost Analysis
Scientific Podium Session 6
Saturday 16th October 2021
14:20 - 14:30
Live Room 1
Pelvic Organ Prolapse Rehabilitation Female Physiotherapy
1. Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater Studiorum, University of Bologna, Bologna, Italy, 2. Department of Health Science, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, The Netherlands, 3. Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genova, Campus of Savona, Italy, 4. Gynecology and Physiopathology of Human Reproduction, IRCCS Azienda Ospedaliero -Universitaria di Bologna; Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy
Presenter
Links

Abstract

Hypothesis / aims of study
This systematic review aimed to assess the completeness of exercise reporting in randomized controlled trials (RCTs) on pelvic floor muscle training (PFMT) for women with pelvic organ prolapse (POP).
Study design, materials and methods
For the reporting of this systematic review, The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) checklist was used.
MEDLINE, Cochrane Central, CINHAL, Embase, SCOPUS, and PEDro databases were searched up to October 2020. Additional records were identified through grey literature (Google scholar) and the reference lists of all relevant studies were checked.
Full-text RCTs comparing PFMT to any type of intervention among women with any type and stage of POP[1] were eligible for inclusion. We included only articles published in English. Given the aim of this review, we excluded RCTs that provided secondary analysis or follow-up of the original article already included.
Completeness of intervention was evaluated by two independent trained reviewers with two tools: the Template for Intervention Description and Replication (TIDieR)[2]  checklist and the Consensus on Exercise Reporting Template (CERT)[3]. According to the explanation and elaboration statements of both guidelines, each item was marked with “1” if it was completely described by authors, incomplete or missing items with “0”, and not applicable items with “NA”.
The total score and the individual item scores from the TIDieR and the CERT tools were analyzed descriptively. For the final analysis, we considered the “NA” items as items not reported and described by authors.
Inter-rater agreement for each item of the tools was calculated.
Results
3918 records were identified with an initial search. 26 RCTs met criteria for inclusion.
Considering the whole included literature, the 57.1% of the 12-TIDieR items was adequately reported (6.8±2.4). The overall completeness of descriptors is illustrated in FIGURE 1. The greatest adherence reached the 83.3%. The most frequently described items were: item 1 (Brief name of the intervention; n=26, 100% of the studies) and item 4 (Procedures; n= 25, 96.2% of the studies). On the contrary, items 9 (Tailoring) and 10 (Modifications) were the least frequently reported (n= 7; 26.9% and n=0; 0%). Only in 2RCTs the core intervention components, represented by items 3 to 9, were completely reported. Items on the TIDieR with the lowest and highest agreement were items 9, 10 (57.7%) and 1 (100%), respectively.
According to the CERT, the mean score of the completely reported items was 6.7 (SD=2.9) out of 19, ranging from 0 to 12, representing the 35.3%. None of the analyzed trials provided a detailed description of PFMT as required by the 19 CERT items (FIGURE 2). Item 14a (generic description if the exercise was tailored or not), and item 14b (detailed descriptors of how exercises were tailored) were the most and the least frequently and completely described items respectively. Analyzing item 13 data (Dosage of the exercise), the adherence was less than 50%. Descriptors regarding PFMT providers (item 2) were largely missing. Regarding the inter-rater agreement, item 16a (How well, 50%) presented the lowest agreement, while items 4 (Supervised/unsupervised), 10 (Non-exercise components) and 11 (Adverse effect) were had the highest one (100%).
Interpretation of results
Describing exercise-based and complex interventions is challenging. 
Anyway, if the goal of clinical research is to provide evidence-based and reliable interventions, detailed descriptors are necessary. The lack of details can compromise the reproducibility and the comparability of the research thus reducing its empirical and practical significance.
Although different tools have been developed to help and guide researchers during the reporting of non-pharmacological and exercise studies, trial descriptions are often suboptimal.
For the first time, in this systematic review we analyzed the extent of lack of implementation of both checklist in this research field. Frequent shortcomings were the undetailed reporting of information regarding providers, tailoring and modifications of exercises and their adherence. 
To ensure adequate replication, comparison and transferability into clinical practice, researchers should apply the existing intervention reporting tools, while peer-reviewers and journal editors should check the relative adherence.
Concluding message
The completeness of PFMT reporting for women with POP is still below desirable standards and it is insufficient to ensure transferability into practice. The results of this review may add relevant knowledge and contribute to improving adequate reporting of exercise.
Figure 1 FIGURE 1. Template for Intervention Description and Replication (TIDieR) percentage of RCTs that completely reported items.
Figure 2 FIGURE 2. Consensus on Exercise Reporting Template (CERT): percentage of RCTs that completely reported items.
References
  1. Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic organ prolapse (POP). Int Urogynecol J. 2016 Apr;27(4):655–84.
  2. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar;348:g1687.
  3. Slade SC, Dionne CE, Underwood M, Buchbinder R, Beck B, Bennell K, et al. Consensus on Exercise Reporting Template (CERT): Modified Delphi Study. Phys Ther. 2016 Oct;96(10):1514–24.
Disclosures
Funding None Clinical Trial No Subjects None
23/11/2024 03:08:01