Monitoring strategies for clinical intervention studies

AbstractBackground and purposeChronic pelvic pain (CPP) is a debilitating condition among women with a major impact on health-related quality of life, work productivity and health care utilisation. The exact prevalence of chronic pelvic pain is not known, but 3.8% is commonly suggested. Musculoskeletal dysfunction is frequently cited as a possible aetiology. Physiotherapy is therefore recommended as one treatment modality. The aim of this systematic review was to source and critically evaluate the evidence for an effect of physiotherapy on pain, physical activity and quality of life in the treatment of female CPP.MethodsElectronic databases, conference proceedings, text books and clinical guidelines were searched for quantitative, observational, and prospective clinical intervention studies of female chronic pelvic pain where physiotherapy was a sole or significant component of the intervention. Trial inclusion, data extraction according to predefined criteria and risk of bias assessment were performed by two independent authors. Methodological quality of the included clinical intervention studies was assessed using The Cochrane Collaboration’s tool for assessing risk of bias. Review Manager (RevMan) version 5.0 was used for data analysis. Effect estimates (relative risk, mean difference and mean change) with 95% confidence intervals were calculated for the above outcomes. For significant outcomes the numbers needed to treat were calculated.ResultsThe search strategy identified 3469 potential articles. Of these, 11 articles, representing 10 studies, met the inclusion criteria. There were 6 randomised clinical trials, 1 cohort study and 3 case series. Methodological quality was dependent on study type. Accordingly, level of evidence was judged higher in randomised clinical trials than in the other study types. Physiotherapy treatments varied between studies and were provided in combination with psychotherapeutic modalities and medical management. This did not allow for the ‘stand-alone’ value of physiotherapy to be determined. Heterogeneity across the studies, with respect to participants, interventions, outcome measures and times of follow-up, prevented meta-analysis. Narrative synthesis of the results, based on effect estimates and clinically relevant pain improvement, disclosed some evidence to support an effect of multidisciplinary intervention and Mensendieck somatocognitive therapy on female chronic pelvic pain.ConclusionChronic pelvic pain in women is a major health care problem with no specific therapies and poor prognosis. There seems to be some evidence to support the use of a multidisciplinary intervention in the management of female chronic pelvic pain. Somatocognitive therapy is a new approach that appears to be promising and randomised clinical trials are underway in order to establish its evidence base.ImplicationsBased on the findings of this review, recommendations for physiotherapy in chronic pelvic pain clinical guidelines, textbooks and narrative reviews should be interpreted with caution due to the lack of a sufficient evidence base. Only small and largely non-randomised studies have been undertaken of physiotherapeutic interventions and this greatly limits the available evidence on which to base clinical practice. High quality randomised clinical trials are therefore urgently needed.

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Five Features to Look for in Early-Phase Clinical Intervention Studies

Neurorehabilitation and Neural Repair ◽

10.1177/1545968320975439 ◽

2020 ◽

Vol 35 (1) ◽

pp. 3-9

Author(s):

Jonathan S. Tsay ◽

Carolee J. Winstein

Keyword(s):

Early Phase ◽

Intervention Studies ◽

Clinical Decision Making ◽

Clinical Intervention ◽

Daily Practice ◽

Stroke Care ◽

Clinical Decision ◽

Balance Sheets ◽

Neural Connections ◽

Busy Clinician

Neurorehabilitation relies on core principles of neuroplasticity to activate and engage latent neural connections, promote detour circuits, and reverse impairments. Clinical interventions incorporating these principles have been shown to promote recovery and demote compensation. However, many clinicians struggle to find interventions centered on these principles in our nascent, rapidly growing body of literature. Not to mention the immense pressure from regulatory bodies and organizational balance sheets that further discourage time-intensive recovery-promoting interventions, incentivizing clinicians to prioritize practical constraints over sound clinical decision making. Modern neurorehabilitation practices that result from these pressures favor strategies that encourage compensation over those that promote recovery. To narrow the gap between the busy clinician and the cutting-edge motor recovery literature, we distilled 5 features found in early-phase clinical intervention studies—ones that value the more enduring biological recovery processes over the more immediate compensatory remedies. Filtering emerging literature through this lens and routinely integrating promising research into daily practice can break down practical barriers for effective clinical translation and ultimately promote durable long-term outcomes. This perspective is meant to serve a new generation of mechanistically minded and caring clinicians, students, activists, and research trainees, who are poised to not only advance rehabilitation science, but also erect evidence-based policy changes to accelerate recovery-based stroke care.

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Why epidemiological and clinical intervention studies often give different or diverging results?

IUBMB Life ◽

10.1002/iub.141 ◽

2009 ◽

Vol 61 (4) ◽

pp. 391-393 ◽

Cited By ~ 2

Author(s):

Henrik E. Poulsen ◽

Jon Traerup Andersen ◽

Niels Keiding ◽

Tina Ken Schramm ◽

Rikke Sørensen ◽

...

Keyword(s):

Intervention Studies ◽

Clinical Intervention

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Microbiota in Health and Disease—Potential Clinical Applications

Nutrients ◽

10.3390/nu13113866 ◽

2021 ◽

Vol 13 (11) ◽

pp. 3866

Author(s):

Matthias Laudes ◽

Corinna Geisler ◽

Nathalie Rohmann ◽

Jildau Bouwman ◽

Tobias Pischon ◽

...

Keyword(s):

Intervention Studies ◽

Association Studies ◽

Bacterial Species ◽

Animal Experiments ◽

Clinical Intervention ◽

Clinical Applications ◽

Point Of View ◽

Special Role ◽

Large Set ◽

Obesity And Diabetes

Within the last two decades tremendous efforts in biomedicine have been undertaken to understand the interplay of commensal bacteria living in and on our human body with our own human physiology. It became clear that (1) a high diversity especially of the microbial communities in the gut are important to preserve health and that (2) certain bacteria via nutrition-microbe-host metabolic axes are beneficially affecting various functions of the host, including metabolic control, energy balance and immune function. While a large set of evidence indicate a special role for small chain fatty acids (SCFA) in that context, recently also metabolites of amino acids (e.g., tryptophan and arginine) moved into scientific attention. Of interest, microbiome alterations are not only important in nutrition associated diseases like obesity and diabetes, but also in many chronic inflammatory, oncological and neurological abnormalities. From a clinician’s point of view, it should be mentioned, that the microbiome is not only interesting to develop novel therapies, but also as a modifiable factor to improve efficiency of modern pharmaceutics, e.g., immune-therapeutics in oncology. However, so far, most data rely on animal experiments or human association studies, whereas controlled clinical intervention studies are spare. Hence, the translation of the knowledge of the last decades into clinical routine will be the challenge of microbiome based biomedical research for the next years. This review aims to provide examples for future clinical applications in various entities and to suggest bacterial species and/or microbial effector molecules as potential targets for intervention studies.

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