Improving care for patients with Clostridioides difficile infection

Photo by Adobe Stock/nsmastersky

Introduction

Clostridioides difficile (C. difficile) is a bacterium commonly restricted to low numbers in the human gut without harm. However, imbalance of the gut environment – often in response to antibiotic use or after gastrointestinal surgery – leads to its overgrowth and production of harmful toxins.^[1], ^[2]

Toxigenic C. difficile infection (CDI) can cause damage to the intestines, sepsis and even death.^[1], ^[3]

While some aspects of the burden of CDI are well understood, including healthcare costs and mortality rates, less is known about challenges faced by patients and clinicians with regard to the diagnosis, treatment and management of this condition.

Purpose

The primary objective of this study was to better understand the key challenges in the clinical care pathway for CDI , including its diagnosis, treatment and ongoing management in order to inform future clinical practice and policy.

Infection prevention and control in hospitals and communities was not in scope.

Countries of focus

This research focused on five high-income countries (Australia, Canada, France, Italy and the United Kingdom [UK]), which were selected based on geographic variety and having public healthcare systems that are free at the point of service.

Methods

Literature review

PubMed searches conducted to identify relevant peer-reviewed literature and web-based grey literature search (June 2021) was also conducted to identify regulations and guidelines on CDI patient care.

Surveys

In-depth semi-structured interviews were conducted with 8 experts across the 5 countries of interest, and 3 online workshops were conducted in small groups/individually to reflect on learnings from the narrative review and interviews.

Expert consultations

An online survey of clinicians and scientific experts was conducted to identify improvement opportunities for CDI patient care.

Challenges in the CDI Clinical Care Pathway

Photo by iStock/Md Babul Hosen

Diagnosis

• No single diagnostic test is recommended for the detection/diagnosis of CDI
• Use of multiple diagnostic tests has both time and cost implications
• There is lack of standardised practices with regard to the type of diagnostic tests used within and across the countries of interest
• Under and misdiagnosis is common
• Long waiting times for a diagnosis are common, especially in community settings

Treatment of first CDI episode

• Antibiotics are often the first-line treatment, but they can have side effects, including further disruptions to the gut microbiome
• Excessive antibiotic use can potentially lead to anti-microbial resistance
• Timely treatment can be an issue, exacerbated by co-morbid conditions
• Lack of evidence on optimal treatment strategies, especially for severe infections

Patient monitoring and follow-up

• Monitoring of symptoms can be challenging due to staff capacity constraint and because bowel movements are not always easy to record
• Difficult to assess whether a patient has been 'cured', as C. difficile can remain in the stool for several weeks after the infection is treated

Managing CDI recurrence

• Difficult to diagnose CDI recurrences due to lack of monitoring of specific 'recurrent' symptoms and the ability to distinguish between a recurrence and a new infection
• Issues with access to some treatments, such as Faecal Microbiota Transplantation (FMT), which presents workforce capacity, infrastructure and resourcing challenges
• FMT is generally considered safe, but it is associated with some risk for adverse events and infection transmission
• Lack of research on the long-term safety of FMT

Wider healthcare system and associated challenges for the treatment and management of CDI

Photo by iStock/Tashi-Delek

Access and service delivery

• Limited integration between primary and secondary care can delay diagnosis and treatment
• FMT presents several challenges:
• Difficulty identifying, recruiting and retaining stool donors
• Limited staff capacity and delivery infrastructure
• Lack of standardisation in its provision

Guidelines and regulations

• Variation within and between countries regarding recommendations for first-line therapy and first recurrences
• Guidelines are not updated on a regular basis
• Guidelines are sometimes modified or applied inconsistently

Economic considerations

• Newer antibiotics and emerging treatments (e.g. monoclonal antibodies) are costly
• Reimbursement for CDI treatments vary within and across countries

Education and awareness raising

Patients

• Stigma, embarrassment and poor awareness of CDI may delay timely diagnosis
• Scarcity of public health campaigns about CDI
• Little research on how CDI impacts patients/care-givers and their quality of life

Healthcare providers

• Awareness about CDI diagnosis and treatment can be low, especially among primary-care providers
• Poor coverage of CDI in medical curricula

Top priorities for improving the CDI Clinical Care Pathway

Priorities ranked as important by at least 50% of expert survey participants within at least 3 countries

Diagnosis and treatment

• New products are needed to prevent CDI recurrence
• New products are needed to better treat CDI recurrence

Access and service delivery

• Multidisciplinary care is needed to improve time to diagnosis and treatment

Guidelines and recommendations

• Guidelines and recommendations should be updated more regularly in light of new research

Education and awareness of patients

• Education is needed on appropriate antibiotic use

Education and awareness of clinicians

• Primary care providers should be educated on CDI symptoms
• Better awareness is needed among non-expert secondary care providers dealing with CDI

Evidence gaps

• More research is needed on optimal treatment regimens

Conclusions

This study identified numerous challenges related to the diagnosis, treatment and management of CDI across the clinical care pathway and the wider health care system, and it has also identified priorities related to improving the clinical care of patients with CDI.

Key Challenges

• The need to conduct multiple tests for a conclusive diagnosis
• Treatment side-effects
• The cost of some antibiotics and emerging treatments
• Barriers to access of FMT
• Difficulties in distinguishing a CDI recurrence from a new infection
• Workforce capacity constraints to effectively monitor patients on treatment and for recurrences
• Ascertaining whether a patient has been cured

Key improvement actions

• Developing innovative products for both preventing and treating recurrences
• Facilitating more multidisciplinary patient care
• Updating diagnosis and treatment guidelines
• Educating and supporting professionals in primary care and those in secondary care who are not CDI experts on identifying symptoms and managing patients

Notes

• [1] Patil R.L. 2013. 'Proton Pump Inhibitors and Clostridium difficile Infection: Are we Propagating an Already Rapidly Growing Healthcare Problem?' Gastroenterology Research 6(5):171–3. doi: 10.4021/gr575w
• [2] Sartelli M., S. Di Bella, L. McFarland, S. Khanna, L. Furuya-Kanamori, N. Abuzeid et al. '2019 update of the WSES Guidelines for Management of Clostridioides (Clostridium) Difficile Infection in Surgical Patients.' World Journal of Emergency Surgery. 14:8. doi: 10.1186/s13017-019-0228-3
• [3] Guery B., T. Galperine & F. Barbut. 2019. 'Clostridioides Difficile: Diagnosis and Treatments.' BMJ. 366:1–19. l4609. doi: 10.1136/bmj.l4609

Available for Download

Download PDF

Additional Downloads

Includes Translations

Topics

• Australia
• Canada
• France
• Gastrointestinal Disorders
• Health Care Delivery Approaches
• Infectious Diseases
• Italy
• United Kingdom