We are missing more. An international measurable model of clinical reasoning using quality indicators and routinely collected data

¹We would like to comment on the Editorial by Collins, Masaracchio and Brismée ‘The future of orthopedic manual therapy: what are we missing?’ [1].

The very short answer to this question is that we are missing the following:

• An international consensus-based and measurable model of clinical reasoning based on quality indicators;

• Routinely collected data as real-world evidence supporting clinical reasoning across the full episode of orthopedic manual physical therapy (OMPT) care.

We would like to consider the following points in an attempt to answer the question ‘What are we missing?’.

International consensus-based and measurable model of clinical reasoning based on quality indicators

We completely agree with the authors that ‘the absence of an explicit clinical reasoning paradigm may be the underlying cause for the lack of long-term benefits of OMPT interventions rather than the OMPT techniques themselves’ [1].

(in)completeness of clinical reasoning

Educational programs around the world report highly variable and inconsistent approaches to teaching the process of clinical reasoning [2,3]. Lack of agreement on the process of clinical reasoning within and between countries has negative implications for research in terms of the effectiveness and efficacy of OMPT in the short and long-term management of patients with musculoskeletal pain, such as neck pain and low back pain.

In this context, the systematic review by Maissan et al. [4] is instructive as it provides insight into the completeness of the clinical reasoning process in randomized clinical trials (RCTs). In the majority of RCTs (n = 122) involving patients with non-specific neck pain the clinical reasoning process was reportedly incomplete, specifically in the diagnostic aspect of the process, with only 6% of RCTs including a complete diagnostic process. Similar findings were reported in a review by Smith and Bolton [5] who found that the RCTs (n = 30) included in their systematic review did not report either the diagnostic strategies or the criteria for spinal manipulative therapy in patients with neck pain. These findings expose the fact that the effectiveness of physical therapy and OMPT interventions in patients with short or long-term neck pain is frequently examined without the support of a prior adequate diagnostic and decision-making process. Furthermore, it is likely that this deficiency applies not only to RCTs in patients with neck pain but also to RCTs for patients with musculoskeletal pain in general. Besides the methodological shortcomings of the studies included in these reviews, the incompleteness of the process of clinical reasoning may partially explain the inconclusive evidence supporting OMPT-related outcomes.

From implicit to explicit measurable processes of clinical reasoning

Clinical reasoning has been defined ‘as a process in which the (orthopedic manual) physical therapist, interacting with the patient and significant others, structures meaning, goals and health management strategies based on scientific evidence, clinical data, client choices and professional judgment and knowledge’ [6, p. 3–15, 7, p. 3–24]. Tools for the practice of clinical reasoning are currently being developed and tested [8,9]. Tools facilitate the process of clinical reasoning but are not a measurement tool for the quality of clinical reasoning.

Clinical decisions based on this clinical reasoning process are not only related specifically to guideline-based recommendations but are also consistent with a more comprehensive approach to managing patients with, for instance, musculoskeletal pain such as non-specific low back pain or neck pain. Shortcomings of most models of clinical reasoning include the processes intended to make them both explicit and measurable. The transparency and measurability of the clinical reasoning process are seen as cornerstones through which orthopedic manual physical therapists can monitor the process of optimal diagnostics, treatment options, and patient-related outcome measurement for each individual patient.

The quality of clinical reasoning can be improved with the use of quantitative measures such as quality indicators (QIs) [10, p. 222–234, 11, p. 6–28]. In the context of an explicit and measurable clinical reasoning process, the development, implementation, and evaluation of clinical reasoning-focused QIs embedded in clinical practice guidelines (CPGs) can be regarded as a relatively new field of OMPT research.

Quality indicators

QIs have been defined as ‘measurable elements of practice performance for which there is evidence or consensus that they can be used to assess the quality of the care provided’ [12–15]. QIs may relate to structures (such as staff, equipment, appointment systems), processes (such as clinical reasoning), or outcomes of care (such as a patient’s functioning, disability, and participation). Rational development of QIs is preferably based on systematic reviews and recommendations from CPGs, supplemented by expert clinical experience and patient perspectives and values.

In contrast to international CPGs, for example for low back pain [16] or neck pain [17], Dutch physical therapy CPGs include an embedded process of clinical reasoning [18]. Today, most Dutch physical therapy CPGs and evidence statements have been translated into the English language under the auspices of the Royal Dutch Society for Physical Therapy (Koninklijk Nederlands Genootschap Fysiotherapie [KNGF]), including those on low back pain [19] and neck pain [20].

In the Dutch physical therapy CPGs, the complete process of clinical reasoning consists of nine steps: I Administration; II History taking; III Objectives of examination; IV Clinical examination; V Analysis and conclusion; VI Treatment plan; VII Treatment; VIII Evaluation; and IX Discharge. All steps are described in detail in the KNGF guideline Patient Health Record [21], and were described more recently, in applied form, for different groups of patients [22–27].

The availability of an explicit and measurable process of clinical reasoning using QIs is the key to genuine insight into the effectiveness and efficacy of OMPT in the short and long-term management of patients with musculoskeletal pain. Lin et al. have recently published a systematic review that aimed to identify consistent recommendations from high-quality CPGs (n = 11) in patients with musculoskeletal pain [28]. Eleven recommendations covering musculoskeletal pain conditions were formulated. For instance, ‘undertake a physical examination, which could include neurological screening tests, assessment of mobility and/or muscle strength’ (recommendation 5) or ‘apply manual therapy only as an adjunct to other evidence-based interventions’ (recommendation 9). Consistent with these recommendations, clinical reasoning-based QIs are expressed as percentages ranging from 0–100%. For instance, ‘the number of patients for whom physical examination was in agreement with history taking and examination objectives’, or ‘which intervention was in agreement with treatment goals, and guideline- and experience-based recommendations’.

Transparency of the clinical reasoning process, as provided by measurable elements such as QIs, is considered one of the first steps in the short and long-term management of patients with musculoskeletal pain and dysfunction.

In summary, the set of QIs embedded in the clinical reasoning process in the Dutch CPGs can be used internationally as a starting point for the development of a general set of QIs designed to measure the quality of OMPT. International consensus on this set of process and outcome QIs would considerably improve our ability to explain real-world evidence concerning short and long-term outcomes following OMPT. Furthermore, the set of QIs found in the Dutch CPGs is consistent with the eleven recommendations derived from high-quality international CPGs [28].

Routinely collected data as real-world evidence supporting clinical reasoning across the full episode of OMPT care

We are also in agreement with Collins et al. [1] regarding their conclusion that assessment of the long-term effectiveness of OMPT based on the results of RCTs remains inconclusive. The dominance of the RCT design as the highest achievable level of evidence is now meeting with increasing resistance. In another, more recent Editorial in this journal, the usefulness of evidence from RCTs for clinical practice in OMPT was again challenged [29]. Other study designs such as prospective or retrospective observational designs could allow better focus on the process of clinical reasoning in OMPT in real-world settings. Re-evaluation of observational studies as real-world evidence is desirable in terms of the pyramid of scientific evidence.

Real-world evidence: routinely collected data

Routinely collected data (RCD) may be useful for filling evidentiary gaps and can provide new opportunities for generating real-world evidence. The use of RCD is one of the preferred methods to measure the (improvement of) clinical reasoning and quality of care. RCD are collected in practices for reasons unrelated to research or prior research questions and are increasingly seen as real-world evidence. RCD have the potential to maximize representativeness and generalizability by capturing data in large populations over the short and long term [30,31]. Data from daily practice are readily available (although the accuracy and completeness may vary) and represent a potentially rich source of information on large numbers of patients with diverse conditions. Use of existing data is less demanding in practical terms and is accompanied by fewer ethical constraints than the planning, funding, and execution of long-term pragmatic or experimental studies. RCD are diverse, available worldwide in both hospitals and general practice, and include clinical information from electronic health records, disease registries and epidemiologic surveillance studies. Nevertheless, examples of RCD in OMPT are scarce [32].

Patient health records

Physical therapists typically collect considerable amounts of patient-related data during the iterative steps of clinical reasoning. These data are registered in a standardized patient health record, preferably electronic, according to the steps of clinical reasoning. In this context, a patient health record is described as a system which collects a (minimum) data set from patients undergoing a clinical reasoning process [21].

Patients’ health records are generally established with a broad range of goals in mind, which may include monitoring of the quality of care, providing internal and external feedback, promoting communication between patients, physical therapists and physicians, recognizing patterns of health profiles over time, reducing variation in diagnostics and treatment, and determining patient-related outcomes over the short and long term. A systematic review by Hoque et al. [33] on the impact of the implementation of the patient health record on the quality of care found a positive effect on the clinical reasoning process and patient-related outcomes.

Recently, a systematic review was published summarizing the evidence on long-term monitoring of patients with chronic diseases in primary care using electronic medical records [34]. Most records were published on type 2 diabetes mellitus while osteoarthritis was the most underrepresented of the five studied diseases. No studies using electronic health records concerning neuromusculoskeletal and movement-related disorders, with the exception of osteoarthritis, were included in this systematic review. Studies evaluating the content and quality of electronic health records in OMPT are lacking.

In summary, the development of a real-world evidence pyramid, based on an explicit process of clinical reasoning using RCD and measured by QIs, is the current challenge facing OMPT. A high-quality patient health record based on international consensus is a prerequisite for using RCD as real-world evidence.

Concluding remarks

Despite the accumulation of a large number of RCTs over several decades, the effectiveness of OMPT remains inconclusive, and the incompleteness or lack of an explicit process of clinical reasoning is one of the most plausible explanations for these inconclusive results.

The use of QIs derived from an international, consensus-based model of clinical reasoning and RCD based on an internationally-uniform patient health record have so far had a limited impact in OMPT. However, their contribution to real-world evidence will undoubtedly be important to the future of OMPT.

We hope our thoughts in response to the editorial by Collins and colleagues will make a positive contribution to the question ‘What are we missing?’. The future of OMPT is in our hands.

Disclosure statement

No potential conflict of interest was reported by the authors.