Wednesday, January 20, 2021

Lupine Publishers | Recurrent Ischemic Stroke as a First Manifestation of Poorly Differentiated Carcinoma (PDC) of Unknown Etiology

  Lupine Publishers | Open Access Journal of Oncology and Medicine (OAJOM)

Introduction

The association between cancer and thrombosis has been known for a long time, and the majority of the thromboembolic events associated with cancer are usually diagnosed after the cancer being identified [1]. However, a thromboembolic event may precede the identification of a cancer and maybe the first manifestation of the underlying malignancy [2]. Malignant cancers promote hypercoagulable state and increases the risk of thromboembolism. Carcinoma is the most common cause of ischemic stroke associated with malignancy [3] with lung cancers being the most common [1,4] while adenocarcinoma confers a higher risk of recurrent venous thromboembolism (VTE) [5]. We report a case of recurrent embolic strokes resistant to anticoagulation as the first manifestation of poorly differentiated carcinoma (PDC) of unknown etiology. It is the first case reported in the literature.

 Case Report

 A 57 years old male patient presented to our hospital with nonfluent aphasia. There was no significant past medical history and he denied smoking, alcohol or illicit drug use. Clinical examination revealed a right inferior quadrantanopsia, a right upper extremity weakness with strength 4/5 according to Medical Research Council Scale. There were difficulties in word-finding, naming and reading with intact repetition. His admission National Institute of Health Stroke Scale (NIHSS) was 6. He was deemed ineligible for thrombolysis due to unclear onset time and was started on aspirin and high intensity statin. The CT angiography of the head and neck showed no evidence of aneurysm, dissection, significant flow stenosis, or arteriovenous malformations. A Transesophageal Echocardiography (TEE) showed normal left ventricular function with no evidence of a thrombus or a Patent Foramen Ovale (PFO). A Magnetic Resonance Imaging (MRI) of the brain showed acute infarcts within multiple vascular territories, involving the bilateral cerebellum, left frontal, temporal, parietal and occipital lobes, consistent with embolic infarcts (Figure1). A four-vessel digital subtraction cerebral angiogram did not show evidence of vasculitis or vessel malformation. A hypercoagulable panel did not reveal evidence of hematologic hypercoagulability. The patient was treated with warfarin with low molecular weight heparin bridging due to the highly embolic nature of the MRI findings, and was discharged to the acute inpatient rehabilitation facility. While at the rehab, the patient started complaining of back and abdominal pain. A CT abdomen and pelvis identified heterogeneously enhancing lesion within the lower pole of kidney with extensive lymphadenopathy (Figure 2). While waiting for biopsy to be done, the patient had worsening of aphasia and dysarthria prompting readmission. Repeat MRI brain showed new scattered areas of acite infarcts in different vascular territories (Figure 3). Anticoagulation was continued. Two days later, he had worsening mental status and repeat imaging showed more acute infarction. Biopsy of the abdominal lymph node was facilitated, and result showed poorly differentiated carcinoma of unknown origin. The family opted for comfort measures only and the patient expired shortly

Discussion

Hypercoagulable state is a common finding in patients with malignancy due to the production of substances with procoagulant activity. Different mechanisms have been implicated in the cerebrovascular complications of cancer patients and includes the following: [6]

I. Cerebral infarction from nonbacterial thrombotic endocarditis (NBTE).

II. Thrombosis due to compression or infiltration of cerebral vessels by tumor or coagulopathy induced by chemotherapy.

III. Cerebral venous sinus thrombosis due to hypercoagulable state or chemotherapy.

IV. Cerebral infarction due to tumor emboli or septic thrombi.

V. Intracranial hemorrhage which is more common in patients with hematological malignancies.

Our patient presented with ischemic stokes involving multiple vascular territories. A complete workup for ischemic stroke was performed, including Brain MRI, TEE and cerebral angiogram that ruled out the presence of brain tumors, atherosclerosis, vasculitis, cardiac embolic source as well as sinus thrombosis. The results were in favor of embolic strokes. The physical examination did not reveal any signs of sepsis or infection. The conventional etiologies of stroke could not be identified. Despite appropriate therapeutic anticoagulation the patient had recurrent ischemic strokes. The commonest cause of stroke in cancer patients is embolic due to hypercoagulation [1,4]. Recent study showed that infarction in multiple vascular territories in stroke patients associated with cancer is significantly elevated (34%), compared to 15% of stroke patients not associated with cancer [5], so it is important to consider the existence of a concealed cancer in stroke patients with multiple vascular territories involvement and conventional mechanisms for stroke etiology not identified. A retrospective study showed that in patients with ischemic stroke associated with cancer, the cumulative rates of recurrent ischemic stroke were 7 % at 1 month, 15 % at 3 and 6 months [3]. In our case the patient experienced recurrent events within a two-week period and continued despite adequate anticoagulation. It is unclear whether initiation of aggressive cancer treatment may have improved patient outcome as the family opted for withdrawal of care. Further study on the early initiation of cancer therapy in malignancy-associated ischemic strokes even during the acute phase may be warranted.

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Monday, January 11, 2021

Lupine Publishers : A Systematic Review of Anterior Cruciate Ligament Reconstructions with Hamstring Autograft in Patients Over 50 Years of Age

  Lupine Publishers |  Orthopedics and Sports Medicine




Abstract

Background: While ACL injuries in older patients have historically been treated non-surgically, several recent studies have demonstrated excellent clinical outcomes with ACL reconstruction in patients over 50 years of age. Despite these outcomes, the ideal graft choice in this age group has yet to be defined.

Objective: The purpose of this study was to systematically review the literature and analyze the clinical outcomes, failure rates and complication rates in patients over the age of 50 who have undergone ACL reconstruction using a hamstring autograft.

Methods: A systematic review of the literature was performed according to the PRISMA guidelines and included English studies from January 2000 to 2020. Studies that reported on outcomes of patients over 50 years of age undergoing ACL reconstruction with a hamstring autograft were included. Studies with other graft types, patients under 50 and expert opinions were excluded. Data consisted of patient demographics, physical exam findings, functional outcome scores, failure rates and complications.

Results: 6 studies met the inclusion criteria and included 167 patients with a mean age of 54.8 (50-71). Mean follow up was 41.4 (12-72) months. All studies demonstrated a significant improvement in functional outcomes at final follow up, including IKDC, Lysholm, and Tegner scores. Very few complications and no clinical failures or revisions were reported in this cohort.

Conclusions: The results of this systematic review support hamstring autograft as a viable graft option for ACLR in patients over 50 with excellent functional outcomes, high patient satisfaction, low failure rates and minimal donor site morbidity.

Keywords: ACL: Anterior Cruciate Ligament; Reconstruction; Hamstring Autograft; Advanced Age

Introduction

Anterior cruciate ligament (ACL) rupture is one of the most common injuries seen in orthopedic sports medicine with over 129,000 occurring every year [1]. Until relatively recently, operative treatment has focused mostly on younger active athletes while older individuals were treated conservatively. Ciccotti et al. have reported an 83% satisfaction rate at final follow-up for older patients with an ACL tear treated conservatively [2]. Despite the high patient satisfaction rate, the authors noted persistent instability on exam in 97% of the patients and a reinjury rate of close to 40%, calling into question the benefit of conservative treatment in this age group. With an ever-increasing number of active individuals and increasing life expectancy, more and more patients are participating in high risk activities for ACL injury well into the later years of life. As a result, there has been an increasing number of studies evaluating the clinical outcomes of ACL reconstruction in older patients [3-16]. While 40 years of age has traditionally been the cut off for older patients, several published case reports have documented satisfactory clinical outcomes in patients in their 70s and 80s [11-15]. Because of this growing evidence, many have advocated for ACL reconstruction (ACLR) regardless of the age of the patient in the absence of advanced degenerative changes in the knee. Despite the positive outcomes of ACL reconstruction in older patients, the ideal graft choice in patients over the age of 50 remains controversial. While allograft is commonly utilized, several studies have advocated for the use of hamstring autograft in this population demonstrating excellent clinical outcomes and minimal donor site morbidity. The purpose of this study was to systematically review the literature and analyze the clinical outcomes in patients over the age of 50 who have undergone ACL reconstruction using a hamstring autograft. The secondary purpose was to characterize the overall failure and complication rate.

Methods

A systematic review of the literature was performed per the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.

Search Strategy and Criteria
A literature search was conducted in the PubMed, Ovid, EMBASE, and Medline databases for studies in the English language between January 2000 and March 2020. Keywords used to identify relevant articles included “anterior cruciate ligament” OR “ACL” AND “50” OR “aged” OR “aging” OR “older patient”. Filters activated included: clinical trial, comparative study, controlled clinical trial, meta-analysis, multicenter study, observational study, randomized controlled trial, review, systematic reviews, validation studies, humans, and English. The focus was to study the various outcomes reported after ACLR among patients who are 50 years or older and had a hamstring autograft. Studies included prospective cohort studies, retrospective studies, and case series. A cohort of patients over the age of 50 years undergoing ACL reconstruction with a hamstring autograft was the primary inclusion criteria. Studies that did not have all patients treated with hamstring autograft, expert opinions, nonclinical studies, clinical studies that did not include a cohort over 50 years of age, clinical studies that were primarily centered on arthroplasty and studies in which the primary pathology did not involve the ACL were excluded from the analysis.

Extraction of Data and Synthesis
The primary outcomes were clinical and functional results such as Lysholm score and International Knee Documentation Committee (IKDC) score. These scores were extracted independently (M.M and G.Y) and presented as the mean with range of values listed in parentheses. Both pre-operative and post-operative scores were evaluated when available. To evaluate patient’s activity level, the Tegner activity score was used where 0 represented disability because of knee problems, and 10 represented the highest score corresponding to national and international elite competitive sports. Failure rate was also extracted which corresponded to a need for surgical revision due to recurrent ACL tear. The Lachman test and pivot-shift test were also assessed. An exam of 0-1 was listed as negative and 2-3 were listed as positive for both tests. Patient satisfaction information was also evaluated when listed.

 

Statistical Analysis

The meta-analyses were carried out using STATA software version 14 (Stata Corp, College Station, TX) and R software version 3.6.3. Heterogeneity was quantified by I2 statistic. A random-effect model was used when significant heterogeneity was detected among studies (p < 0.10, I2 ≥ 50%). The Egger’s linear regression test and funnel plots were used to examine the possibility of publication bias due to small-study effects (Figure 1 and 2). Differences in change of mean and standard deviation were calculated using:

Conclusion

The results of this systematic review support hamstring autograft as a viable graft option for ACLR in patients over 50 with excellent functional outcomes, high patient satisfaction, low failure rates and minimal donor site morbidity. 

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Thursday, January 7, 2021

 Orthopedics and Sports Medicine Open Access Journal (OSMOAJ)



Abstract

This study aimed to analyze the effect of a training circuit, applied for 3 weeks, during the warm-up phase of practical physical education classes, and to verify the resulting effects on the analyzed variables. Twenty-five students participated in the study (mean ± age = 15.67 ± 1.02), weight (67.31 ± 9.29 kg), height (1.72 ± 0.08 m). The training program in circuit was applied twice a week, for 3 weeks, and it was containing burpees, jumping together, squats, sit-ups, push-ups, countermovement jumps, sprints with change direction. The students were analyzed in two different moments (i.e., pre/post application of the training program). The results indicated that the application of the training program induced positive effects in the optimization of aerobics fitness, specifically in the shuttle test. The study also concluded that the circuit training program, in addition to inducing positive changes in the shuttle test, is also a viable alternative for warming up in the physical education class.

Introduction

Physical education plays a fundamental role in the integral development of the student, enabling cognitive, psychomotor, and affective development while also encouraging healthy lifestyles, socialization, team spirit, and sports practice. The benefits of regular physical activity are diverse; namely, improvements in cardiovascular and respiratory function, decreased levels of anxiety and depression, and increased sense of well-being, and the development of cognitive and social valences [1-43]. In contrast, a sedentary lifestyle in adults is associated with a decrease in functional capacity, an increase in morbidity and mortality, and chronic diseases [19-32]. Therefore, it is essential to promote healthy living habits and physical activity during childhood, which, when prolonged during adolescence until adulthood, can be useful in combating physical inactivity and also have a beneficial influence on health in general [22-24]. Currently, and in the face of an increasingly challenging and stimulating world, it would be expected that there would be concerns regarding the development of motor, social, and cognitive abilities from an early age [5-35]. However, the reality is that an increase in sedentary lifestyle, interaction problems, and less contact with nature is exponential and endangering the development of children’s motor skills [40]. The daily recommendation for physical activity for young people is 60 minutes of moderate to vigorous activity, 5 times a week [42]. However, in most cases, this is not the case, as most adolescents practice exercise only in a school context, particularly during physical education classes, hence its exponential importance in children’s development [28]. Therefore, the school can be characterized as the perfect location to implement health promotion strategies and promote healthy lifestyle habits [18]. In particular, with regard to physical education classes, one of the strategies that can increase their efficiency, and which has been increasingly implemented in the school context, is circuit training, which, when properly adapted, enables the inclusion of various content and the development of several individual skills [10] as well as the enhancement of physical exercise practices [17]. In fact, the need for training and increased strength in children and young people has gained greater significance, as well as the knowledge that there are significant improvements associated with the application of these programs, provided that they be run in sufficient quantities-with functional loads that exceed the usual muscular activity-and are adequate, in that they strictly follow the methodological recommendations for the development of strength in children and young people [21].

This type of training program is carried out through interval training and consists of several stations that involve work on strength, balance, resistance, and coordination, depending on the objectives [37]. This type of training program has several advantages: it is easy to adapt to the target audience and existing resources; it enables the stimulation of several muscle groups in each season and the application of different loads, and allows results to be obtained in a short period of time [12]. In this regard, recent studies indicate that children and adolescents could benefit from this type of training program in a school context [2-30]. A recent study [7] showed significant improvements in all investigated physical capacities after the application of this type of program. Efficiency was demonstrated even in a short period, and these conclusions have been corroborated by a previous investigation [29]. Another study [2] also found improvements in the physical fitness of the students, although the program application time was different. Emphasizing these results [11] considered that physical fitness is an important health marker that should be monitored from a young age and be assessed through aptitude tests, which are easy to apply, do not require many resources, and enable an evaluation in little time, therefore offering an excellent alternative for schools in symbiosis with the training programs mentioned above [36] mentioned the importance of physical education teachers using this type of test, given that, in addition to being a vehicle for promoting physical activity, it also detects certain health problems. Based on the evidence that indicates that physical fitness has a fundamental role in our society and health, at any age [34] as well as the indicators pointed out by some studies regarding the relevance of the application of programs of training in the school context, it is important to consolidate this idea and continue to investigate the effects of the application of training programs in the school context, in order to analyze the potential of application to the alternative development of students’ physical condition in physical education classes. Despite the variability of studies on this subject, which emphasize the improvements resulting from the application of various training programs, there is still no consensus regarding the characteristics they should have, namely with regard to their duration, intensity, type of training, exercise, and ideal application time. Thus, the objective of this study was to analyze the effect of a training circuit, applied for 3 weeks, at the beginning of each physical education class, and to verify the resulting effects on the analyzed variables. As a study hypothesis, it was considered that the varied program may have positive effects on the physical condition of the participants across determined variables, including the horizontal thrust, reciprocating, abdominals, and push-ups.

Methods

Participants

A group of 25 students belonging to a Portuguese school-mean age (15.67 ± 1.02), weight (67.31 ± 9.29 kg), height (1.72 ± 0.08 m) and index of body mass (BMI) (22.50 ± 2.65%)-participated in the study. None of the participants had regular strength training habits. Before the study began, students underwent a physical examination by a doctor, and each was considered free from any disorder that would prevent full participation in the investigation. All participants and the teacher were fully informed verbally and in writing about the nature of the study. As for the nature and requirements of the study, as well as the known health risks, the participants filled out a questionnaire about their health history and were informed that they could withdraw from the study at any time. All guardians provided their consent through informed consent, attesting to their children’s voluntary participation in the study. The study was approved by the school’s Ethical Advisory Committee and conducted in accordance with the Declaration of Helsinki.

Experimental Design This study aimed to verify the effects of applying a circuit training program during the warm-up phase of practical physical education classes on specific physical fitness variables (i.e., the shuttle test, sit-up test, push-up test, and horizontal impulse test). A varied circuit training program was applied, with the aim of stimulating increments in four indicators of physical fitness (i.e., shuttle, horizontal thrust, extension of arms, and abdominals). These were evaluated at two different points: before the start of the training program (pre-test) (T1) and after applying the training program (post-test) (T2). The training program lasted for 3 weeks and was run during the academic year, between February and March, during the warm-up period of physical education classes. In addition, on a weekly timetable of 3 hours per week, divided into 2 classes of 1h 30m, the students took part in a training program that included exercises lasting 15 minutes. All experimental procedures were performed in coordination with the teachers and, therefore, did not cause any change in the individuals’ routine. Pre and posttests were carried out in the internal space to eliminate the effect of climatic conditions on the results. These tests were chosen because they could be applied quickly and because they did not influence the normal course of activities in the classroom.Procedures

Four specific variables were analyzed with adaptations to previously used protocols: the shuttle test [14], sit-up test [9], pushup test [4], and horizontal impulse test [31]. These were evaluated in 2 distinct phases: before the application of the training program (i.e. pre-test) and after the application of the training program (i.e. post-test). The values for each test were recorded for subsequent analysis. The anthropometric variables of height and body mass were measured for each subject, on a levelled platform scale (Año Sayol, Barcelona, Spain), with an accuracy of 0.001 m and 0.01 kg, respectively.

Training Program

The training program was applied twice a week for a total of 3 weeks. The program had a weekly increment of one repetition. The exercises applied contained strength exercises: burpees, jumping together, squats, sit-ups, push-ups, and countermovement jumps. The program was also composed of sprints, with changes in direction (5 m) and speed (20 m), as shown in Table 1, and were performed according to the protocol described in Figure 1 [15].

Statistical Analysis

The calculation of means, standard deviations, and 95% confidence intervals (95% CI) was performed using standardized statistical methods. The normality of the distribution was examined using the Shapiro-Wilk test (n <30) and, depending on the existence of normality, parametric or nonparametric tests were adopted for data analysis. To compare the physiological variables at rest in the two assessment sessions and to compare the responses to the exercises, the paired T-test and the non-parametric correspondent, the Wilcoxin test, were used. The level of statistical significance was found to be p≤0.05. The effect size (TDE), with a 90% CI, was calculated using the Hedge’s g formula, as it produces more reliable results when n <20 [20]. To classify the TDE, a modified classification system was used (trivial: 0.0–0.2; small: 0.2–0.6; moderate: 0.6–1.2; large: 1.2–2 , 0; very large:> 2.0; extremely large:> 4.0) (Hopkins et al., 2009). Percentage variations between the initial evaluation (pre) and the evaluation after the academic period (post) [(posttraining - pre-training) / pre-training) x100] were also calculated and considered statistically significant when 95% of the difference confidence did not include the zero value.

Results

The two moments of evaluation were analyzed and paired, as shown in Table 2 (pre- vs post-training test). The results showed that there were no statistically significant differences (p> 0.05) for the push-up test, sit-up test, and horizontal impulse test (p = 0.085; p = 1.0; p = 0.052) respectively. Regarding the effect size, the results showed a small effect for the push-up test (d = 0.18) a moderate effect for the sit-up test (d = 0.9), and a trivial effect for the horizontal push test (d = 0). With regard to the shuttle test, there were statistically significant differences between the 2 evaluation moments (p <0.05) with a small effect size (d = 0.25). The difference between the pre and post-workout for the push-up test was 6.60%, whereas for the sit-up test it was 4.27%; the shuttle test, however, had a variation of 7.26%, whereas for the horizontal impulse it was 0%.

Table 2: Comparison between Pre- and Post-test Training.

Discussion

Go to

This study aimed to analyze the effects of applying a training circuit on the physical condition of a school community. This circuit consisted of exercises such as burpees, sit-ups, squats, sprints, pushups, and changes in direction. The findings indicate that it induced positive effects in the optimization of aerobic fitness. The results of this study demonstrate that the training program has a positive effect for the shuttle test only. The shuttle test variable was the only one that showed significant differences after the application of a training circuit in the school context, manifesting changes between the pre-and the post-test, which contradicts previous studies [27- 29]. In this regard, another study [2] also found improvements in the performance of the shuttle test, concluding that circuit training could be an effective way to develop resilience in school. In fact, these results contradict a previous investigation [23], where benefits resulting from the application of training circuits were evidenced, such as an increase in muscular strength and muscular endurance capacity as well as a reduction in the risk of occurrences of injuries during the practice of physical and recreational activities. The analysis of the push-up variable showed that there were no significant changes, probably due to the limited time of application of the circuit, although there was a slight variation between the pretraining and post-training moments. In addition, previous studies have shown that push-up tests are those with the highest failure rates [6-41]. Regarding the horizontal impulse test, it was found that the present study contradicts the data found in previous investigations [8], as there were no significant changes. However, it was expected that there would be an improvement in the results based on the regular use of the muscles of the lower limbs during the daily activities [2]. Other investigations that evaluated the horizontal impulse [38,39] found average values of 177.89 cm after application of the training program, whereas the results of this study show average values of 196.6 cm, a much higher value that may be related to the height of the participants, based on the strong correlation between height and the force of the impulse [38]. The lack of evolution in this variable may also be related to the fact that the students have not assimilated the correct mechanics of the exercises and, therefore, there may be a deficiency in the technique that will not translate into exercise efficiency [44]. Likewise, there were also no significant differences between the moments of analysis (i.e., pre-workout and post-workout) in the sit-up test. In this regard, other investigations that have investigated this variable [13-33] obtained mean values of 35.6 cm, but the current investigation obtained a considerably higher value (i.e., 46.8 cm); in fact, this result may be related to the practice of physical activity outside the school context, which was previously considered decisive for the test result [26]. A study of characteristics similar to ours [25] found significant differences in the variables considered after the application of the training program, which consisted of a training circuit applied weekly, where the degree of difficulty of the exercises increased each week. The fact that the training program had a significant effect only on the variable of aerobic fitness may also be due to the fact that the students do not yet have an established action plan. In other words, the action scheme is enhanced and developed using repeated action, which occurs in all sports movements. This same scheme is kept in memory and can be evoked later. In this specific case, students had little time to assimilate the circuit diagram, which helps to justify the results found. It is also important to note that comparison with other investigations becomes a little reductive due to the methodological differences verified between the studies, such as circuit duration, distinct and adapted circuits, and the sample size, as well as their characteristics.

Conclusion

Go to

This investigation aimed to investigate the effects of the application of a training program in circuit format in the initial part of physical education classes, and to verify its impact on physical fitness variables in students aged between 15 and 18. After 3 weeks of application of the training circuit, the results indicate that despite the short time of exercise applied, significant improvements were obtained in the variable of aerobic fitness (the shuttle test). However, and most likely due to the short period of application of the training program, the remaining analyzed variables did not show statistically significant differences, which also allows for the possibility that if the training program was applied over a longer period, the results of the analyzed variables could show a significant increase. Nevertheless, it appears that the development of similar programs in the school context and during the teaching of teaching units may be beneficial for students in terms of improving their physical fitness and implementing training habits, as well as regular and healthy lifestyles. This investigation also presents a different proposal for the initial part of the physical education class that may be more motivating for the student, in addition to guaranteeing a different practical utility in relation to the time traditionally dedicated to warming up. With regard to study limitations, the fact that only one female member participated in the investigation prevented the results from being compared between genders, which would have been an interesting and enriching route for the study and is therefore recommended for further research. Finally, food and sleep hours were not controlled during pre-training and post-training and are variables that can affect students’ performance.

Disclosure Statement

The authors declare that there are no conflicts of interest.

For more Orthopedics and Sports Medicine Open Access Journal (OSMOAJ)

Wednesday, January 6, 2021

Lupine Publishers | The Importance of Pragmatic over Explanatory Randomised Controlled Trial in Musculoskeletal Physiotherapy Practice

 Lupine Publishers |  Orthopedics and Sports Medicine



Abstract

Depending on the choice of research methodology, there are several research designs such as a single observational case study, a cohort or case-controlled design, nonrandomised and randomised controlled trials (RCTs). While RCTs are widely considered as the gold standard for assessing the effectiveness of different physiotherapy interventions, there are two types of RCT mainly explanatory and pragmatic RCT. It is the opinion of the author a pragmatic RCT approach that not only have realistic treatment sessions but also involve less costs and personnel are best suited for musculoskeletal studies undertaken in a normal clinical environment to enhance their generalisation.

Introduction

Research evidence suggests the number of physiotherapy treatment sessions varies over treatment episodes [1], however, according to the Chartered Society of Physiotherapy [2] (CSP, 2011) the average physiotherapy (face-to-face) treatment sessions per episode of care for a patient was on average four-with a first to follow-up ratio of 1:3.4. The minimum number of physiotherapy treatments per episode was one with maximum of six treatment sessions. These figures were from the research findings of a large comprehensive review of physiotherapy outpatient services across the United Kingdom by JJ Consulting on behalf of the [2] CSP (2011). These figures are important benchmarks for Physiotherapy managers and physiotherapy service providers to them guide on staffing levels and management of caseloads to support a range of areas such as business planning, capacity and demand management, and service re-design. Thus, it is important for researchers and those funding physiotherapy researches to take into consideration the average number of treatment sessions that occurs in normal clinical practice when developing research designs that investigates the effectiveness of treatment interventions in musculoskeletal practice. This is so that the findings of such research could easily be transferable to real physiotherapy clinical situations. Pragmatic randomized controlled trials (RCTs) are designed and conducted to establish the clinical effectiveness of interventions i.e. does this intervention work under usual clinical conditions? (Tunis et al 2003 and Tunis 2005). According to [3] for a trial to fulfil the requirements of the design and conduct of a pragmatic RCT, it should have the nine dimensions for assessing the level of pragmatism in a trial. These include eligibility, recruitment, setting, and organisation, flexibility in delivery, flexibility in adherence, follow-up, primary outcome and primary analysis. Although most pragmatic RCTs follow this protocol in their design and conduct, some of them that have investigated the clinical effectiveness of interventions in musculoskeletal conditions such as low back pain (LBP) but have done so with follow-up contact of the study participants in excess of the usual practice (Table 1). Follow-up visits (timing and frequency) are pre-specified in the protocol of RCTs. However, “follow-up visits are more frequent than typically would occur outside the trial (i.e., under usual care)” [3] Loudon et al (2015) (Table 1).

Table 1 shows that in some randomised controlled trials (RCTs) on musculoskeletal physiotherapy interventions that there are difficulties with transferring the results of those trials into daily clinical practice due to their unrealistic treatment occasions. For example, an RCT [4] that was conducted to evaluate the relative efficacy of strengthening exercises versus spinal manipulation on low back pain (LBP) patients were provided a one-hour session twice per week for 6 weeks – bringing the total treatment episodes to 12 one-hour treatment sessions. Similarly, [5] Alp et al, (2014) in a RCT of management low back pain that investigated selfmanagement (unsupervised exercise) versus group biomechanical exercise used 45-60 minute, 3 times per week for 6 weeks as their treatment regime. The findings of these trials are in sharp contrast to the [2] CSP (2011) findings on the maximum number of treatments per episode care, which was six. Furthermore, anecdotal evidence suggests that initial musculoskeletal physiotherapy treatment is maximum of one hour and follow-up treatment ranges from 20- 45 minutes. The implications of the treatment regimens of both RCTs [4,5] suggests that they have unrealistic treatment occasions which cannot be transferred to practice. It is therefore imperative for clinical trials investigating the effects of physiotherapy interventions to take into consideration that study designs should mirror what occur in normal clinical practice. There are many different research designs ranging from a single observational case study, a cohort or case-controlled design, to experimental studies such as nonrandomised and randomised controlled trials (RCTs). Each design has its own strengths and weaknesses. The choice of methodology may be influenced by factors such as the research question, ethical issues, sample size and funding [6]. Although case studies are likely to demonstrate clinically significant improvement in outcomes of pain and function, it must not be forgotten that they cannot rule out the effects of natural resolution, bias and other confounders such as the real cause of the improvement (Ainsworth & Lewis 2007). However, single case studies should provide some motivation for conducting the appropriate and necessary trials such as nonRCTs and RCTs [7]. NonRCTs can detect associations between an intervention and an outcome, however they cannot rule out the possibility that the association was caused by a third factor linked to both intervention and outcome [8]. RCTs are widely considered as the gold standard for assessing the effectiveness of different interventions such as shoulder injections, because they allow us to be confident that a difference in outcome can be directly attributed to a difference in the treatments, rather than some other confounding variables (age and gender) [9,10]. However, other factors, such as patient’s clinical experience of the intervention, as well as the quality and quantity of treatment received been suggested to play a role in determining treatment outcomes [11]. Therefore, an RCT that combines these aspects by investigating the effectiveness of the interventions in real life clinical situation is important. To achieve this, RCTs investigating the effectiveness of two interventions (usual or routine versus intervention) to treatment should as part of their research methodology take into consideration the practicality of number treatment sessions, follow-up regimes and outcomes that are comparable to those observed in every day clinical practice – both in community and acute settings. This so that any treatment effect from those studies can be easily transferable to normal clinical practice situations. RCTs help to reduce the risks of bias (threats to interval validity), mostly selection bias, and are thus best suited for research designs about the effectiveness of different interventions [12]. However, it is the opinion of Cochrane, that randomisation does not, of itself, enhance the applicability of the results of a trial (external validity) to situations other than the exact one in which it was conducted [13]. It is possible for a trial to be free of bias but lacking in its application beyond the immediate clinical environment in which it was conducted [12]. This view was strongly re-echoed by [14] which it stated: “Lack of consideration of external validity is the most frequent criticism by clinicians of RCTs, systematic reviews, and clinical guidelines” [14]. To resolve this problem [12] has suggested the use of well-designed trials that adopt a pragmatic approach. Therefore, it is my opinion that for a pragmatic RCT approach to be adopted as a research design, it should have realistic treatment occasions and transferable to normal clinical environment where most people with musculoskeletal conditions are easily, are diagnosed and treated [15] to enhance its generalisation.

Pragmatic Versus Explanatory Randomised Controlled Trial

[16] describe two different types of RCT, explanatory and pragmatic. They proposed a distinction between explanatory and pragmatic trials. It is their view that many trials (such as explanatory trials) were limited in their applicability beyond the artificial, laboratory environment. Explanatory trials are aimed at validating a physiological hypothesis by specifically proving a causal relationship between administration of a treatment (a drug) and a physiological outcome (such as inflammation) [16]. Although pragmatic trials do not necessarily decrease occasions of service or necessarily curtail follow-up, they provide an explanation between interventions and treatment outcomes, and they are intended to inform healthcare decision-making. This decision involves the choice between two or more treatments occurring in real life clinical environment. On the other hand, explanatory trials provide knowledge about the effects of precisely defined interventions applied to selected groups under highly controlled conditions; however, they are not applicable in normal physiotherapy practice that lack such highly controlled environments. Pragmatic trials have been offered as a solution in that they retain the rigour of randomisation but are still applicable to normal clinical practice [17] (Relton et al 2010). It is for these reasons that musculoskeletal studies should adopt a pragmatic approach which takes into account realistic treatment occasions which occurs in a normal clinical so that findings from such trials can be easily transferable to practice. For example [18], in a pragmatic RCT that investigated exercise versus group biomechanical exercise in chronic low back patients using a one-hour session per week, which what obtains in every day, practice. The implication of this study findings is that it has realistic treatment occasion that is easily transferable to practice. The differences between the two approaches are also highlighted in the use of efficacy and effectiveness [19]. Explanatory trials deal with efficacy as these studies assess differences in effect between two or more conditions under ideal, highly controlled conditions. Although the tight controls of explanatory trials result in maximal internal validity, external validity could be lost (Alford 2007) because replicating them under normal clinical practice is difficult. Explanatory trials are thought to be well suited to medical drug trials, which are usually double or triple blinded, and involve the use of a placebo control group (Alford 2007). Pragmatic RCTs utilise effectiveness, which assesses differences in effect between two or more conditions in normal clinical circumstances, thus retaining internal validity and enhancing external validity (Alford 2007). It is the opinion of Alford (2007) that pragmatic RCTs are generally more suited to assessing musculoskeletal interventions such as exercise prescription for managing low back or shoulder pain. Explanatory trials are usually more expensive, take more time and involve more personnel, unlike pragmatic trials. These difficulties are the reasons why a pragmatic approach is best suited for musculoskeletal research within the community. The benefits are that less extra costs or personnel would involve in such studies because they are more likely to take place within normal clinical hours with the usual staff involved.

Pragmatic Randomised Controlled Trial-Why it is Important

In a normal community practice where most people with musculoskeletal pain are diagnosed and managed [15], a pragmatic RCT design is important if they have realistic treatment, occasions, which can be transferred to practice. A pragmatic RCT is aimed at determining the effectiveness of two or more interventions under the usual conditions or real-life settings in which they are applied [20]. Pragmatic trials including RCT are aimed at ensuring that the care delivered in the setting in which trials are conducted matches the care delivered in the setting to which its results are applied [3]. Pragmatic RCTs are generally linked with clinical practice and they incorporate clinical outcomes that are relevant to inform decision makers such as patients, clinicians, health commissioners and policy makers about interventions that are applicable to a wide range of clinical settings [20]. These trials adopt minimal exclusion criteria in order for the patients to reflect those receiving care within the normal population [20]. This is so that treatment interventions and decision making by both the patients and healthcare providers regarding the management of musculoskeletal conditions could be enhanced. Musculoskeletal studies should include participants drawn from a population of patients attending a community (MSK) service as they would representative of the general population. The benefits of pragmatic trials less costs and personnel because they are more likely to take place within normal clinical hours with the usual staff involved. The nine dimensions for assessing the level of pragmatism in a trial (Figure 1), as proposed in the pragmaticexplanatory continuum indicator summary 2 (PRECIS-2) tool should be adoped by musculoskeletal studies so that they can be easily transferred to practice [3]. With the current economic climate and given the pressure to improve healthcare delivery within the community, pragmatic RCTs have received widespread support and acceptance from clinicians, researchers and policy makers [21]. Healthcare commissioners and policy makers are very interested in pragmatic trials because they are designed to answer important and relevant questions, which are centred on comparative effectiveness of interventions in the normal clinical practice [22]. However, those trails should not only have realistic treatment sessions but also involve less costs and personnel. Since the local Clinical Commissioning who commissions musculoskeletal practice are interested in knowing the clinical outcomes, involving them and GPs during the planning stages of musculoskeletal research is very important. This is consistent with the suggestion by [22] that decision makers such healthcare providers and policy makers should be included in the design of pragmatic trials.

Conclusion

While RCTs are widely considered as the gold standard for assessing the effectiveness of different interventions such as shoulder injections, there are basically two types of RCT mainly explanatory and pragmatic RCT. Although each design has its own strengths and weaknesses, the choice of methodology may be influenced by factors such as the research question, ethical issues and clinical practice environment [6-31]. It is the opinion of the author a pragmatic RCT approach that not only have realistic treatment sessions but also involve less costs and personnel are best suited for musculoskeletal studies undertaken in a normal clinical environment to enhance their generalisation.

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