ࡱ> q bjbjt+t+ %AAֈ]8$:I::"\\\\\\HHHHHHH$IKHI\\\\\I \\:   \\\H\H  DH\4d |H`theoretical framework Introduction In order to answer the main question of this report, and to be able to understand the report's progression, some important elements need to be reminded. This chapter provides the theoretical framework for this review on the effects of aquatic therapy on people with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, on pain, Activities of Daily Living (ADL functioning) and Health Related Quality of Life (HRQL). This chapter will therefore explain and synthesise basic knowledge currently available in the literature and related to this question. In order to do so, this chapter will be divided in the following sections: Aquatic therapy Rheumatic disorders, with a focus on osteoarthritis, rheumatoid arthritis and ankylosing spondylitis Methods for measuring impacts of rheumatic disorders Relevancy of a literature review The use of the different data bases Aquatic therapy Definition The choice of the appellation aquatic therapy for this review was done with the desire to avoid confusion of what was the type of therapy in water under focus. Literature is making use of various terms for this intervention. The term Hydrotherapy, is widely used, along with other terms such as balneo-therapy (28), spa therapy (17), exercise therapy in water (13), aquaerobics (9), immersion (4) etc. All of those terms were met in the different studies during the progression of this review. Mrs. Arianne Verhagen, lead author of the Cochrane Collaborations systematic review on balneotherapy, suggested to use the term aquatic therapy. Another Cochrane reviewer, Mr. Jefferson Cardoso, who is a lead author on a systematic review on aquatic therapy for people with RA, currently uses this term. Aquatic therapy, the intervention of interest for this project is often defined in literature as a therapy making use of two important components: immersion in warm water and with exercise (4) , and not only a passive form of treatment in water. It is therefore under this definition that aquatic therapy will be understood in this review. The interventions being implemented in the different studies are specified by the different authors into their duration in time, frequency of sessions, length of sessions, intensity and nature of activity (whenever this information is reported). History Bathing in water has been considered healing since the beginning of time and across many cultures. From Hippocrates in the fourth and fifth century before Christ who used contrast baths (hot and cold water) in the treatment of various diseases, to the Romans at the beginning of the first century after Christ, who constructed therapeutic baths across their empire. The Greeks were among the first to appreciate the relationship between physical and mental well being, illustrating an early interest for Health Related Quality of Life (32). Around the year 340, some of these baths were used solely for healing purposes and treatment was already indicated for rheumatic disorders. After a long dark age period where hydrotherapy was condemned because of its association with physical forces, it became popular again in Europe in the late 19th century, with the development of health spas. In the 1920s, the first Hubbard tank started associating immersion with therapeutic exercises (32). Today, the increasing popularity and value of hydrotherapy is getting reinforced by the upsurge in research into many different aspects of water, the physiology of exercise in water and so on (32). Physical principles Almost all of the biological, physical and psychological effects of immersion and movement in water are in some ways related to the fundamental physical principles of water at rest, in movement and water temperature. It is therefore important to know the basics of these principles in order to understand the objectives and eventually effects of aquatic therapy (31). - Buoyancy: Force acting in the opposite direction to the force of gravity and being experienced as a thrust upwards. The force of buoyancy can thus provide weight relief. The extent of that effect is dependent on the proportion of the body below water level. - Hydrostatic pressure: this property of water provides an even pressure on all surfaces of an immersed limb or body at anyone given depth. However, the pressure is greater deeper in the water and less, closer to the surface. The effects of hydrostatic pressure aid the flow of venous blood in an anti gravitational direction when the person is standing in the pool. - Turbulence: this is an irregular movement of water molecules, which in a pool, may be created by an underwater douche or by movements that the patient may initiate himself. - Temperature: the water in a hydrotherapy pool is generally at a temperature of between 32 degrees to 36 degrees Celsius. When the form of the exercise in water is active, the temperature is around 32 degrees C. With a high heat specificity (ability to retain thermal energy) and a even higher conductivity (ability to transfer thermal energy in a certain time), warm water provides heat quickly and more efficiently to the immersed body (31). Aims of aquatic therapy Rather than listing the different effects of aquatic therapy for people with rheumatic disorders, it is maybe more prudent to talk about its aims. The reason the tendency in todays literature to connect the physiological effects of aquatic therapy to its therapeutic effects, much more difficult to prove scientifically. It is important however to precise that the physiological effects of aquatic therapy combine the properties of water to parameters dependent on the exercise program: length of treatment, type of activity, intensity and frequency of session. Because of joint pain, people with arthritis have often been limited in their ability to exercise on land (19). A mode of exercise that will produce a sufficient beneficial response to training (by improving for example range of motion, strength, stamina), without muscle or joint pain limiting the intensity or duration of the exercise, would seem to be necessary for these people. Aquatic therapy is often of great subjective benefit and may be valuable for patients affected by RA, OA and AS. This will later be explained while presenting the characteristics of each disease (see 1.3). Rheumatic disorders Rheumatic disorders is a group bridging a broad spectrum, including both articular and non-articular disorders. They are usually chronic, remitting and relapsing. They are variable in their course and affect multiple organ systems in addition to joints (34). Rheumatic disorders are usually classified as inflammatory or non-inflammatory; symmetrical or asymmetrical and accompanied, or not, by systemic and extra-articular manifestations (29, 34). They require multidisciplinary long-term treatments involving medical, surgical and/or conservative approaches. Tables 1.1, 1.2, 1.3 present the characteristics of the diseases selected for this review: Table 1.1: Characteristics of osteoarthritis: CharacteristicsOsteoarthritisDefinitionOsteoarthritis is the most common form of arthritis (affects 80 % of adults over the age of 55; females >males) and one of the most common conditions treated by physiotherapists. It is a degenerative asymmetrical joint disorder in which there is a progressive loss of articular cartilage accompanied by new bone formation and capsular fibrosis. It is defined as primary when no cause is obvious, and secondary when it follows a demonstrable abnormality (29, 33). Aetiology, pathologyThere are many theories regarding the aetiology of OA. Primary OA is essentially still a condition of unknown aetiology typically found in women of menopausal age. Secondary OA (often traumatic), results from a disparity between the stress applied to articular cartilage and the ability of the cartilage to withstand that stress. The cardinal features are progressive cartilage destruction, sub-articular cyst formation, remodelling of the bone ends with osteophytes and capsular fibrosis (29,33). Clinical featuresThere are several interrelated features common to osteoarthritic joints: Pain: starts insidiously and increases slowly over months and years. It is often eased by movement and worse at night. Stiffness: characteristically worst after periods of rest "early morning stiffness" of up to 30 minutes is common ), and relieved by movement. Loss of range of motion (ROM). The combination of pain, stiffness and possible effusion (swelling) will often cause people with OA to limit their activities. Consequently, loss of ROM is frequent. Reduced function: the clinical features described above can result in functional difficulties, although this is variable. DiagnosisBased on history, X-ray changes and an absence of inflammatory markers in the blood. Aims of aquatic therapy for people with OAPeople with O.A. of the spine, hips, knees or shoulders might benefit from aquatic therapy by allowing muscle strengthening and pain relief, this resulting maybe in improving the functional level. Table 1.2: Characteristics of rheumatoid arthritis: CharacteristicsRheumatoid arthritisDefinitionRA has been described as the commonest potentially treatable cause of disability in the western world (33). It is a symmetrical inflammatory polyarthritis with systemic manifestations, classically starting peripherally and spreading proximally. The disorder affects about 3% of the population. Women are affected three times more often than men. It often starts in the fourth or fifth decade and is characterised by exacerbations and remissions. Aetiology, pathologyThe cause of RA is unknown, but genetic factors clearly play a part since up to 10 % of the people with RA report a first degree relative with the condition. In addition, the pathology seems to have an autoimmune focus (29,33). The initial changes of inflammation occur in the synovial membrane (synovitis), progressively causing periarticular destruction and deformity.Clinical featuresSince the early stage of the condition is one of inflammation, the presenting features are those associated with the cardinal signs of inflammation: Pain: This is the symptom that affects people with RA most and it is the one towards which many of the interventions selected by the physiotherapist (among them aquatic therapy) will be directed. Pain is experienced at rest and may intensify or lessen after a period of activity. It is often difficult to separate the pain in RA. (often steady and aching), from stiffness and tenderness on palpation. Swelling and warmth: Occur around the joints and synovial membranes affected. Often the metacarpo-phalangeal joints, proximal inter-phalangeal joints, wrist joints and metatarsi-phalangeal joints are affected in a symmetrical pattern. Stiffness: the longer the early morning stiffness (EMS), the more active the disease. It tends to be more prolonged (greater than 30 minutes) than compared to the EMS of OA. Loss of function: directly linked to the symptoms mentioned above, loss of function often leads to frustration and despair. Other clinical features: erythema, muscle wasting, decreased range of motion, and a number of extra-articular manifestations such as anaemia, fatigue, general lack of well-being and vasculitis. DiagnosisUsually based on history, clinical findings, X-ray examination and blood tests. The New-York epidemiological criteria for RA (1968) standardise the minimal criteria (33). Aims of aquatic therapy for people with RA People with rheumatoid arthritis might benefit from the effects of buoyancy, particularly on the joints that are recovering an active stage of the disease. With the warmth and support of the water, subjects are able to exercise with a possible reduced pain level, increasing muscle strength, maintaining or increasing range of motion and improving stamina and general fitness (37). Table 1.3: Characteristics of ankylosing spondylitis: CharacteristicsAnkylosing spondylitisDefinition:Like RA, ankylosing spondylitis is an inflammatory systemic disease predominantly affecting the axial skeleton in genetically predisposed individuals. It is probably induced by environmental factors. It is a rather rare disease (0.2 % of the population, affecting men three times more often than women. Its effects are seen mainly in the spine and sacroiliac joints and the usual age of onset is between 15 to 25 years (33,34). Aetiology, pathology There are two thoughts on the causes of AS. The first is that an infectious agent is the initiating factor and the second is that people have an inherited susceptibility to develop spondylarthropaty. Human leukocyte antigen (HLA) B27 and AS show the strongest association of all the rheumatic diseases. The disease starts as an inflammation of the sacroiliac and vertebral joints and ligaments, and is followed by formation of tissue granulation, erosion of articular cartilage or bone and ossification of the fibrous tissue. Clinical features Pain and stiffness: most people affected are young men who complain of persistent backache and stiffness ("bamboo spine"), often worse in the early morning or after inactivity. Disability: this is as well one of the most important complaints. People affected with AS rate highly in the inability to do everyday tasks when compared to patients with OA and RA. This is not given the early onset of the disease and the well-known axial effect of the disease. Fatigue: considered a major problem in AS. Depression: reported by one third of the people affected, women being affected more than men are. Diagnosis Involves history as well as radiographic and pathological evaluation of the signs and symptoms (bony ankylosis, enthesitis, and disco-vertebral junction). Diagnosis is defined by the modified New-York criteria for ankylosing spondylitis (33). Aims of aquatic therapy for people with ASAquatic therapy might have a prophylactic effect in AS by reducing a widespread pain, relaxing tensed muscles (particularly flexor muscles) and helping for increasing spinal mobility and respiration capacity (37).  Beside the possible beneficial effect exposed above on pain, muscle spasm, ROM, muscle weakness and stamina, aquatic therapy for rheumatic diseases focuses as well on other aims: - Functional training: the many qualities of water makes possible to perform movements in water that would be impossible on land. People with a disability which restrict them on land, are in water able to perform and train functional movements like walking, standing up, sitting down, eventually running. -Quality of life: exercise therapy in water often takes the form of a group training, providing to the individual a feeling of fellowship and maybe helping to concentrate less on ones own problems. An important aspect is as well the active participation that the person shows in his/her own rehabilitation program, maybe helping to increase the level of his life satisfaction. A possible disadvantage of this is that individual functional limitations might not be addressed and gains in functional status may be limited. 1.4. Methods for measuring impacts of rheumatic disorders Pain, ADL-functioning and Health Related Quality of Life were selected as outcome measures to be investigated in this review on the basis of what the World Health Organisation (WHO) and the International League Against Rheumatism (ILAR) had determined to be the most important endpoints in clinical trials concerning people affected with chronic rheumatic disease (28): Pain Patient global assessment Physical disability Swollen joint Tender joints Acute phase reactants Physician global assessment Radiographs of joints (in studies of one or more years of duration). Pain, ADL-functioning and Health Related Quality of Life are closely related to the first three WHO/ILAR endpoints: pain, patient global assessment, and physical disability. In order to understand the later phases of this review, one must have an understanding about the methods used today to assess those aspects of a person's life. 1.4.1 Methods for measuring pain in rheumatic disorders Pain is a nearly universal problem for individuals affected with a rheumatic disease. With the major advances in anatomy and physiology over the last 300 years, pain and its complex mechanisms is today better understood (though only partially) by researchers and health professionals. There is however a constant discussion on how to define pain, from a pure neuro-physiological point of view, to a more emotional and psychological angle. The complexity of pain makes it a unique experience for the individual (38). When considering the wide spectrum of rheumatic diseases and the interrelated influence different symptoms may have on each other, one must be cautious about interpreting what is known about pain and how a person describes it. In rheumatology, painful sensations may indicate further damage or pathology, and this in itself can lead to anxiety (33). A consequence of this is that a person in pain avoids movement fearing it may aggravate the pain. If this continues, it leads to deconditioning which in it self may become a cause of more pain, increase in disability and loss of confidence (33). Pain in rheumatic conditions tends to be variable and unpredictable. Symptoms may occur independently of the underlying condition, sometimes in the absence of demonstrable clinical pathology. Conversely, obviously damaged joints may be pain free (33). However, a person description of his or her pain may be useful in differentiating the diagnosis. For instance, pain associated with RA is usually steady and aching (see table 1.2). If pain is described as agonising or excruciating, it may be due to sepsis, nerve entrapment or non-organic causes. It is often difficult to separate pain and stiffness in RA. Its nature may be localised or diffuse, unilateral or bilateral, aching or sharp, present only with use or constant, worse at night or at rest (33). Pain in osteoarthritis may arise from many structures: sub-chondral bone, synovium, capsule or ligaments. It is often worse at night and after rest and is often eased by movement (33). The complexity of pain, makes its measurement far from straightforward, as it is often based on a person self report. Pain measures should be as reliable and valid as possible. They must be easy to use as well as having some meaning for the individual. For some people the intensity of pain could be part of the overall picture only, and it could be the persons functional activity that best reflects the impact of pain on his/her life. Measures that take into account physical, emotional and cognitive components may be much more useful than isolated measures. The difficulty to explain and therefore assess pain is illustrated later in this review by the various measurement instruments (using quantitative and/or qualitative aspects of pain) used by the authors selected. Table 1.4 presents a summary of the pain measurement instruments used later in this review by the authors. Table 1.4: Main pain measurement instruments used in this review. InstrumentDescriptionStrengths and weaknessesVisual analogue scale (VAS): 10 cm horizontal line labelled no pain at one end and extreme pain at the other. The patient is asked to mark a point on the line that best indicates his or her level of pain over a particular interval of time.A high degree of reliability with certain patient groups, but may pose challenges to others. Poor content validity. Potentially highly responsive.McGill Pain Questionnaire (long and short version) (MPQ):Assesses the quantitative and qualitative aspects of pain through a choice of adjectives. Pain location is also recorded (not in the short version).Suitable for acute and chronic pain. Fair degree of reliability, if completion is supervised. Time consuming (long version) and complex to score.Ritchie Articular Index (RAI):Measures tenderness: Pressure is applied around the margin of every affected joint, and tenderness is assessed by passive movement. An index is then calculated with a point system, going from no point: not tender, to 3 points: tender, winced and withdrew. Scores from 0 to 78.As the index is calculated by the persons response to palpation, it is important that the same assessor is used for the same person. Quick and easy to perform.Analgesic requirement: People note their weekly intake of symptomatic drugs on a questionnaire. Analgesic requirement score is calculated by the sum of tablet and capsule intake, using an equivalence score table.Unknown.Beliefs in pain control questionnaire (BPCQ)Based on research, suggesting that belief about controlling pain may be as important in controlling pain than pain control itself. 13 items in 3 subscales: the internal scale measures beliefs that pain is within ones personal control: The other two scales measure beliefs that pain is controlled by factors beyond ones personal control. Relatively reliable and valid. Methods for measuring ADL functioning in rheumatic disorders. ADL functioning can be defined as the result of processes responding to interactions between organ systems and body parts, the entire body and the environment. It is often not assessable from simply identifying anatomic or physiologic deficits (30). All the ADL representing physical ability are of the highest importance for the vast majority of people affected with rheumatic diseases. Multiple aspects of physical function are relevant and to be considered when assessing ADL functioning, including: Lower extremity function: e.g. walking, climbing stairs, moving about. Higher extremity function: e.g. turning a key, opening a door, arm activities such as reaching and carrying. Personal care: e.g. eating, toileting, grooming. Recreation: e.g. leisure time activities. Occupation: e.g. ability to perform habitual work, including house or school work. It will be seen later in this review that some authors assess ADL functioning by only focusing on some of those above mentioned aspects (ex. "time to walk up and down a fix staircase", or "ability to rise from a chair"). Disability is often specific for each rheumatic disease. One example: because most people with RA have involvement of the small joints of the hands, many questions including those indices focuses towards limb function, i.e. capacity to open a door, lift a cup, open a shirt In his book, Lloyd recalls the Steinbrocker functional index that, in 1949 divided patients with rheumatoid arthritis into four functional categories (this index has been revised in 1992 by Hochberg and Collins (33). - Class I: those who function normally, - Class II: those who manage work normally, even though with pain or difficulty, - Class III: those whom ability to do paid work or housework is diminished, - Class IV: those who are chair or bed bound. This classification, though crude, can be applied to any form of joint disease and is still used today because it is quick to apply for other rheumatic diseases. But this classification is in itself not an assessment method, it lacks sensitivity to change and has thus been superseded by instruments which are more sensitive and more specific to the different diseases (33). Some of the most used ADL measurement instruments seen later in this review are described in table 1.5: Table 1.5: Main ADL measurement instruments used in this review: InstrumentDescriptionStrength and weaknessesThe modified Stanford Health Assessment Questionnaire (HAQ):List of 20 everyday-tasks and asking the patient to grade the difficulty in performing jobs on a 4 points scale, from without any difficulty to unable to do so. The 20 items scale is divided in 8 sub-components: dressing and grooming, arising, eating, walking/mobility, hygiene, reach/bending, gripping, and activity.Reliable measure of functional ability. HAQ is today widely used, easy to understand by the person and quick to perform. The Arthritis Impact Measurement Scales (AIMS & AIMS 2):The original questionnaire was designed to assess health status by making an account of the variety of effects of disease including disease activity, functional status, general well-being and psychological factors. The revised version, the AIMS 2 (55 questions) is divided into 12 subclasses, each of them ranged from 0 to 10. The total AIMS 2 score is the mean of the values obtained in those 12 different domains: mobility level, walking and bending, hand and finger function, arm function, self care tasks, household tasks, social activity, support from family and friends, arthritis pain, work, level of tension, and mood.Reliable, valid measure that is sensitive to clinical changeFrenchay activity index (FAI):Self report questionnaire related to perceived health status, self-reported levels of activity, and presence of long-standing illness/disability  Other ADL measurement tools used later in this review by the different selected authors include: - Ability to rise from chair, - Time taken to walk up and down a fixed staircase, - Time and no. of steps taken to walk a fixed distance, - Owestry low back pain disability questionnaire, - Kistler force platform configuration. Methods for measuring Quality of life in rheumatic diorders The World Health Organisation (1948) recognised some 50 years ago that health was not simply the absence of disease: it implies a state of complete physical, social and mental well-being. This broader definition of health has been accepted increasingly by the medical community. Factors such as physical, social, cognitive, and emotional functioning, personal productivity, and intimacy can all influence the overall quality of an individuals life (36). One major problem in making an assessment about a persons quality of life is that the responses are highly individualistic (in that respect, this element is common to assessing pain or ADL functioning). The reported scores depend on the reaction of the individual to any physical or psychological impairment, on the way to avoid disabilities and the attitude to adapt to any potential handicap. Early investigators represented quality of life by a single number. Todays assessment tools for quality of life are more detailed and include a wide range of perceptions of health, function and mood giving in this way an idea of the persons core problem and coping strategy. They try to give elements of physical as well as psychological well-being (pain, function, fatigue, self-efficacy, stress, anxiety, depression, level of satisfaction) The different quality of life assessment tools seen today in literature concerning rheumatic disorders try to be disease specific (36). Instruments such as the Health Assessment Questionnaire or the Arthritic Impact Measurement Scale can be extended to include additional questions specific to RA, OA or AS (33). Table 1.6: Main Health Related Quality of Life measurement intstruments discussed later in this report: Instrument DescriptionArthritis Self Efficacy Questionnaire (SEQ)Consists of three instrument sub scales: pain, function and other symptoms such as frustration and fatigue. Self efficacy is similar to other psychological concepts such as locus of control, learned helplessness and self esteem, but differs in that it is behaviour-specific. Philadelphia QuesionnaireSelf-rating scale which measures the satisfaction level of subjects with their own life, and their moral. Consists of a series of simple closed questions, the answers to which are scored and expressed as a percentage.  Other measurement tools to evaluate HRQL used later in this review by the authors include: - Zungfeld rating depression scale, - AIMS & AIMS 2 (see table 1.5), - Illness behaviour questionnaire, - Stanford Health assessment Questionnaire (see table 1.5), - Frenchay Activity Index (see table 1.5). It is now necessary to understand why a systematic review was the form chosen by the authors of this report: 1.5 Relevancy of a systematic review Health care providers, consumers, researchers and policymakers are overwhelmed with the unmanageable amount of information available in literature. In order to make good decisions in health care, current evidence must be readily available. Systematic reviews help to establish where effects of health care are consistent and how results can be applied across different populations, places and with which treatments (38). The use of a systematic methodological approach to produce reviews help to limit bias (systematic errors), and to reduce chance effects. This provides more reliable results upon which it is sometimes possible to draw conclusions and make good decisions (38). Archie Cochrane, a British epidemiologist, drew in the 1970s attention on the great ignorance of health care. He recognized that reviews of current evidence was not readily available for many decision makers in health care and stimulated the establishment during the 1980s of an international collaboration to develop the Oxford Database of Perinatal Trials. In 1987, he referred to a systematic review of randomized controlled trials of care during pregnancy and childbirth as "a real milestone in the history of randomized trials and in the evaluation of care", and suggested that other specialities should copy the methods used. This led to the creation in 1992 of the international non profitable organisation "Cochrane Collaboration" providing up-to-date accurate information about the effects of health care in the form of reviews of randomized controlled trials. 1.6. Use of the different data bases 1.6.1. Database searching When searching the databases, use was made of Boolean operators. The Boolean operators are AND, OR and NOT. These operators can be used to create very broad or very narrow searches. AND combines search terms so that each search results contain all of the terms. For example, aquatic therapy AND osteoarthrtis finds articles that contain both aquatic therapy and osteoarthritis. OR combines search terms so that each search result contains at least one of the terms. For example, aquatic therapy OR hydrotherapy finds results that contain either aquatic therapy or hydrotherapy. NOT excludes terms so that each search result does not contain any of the terms that follow it. For example, aquatic therapy NOT bathing finds results that contain aquatic therapy but not bathing. On some databases searching can be done with either free text search terms or Medical Subject Headings (MeSH). A MeSH thesaurus may be available with search terms that are standard search terms for searching the databases. In addition, use of truncation can facilitate searching. Truncation is a way to search for word beginning with the word stem followed by an asterisk (*). For example, type: rheuma* to find results with rheumatoid, rheumatic, rheumatics, etc. See section 2.4.1 for the specific use of these items in our search strategy. Databases that were searched for this systematic review were The Cochrane library, the PEDro database, Medline and Cinahl: The Cochrane library (39) is an online information service, which comprises several databases. It is specialised in producing systematic reviews of clinical trials. It also provide registers of controlled clinical trials, as well as other registers and databases regarding medical information. The PEDro database (40) has been developed to give rapid access to bibliographic details and abstracts of randomised controlled trials and systematic reviews in physiotherapy.. Medline (42) is the primary source in the United States for information from the biomedical literature, containing references to articles from more than 3500 journals. Cinahl (41) is an abbreviation for Cumulative Index to Nursing & Allied Health Literature. This is a database that contains references to articles from more than 950 English paramedical and nursing journals. 1.6.2. The PEDro scale: assessing methodological validity Trials included in this systematic review were rated with a checklist called the PEDro scale. This scale considers two aspects of trial quality: The Internal validity, or believability, of the trial Whether or not the trial contains sufficient statistical information to make it interpretable. The scale does not rate the external validity, or generalisability, of the trials, or the size of the treatment effect. To assess internal validity, a number of criteria should be looked for, including random allocation, concealment of allocation, comparability of groups at baseline, blinding of patients, therapists and assessors, analysis by intention to treat and adequacy of follow-up. To assess interpretability, between-group statistical comparisons and reports of both point estimates and measures of variability should be looked for. In total the PEDro scale contains 11 items. One item, the item on eligibility criteria, is related to external validity, and is therefore not calculated in the total score. The maximum score a trial can obtain by use of the PEDro scale is therefore 10. (For notes on administration of the PEDro scale, see appendix no 3) The PEDro scale is based on the Delphi list. The Delphi list is a list of trial characteristics that was thought to be related to trial "quality" by a group of clinical trial experts (27). See the table 1.7 for comparisons with the criteria on the PEDro scale with those on the Delphi list: Table 1.7: Comparison between the items on the Pedro scale and the Delphi List Delphi ListPEDro Scale1 A. Was a method of randomisation performed?1Eligibility criteria were specifiedB. Was the treatment allocation concealed2Random allocation2Where the groups similar at baseline regarding the most important prognostic factors?3Concealment of allocation3Were the eligibility criteria specified?4Groups were similar at baseline regarding the most important prognostic indicators4Was the outcome assessor blinded?5Blinding of all subjects.5Was the care provider blinded?6Blinding of all therapists. 6Was the patient blinded?7Blinding of all assessors 7Were point estimates an measures of variability presented for the primary outcome measures?8Adequacy of follow-up ( at least 85% ) 8Did the analysis include an intention to treat analysis?9All subjects received the treatment or control condition as allocated or data for at least one key outcome was analysed by intention to treat. N/A10The results betweengroup statistical comparisons are reported for at least one key outcome. 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