SUMMATIVE ASSIGNMENT – PROTOCOL FOR A SYSTEMATIC REVIEW (3,000 WORDS).

 

 

The assignment for this module has been designed to give all students the opportunity to prepare a document demonstrating their ability to produce a coherent, theoretically based argument justifying secondary research within a specific field. The development of a protocol is a key requisite for systematic review work. The format for this assignment is informed mainly by Cochrane resources for preparing protocols and students are strongly encouraged to visit www.cochrane-handbook.org.

 

Remember this assignment is basically a statement of intent; the protocol outlines the plan for the review and should describe the rationale for the review; the objectives; and the methods that will be used to locate, select and critically appraise the studies, and to collect and analyze data from the included studies. Preparing a protocol for a review makes you stop and think about what you’re doing; it can act as a working document for the reviewer(s); it can prevent duplication; and very importantly it can minimise bias by being transparent about what you plan to do in advance. The following guidelines have been devised to help in the preparation of the assignment.

 

THE TITLE

 

The title has to provide enough information to help the reader decide if the review protocol is going to be relevant to them. The Cochrane Collaboration has decided on a standard format for titles which helps convey information as quickly as possible:

 

[Intervention] for [Problem] in [Category]

 

E.g. Topical negative pressure (TNP) for treating chronic wounds.

 

BACKGROUND/RATIONALE

 

You need to indicate the time span, languages and countries from which background information has been gained.

 

You need to present the background literature as a logical discussion, if necessary using sub-headings for clarification. It should include the size of the problem, uncertainty about dealing with it, why the intervention might work, and what it is supposed to achieve.

 

You need to critically analyse and appraise the background literature in two ways, consider firstly the data/theory proposed, secondly whether the methods used to gather the data were appropriate.

 

You need to conclude in a way that identifies the issues which arise from the background literature and leads into, or suggests the need for the proposed review. By the time the reader finishes your Background section they should be able to understand why you are asking the review question.

 

 

OBJECTIVES/REVIEW QUESTION(S)

 

In this section the main review question(s) to be addressed in your protocol needs to be stated. Getting the review question right is the most important step in doing your protocol. As well as telling others what the review is about, it will guide how you propose to search, select, appraise and analyse your studies. Make sure you spend time on this section. It is recommended that you structure your question using PICOD, PICO or PIO – this will depend on the type of question being asked.

 

P = Population i.e. the people affected by the intervention/exposure

I = Intervention/exposure under scrutiny

C = Counter intervention

O = Outcome(s) of interest

D = Design of the studies likely to yield the most valid data

 

E.g. To undertake a systematic review of all randomised controlled trials (RCTs) using TNP in the treatment of any patient with a chronic wound to determine:

a) If TNP is more effective than wound dressings in terms of improving healing rates, reducing cost, improving quality of life, minimising pain and providing comfort.

b) If there is an optimum TNP regimen in terms of foam type, degree of suction, continuous/intermittent suction, duration of suction.

 

 

METHODS OF THE REVIEW

This section is the formal description of what you plan to do once you have decided on your review question:

 

SEARCH STRATEGY

In your protocol the search strategy needs to be clearly described. PI(C)O(D) will help determine key words, Medical subject headings (MeSH), wildcards, acronyms, synonyms, transatlantic terms that will be used in your search strategy. You will need to describe how these will be linked with the appropriate Boolean operators (e.g. AND, OR, NOT) to develop a search strategy that will be used to search for primary studies from a variety of resources, which you need to state, such as electronic databases, journals, conference proceedings, reference lists, grey literature, research registers, researchers and manufacturers.

 

STUDY SELECTION CRITERIA AND PROCEDURES.

Following the search you need to clearly describe in your protocol the processes that will be used to decide if a primary study will be included or excluded from the review. This will initially depend on whether it fulfils the scope (PI(C)O(D))of the review protocol.

 

 

 

 

For types of participants you need to think about the health problem or population or setting.

E.g. You would consider a study fulfilling the scope of the TNP review protocol if it defined chronic wounds as…

 

For types of interventions with a medication for example, you need to think about drug preparation, route of administration, dose, duration, frequency. For non-drug interventions such as an educational intervention, defining the intervention can be a bit more difficult – you need to consider exactly what was done, how often it was done, who did it, were they trained, etc.

E.g. You would consider a study fulfilling the scope of the TNP review protocol if it described the intervention of interest (in this example TNP) as…

 

For types of counter interventions you need to decide whether you will be comparing the intervention group with a placebo, nothing, sham treatment or some other treatment.

E.g. You would consider any RCTs as fulfilling the scope of the TNP review protocol where topical negative pressure was compared with no treatment/sham/standard (which needs to be defined)/other experimental interventions.

 

For types of outcome measures you need to think about the primary outcome of interest and how that can be determined in a valid and reliable way. There may be secondary outcomes of interest e.g. cost, quality of life, pain, comfort and adverse effects and how they too can be determined in a valid and reliable way.

E.g. As there is no consensus as to the most valid and reliable means of measuring healing rates of wounds, you would consider a study fulfilling the scope of the TNP review protocol if it measured healing by some objective method such as the time to complete healing.

 

For types of studies you need to consider the design that will best answer the question and whether you will restrict studies on the basis of language, date or publication status.

E.g. To evaluate topical negative pressure for the treatment of any patient with a chronic wound – you would consider a study fulfilling the scope of the TNP review protocol, in the first instance, if it was a randomized controlled trial – and in the absence of any RCTs, controlled clinical trials would be considered.

 

 

STUDY QUALITY ASSESSMENT CHECKLISTS AND PROCEDURES

If the study fulfils the scope PI(C)O(D) of the review you need to clearly describe in your protocol the processes used to determine the methodological quality of the primary study to decide if it will remain included, or be excluded, from the review. It is best to refer to www.cochrane-handbook.org. in order to determine the best way of assessing bias in a study. The CONSORT statement also provides useful guidance for what ought to be reported in RCTS at www.consort-statement.org.

 

 

 

 

DATA SYNTHESIS

If the study fulfils the scope of the review, and is of high methodological quality, the results of this study need to be extracted and considered for data synthesis. Data synthesis involves collating and summarising the results of included primary studies You need describe in your protocol your proposed method of extracting and synthesising the results of primary studies and how this will depend upon heterogeneity of the studies identified. You need to consider whether your synthesis would provide an estimate of overall effectiveness of an intervention; review effectiveness in different studies, populations and settings; investigate differences; answer the review question.

 

Within your protocol you need to consider how a data extraction form might be designed to collect all the information needed to address the review question(s) which includes the name of the review, date of data extraction, publication details, the scope (PI(C)O(D)), methodological quality (specific factors), and results of the primary studies.

 

 

REFERENCES

All references should be appended to the protocol using the Harvard system.

 

 

 

 

Guidelines for preparing a protocol for a systematic review approach/level 7/Dr Debra Evans/September 2010

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Home>Homework Answsers>Nursing homework helpAPA format 3 peer references and discussion needs to be related to what is posted as response to the persons diagnosisPatient Initials:RFAge:15Gender:MSUBJECTIVE DATA:Chief Complaint (CC):A dull pain in both knees with occasional clicking in one or both knees and the sensation of the patella catching.History of Present Illness (HPI):RF is a 15-year-old male who reports dull pain in both knees. Sometimes one or both knees click, and the patient describes a catching sensation under the patella. He states that the pain has been on and off for the last four months and initially only present after intense activity but has gotten worse since starting track this summer and seems to be present more often than before.The patient states that the clicking comes and goes and isn’t always present in both knees at the same time. The catching sensation under the patella is more pronounced since he started doing the long jump in track. The patient states that he is able to bear weight as the pain is a dull ache. Icing his knees after sports and taking ibuprofen help to reduce the pain and swelling but both occur more frequently now making it difficult to participate in sports. The patient feels that he may be overdoing it with all of the sports he participates in and is worried about not being able to play soccer if it continues to get worse. The patient rates the pain 7/10 after intense activity.Medications:Ibuprofen 200 mg oral tab, two tabs every 6 hours as needed for pain.Allergies:No known drug, food, or environmental allergies.Past Medical History (PMH):NonePast Surgical History (PSH):NoneSexual/Reproductive History:Patient is not sexually active at this time.Personal/Social History:Patient denies smoking, alcohol use, and illicit drug use. The patient is very active with sports playing soccer, basketball, baseball, and track. He states that he tries to eat well mainly because of sports but doesn’t always make the best choices for snacks. He tries to avoid soda most of the time and reports drinking a lot of water.Immunization History:Immunizations are up to date. Gets influenza vaccine annually.Significant Family History:Paternal grandfather has hypertension, and father has borderline hypertension. Maternal grandfather has type II diabetes.Lifestyle:RF is a freshman in high school who lives with both of his parents and older sister. RF plays soccer, basketball, baseball and participates in track for high school. RF also plays club soccer playing and traveling most of the year. RF is a good student, athletic, and enjoys being active. He also participates in winter sports and skis during winter break.  RF works part-time as a referee during the summers due to his commitment to school and sports.Review of Systems:General:No recent weight gain or loss of significance. Patient denies fatigue, fever, or chills.HEENT:No headaches or dizziness. No changes in vision. He does not wear glasses, and his last eye exam was just under a year ago. Denies eye drainage, pain, or double vision. No changes in hearing. Has had no recent ear infections, tinnitus or ringing in the ears. Denies sinus infections, congestion, and epistaxis. He reports his sense of small is intact. Last dental exam was four months ago for regular cleaning. Denies bleeding gums or a toothache. Denies dysphagia or throat pain.Neck:No history of trauma, denies recent injury or pain. He denies neck stiffness.Breasts:Denies any breast changes. Denies history rashes. Denies history of masses or pain.Respiratory:Denies a cough, hemoptysis, and sputum production. Patient denies any shortness of breath with resting or with exertion. Patient reports no pain with inspiration or expiration.Cardiovascular/Peripheral Vascular:No history of murmur or chest palpitations. No edema or claudication. Denies chest pain. No history of arrhythmias.Gastrointestinal:Denies nausea or vomiting. Patient reports no abdominal pain, diarrhea, or constipation. Last bowel movement was this morning. Denies rectal pain or bleeding. Denies changes in bowel habits. Denies history of dyspepsia.Genitourinary:Denies changes in urinary pattern. No incontinence, no history of STDs or HPV, the patient is heterosexual and not sexually active. Denies hematuria. Denies urgency, frequency, and dysuria.Musculoskeletal:No limitation in range of motion for all limbs though patient reports difficulty moving knees after excessive strain from sports.  No history of trauma or fractures. Patient reports dull pain in both knees. The patient states occasional swelling in knee joints after participating in sports. Patient reports clicking in one knee and sometimes both. The patient states that the pain is worse after participating in the long jump or running long distances. Patient denies history or presence of misalignment of either knee.Psychiatric:Denies suicidal or homicidal history. No mental health history. Denies anxiety and depression.Neurological:No dizziness. No problems with coordination. Denies falls or seizures. Denies numbness or tingling. Denies changes in memory or thinking patterns.Skin:No history of skin cancer. Denies any new rashes or sores. Patient reports many blisters from sports which are treated with Neosporin, band-aids, and NewSkin spray. Denies eczema and psoriasis. Denies itching or swelling.Hematologic:No bleeding disorders or history of blood transfusion. Denies excessive bruising.Endocrine:Patient reports no endocrine symptoms. Denies polyuria, polydipsia. Patient denies no intolerance to heat or cold.Allergic/Immunologic:Denies environmental, food, or drug allergies. No known immune deficiencies.OBJECTIVE DATA:Physical Exam:Vital signs:B/P 118/74; P 65 and regular; T 98.6; RR 16; O2 100% on room air; Wt: 125 lbs.; Ht: 5’7”; BMI 19.1General:RF is a well-developed, well-nourished Caucasian teenage male who appears to be in no apparent distress.HEENT:Head: Skull is normocephalic, atraumatic. No masses or lesions.Eyes: PERRLA, +direct and consensual pupil response. EOM intact, 20/20 vision bilaterally without correction. Fundoscopic exam normal, vessels intact, the optic disc with clear margins.Ears: Bilateral external ears no lesions, masses, drainage or tenderness. Tympanic membranes intact, pearly gray, no bulging, no erythema, and landmarks appreciated bilaterally. Hearing intact bilaterally.Nose: No nasal flaring, no discharge, no obstruction, septum not deviated. Turbinates pink and moist. No polyps or lesions bilaterally. Nares patent with no edema or erythema.Throat:Oropharynx clear and mucosa moist. No erythema or exudate. Uvula midline, palate rises symmetrically.Mouth:No lesions, no thrush. Moist mucous membranes. Healthy dentition present. Tongue midline.Neck:Supple, non-tender. Full range of motion. Trachea midline. No masses. Thyroid and lymph nodes not palpable.Chest/Lungs:Thorax non-tender with symmetric expansion. Respiration regular and unlabored, without a cough. Tactile fremitus equal bilaterally and greater in upper lung fields.  Breath sounds clear with adventitious sounds. All lung fields with resonant percussion tones.Heart:Regular rate and rhythm; normal S1, S2; no murmurs, rubs, or gallops. Apical pulse not visible. Apical pulse was barely palpable. JVP appears to be approximately less than 6 cm with HOB elevated to 45 degrees. No carotid bruits or JVD appreciated.Peripheral Vascular:Pulses 2+ bilateral pedal and 2+ radial bilaterally. No pedal edema. Popliteal pulses 2+ bilaterally.Abdomen:Abdomen round, soft, and non-tender without rash, palpable mass or organomegaly. Active bowel sounds. Tympany over most quadrants with areas of dullness noted upon percussion. No abdominal bruits.Genital/Rectal:Adequate tone, no masses noted, eternal genitalia intact.Musculoskeletal: Normal passive and active ROM in upper and lower extremities. No focal joint inflammation or abnormalities appreciated in upper extremities. + tenderness to palpation at the inferior pole of the patella bilaterally. + Q angle greater than 10 degrees bilaterally. Clicking present with movement in right knee. Normal alignment of the knees bilaterally. All upper and lower extremity joints without effusions or erythema. Spine without tenderness and range of motion is full. Greater tenderness was noted in knees bilaterally when extended, and quadriceps are relaxed. Normal muscle strength present against resistance.Neurological:CN ll-Xll grossly intact. Awake, alert, and oriented to person, place and time. The patient can move all limbs on command and spontaneously.Skin:Warm, moist, and intact. Skin is pale. + edema right knee. No peripheral cyanosis. No clubbing. No rashes or bruises present.ASSESSMENT:Lab Tests and Results:CBC- NormalErythrocyte sedimentation rate (ESR) – NormalDiagnostic test:Passive extension-flexion sign- positive- which is tenderness on palpation of the tendon at the inferior pole of the patella.McMurray test- Negative for locking during joint movement.X-ray- negativeMRI- Showed high signal intensity within the proximal posterior central aspect of the tendon at its origin.Differential Diagnosis:Patellar tendinitis: This is the most likely diagnosis based on the patients HPI, ROS, physical assessment, and diagnostic studies. The patient’s chief complaint was a dull pain in the knees with occasional clicking in one or both knees. The patient is athletic and participates in many sports that continuously put a strain on his knees. The quadriceps angle was greater than ten which suggests patellar tendinitis. The patient plays sports that include a lot of running and jumping which adds strain to the knee joints. The patient was also positive for tenderness on palpation at the inferior pole of the patella bilaterally. Lastly, the MRI was positive for high signal intensity within the proximal posterior central aspect of the tendon where it originates from.Osgood Schlatter’s disease: A possible diagnosis as it is a common problem which typically occurs during times of fast growth usually in fit, active boys. Osgood Schlatter’s disease is associated with pain just below the kneecap in one or both knees, often worse after sports especially high impact activities using the quadriceps muscles. However, limping is often a present, and the patient denied limping in the ROS. Pain is greater with stair climbing and kneeling, and the patient did not admit to either. Flexion and extension will increase pain in the tibial tubercle which was not present upon physical exam of the patient.Chondromalacia patellae: This is a possible diagnosis due to the presence of knee pain upon palpitation and increased pain with activity. However, chondromalacia patellae are more common in females or persons with a history of knee trauma. The patient is male and denied trauma to either knee. The patient denied a history of misalignment which is also related to chondromalacia patellae. An x-ray of the knee would show irregularities of the patellofemoral joint.Medial meniscus tear: This diagnosis is a possibility because it can occur after a twisting injury and the patient participates in sports such as soccer, basketball, and skiing that involve twisting movements. Clicking may be present with a medial meniscus tear which the patient reported and was also appreciated upon physical assessment in the right knee. McMurray test was negative for locking during joint movement. The patient denied difficulty with weight bearing.Juvenile rheumatoid arthritis (JRA):Possible due to knee joint soreness and stiffness, however, both typically improve with activity. Joint swelling may also present with JRA and was reported by the patient in his ROS. The patient denied weight loss and fatigue which are common symptoms. The patient also denied night pain. A CBC would show anemia, leukocytosis, and thrombocytosis. The ESR would be elevated.ReferencesBall, J. W., Dains, J. E., Flynn, J. A., Solomon, B. S., & Stewart, R. W. (2015).Seidel’s guide to physical examination(8th ed.). St. Louis, MO: Elsevier Mosby.Dains, J. E., Baumann, L. C., & Scheibel, P. (2016).Advanced health assessment and clinical diagnosis in primary care(5th ed.). St. Louis, MO: Elsevier Mosby.Huether, S. E., & McCance, K. L. (2017).Disorder of the joints. In alterations of musculoskeletal function(6th ed., pp. 991-1038).Rath, E., Schwarzkopf, R., & Richmond, J. (2010). Clinical signs and anatomical correlation ofpatellar tendinitis.Indian Journal of Orthopaedics,44(4), 435-437 3p. doi:10.4103/0019-5413.69317 years ago19.10.201815Report issueAnswer(0)Bids(60)Favorite PROFprofessor HarveyProfRubbsMichelle OwensBrainy BrianArizona WriterGreat-WritersDr. Claver-NNA-plus WriterPROF washington watsonMelissa OwensRima MakenzieAngelina MayLady Taylor PhDCatherine OwensMiss EmilyMUSYOKIONES A+Wendy LewisGifted-writerJenny BoomShow All Bidsother Questions(10)I need someone to help me put together simple Spanish dialogues for 5 different categories like “Una entrevista de trabajo”…english helpwhat is 9/3 in it’s simplest form?Write a procedure which uses the Newton-Raphson method to evaluate a root of a given
function, when given an initial…sfgManagerial AccountingExplain what is meant by the variance of a set of obervations and then define the standard deviation of a set of obervations.At a certain temperature, the solubility of strontium arsenate, Sr3(AsO4)2, is 0.0640 g/L. What is the Ksp of this salt…for youWhen and where did the crusades happen?

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