Introduction to clinical research methods

@#<p style="text-align: justify;" data-mce-style="text-align: justify;">Clinical research either directly involves a particular person or group of people or uses materials from humans such their behavior or samples of their tissue. It can involve epidemiological and behavioral research, health services research and patient-oriented research like drug trials or accuracies of diagnostic tests. It is a series of steps that lead from question to answer. There is an organized structure by which we formulate questions, develop methods to gather information and answer clinical problems. The purpose of organizing the structure is to allow studies to be repeated and validated by other researchers. There are several research designs, and the choice should be influenced by the main objective of the research. The methodology is the manner of collection of data that will give confidence in the results and conclusion. This requires identifying all sources of bias and uncertainty, and developing a method that can minimize them. Actual data collection can be obtained by inspecting the records, by conducting interview or physical examination or laboratory/ imaging investigations, or by a combination of these data-eliciting methods. Lastly, the final report should be concise but contain all the details in relation to the objective of the research. The format of the written report depends on the methodology and the requirement of the journal where it is intended to be published.</p>

Primary care services in the UHC: Cost identification study

Background@#In order to financially sustain the participation of the private sector in the UHC, there is a need to find reasonable balance of accountability in the costing of health services. The costing must be based on actual resources used from the perspective of the private health service provider. @*Objective@#The objective of this paper was to determine the cost of primary care services from the framework of the UHC reform in the private sector.@*Method@#This is a multi-method approach to cost-identification in establishing and providing primary care health service in the UHC. The approaches used by the authors included review of published literature, laws and policies from DOH and other regulatory agencies. From this review, they develop the minimum facility requirement for basic primary care facility and primary care facility with ancillary services. They used the actual expenditures of existing primary care clinics, 2021 quotations from equipment and supplies companies, published construction rates and consensus approach to establish the cost. Based on 2021 value of Philippine Peso, they estimated the cost of constructing and operating a primary care facility.@*Results@#The total estimated cost of building a primary health care facility based on the DOH licensing standard was estimated to be around PhP2,490,000. The cost of furniture and equipment as required in the DOH AO was PhP474,685. Thus, the total cost of the construction and equipment for a basic primary care facility setup is PhP2,964,685. We estimated the annual operating cost with the building estimated to depreciate in 20 years and the furniture and equipment in 5 years, the annualized cost for the building is PhP124,500 and for the furniture and equipment PhP94,937. The total annual salary of the staff based on government standards was PhP2,381,962. The maintenance, operating and overhead expenses (MOOE) which included water and electricity, repair and maintenance, waste disposal, supplies and other fees was PhP451,190. The total annual operating cost of a basic primary care facility is PhP3,052,590. This facility can provide basic services such as outpatient consultation and minor surgeries. Using the same approach for the basic facility, the total annual operating cost of a basic primary care facility with ancillary service is PhP11,023,670. This facility can provide outpatient consultation, minor surgeries and primary care services such as health education and preventive care plus the ancillary services like pharmacy, clinical laboratory and x-ray. For patients with diabetes, the total annual cost is PhP8,986. The significant cost driver is the clinical assessment and non-pharmacologic intervention. The researchers found the same cost pattern for the annual cost care of patients with hypertension but with a slightly higher annual total with PhP9,963. Their sensitivity analysis based on inflation, construction, equipment and operating expense may increase these cost estimates by 20% in the next 5 years. @*Conclusion@#Based on their findings, the current per capita support from PHIC Konsulta package is not adequate in the private sector both for wellness and care of patients with chronic condition. PHIC needs to consider adjusting per capita rates and consider case rate payment as it is currently doing for hospital care. Without this proposed adjustment, only those patients in the higher socioeconomic status will be capable of consulting the private sector. This scenario defeats the equity issue that is a primary concern in the UHC.

Clinical pathway for the diagnosis and management of patients with COVID-19 in family practice

Background@#Coronavirus disease 2019 (COVID-19) has rapidly spread worldwide, causing a pandemic. The Philippines ranks 3rd in Southeast Asia with more than 15,000 confirmed cases, and a case fatality rate of 6.01%, close to the global average of 6.33%.@*Objective@#This clinical pathway was developed to guide family and community physicians on the diagnosis and initial management of COVID-19 in terms of 1) clinical history and physical examination; 2) laboratory and ancillary procedures to be requested; 3) pharmacologic interventions; 4) non-pharmacologic interventions, and 5) patient outcomes to expect.@*Method@#The PAFP Clinical Pathways Group reviewed the published medical literature to identify, summarize, and operationalize the evidence in clinical publication on the management of patients with COVID-19 in family and community practice.@*Recommendations@#The recommendations are time-bound tasks on patient care processes, in terms of history and physical examination, laboratory tests, pharmacologic and non-pharmacologic interventions. The recommendations are presented as a table and algorithm.@*Implementation@#At the clinic level, self-audit using the recommendations of this clinical pathway as the standard may be done. At the organizational level, the PAFP should establish a new model of quality improvement initiative where self-practice audits are included as part of the program.

Management of isolated mandibular body fractures in adults

Objective@#The mandible is the most common fractured craniofacial bone of all craniofacial fractures in the Philippines, with the mandibular body as the most involved segment of all mandibular fractures. To the best of our knowledge, there are no existing guidelines for the diagnosis and management of mandibular body fractures in particular. General guidelines include the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAOHNSF) Resident Manual of Trauma to the Face, Head, and Neck chapter on Mandibular Trauma, the American Association of Oral and Maxillofacial Surgeons (AAOMS) Clinical Practice Guidelines for Oral and Maxillofacial Surgery section on the Mandibular Angle, Body, and Ramus, and a 2013 Cochrane Systematic Review on interventions for the management of mandibular fractures. On the other hand, a very specific Clinical Practice Guideline on the Management of Unilateral Condylar Fracture of the Mandible was published by the Ministry of Health Malaysia in 2005. Addressing the prevalence of mandibular body fractures, and dearth of specific guidelines for its diagnosis and management, this clinical practice guideline focuses on the management of isolated mandibular body fractures in adults.@*Purpose@#This guideline is meant for all clinicians (otolaryngologists – head and neck surgeons, as well as primary care and specialist physicians, nurses and nurse practitioners, midwives and community health workers, dentists, and emergency first-responders) who may provide care to adults aged 18 years and above that may present with an acute history and physical and/or laboratory examination findings that may lead to a diagnosis of isolated mandibular body fracture and its subsequent medical and surgical management, including health promotion and disease prevention. It is applicable in any setting (including urban and rural primary-care, community centers, treatment units, hospital emergency rooms, operating rooms) in which adults with isolated mandibular body fractures would be identified, diagnosed, or managed. Outcomes are functional resolution of isolated mandibular body fractures; achieving premorbid form; avoiding use of context-inappropriate diagnostics and therapeutics; minimizing use of ineffective interventions; avoiding co-morbid infections, conditions, complications and adverse events; minimizing cost; maximizing health-related quality of life of individuals with isolated mandibular body fracture; increasing patient satisfaction; and preventing recurrence in patients and occurrence in others.@*Action Statements@#The guideline development group made strong recommendationsfor the following key action statements: (6) pain management- clinicians should routinely evaluate pain in patients with isolated mandibular body fractures using a numerical rating scale (NRS) or visual analog scale (VAS); analgesics should be routinely offered to patients with a numerical rating pain scale score or VAS of at least 4/10 (paracetamol and a mild opioid with or without an adjuvant analgesic) until the numerical rating pain scale score or VAS is 3/10 at most; (7) antibiotics- prophylactic antibiotics should be given to adult patients with isolated mandibular body fractures with concomitant mucosal or skin opening with or without direct visualization of bone fragments; penicillin is the drug of choice while clindamycin may be used as an alternative; and (14) prevention- clinicians should advocate for compliance with road traffic safety laws (speed limit, anti-drunk driving, seatbelt and helmet use) for the prevention of motor vehicle, cycling and pedestrian accidents and maxillofacial injuries.The guideline development group made recommendations for the following key action statements: (1) history, clinical presentation, and diagnosis - clinicians should consider a presumptive diagnosis of mandibular fracture in adults presenting with a history of traumatic injury to the jaw plus a positive tongue blade test, and any of the following: malocclusion, trismus, tenderness on jaw closure and broken tooth; (2) panoramic x-ray - clinicians may request for panoramic x-ray as the initial imaging tool in evaluating patients with a presumptive clinical diagnosis; (3) radiographs - where panoramic radiography is not available, clinicians may recommend plain mandibular radiography; (4) computed tomography - if available, non-contrast facial CT Scan may be obtained; (5) immobilization - fractures should be temporarily immobilized/splinted with a figure-of-eight bandage until definitive surgical management can be performed or while initiating transport during emergency situations; (8) anesthesia - nasotracheal intubation is the preferred route of anesthesia; in the presence of contraindications, submental intubation or tracheostomy may be performed; (9) observation - with a soft diet may serve as management for favorable isolated nondisplaced and nonmobile mandibular body fractures with unchanged pre - traumatic occlusion; (10) closed reduction - with immobilization by maxillomandibular fixation for 4-6 weeks may be considered for minimally displaced favorable isolated mandibular body fractures with stable dentition, good nutrition and willingness to comply with post-procedure care that may affect oral hygiene, diet modifications, appearance, oral health and functional concerns (eating, swallowing and speech); (11) open reduction with transosseous wiring - with MMF is an option for isolated displaced unfavorable and unstable mandibular body fracture patients who cannot afford or avail of titanium plates; (12) open reduction with titanium plates - ORIF using titanium plates and screws should be performed in isolated displaced unfavorable and unstable mandibular body fracture; (13) maxillomandibular fixation - intraoperative MMF may not be routinely needed prior to reduction and internal fixation; and (15) promotion - clinicians should play a positive role in the prevention of interpersonal and collective violence as well as the settings in which violence occurs in order to avoid injuries in general and mandibular fractures in particular.

Family-focused home care plan during a COVID 19 epidemic: A consensus statement by the PAFP task force on COVID 19

Initial Planning@#Statement 1: Develop a Family-focused Care Plan that contains tasks and activities related to the family structure, home environment and processes in order to mitigate the effect of the COVID-19 epidemic@*Adjustment in the Family Structure and Home Environment@#Statement 2: Identify a Family Caregiver who will remind the family to follow and implement the plan. Make sure this person is supported by all the members of the family. Statement 3: Identify a room or area that can be used for isolation in the event that a family member will be exposed to a diagnosed COVID-19 patient. Statement 4: Identify those who are at risk i.e. more than 60 years old, with existing chronic illness or other life-threatening condition and advice to take extra precaution. Statement 5: During the declared community quarantine period, all family members should stay at home, limit family celebrations, avoid home parties with outside guests, cancel travels as much as possible and be ready to have more members staying at home@*Performance of Routine Tasks and Activities @#Statement 6: Practice personal hygiene that includes regular and appropriate hand washing, daily bath, cough and sneezing etiquette, minimize hand contact with eyes, nose and mouth and strict personal use of eating utensils, bath towels, etc. Statement 7: Daily cleaning of frequently touched surface like doorknobs, light and appliance control switch, gadgets, armchairs and tabletops. Cleaning agents can be ordinary detergents and water or 70% alcohol@*What to Do When a Member is Exposed@#Statement 8: Advice an exposed family member to stay home and in the room or area allocated for isolation, wear mask and maintain at least 2 meters physical distance from the other family members. Make sure their clothing, personal belongings and other things that they usually hold is cleaned regularly and not touch by other members. Statement 9: Watch out and monitor for the appearance of symptoms like fever, colds and cough. If the person exposed is low risk and there is difficulty of breathing or worsening of symptoms, consult your family doctor. If the person is high risk i.e. elderly or with exiting chronic disease and symptoms appear, consult your family doctor right away. Call first before going to the clinic or hospital. Statement 10: If the symptoms are mild, continue home quarantine, take over-the-counter medications like paracetamol for fever, increase water intake and ensure adequate nutrition, sleep and rest. Other family members are encouraged to provide psychological and social support to an exposed and isolated member. Statement 11: Symptoms usually resolved within 14 days, after which home quarantine can be discontinued between 14-21 days. If symptoms persist beyond 14 days consult your family doctor for advice

Community-oriented health care during a COVID-19 epidemic: A consensus statement by the PAFP task force on COVID-19

Initial Planning@#Statement 1: A Community-oriented Health Care Plan that contains tasks and activities related to the community organization, environment, health care and social processes in order to mitigate the effect of the COVID-19 epidemic on the community should be developed. Statement 2: The plan should also include adjustments needed to continue the delivery of other health services i.e. maternal and child health, immunization, treatment of other communicable and non-communicable disease but with strict COVID-19 transmission precautions.@*Adjustment in the Community Organization and Environment@#Statement 3: A local task force should be organized to develop and implement the community health plan. The task force should be recognized and supported by the whole community. Statement 4: A facility in the barangay that can be used for isolation in case that a member will be diagnosed to have mild COVID-19. A hospital facility for referral of high-risk cases should also be identified and an emergency referral and transport plan should be established. Statement 5: All community health workers should wear appropriate personal protective equipment in the process of performing their community health work. Statement 6: Households in the community who have members at high-risk i.e. more than 60 years old, with existing chronic illness or other life-threatening condition should be identified and advised to take extra precautions i.e. personal hygiene, wearing mask and physical distancing. Statement 7: During the declared community quarantine period by the community or higher-level authority, all community members and household should be advised to stay at home, limit celebrations and community gatherings@*Performance of Routine Tasks and Activities@#Statement 8: A community-directed information, education and communication (IEC) plan should be developed and implemented for the following: a) Informing every household in the community on the basic and accurate information about COVID-19 and the community plan. b) Encouraging everyone to practice personal hygiene that includes regular and appropriate hand washing, daily bath, coughing and sneezing etiquette, wearing of mask, minimizing hand contact with eyes, nose and mouth and strict personal use of eating utensils, bath towels, etc. c) Encouraging everyone to clean everyday frequently touched surface like doorknobs, light and appliance control switch, gadgets, armchairs and tabletops. Cleaning agents can be ordinary detergents and water or 70% alcohol. d) Encouraging everyone to report and seek help to the community health worker if a household member is exposed and developed mild symptoms of COVID-19@*What to Do When a Member or Household is Exposed or Diagnosed COVID-19@#Statement 9: If there is a household whose member is exposed to a COVID-19, the person should be encouraged to stay home preferably in a room or area adequate for isolation, wear mask and maintain at least 2 meters physical distance from other family members. Statement 10: Other household members should be advised to watch out and monitor for the appearance of symptoms like fever, colds and cough. If the person is low risk but there is difficulty of breathing or worsening of symptoms or if the person is high risk i.e. elderly or with existing chronic disease and symptoms appear, they encouraged to inform the community health worker and facilitate the necessary referral and transport arrangement to the hospital. Call first before going. Statement 11: If the symptoms are mild, continue home isolation or in the isolation facility identified by the community, take over-thecounter medications like paracetamol for fever, increase water intake and ensure adequate nutrition, sleep and rest. Family members and community health workers are encouraged to provide psychological and social support to isolated patients. Discontinuation of isolation can be done if symptoms resolve within 14-21 days@*Epidemiology and Surveillance@#Statement 12: The municipal or city health office should be provided daily with a situation report of the implementation of communityoriented health care for COVID-19. Situation report should include: a) The number of exposed, number of diagnosed cases, number of mild cases, number of cases referred to the hospital and number of cases recovered or died in the community. b) Brief description of best practices

Primary care orientation of family practice in the Philippines: Cross-sectional study in pilot sites

Background@#Universal Health Care law calls for strong primary care where essential services are responsive to the health needs of individuals, families, and communities. Similar to other countries, family physicians are the biggest workforce in primary care, but little is known about the kind of care that they provide. This study aimed to determine the process of care rendered by family physicians in the country to assess their readiness in implementing the standards of primary care services according to the Universal Health Care law.@*Methods@#Cross-sectional survey using a questionnaire that includes 6 key elements of UHC was conducted to family physicians participating in the pilot project of the Philippine Academy of Family Physicians practice networks. Process of care is part of the big data collected in the survey. The process of care variables was analyzed using descriptive statistics.@*Results@#There were 195 family physicians who completed the survey. There were about 14.87% from Luzon, 18.46% from NCR, 27.18% from the Visayas, and 39.49% from Mindanao. Overall, the participants provide comprehensive, coordinated, and continuing care. Few utilized electronic medical records (9%). Preventive services provided are immunization (82.05%), alcohol and smoking cessation (77.44%), nutrition advice (76.92%), and exercise prescription (73.33%). @*Conclusion@#Family physicians in the pilot sites provide comprehensive, coordinated, and continuing care. The majority also offer common preventive services such as immunization, smoking cessation, nutrition advice, and exercise prescription. Some process needed for UHC needs improvement such as the use of EMR and quality assurance activities.